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

  • Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella Vaccine in healthy children.
    European journal of pediatrics, 2011
    Co-Authors: Markus Knuf, Klaus F. Helm, Martine Douha, Fred Zepp, Albrecht Prieler, Hartwig Maurer, Dorothee Kieninger-baum, Paul Willems
    Abstract:

    Two doses of a varicella-containing Vaccine in healthy children <12 years are suggested to induce better protection than a single dose. Persistence of immunity against measles, mumps, rubella, and varicella as well as varicella breakthrough cases were assessed 3 years after two-dose measles, mumps, rubella, and varicella (MMRV) vaccination or concomitant MMR (Priorix™) and varicella (Varilrix™) vaccination. Four hundred ninety-four healthy children, 12-18 months old at the time of the first dose, received either two doses of MMRV Vaccine (GlaxoSmithKline Biologicals) 42-56 days apart (MMRV, N = 371) or one dose of MMR and varicella Vaccines administered simultaneously at separate sites, followed by another MMR vaccination 42-56 days later (MMR + V, N = 123). Three hundred-four subjects participated in 3-year follow-up for persistence of immunity and occurrence of breakthrough varicella (MMRV, N = 225; MMR + V, N = 79). Antibodies were measured by ELISA (measles, mumps, rubella) and immunofluorescence (varicella). Contacts with individuals with varicella or zoster and cases of breakthrough varicella disease were recorded. Three years post-vaccination seropositivity rates in subjects seronegative before vaccination were: MMRV-measles, 98.5% (geometric mean titer [GMT] = 3,599.6); mumps, 97.4% (GMT = 1,754.5); rubella, 100% (GMT = 51.9); varicella, 99.4% (GMT = 225.5); MMR + V-measles, 97.0% (GMT = 1,818.8); mumps, 93.8% (GMT = 1,454.6); rubella, 100% (GMT = 53.8); and varicella, 96.8% (GMT = 105.8). Of the subjects, 15-20% reported contact with individuals with varicella/zoster each year. After 3 years, the cumulative varicella breakthrough disease rate was 0.7% (two cases) in the MMRV group and 5.4% (five cases) in the MMR + V group. Immunogenicity of the combined MMRV Vaccine was sustained 3 years post-vaccination. (208136/041/NCT00406211).

  • Immunogenicity and safety of a measles–mumps–rubella–varicella Vaccine following a 4-week or a 12-month interval between two doses
    Vaccine, 2011
    Co-Authors: H.c. Rumke, Klaus F. Helm, Martine Douha, Hp Loch, Karel Hoppenbrouwers, Corinne Vandermeulen, Anne Malfroot, Paul Willems
    Abstract:

    Abstract Background The MMRV combination Vaccine, Priorix-Tetra ™, is currently licensed in several European countries using a two-dose schedule in infants aged ≥9 months, with a preferred 6-week to 3-month interval between doses. This study was undertaken to generate safety and immunogenicity data for two doses of MMRV Vaccine administered according to dose schedules using the shortest permitted interval of 4 weeks versus a longer interval of 12 months, which would allow flexible adaptation to local immunization calendars. Methods Healthy children aged 11–13 months were randomized (1:1:1) to receive 2 doses of either: MMRV Vaccine with a 4-week interval between doses (MMRV-4W group, N  = 188), MMRV Vaccine with a 12-month interval between doses (MMRV-12M group, N  = 184), or MMR Vaccine with a 4-week interval between doses (MMR group, N  = 187). Blood samples were taken prior to, and 4–6 weeks after each vaccination. Results Post-Dose 2, both MMRV groups exhibited an adequate immunogenic response for all components; however the MMRV-12M group showed significantly greater geometric mean titers for mumps, rubella and varicella. Two varicella breakthrough cases occurred within the 12-month interval between doses in the MMRV-12M group. Local and general reactogenicity results were similar for all groups except for the MMRV-4W group, which had a greater incidence of fever during Days 0–14 post-Dose 1. Conclusions Two doses of MMRV Vaccine administered in the second year of life elicited adequate immunogenicity and were well-tolerated whether administered with a dose interval of 4 weeks or 12 months.

  • Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella Vaccine to children aged 11–21 months
    European Journal of Pediatrics, 2010
    Co-Authors: Markus Knuf, Ulrich Behre, Fred Zepp, Paul Willems, Pirmin Habermehl, Lothar Maurer, Claudius U. Meyer, Hanns-michael Burow, Michel Janssens, Helmtrud Bisanz
    Abstract:

    This study compared intramuscular and subcutaneous administration of two doses of measles–mumps–rubella–varicella (MMRV) combination Vaccine ( Priorix-Tetra ™, GlaxoSmithKline Biologicals) in children. Healthy children ( N  = 328) were randomised to receive MMRV either intramuscularly or subcutaneously. Reactogenicity was similar between treatment groups for immediate vaccination pain, vaccination site pain, redness and incidence of fever and rashes. Slightly less vaccination site swelling occurred during days 0–3 of the post-vaccination period after intramuscular administration. Seroconversion rates for all components, 42–56 days post-dose 2, ranged from 99.3% to 100% in the intramuscular group and from 98.6% to 100% in the subcutaneous. Cell-mediated immunity data supported the humoral immunogenicity findings. In summary, the MMRV Vaccine is well tolerated and highly immunogenic when administered either subcutaneously or intramuscularly to children in the second year of life.

  • Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella Vaccine to children aged 11–21 months
    European journal of pediatrics, 2010
    Co-Authors: Markus Knuf, Ulrich Behre, Fred Zepp, Paul Willems, Pirmin Habermehl, Lothar Maurer, Claudius U. Meyer, Hanns-michael Burow, Michel Janssens, Helmtrud Bisanz
    Abstract:

    This study compared intramuscular and subcutaneous administration of two doses of measles–mumps–rubella–varicella (MMRV) combination Vaccine (Priorix-Tetra™, GlaxoSmithKline Biologicals) in children. Healthy children (N = 328) were randomised to receive MMRV either intramuscularly or subcutaneously. Reactogenicity was similar between treatment groups for immediate vaccination pain, vaccination site pain, redness and incidence of fever and rashes. Slightly less vaccination site swelling occurred during days 0–3 of the post-vaccination period after intramuscular administration. Seroconversion rates for all components, 42–56 days post-dose 2, ranged from 99.3% to 100% in the intramuscular group and from 98.6% to 100% in the subcutaneous. Cell-mediated immunity data supported the humoral immunogenicity findings. In summary, the MMRV Vaccine is well tolerated and highly immunogenic when administered either subcutaneously or intramuscularly to children in the second year of life.

  • Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate Vaccine coadministered with measles-mumps-rubella-varicella Vaccine in children aged 12 to 16 months.
    The Pediatric infectious disease journal, 2010
    Co-Authors: Timo Vesikari, Paul Willems, Aino Karvonen, Niklas Lindblad, Tiina Korhonen, Patricia Lommel, Ilse Dieussaert, Lode Schuerman
    Abstract:

    A booster dose of pneumococcal conjugate Vaccine may be administered at the same age as measles-mumps-rubella-varicella (MMRV) vaccination. This study examined the safety, reactogenicity, and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate Vaccine (PHiD-CV) when coadministered with MMRV Vaccine. In this open, controlled study, 325 healthy children aged 12 to 14 months were randomized to 1 of 3 groups: the first group (N = 110) received PHiD-CV and MMRV Vaccine followed 6 to 8 weeks later by MMRV and DTPa-HBV-IPV/Hib Vaccines; the second group (N = 101) received DTPa-HBV-IPV/Hib and MMRV Vaccines followed 6 to 8 weeks later by PHiD-CV and MMRV Vaccine; the third group (N = 114) received PHiD-CV and DTPa-HBV-IPV/Hib Vaccine during 1 vaccination visit. Immune responses were assessed with GlaxoSmithKline's 22F-inhibition enzyme-linked immunosorbent assay (for PHiD-CV), commercial enzyme-linked immunosorbent assay (for MMR), or indirect immunofluorescence assay (for varicella). Adverse events were recorded by the parents/guardians. After the first vaccination, 2 peaks in fever (rectal temperature > or =38 degrees C) were observed; at days 0 to 2, related to PHiD-CV and DTPa-HBV-IPV/Hib vaccination, and at days 4 to 12, related to MMRV vaccination. Booster responses to pneumococcal antigens and protein D and seroconversion rates for all MMRV Vaccine components were high. PHiD-CV and MMRV Vaccine can be coadministered without compromising the safety and immunogenicity profiles of either Vaccine.

