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Markus Knuf - One of the best experts on this subject based on the ideXlab platform.

  • immunization of preterm infants with gsk s hexavalent combined diphtheria tetanus acellular pertussis hepatitis b inactivated poliovirus haemophilus influenzae type b conjugate Vaccine a review of safety and immunogenicity
    Vaccine, 2018
    Co-Authors: Felix Omenaca, Liliana Vazquez, Narcisa Mesaros, Pilar Garciacorbeira, L Hanssens, Jan Dolhain, Ivonne Puente Gomez, Johannes G Liese, Markus Knuf
    Abstract:

    Abstract Background Infants with history of prematurity ( Methods Here we summarize 10 clinical studies and 15 years of post-marketing safety surveillance of GSK’s hexavalent Vaccine (DTPa-HBV-IPV/Hib), a combined diphtheria-tetanus-acellular-pertussis-hepatitis-B-inactivated-poliovirus-Haemophilus influenzae-type-b (Hib) conjugate Vaccine, when administered alone, or co-administered with pneumococcal conjugate, rotavirus, and meningococcal Vaccines and respiratory syncytial virus IgG to infants with history of prematurity/LBW in clinical trials. Results At least 92.5% of infants with history of prematurity/LBW as young as 24 weeks gestation in clinical studies were seropositive to all Vaccine antigens after 3-dose primary vaccination with GSK’s hexavalent DTPa-HBV-IPV/Hib Vaccine, with robust immune responses to booster vaccination. Seropositivity rates and antibody concentrations to hepatitis B and Hib appeared lower in infants with history of prematurity/LBW than term infants. Between 13–30% of medically stable infants with history of prematurity developed apnea after vaccination with GSK’s hexavalent DTPa-HBV-IPV/Hib Vaccine; usually after dose 1. The occurrence of post-immunization cardiorespiratory events appears to be influenced by the severity of any underlying neonatal condition. Most cardiorespiratory events resolve spontaneously or require minimal intervention. GSK’s hexavalent DTPa-HBV-IPV/Hib Vaccine was well tolerated in co-administration regimens. Conclusion GSK’s hexavalent DTPa-HBV-IPV/Hib Vaccine alone or co-administered with other pediatric Vaccines has a clinically acceptable safety and immunogenicity profile when used in infants with history of prematurity/LBW for primary and booster vaccination. Additional studies are needed in very premature and very LBW infants. However, currently available data support using GSK’s hexavalent DTPa-HBV-IPV/Hib Vaccine to immunize infants with history of prematurity/LBW according to chronological age.

  • two versus three doses of a meningococcal c conjugate Vaccine concomitantly administered with a hexavalent dtap ipv hbv Hib Vaccine in healthy infants
    Vaccine, 2008
    Co-Authors: Heinz-j. Schmitt, Katrin Steul, Astrid Borkowski, Francesca Ceddia, Ellen Ypma, Markus Knuf
    Abstract:

    The immunogenicity and reactogenicity of a meningococcal serogroup C (MenC) conjugate Vaccine given concomitantly with DTaP-IPV-HBV/Hib Vaccine according to a two- or three-dose schedule in healthy infants was evaluated. At 1 month post-vaccination, 98% (two doses) and 100% (three doses) of subjects had serum bactericidal antibody using human complement assay (hSBA) titres > or =1:8; at 12 months of age > or =89% of subjects in each group remained seroprotected. Induction of immunological memory, as evaluated by administration of a meningococcal serogroup A/C polysaccharide Vaccine challenge dose, was similar for both regimens and no interference was observed in the immune response to MenC or hepatitis B virus antigens. Reactogenicity was similar in each group. MenC conjugate Vaccine given concomitantly with DTaP-IPV-HBV/Hib to healthy infants in the first year of life using a two-dose schedule is as safe and immunogenic as a three-dose regimen.

  • Two versus three doses of a meningococcal C conjugate Vaccine concomitantly administered with a hexavalent DTaP-IPV-HBV/Hib Vaccine in healthy infants.
    Vaccine, 2008
    Co-Authors: Heinz-j. Schmitt, Katrin Steul, Astrid Borkowski, Francesca Ceddia, Ellen Ypma, Markus Knuf
    Abstract:

    The immunogenicity and reactogenicity of a meningococcal serogroup C (MenC) conjugate Vaccine given concomitantly with DTaP-IPV-HBV/Hib Vaccine according to a two- or three-dose schedule in healthy infants was evaluated. At 1 month post-vaccination, 98% (two doses) and 100% (three doses) of subjects had serum bactericidal antibody using human complement assay (hSBA) titres > or =1:8; at 12 months of age > or =89% of subjects in each group remained seroprotected. Induction of immunological memory, as evaluated by administration of a meningococcal serogroup A/C polysaccharide Vaccine challenge dose, was similar for both regimens and no interference was observed in the immune response to MenC or hepatitis B virus antigens. Reactogenicity was similar in each group. MenC conjugate Vaccine given concomitantly with DTaP-IPV-HBV/Hib to healthy infants in the first year of life using a two-dose schedule is as safe and immunogenic as a three-dose regimen.