Monique P. Curran - One of the best experts on this subject based on the ideXlab platform.

  • Live Attenuated Measles, Mumps, Rubella, and Varicella Zoster Virus Vaccine (Priorix-Tetra™)
    Pediatric Drugs, 2008
    Co-Authors: Sohita Dhillon, Monique P. Curran
    Abstract:

    ▲ The live attenuated tetravalent Vaccine against measles, mumps, rubella, and varicella zoster viruses (MMRV) is a combination of the measles, mumps, and rubella (MMR) Vaccine and the varicella zoster virus Vaccine. ▲ The immunogenicity after each dose of a two-dose vaccination course of MMRV Vaccine was generally similar to that of two doses of separately administered MMR plus varicella zoster Vaccines, or a single dose of separately administered MMR plus varicella zoster Vaccines followed by a dose of MMR Vaccine, in infants aged 9–24 months. ▲ In infants aged 9–24 months administered a two-dose course of MMRV Vaccine, geometric mean titers for antibodies against all Vaccine antigens increased after the second dose relative to the first dose, with the increase being most pronounced for varicella zoster virus antibodies (10- to 21-fold). ▲ MMRV as the second vaccination was immunogenic in children aged 5–6 years who had previously received either MMRV or MMR as the first vaccination at 12–24 months of age. ▲ The immunogenicity for measles, mumps, rubella, and varicella zoster viruses, in terms of seropositivity and antibody titers, was not altered when MMRV was coadministered with a booster dose of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b conjugate Vaccine in infants aged 12–23 months. Nor was the immunogenicity of the latter Vaccine altered by coadministration. ▲ The tolerability profile of MMRV Vaccine was comparable to that of separately administered MMR plus varicella zoster Vaccines or of MMR Vaccine alone. Injection-site redness and fever (rectal temperature ≥38°C or axillary temperature ≥37.5°C) were the most frequent adverse events in both groups.

  • Live attenuated measles, mumps, rubella, and varicella zoster virus Vaccine (Priorix-Tetra).
    Paediatric drugs, 2008
    Co-Authors: Sohita Dhillon, Monique P. Curran
    Abstract:

    The live attenuated tetravalent Vaccine against measles, mumps, rubella, and varicella zoster viruses (MMRV) is a combination of the measles, mumps, and rubella (MMR) Vaccine and the varicella zoster virus Vaccine. The immunogenicity after each dose of a two-dose vaccination course of MMRV Vaccine was generally similar to that of two doses of separately administered MMR plus varicella zoster Vaccines, or a single dose of separately administered MMR plus varicella zoster Vaccines followed by a dose of MMR Vaccine, in infants aged 9-24 months. In infants aged 9-24 months administered a two-dose course of MMRV Vaccine, geometric mean titers for antibodies against all Vaccine antigens increased after the second dose relative to the first dose, with the increase being most pronounced for varicella zoster virus antibodies (10- to 21-fold). MMRV as the second vaccination was immunogenic in children aged 5-6 years who had previously received either MMRV or MMR as the first vaccination at 12-24 months of age. The immunogenicity for measles, mumps, rubella, and varicella zoster viruses, in terms of seropositivity and antibody titers, was not altered when MMRV was coadministered with a booster dose of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b conjugate Vaccine in infants aged 12-23 months. Nor was the immunogenicity of the latter Vaccine altered by coadministration. The tolerability profile of MMRV Vaccine was comparable to that of separately administered MMR plus varicella zoster Vaccines or of MMR Vaccine alone. Injection-site redness and fever (rectal temperature > or =38degreesC or axillary temperature > or =37.5degreesC) were the most frequent adverse events in both groups.

Fred Zepp - One of the best experts on this subject based on the ideXlab platform.

  • Risk of febrile convulsions after MMRV vaccination in comparison to MMR or MMR+V vaccination.
    Vaccine, 2013
    Co-Authors: Tania Schink, Fred Zepp, Jakob Holstiege, Frank Kowalzik, Edeltraut Garbe
    Abstract:

    In July 2006, Priorix-Tetra™, a combined measles-mumps-rubella-varicella (MMRV) Vaccine, was licensed in Germany. Since a postlicensure study had shown a more than twofold elevated risk of febrile convulsions (FC) after first dose vaccination with the combined MMRV Vaccine ProQuad(®) compared to separately administered MMR and V Vaccines (MMR+V), the Paul-Ehrlich-Institute, the German regulatory agency for Vaccine licensing and safety, requested a study investigating the risk of FC for Priorix-Tetra™. We performed a matched cohort study based on claims data of more than 17 million insurees in the German Pharmacoepidemiological Research Database. All children born between 01.01.2004 and 31.12.2008 who received a 1st dose of MMRV Vaccine were matched to children vaccinated with MMR, MMR+V and MMR or MMR+V (combined group), respectively, by sex, age, month of vaccination and statutory health insurance. The primary outcome was defined as hospitalization with a diagnosis of FC without any alternative plausible cause of FC, e.g. an infection or neurological condition, coded as main discharge diagnosis. The secondary outcome excluded only neurological conditions to provide a more comparable outcome definition to the one used in the ProQuad(®) study. Numbers needed to harm (NNH), risk ratios and confounder adjusted odds ratios (ORs) with 95% CIs were estimated to compare the exposure groups. In the main risk period 5-12 days after immunization, the adjusted ORs of the primary endpoint for immunization with MMRV Vaccine relative to the comparator Vaccine indicated in brackets were 4.1 [95% CI 1.3-12.7; MMR], 3.5 [0.7-19.0; MMR+V], and 4.1 [1.5-11.1; MMR and MMR+V]. The corresponding ORs for the secondary outcome were 2.3 [1.4-3.9; MMR], 1.5 [0.8-2.9; MMR+V] and 2.4 [1.5-3.9; MMR and MMR+V]. This study in children younger than 5 years, 90% of them between 11 and 23 months, shows a risk of FC similar in magnitude for Priorix-Tetra™ as has previously been reported for ProQuad(®) suggesting a class effect for these quadrivalent Vaccines. Copyright © 2013 Elsevier Ltd. All rights reserved.

  • Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella Vaccine in healthy children.
    European journal of pediatrics, 2011
    Co-Authors: Markus Knuf, Klaus F. Helm, Martine Douha, Fred Zepp, Albrecht Prieler, Hartwig Maurer, Dorothee Kieninger-baum, Paul Willems
    Abstract:

    Two doses of a varicella-containing Vaccine in healthy children <12 years are suggested to induce better protection than a single dose. Persistence of immunity against measles, mumps, rubella, and varicella as well as varicella breakthrough cases were assessed 3 years after two-dose measles, mumps, rubella, and varicella (MMRV) vaccination or concomitant MMR (Priorix™) and varicella (Varilrix™) vaccination. Four hundred ninety-four healthy children, 12-18 months old at the time of the first dose, received either two doses of MMRV Vaccine (GlaxoSmithKline Biologicals) 42-56 days apart (MMRV, N = 371) or one dose of MMR and varicella Vaccines administered simultaneously at separate sites, followed by another MMR vaccination 42-56 days later (MMR + V, N = 123). Three hundred-four subjects participated in 3-year follow-up for persistence of immunity and occurrence of breakthrough varicella (MMRV, N = 225; MMR + V, N = 79). Antibodies were measured by ELISA (measles, mumps, rubella) and immunofluorescence (varicella). Contacts with individuals with varicella or zoster and cases of breakthrough varicella disease were recorded. Three years post-vaccination seropositivity rates in subjects seronegative before vaccination were: MMRV-measles, 98.5% (geometric mean titer [GMT] = 3,599.6); mumps, 97.4% (GMT = 1,754.5); rubella, 100% (GMT = 51.9); varicella, 99.4% (GMT = 225.5); MMR + V-measles, 97.0% (GMT = 1,818.8); mumps, 93.8% (GMT = 1,454.6); rubella, 100% (GMT = 53.8); and varicella, 96.8% (GMT = 105.8). Of the subjects, 15-20% reported contact with individuals with varicella/zoster each year. After 3 years, the cumulative varicella breakthrough disease rate was 0.7% (two cases) in the MMRV group and 5.4% (five cases) in the MMR + V group. Immunogenicity of the combined MMRV Vaccine was sustained 3 years post-vaccination. (208136/041/NCT00406211).

  • Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella Vaccine to children aged 11–21 months
    European Journal of Pediatrics, 2010
    Co-Authors: Markus Knuf, Ulrich Behre, Fred Zepp, Paul Willems, Pirmin Habermehl, Lothar Maurer, Claudius U. Meyer, Hanns-michael Burow, Michel Janssens, Helmtrud Bisanz
    Abstract:

    This study compared intramuscular and subcutaneous administration of two doses of measles–mumps–rubella–varicella (MMRV) combination Vaccine ( Priorix-Tetra ™, GlaxoSmithKline Biologicals) in children. Healthy children ( N  = 328) were randomised to receive MMRV either intramuscularly or subcutaneously. Reactogenicity was similar between treatment groups for immediate vaccination pain, vaccination site pain, redness and incidence of fever and rashes. Slightly less vaccination site swelling occurred during days 0–3 of the post-vaccination period after intramuscular administration. Seroconversion rates for all components, 42–56 days post-dose 2, ranged from 99.3% to 100% in the intramuscular group and from 98.6% to 100% in the subcutaneous. Cell-mediated immunity data supported the humoral immunogenicity findings. In summary, the MMRV Vaccine is well tolerated and highly immunogenic when administered either subcutaneously or intramuscularly to children in the second year of life.

  • Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella Vaccine to children aged 11–21 months
    European journal of pediatrics, 2010
    Co-Authors: Markus Knuf, Ulrich Behre, Fred Zepp, Paul Willems, Pirmin Habermehl, Lothar Maurer, Claudius U. Meyer, Hanns-michael Burow, Michel Janssens, Helmtrud Bisanz
    Abstract:

    This study compared intramuscular and subcutaneous administration of two doses of measles–mumps–rubella–varicella (MMRV) combination Vaccine (Priorix-Tetra™, GlaxoSmithKline Biologicals) in children. Healthy children (N = 328) were randomised to receive MMRV either intramuscularly or subcutaneously. Reactogenicity was similar between treatment groups for immediate vaccination pain, vaccination site pain, redness and incidence of fever and rashes. Slightly less vaccination site swelling occurred during days 0–3 of the post-vaccination period after intramuscular administration. Seroconversion rates for all components, 42–56 days post-dose 2, ranged from 99.3% to 100% in the intramuscular group and from 98.6% to 100% in the subcutaneous. Cell-mediated immunity data supported the humoral immunogenicity findings. In summary, the MMRV Vaccine is well tolerated and highly immunogenic when administered either subcutaneously or intramuscularly to children in the second year of life.

  • A combined measles, mumps, rubella and varicella Vaccine (Priorix-Tetra™): Immunogenicity and safety profile
    Vaccine, 2009
    Co-Authors: Hanna Czajka, Susanna Esposito, Martine Douha, Volker Schuster, Fred Zepp, Paul Willems
    Abstract:

    Priorix-Tetra (GlaxoSmithKline Biologicals) is a combined measles, mumps, rubella and varicella (MMRV) Vaccine. Eight studies involving more than 3000 children were reviewed. Compared with co-administration of MMR (Priorix) and varicella (Varilrix) Vaccines, the MMRV Vaccine showed: similar immunogenicity, with immunity shown up to 3 years post-vaccination; a higher rate of fever after the first dose; a slight increase in mild local reactions after the second dose. This MMRV Vaccine can be used either as a two-dose Vaccine or as a second dose in children primed with separate MMR and/or varicella Vaccines, offering a convenient way to introduce varicella vaccination into routine vaccination programmes.

Sohita Dhillon - One of the best experts on this subject based on the ideXlab platform.