  • Booster vaccination with hexavalent DTPa-HBV-IPV/Hib Vaccine in the second year of life is as safe as concomitant DTPa-IPV/Hib + HBV administered separately.
    Vaccine, 2005
    Co-Authors: Roland Herbert Saenger, Fred Zepp, Gudrun Maechler, M. Potreck, Markus Knuf, Pirmin Habermehl, Lode Schuerman
    Abstract:

    The safety and reactogenicity of a booster dose of GSK Biologicals’ hexavalent DTPa-HBV-IPV/Hib Vaccine (N = 4725) was compared with the separate administration of GSK Biologicals’ DTPa-IPV/Hib and HBV Vaccines (N = 4474) in two open, randomized multicenter studies (A and B). Solicited symptoms occurring within 4 days of vaccination were recorded on diary cards and serious adverse events (SAEs) were collected throughout the study period. In Study A (N = 1149), incidences of solicited symptoms were similar in both groups; there were no SAEs either reported within 4 days of vaccination or considered to be causally related to vaccination. In study B (N = 8050), where fever was the only solicited symptom, rectal temperature ≥39.5 °C was observed in 2.5% and 2.8% of the subjects, respectively. Fever ≥40.0 °C was rare (0.6%), and only two cases of febrile convulsions were recorded during the 4 days following vaccination both in the control group. Large swelling reactions (defined as local injection site swelling with diameter >50 mm, noticeable diffuse injection site swelling or noticeable increased circumference of the injected limb) were reported following 2.3% of the booster Vaccine doses, regardless of the Vaccine used. Extensive swelling reactions involving an adjacent joint were reported in 0.1% of the subjects. Two SAEs, both reported after booster doses of DTPa-IPV/Hib and HBV Vaccines administered separately, were considered by the investigators to be related to vaccination. Both resolved completely without sequelae. The hexavalent DTPa-HBV-IPV/Hib Vaccine and the DTPa-IPV/Hib and HBV Vaccines administered separately have similar good reactogenicity and safety profiles when given as booster doses in the second year of life.

  • booster vaccination with hexavalent dtpa hbv ipv Hib Vaccine in the second year of life is as safe as concomitant dtpa ipv Hib hbv administered separately
    Vaccine, 2005
    Co-Authors: Roland Herbert Saenger, Fred Zepp, Gudrun Maechler, M. Potreck, Markus Knuf, Pirmin Habermehl, Lode Schuerman
    Abstract:

    The safety and reactogenicity of a booster dose of GSK Biologicals’ hexavalent DTPa-HBV-IPV/Hib Vaccine (N = 4725) was compared with the separate administration of GSK Biologicals’ DTPa-IPV/Hib and HBV Vaccines (N = 4474) in two open, randomized multicenter studies (A and B). Solicited symptoms occurring within 4 days of vaccination were recorded on diary cards and serious adverse events (SAEs) were collected throughout the study period. In Study A (N = 1149), incidences of solicited symptoms were similar in both groups; there were no SAEs either reported within 4 days of vaccination or considered to be causally related to vaccination. In study B (N = 8050), where fever was the only solicited symptom, rectal temperature ≥39.5 °C was observed in 2.5% and 2.8% of the subjects, respectively. Fever ≥40.0 °C was rare (0.6%), and only two cases of febrile convulsions were recorded during the 4 days following vaccination both in the control group. Large swelling reactions (defined as local injection site swelling with diameter >50 mm, noticeable diffuse injection site swelling or noticeable increased circumference of the injected limb) were reported following 2.3% of the booster Vaccine doses, regardless of the Vaccine used. Extensive swelling reactions involving an adjacent joint were reported in 0.1% of the subjects. Two SAEs, both reported after booster doses of DTPa-IPV/Hib and HBV Vaccines administered separately, were considered by the investigators to be related to vaccination. Both resolved completely without sequelae. The hexavalent DTPa-HBV-IPV/Hib Vaccine and the DTPa-IPV/Hib and HBV Vaccines administered separately have similar good reactogenicity and safety profiles when given as booster doses in the second year of life.

Htay Htay Han - One of the best experts on this subject based on the ideXlab platform.

  • safety and reactogenicity of the combined diphtheria tetanus acellular pertussis inactivated poliovirus haemophilus influenzae type b dtpa ipv Hib Vaccine in healthy vietnamese toddlers an open label phase iii study
    Human Vaccines & Immunotherapeutics, 2016
    Co-Authors: Dang Duc Anh, Olivier Van Der Meeren, Naveen Karkada, Deepak Assudani, Htay Htay Han
    Abstract:

    The introduction of combination Vaccines plays a significant role in increasing Vaccine acceptance and widening Vaccine coverage. Primary vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b (Hib) diseases has been implemented in Vietnam. In this study we evaluated the safety and reactogenicity of combined diphtheria-tetanus-pertussis-inactivated polio (DTPa-IPV)/Hib Vaccine when administered as a booster dose in 300 healthy Vietnamese children <2 years of age (mean age: 15.8 months). During the 4-day follow-up period, pain (31.7%) and redness (27.3%) were the most frequent solicited local symptoms. Pain (2%) was also the most frequent grade 3 local symptom. One subject reported 2 serious adverse events that were not causally related to the study Vaccine. DTPa-IPV/Hib conjugate Vaccine was well tolerated as a booster dose in healthy Vietnamese children aged <2 years.

  • Safety and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) Vaccine in healthy Vietnamese toddlers: An open-label, phase III study.
    Human vaccines & immunotherapeutics, 2015
    Co-Authors: Dang Duc Anh, Olivier Van Der Meeren, Naveen Karkada, Deepak Assudani, Htay Htay Han
    Abstract:

    The introduction of combination Vaccines plays a significant role in increasing Vaccine acceptance and widening Vaccine coverage. Primary vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b (Hib) diseases has been implemented in Vietnam. In this study we evaluated the safety and reactogenicity of combined diphtheria-tetanus-pertussis-inactivated polio (DTPa-IPV)/Hib Vaccine when administered as a booster dose in 300 healthy Vietnamese children

  • A new DTPw-HBV/Hib Vaccine: immune memory after primary vaccination and booster dosing in the second year of life.
    Human vaccines, 2007
    Co-Authors: Salvacion Gatchalian, Marietta Reyes, Nancy Bermal, Vijayalakshmi Chandrasekaran, Htay Htay Han, Hans L. Bock, Inge Lefevre
    Abstract:

    The response to booster vaccination at 15-18 months of age and the presence of immune memory in 10-month old children, primed with a new combined diphtheria-tetanus-hepatitis B-whole cell pertussis Vaccine extemporaneously mixed with Haemophilus influenzae type b-tetanus toxoid conjugate (DTPw-HBV/Hib) from new antigen sources and containing 2.5 microg polyribosyl-ribitol-phosphate (PRP) was assessed. Primary vaccination with the new DTPw-HBV/Hib Vaccine was immunogenic and of comparable tolerability to commercially available Tritanrix HepB/Hiberix. Children were boosted with DTPw-HBV, DTPw-HBV/Hib or separate DTPw-HBV+Hiberix. Immune memory was assessed through administration of 10 microg PRP polysaccharide. Anti-PRP antibody GMCs increased substantially after the challenge in DTPw-HBV/Hib-primed subjects indicating the presence of immune memory. One month after the booster dose, 100% of subjects had seroprotective antibody concentrations against PRP, diphtheria and tetanus, >95% were seroprotected against hepatitis B, > or =94.0% had a pertussis booster response. Substantial increases in antibody GMCs against all antigens were observed. Swelling >20 mm was the most common Grade 3 solicited symptom reported (up to 26.0% of subjects). Fever >39.5 degrees C was uncommon (>2.5%). Eleven large swelling reactions were reported; none involved an adjacent joint. One serious adverse event occurred that was considered unrelated to vaccination. This new DTPw-HBV/Hib Vaccine with new Vaccine components and 2.5 microg PRP induced effective priming against Hib evidenced by a vigorous anamnestic response on exposure to PRP polysaccharide. The booster dose was immunogenic and the safety profile was acceptable. Combined DTPw-HBV and DTPw-HBV/Hib Vaccines using new Vaccine antigen sources will promote continued supply of combined DTPw-based Vaccines to global mass vaccination campaigns.

  • a new dtpw hbv Hib Vaccine is immunogenic and safe when administered according to the epi expanded programme for immunization schedule and following hepatitis b vaccination at birth
    Human Vaccines, 2005
    Co-Authors: Salvacion Gatchalian, Marie-pierre David, Marietta Reyes, Htay Htay Han, Hans L. Bock, Inge Lefevre, Nancy Bernal, Joanne Wolter, Lode Schuerman
    Abstract:

    New combination Vaccines and reliable sources of Vaccine components are essential to ensure the success of mass immunisation programmes in the 21st century. We evaluated a new combined diphtheria-tetanus-whole-cell-pertussis-hepatitis B Vaccine, extemporaneously mixed with a Haemophilus influenzae type b conjugate Vaccine (DTPw-HBV/Hib) containing 2.5 microg PRP in 913 Philippino infants, administered according to the EPI schedule at 6, 10 and 14 weeks of age after a birth dose of hepatitis B Vaccine (HBV; trial DTPw-HBV/Hib-001). One month after the third dose of DTPw-HBV/Hib (N = 182), 99.4% and 94.2% of subjects had anti-PRP antibody levels > or =0.15 microg/mL and > or =1.0 microg/mL, respectively. In addition, 95.9%, 100.0% and 87.6% of subjects had seroprotective antibody concentrations against diphtheria, tetanus and hepatitis B, respectively. The seroprotection rate to hepatitis B increased significantly to 94.3% in subjects who received a dose of HBV at birth. The pertussis Vaccine response rate was > or =95%. Seroprotection/Vaccine response rates to all antigens after DTPw-HBV/Hib were at least as good as those observed after vaccination with GSK Biologicals' licensed Tritanrix HepB/Hiberix (containing 10 microg PRP) which was used as comparator. Although redness >20 mm in diameter and fever > or = 37.5 degrees C (axillary route) occurred more often after the new DTPw-HBV/Hib Vaccine (p < 0.05), other Grade 3 adverse events occurred similarly between the groups. The new DTPw-HBV/Hib Vaccine was as immunogenic and well tolerated as the licensed control Vaccine when administered according to the immunologically challenging EPI schedule. A birth dose of HBV is important to maximize protection against hepatitis B in endemic regions where the EPI schedule is in place.

  • A New DTPw-HBV/Hib Vaccine is Immunogenic and Safe when Administered According to the EPI (Expanded Programme for Immunization) Schedule and Following Hepatitis B Vaccination at Birth
    Human vaccines, 2005
    Co-Authors: Salvacion Gatchalian, Marie-pierre David, Marietta Reyes, Htay Htay Han, Hans L. Bock, Inge Lefevre, Nancy Bernal, Joanne Wolter, Lode Schuerman
    Abstract:

    New combination Vaccines and reliable sources of Vaccine components are essential to ensure the success of mass immunisation programmes in the 21st century. We evaluated a new combined diphtheria-tetanus-whole-cell-pertussis-hepatitis B Vaccine, extemporaneously mixed with a Haemophilus influenzae type b conjugate Vaccine (DTPw-HBV/Hib) containing 2.5 microg PRP in 913 Philippino infants, administered according to the EPI schedule at 6, 10 and 14 weeks of age after a birth dose of hepatitis B Vaccine (HBV; trial DTPw-HBV/Hib-001). One month after the third dose of DTPw-HBV/Hib (N = 182), 99.4% and 94.2% of subjects had anti-PRP antibody levels > or =0.15 microg/mL and > or =1.0 microg/mL, respectively. In addition, 95.9%, 100.0% and 87.6% of subjects had seroprotective antibody concentrations against diphtheria, tetanus and hepatitis B, respectively. The seroprotection rate to hepatitis B increased significantly to 94.3% in subjects who received a dose of HBV at birth. The pertussis Vaccine response rate was > or =95%. Seroprotection/Vaccine response rates to all antigens after DTPw-HBV/Hib were at least as good as those observed after vaccination with GSK Biologicals' licensed Tritanrix HepB/Hiberix (containing 10 microg PRP) which was used as comparator. Although redness >20 mm in diameter and fever > or = 37.5 degrees C (axillary route) occurred more often after the new DTPw-HBV/Hib Vaccine (p < 0.05), other Grade 3 adverse events occurred similarly between the groups. The new DTPw-HBV/Hib Vaccine was as immunogenic and well tolerated as the licensed control Vaccine when administered according to the immunologically challenging EPI schedule. A birth dose of HBV is important to maximize protection against hepatitis B in endemic regions where the EPI schedule is in place.

Lode Schuerman - One of the best experts on this subject based on the ideXlab platform.

  • immunogenicity and reactogenicity of dtpa hbv ipv Hib Vaccine as primary and booster vaccination in low birth weight premature infants
    Acta Paediatrica, 2008
    Co-Authors: Liliana Vazquez, Fabiana Garcia, Ricardo Rüttimann, Gustavo Coconier, Jeanne-marie Jacquet, Lode Schuerman
    Abstract:

    The aim was to assess suitability of a combined DTPa-HBV-IPV/Hib Vaccine (Infanrix hexa) for immunization of low-birth-weight (less than 2.0 kg) preterm infants with particular focus on the hepatitis B response. Open-label study in 170 preterm infants receiving primary vaccination at 2 4 and 6 months of age and booster vaccination at 18-24 months. Enrolment and analysis were stratified in two groups: infants with birth weight between 1.5 kg and 2.0 kg (low birth weight: LBW) infants with BW less than 1.5 kg (very low birth weight: VLBW). One month after the three dose primary vaccination 93.7% and 94.9% of infants in VLBW and LBW groups respectively had anti-HBs antibody concentrations greater than or equal to 10 mIU/mL. High seroprotection and response rates (92.4-100%) to all Vaccine antigens were observed. Those were reinforced (greater than 98%) by booster vaccination for all antigens except for HBs in VLBW children: only 88.7% of those had anti-HBs antibody concentrations greater than or equal to 10 mIU/mL compared with 96.5% of LBW children (difference statistically not significant). The Vaccine was well tolerated in both groups of infants. Preterm infants will benefit by the administration of a primary and booster vaccination with DTPa-HBV-IPV/Hib Vaccine. (authors)

  • Immunogenicity and reactogenicity of DTPa-HBV-IPV/Hib Vaccine as primary and booster vaccination in low-birth-weight premature infants
    Acta paediatrica (Oslo Norway : 1992), 2008
    Co-Authors: Liliana N. Vazquez, Fabiana Garcia, Ricardo Rüttimann, Gustavo Coconier, Jeanne-marie Jacquet, Lode Schuerman
    Abstract:

    The aim was to assess suitability of a combined DTPa-HBV-IPV/Hib Vaccine (Infanrix hexa) for immunization of low-birth-weight (less than 2.0 kg) preterm infants with particular focus on the hepatitis B response. Open-label study in 170 preterm infants receiving primary vaccination at 2 4 and 6 months of age and booster vaccination at 18-24 months. Enrolment and analysis were stratified in two groups: infants with birth weight between 1.5 kg and 2.0 kg (low birth weight: LBW) infants with BW less than 1.5 kg (very low birth weight: VLBW). One month after the three dose primary vaccination 93.7% and 94.9% of infants in VLBW and LBW groups respectively had anti-HBs antibody concentrations greater than or equal to 10 mIU/mL. High seroprotection and response rates (92.4-100%) to all Vaccine antigens were observed. Those were reinforced (greater than 98%) by booster vaccination for all antigens except for HBs in VLBW children: only 88.7% of those had anti-HBs antibody concentrations greater than or equal to 10 mIU/mL compared with 96.5% of LBW children (difference statistically not significant). The Vaccine was well tolerated in both groups of infants. Preterm infants will benefit by the administration of a primary and booster vaccination with DTPa-HBV-IPV/Hib Vaccine. (authors)

  • a new dtpw hbv Hib Vaccine is immunogenic and safe when administered according to the epi expanded programme for immunization schedule and following hepatitis b vaccination at birth
    Human Vaccines, 2005
    Co-Authors: Salvacion Gatchalian, Marie-pierre David, Marietta Reyes, Htay Htay Han, Hans L. Bock, Inge Lefevre, Nancy Bernal, Joanne Wolter, Lode Schuerman
    Abstract:

    New combination Vaccines and reliable sources of Vaccine components are essential to ensure the success of mass immunisation programmes in the 21st century. We evaluated a new combined diphtheria-tetanus-whole-cell-pertussis-hepatitis B Vaccine, extemporaneously mixed with a Haemophilus influenzae type b conjugate Vaccine (DTPw-HBV/Hib) containing 2.5 microg PRP in 913 Philippino infants, administered according to the EPI schedule at 6, 10 and 14 weeks of age after a birth dose of hepatitis B Vaccine (HBV; trial DTPw-HBV/Hib-001). One month after the third dose of DTPw-HBV/Hib (N = 182), 99.4% and 94.2% of subjects had anti-PRP antibody levels > or =0.15 microg/mL and > or =1.0 microg/mL, respectively. In addition, 95.9%, 100.0% and 87.6% of subjects had seroprotective antibody concentrations against diphtheria, tetanus and hepatitis B, respectively. The seroprotection rate to hepatitis B increased significantly to 94.3% in subjects who received a dose of HBV at birth. The pertussis Vaccine response rate was > or =95%. Seroprotection/Vaccine response rates to all antigens after DTPw-HBV/Hib were at least as good as those observed after vaccination with GSK Biologicals' licensed Tritanrix HepB/Hiberix (containing 10 microg PRP) which was used as comparator. Although redness >20 mm in diameter and fever > or = 37.5 degrees C (axillary route) occurred more often after the new DTPw-HBV/Hib Vaccine (p < 0.05), other Grade 3 adverse events occurred similarly between the groups. The new DTPw-HBV/Hib Vaccine was as immunogenic and well tolerated as the licensed control Vaccine when administered according to the immunologically challenging EPI schedule. A birth dose of HBV is important to maximize protection against hepatitis B in endemic regions where the EPI schedule is in place.

  • A New DTPw-HBV/Hib Vaccine is Immunogenic and Safe when Administered According to the EPI (Expanded Programme for Immunization) Schedule and Following Hepatitis B Vaccination at Birth
    Human vaccines, 2005
    Co-Authors: Salvacion Gatchalian, Marie-pierre David, Marietta Reyes, Htay Htay Han, Hans L. Bock, Inge Lefevre, Nancy Bernal, Joanne Wolter, Lode Schuerman
    Abstract:

    New combination Vaccines and reliable sources of Vaccine components are essential to ensure the success of mass immunisation programmes in the 21st century. We evaluated a new combined diphtheria-tetanus-whole-cell-pertussis-hepatitis B Vaccine, extemporaneously mixed with a Haemophilus influenzae type b conjugate Vaccine (DTPw-HBV/Hib) containing 2.5 microg PRP in 913 Philippino infants, administered according to the EPI schedule at 6, 10 and 14 weeks of age after a birth dose of hepatitis B Vaccine (HBV; trial DTPw-HBV/Hib-001). One month after the third dose of DTPw-HBV/Hib (N = 182), 99.4% and 94.2% of subjects had anti-PRP antibody levels > or =0.15 microg/mL and > or =1.0 microg/mL, respectively. In addition, 95.9%, 100.0% and 87.6% of subjects had seroprotective antibody concentrations against diphtheria, tetanus and hepatitis B, respectively. The seroprotection rate to hepatitis B increased significantly to 94.3% in subjects who received a dose of HBV at birth. The pertussis Vaccine response rate was > or =95%. Seroprotection/Vaccine response rates to all antigens after DTPw-HBV/Hib were at least as good as those observed after vaccination with GSK Biologicals' licensed Tritanrix HepB/Hiberix (containing 10 microg PRP) which was used as comparator. Although redness >20 mm in diameter and fever > or = 37.5 degrees C (axillary route) occurred more often after the new DTPw-HBV/Hib Vaccine (p < 0.05), other Grade 3 adverse events occurred similarly between the groups. The new DTPw-HBV/Hib Vaccine was as immunogenic and well tolerated as the licensed control Vaccine when administered according to the immunologically challenging EPI schedule. A birth dose of HBV is important to maximize protection against hepatitis B in endemic regions where the EPI schedule is in place.

  • Booster vaccination with hexavalent DTPa-HBV-IPV/Hib Vaccine in the second year of life is as safe as concomitant DTPa-IPV/Hib + HBV administered separately.
    Vaccine, 2005
    Co-Authors: Roland Herbert Saenger, Fred Zepp, Gudrun Maechler, M. Potreck, Markus Knuf, Pirmin Habermehl, Lode Schuerman
    Abstract:

    The safety and reactogenicity of a booster dose of GSK Biologicals’ hexavalent DTPa-HBV-IPV/Hib Vaccine (N = 4725) was compared with the separate administration of GSK Biologicals’ DTPa-IPV/Hib and HBV Vaccines (N = 4474) in two open, randomized multicenter studies (A and B). Solicited symptoms occurring within 4 days of vaccination were recorded on diary cards and serious adverse events (SAEs) were collected throughout the study period. In Study A (N = 1149), incidences of solicited symptoms were similar in both groups; there were no SAEs either reported within 4 days of vaccination or considered to be causally related to vaccination. In study B (N = 8050), where fever was the only solicited symptom, rectal temperature ≥39.5 °C was observed in 2.5% and 2.8% of the subjects, respectively. Fever ≥40.0 °C was rare (0.6%), and only two cases of febrile convulsions were recorded during the 4 days following vaccination both in the control group. Large swelling reactions (defined as local injection site swelling with diameter >50 mm, noticeable diffuse injection site swelling or noticeable increased circumference of the injected limb) were reported following 2.3% of the booster Vaccine doses, regardless of the Vaccine used. Extensive swelling reactions involving an adjacent joint were reported in 0.1% of the subjects. Two SAEs, both reported after booster doses of DTPa-IPV/Hib and HBV Vaccines administered separately, were considered by the investigators to be related to vaccination. Both resolved completely without sequelae. The hexavalent DTPa-HBV-IPV/Hib Vaccine and the DTPa-IPV/Hib and HBV Vaccines administered separately have similar good reactogenicity and safety profiles when given as booster doses in the second year of life.

Paul Willems - One of the best experts on this subject based on the ideXlab platform.

  • Immunologic response to Hib tetanus toxoid conjugated Vaccine coadministered with DTPa either mixed or in two separate injections in toddlers not primed with Hib Vaccine.
    Human vaccines, 2007
    Co-Authors: Sirli Meriste, Paul Willems, Jeanne-marie Jacquet, Irja Lutsar
    Abstract:

    This open randomized study compared the immunogenicity and safety of a diphtheria-tetanus-acellular pertussis (DTPa) and H. influenzae polyribosylribitol phosphate conjugated to the tetanus toxoid (Hib-PRP-T) Vaccine (mixed prior to administration) with separate injections of DTPa and Hib Vaccines in toddlers aged two years. A total of 119 children (60 mixed; 59 separate administration), primed with DTPw, but not with Hib Vaccine were enrolled. Prior to immunization only 10.3% of toddlers had anti-PRP antibody titres > or =1.0 microg/ml, compared with all children on Days 7 and 30. The anti-PRP and anti-tetanus antibody geometric mean concentrations were lower after the combined DTPa/Hib Vaccine compared to separately administered Vaccines (47.16 microg/ml vs 78.36 microg/ml and 24.95 IU/ml vs 40.63 IU/ml, respectively). One month after vaccination all children had anti-tetanus and anti-diphtheria antibody titres above the protective level of > or =0.1 IU/ml. The rates of recorded adverse events were similar and mostly mild or moderate in intensity whether the Vaccines were combined as a single injection or given separately. We conclude that in 2-year old children, previously not immunized against Hib, a single dose of DTPa and Hib was safe and highly immunogenic irrespective of whether it was given as a combined Vaccine or separate injections. Although the increase in anti-T and early (7-10 days after) anti-PRP concentrations was greater when the Vaccine components were given separately than after combined administration, the DTPa/Hib combined Vaccine would provide an effective method of delivering primary Hib vaccination in unprimed toddlers.

  • immunogenicity and safety of a tetravalent measles mumps rubella varicella Vaccine co administered with a booster dose of a combined diphtheria tetanus acellular pertussis hepatitis b inactivated poliovirus haemophilus influenzae type b conjugate vac
    European Journal of Pediatrics, 2007
    Co-Authors: Fred Zepp, Ulrich Behre, Dominique Descamps, Klaus Kindler, Karl-heinz Laakmann, Heidemarie Pankow-culot, Wilma Mannhardt-laakmann, François Beckers, Paul Willems
    Abstract:

    This study was undertaken to assess the co-administration of an experimental measles-mumps-rubella-varicella Vaccine (MMRV, GlaxoSmithKline Biologicals) with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate (DTPa-HBV-IPV/Hib) Vaccine in healthy children. Healthy children aged 12–23 months (N = 451) were randomised to one of three parallel groups to receive one dose of MMRV Vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib Vaccine (co-administration group), or one dose of MMRV Vaccine alone (MMRV group), or a booster dose of DTPa-HBV-IPV/Hib Vaccine alone (DTPa-HBV-IPV/Hib group). No differences in seroconversion rates for measles (>95%), mumps (>80%), rubella (>99%) and varicella (>98%) were seen between the co-administration group and the MMRV group. No differences in geometric mean titres (GMTs) were observed between the two groups with the exception of anti-measles titres, which were observed to be higher in the MMRV group than in the co-administration group (4,419.2 vs. 3,441.8 mIU/ml respectively). Immune response to the booster dose of DTPa-HBV-IPV/Hib Vaccine was observed to be similar in the co-administration group and the DTPa-HBV-IPV/Hib group. Co-administration of the MMRV Vaccine with a booster dose of DTPa-HBV-IPV/Hib Vaccine was well-tolerated and did not exacerbate the reactogenicity profile of either Vaccine. In summary, GlaxoSmithKline Biologicals’ experimental MMRV Vaccine was immunogenic and well-tolerated when administered with a booster dose of DTPa-HBV-IPV/Hib Vaccine during the second year of life. The ability to co-administer the MMRV Vaccine at the same time as other routine childhood immunisation Vaccines could increase compliance with varicella vaccination in countries where this Vaccine is already recommended and may facilitate implementation of varicella vaccination elsewhere.

  • immunogenicity and reactogenicity of a novel hexavalent dtpa hbv ipv Hib Vaccine compared to separate concomitant injections of dtpa ipv Hib and hbv Vaccines when administered according to a 3 5 and 11 month vaccination schedule
    European Journal of Pediatrics, 2002
    Co-Authors: Maria Avdicova, Viktor Prikazský, Henrieta Hudeckova, Lode Schuerman, Paul Willems
    Abstract:

    In an open randomised trial, 312 eligible infants were enrolled to receive either a single injection of the hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/Haemophilus influenzae b (DTPa-HBV-IPV/Hib) Vaccine, or concomitant injections of commercial DTPa-IPV/Hib and HBV Vaccines (comparator). Vaccines were administered at 3, 5 and 11 months of age. The statistical approach for non-inferiority showed that the DTPa-HBV-IPV/Hib Vaccine was at least as immunogenic as the comparator Vaccines in terms of immunogenicity of all antigens 1 month after the 2nd dose. Non-inferiority criteria were also met immediately before and 1 month after the 3rd dose for all antigens except poliovirus type 3 prior to the 3rd dose. The majority of subjects were seroprotected against diphtheria, tetanus, polyribosyl-ribitol-phosphate, hepatitis B and poliovirus after the 2nd dose and maintained seroprotective antibody levels until the 3rd dose. A marked difference was observed in anti-HBs antibody geometric mean antibody concentrations (GMCs) at 1 month after the 2nd dose (higher GMCs in DTPa-HBV-IPV/Hib group). Reactogenicity (incidence of solicited local and general symptoms) was similar between the two study groups and no Vaccine-related serious adverse events occurred. Conclusion: the new diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/Haemophilus influenzae b Vaccine administered at 3, 5 and 11 months of age was safe and at least as immunogenic as the comparator Vaccines thus providing an effective and more comfortable option for this infant vaccination schedule.

  • Immunogenicity and reactogenicity of a novel hexavalent DTPa-HBV-IPV/Hib Vaccine compared to separate concomitant injections of DTPa-IPV/Hib and HBV Vaccines, when administered according to a 3, 5 and 11 month vaccination schedule
    European journal of pediatrics, 2002
    Co-Authors: Maria Avdicova, Viktor Prikazský, Henrieta Hudeckova, Lode Schuerman, Paul Willems
    Abstract:

    In an open randomised trial, 312 eligible infants were enrolled to receive either a single injection of the hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/Haemophilus influenzae b (DTPa-HBV-IPV/Hib) Vaccine, or concomitant injections of commercial DTPa-IPV/Hib and HBV Vaccines (comparator). Vaccines were administered at 3, 5 and 11 months of age. The statistical approach for non-inferiority showed that the DTPa-HBV-IPV/Hib Vaccine was at least as immunogenic as the comparator Vaccines in terms of immunogenicity of all antigens 1 month after the 2nd dose. Non-inferiority criteria were also met immediately before and 1 month after the 3rd dose for all antigens except poliovirus type 3 prior to the 3rd dose. The majority of subjects were seroprotected against diphtheria, tetanus, polyribosyl-ribitol-phosphate, hepatitis B and poliovirus after the 2nd dose and maintained seroprotective antibody levels until the 3rd dose. A marked difference was observed in anti-HBs antibody geometric mean antibody concentrations (GMCs) at 1 month after the 2nd dose (higher GMCs in DTPa-HBV-IPV/Hib group). Reactogenicity (incidence of solicited local and general symptoms) was similar between the two study groups and no Vaccine-related serious adverse events occurred. Conclusion: the new diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/Haemophilus influenzae b Vaccine administered at 3, 5 and 11 months of age was safe and at least as immunogenic as the comparator Vaccines thus providing an effective and more comfortable option for this infant vaccination schedule.

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  • A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP–HepB–Hib Vaccine in indian infants
    Human vaccines & immunotherapeutics, 2013
    Co-Authors: Adarsh Eregowda, Sanjay Lalwani, Sukanta Chatterjee, Hoshang Vakil, Khaleel Ahmed, Marco Costantini, Maria Lattanzi
    Abstract:

    Compliance with recommended vaccinations for Indian infants is facilitated by using combination Vaccines to minimize the number of required injections. The ready-to-use, preservative free, fully-liquid combination DTwP–HepB–Hib Vaccine, Quinvaxem®, offers convenience of administering five important Vaccine antigens to infants in a single injection. This phase III, single-arm, multicenter study was designed to assess immunogenicity and safety of three doses of Quinvaxem® to Indian infants administered at 6, 10, and 14 weeks of age. Blood samples were taken prior to the first dose and at one month post last vaccination. Infants were observed clinically for any reaction approximately 30 min following each vaccination, and parents completed subject diaries for solicited local, systemic and any adverse events (AEs) following over a 5 d period. DTwP–HepB–Hib Vaccine elicited strong immune responses that exceeded seroprotection/seroconversion thresholds against all Vaccine antigens. At one month after third vacc...

  • a phase iii single arm multicenter open label study to assess the immunogenicity and tolerability of a pentavalent dtwp hepb Hib Vaccine in indian infants
    Human Vaccines & Immunotherapeutics, 2013
    Co-Authors: Adarsh Eregowda, Sanjay Lalwani, Sukanta Chatterjee, Hoshang Vakil, Khaleel Ahmed, Marco Costantini, Maria Lattanzi
    Abstract:

    Compliance with recommended vaccinations for Indian infants is facilitated by using combination Vaccines to minimize the number of required injections. The ready-to-use, preservative free, fully-liquid combination DTwP–HepB–Hib Vaccine, Quinvaxem®, offers convenience of administering five important Vaccine antigens to infants in a single injection. This phase III, single-arm, multicenter study was designed to assess immunogenicity and safety of three doses of Quinvaxem® to Indian infants administered at 6, 10, and 14 weeks of age. Blood samples were taken prior to the first dose and at one month post last vaccination. Infants were observed clinically for any reaction approximately 30 min following each vaccination, and parents completed subject diaries for solicited local, systemic and any adverse events (AEs) following over a 5 d period. DTwP–HepB–Hib Vaccine elicited strong immune responses that exceeded seroprotection/seroconversion thresholds against all Vaccine antigens. At one month after third vacc...