  • Live Attenuated Measles, Mumps, Rubella, and Varicella Zoster Virus Vaccine (Priorix-Tetra™)
    Pediatric Drugs, 2008
    Co-Authors: Sohita Dhillon, Monique P. Curran
    Abstract:

    ▲ The live attenuated tetravalent Vaccine against measles, mumps, rubella, and varicella zoster viruses (MMRV) is a combination of the measles, mumps, and rubella (MMR) Vaccine and the varicella zoster virus Vaccine. ▲ The immunogenicity after each dose of a two-dose vaccination course of MMRV Vaccine was generally similar to that of two doses of separately administered MMR plus varicella zoster Vaccines, or a single dose of separately administered MMR plus varicella zoster Vaccines followed by a dose of MMR Vaccine, in infants aged 9–24 months. ▲ In infants aged 9–24 months administered a two-dose course of MMRV Vaccine, geometric mean titers for antibodies against all Vaccine antigens increased after the second dose relative to the first dose, with the increase being most pronounced for varicella zoster virus antibodies (10- to 21-fold). ▲ MMRV as the second vaccination was immunogenic in children aged 5–6 years who had previously received either MMRV or MMR as the first vaccination at 12–24 months of age. ▲ The immunogenicity for measles, mumps, rubella, and varicella zoster viruses, in terms of seropositivity and antibody titers, was not altered when MMRV was coadministered with a booster dose of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b conjugate Vaccine in infants aged 12–23 months. Nor was the immunogenicity of the latter Vaccine altered by coadministration. ▲ The tolerability profile of MMRV Vaccine was comparable to that of separately administered MMR plus varicella zoster Vaccines or of MMR Vaccine alone. Injection-site redness and fever (rectal temperature ≥38°C or axillary temperature ≥37.5°C) were the most frequent adverse events in both groups.

  • Live attenuated measles, mumps, rubella, and varicella zoster virus Vaccine (Priorix-Tetra).
    Paediatric drugs, 2008
    Co-Authors: Sohita Dhillon, Monique P. Curran
    Abstract:

    The live attenuated tetravalent Vaccine against measles, mumps, rubella, and varicella zoster viruses (MMRV) is a combination of the measles, mumps, and rubella (MMR) Vaccine and the varicella zoster virus Vaccine. The immunogenicity after each dose of a two-dose vaccination course of MMRV Vaccine was generally similar to that of two doses of separately administered MMR plus varicella zoster Vaccines, or a single dose of separately administered MMR plus varicella zoster Vaccines followed by a dose of MMR Vaccine, in infants aged 9-24 months. In infants aged 9-24 months administered a two-dose course of MMRV Vaccine, geometric mean titers for antibodies against all Vaccine antigens increased after the second dose relative to the first dose, with the increase being most pronounced for varicella zoster virus antibodies (10- to 21-fold). MMRV as the second vaccination was immunogenic in children aged 5-6 years who had previously received either MMRV or MMR as the first vaccination at 12-24 months of age. The immunogenicity for measles, mumps, rubella, and varicella zoster viruses, in terms of seropositivity and antibody titers, was not altered when MMRV was coadministered with a booster dose of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b conjugate Vaccine in infants aged 12-23 months. Nor was the immunogenicity of the latter Vaccine altered by coadministration. The tolerability profile of MMRV Vaccine was comparable to that of separately administered MMR plus varicella zoster Vaccines or of MMR Vaccine alone. Injection-site redness and fever (rectal temperature > or =38degreesC or axillary temperature > or =37.5degreesC) were the most frequent adverse events in both groups.

Susanna Esposito - One of the best experts on this subject based on the ideXlab platform.

  • The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella Vaccine when co-administered with conjugated meningococcal C Vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy
    Vaccine, 2016
    Co-Authors: Paolo Durando, Susanna Esposito, Maria Giuseppina Desole, Giovanni Gabutti, M. Cuccia, G. Bona, Giuseppe Ferrera, Angelo Pellegrino, Filippo Salvini, Ouzama Henry
    Abstract:

    Abstract Introduction Multiple vaccination visits and administrations can be stressful for infants, parents and healthcare providers. Multivalent combination Vaccines can deliver the required number of antigens in fewer injections and clinic visits, while Vaccine co-administration can also reduce the number of visits. This non-inferiority study was undertaken to evaluate the feasibility of co-administering a combined measles-mumps-rubella-varicella (MMRV) Vaccine with conjugated meningococcal C (MenC) Vaccine in a large cohort of healthy Italian toddlers. Methods Healthy subjects aged 13–15 months were randomized (2:1:1) to receive single doses of either: co-administered MMRV + MenC at the same visit (MMRV + MenC group); or MMRV followed 42 days later by MenC (MMRV group); or MenC followed 42 days later by MMRV (MenC group). Blood samples were collected before and 43 days after vaccination. Antibody titers against MMRV were measured using ELISA. Functional-anti-meningococcal-serogroup activity (rSBAMenC) was assessed using a serum bactericidal test. Solicited local and general reactions were recorded for up to 4 and 42 days post-vaccination, respectively. Non-inferiority of MMRV + MenC to MMRV (post-dose-1 seroconversion rates) and MMRV + MenC to MenC (post-dose-1 seroprotection rates) was achieved if the lower limit (LL) of the 95% confidence interval (CI) for the group difference was ⩾−10% for each antigen. Results 716 subjects were enrolled in the study. At 42 days post-vaccination, the MMRV seroconversion rates were 99.3% (measles), 94.5% (mumps), 100% (rubella) and 99.7% (varicella) in the MMRV + MenC group, and 99.4%, 93.2%, 100% and 100%, respectively, in the MMRV group. The seroprotection rates against rSBA-MenC were 98.3% in the MMRV + MenC group and 99.3% in the MenC group. Non-inferiority was reached for all the Vaccine antigens. The safety profiles were as expected for these Vaccines. Conclusion The immune responses elicited by co-administered MMRV + MenC were non-inferior to those elicited by MMRV or MenC alone and support vaccination of children with both Vaccines at a single visit. Clinical Trials registration: NCT01506193 .

  • Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B Vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials
    Lancet (London England), 2013
    Co-Authors: Timo Vesikari, Susanna Esposito, Roman Prymula, Ellen Ypma, Igor Kohl, Daniela Toneatto, Peter M. Dull, Alan Kimura
    Abstract:

    Summary Background Meningococcal serogroup B disease disproportionately affects infants. We assessed lot-to-lot consistency, safety and immunogenicity, and the effect of concomitant vaccination on responses to routine Vaccines of an investigational multicomponent Vaccine (4CMenB) in this population. Methods We did primary and booster phase 3 studies between March 31, 2008, and Aug 16, 2010, in 70 sites in Europe. We used two series of sponsor-supplied, computer-generated randomisation envelopes to allocate healthy 2 month-old infants to receive routine vaccinations (diphtheria-tetanus-acellular pertussis, inactivated poliovirus, hepatitis B plus Haemophilus influenzae type b, and seven-valent pneumococcal Vaccine) at 2, 4, and 6 months of age alone, or concomitantly with 4CMenB or serogroup C conjugate Vaccine (MenC) in: 1) an open-label, lot-to-lot immunogenicity and safety substudy of three 4CMenB lots compared with routine Vaccines alone (1:1:1:1, block size eight); or 2) an observer-blind, lot-to-lot safety substudy of three 4CMenB lots compared with MenC (1:1:1:3, block size six). At 12 months, 4CMenB-primed children from either substudy were randomised (1:1, block size two) to receive 4CMenB booster, with or without measles-mumps-rubella-varicella (MMRV) Vaccine. Immunogenicity was assessed by serum bactericidal assay with human complement (hSBA) against serogroup B test strains, and on randomly selected subsets of serum samples for routine Vaccines; laboratory personnel were masked to assignment. The first coprimary outcome was lot-to-lot consistency (hSBA geometric mean ratio of all lots between 0·5 and 2·0), and the second was an immune response (hSBA titre ≥5) for each of the three strains. The primary outcome for the booster study was immune response to booster dose. Immunogenicity data for 4CMenB were for the modified intention-to-treat population, including all infants from the open-label substudy who provided serum samples. The safety population included all participants who contributed safety data after at least one dose of study Vaccine. These trials are registered with ClinicalTrials.gov, numbers NCT00657709 and NCT00847145. Findings We enrolled 2627 infants in the open-label phase, 1003 in the observer-blind phase, and 1555 in the booster study. Lot-to-lot consistency was shown for the three 4CMenB lots, with the lowest 95% lower confidence limit being 0·74 and the highest upper limit being 1·33. Of 1181–1184 infants tested 1 month after three 4CMenB doses (all lots pooled), 100% (95% CI 99–100) had hSBA titres of 5 or more against strains selective for factor H binding protein and neisserial adhesin A, and 84% (82–86) for New Zealand outer-membrane vesicle. In a subset (n=100), 84% (75–91) of infants had hSBA titres of 5 or more against neisseria heparin binding antigen. At 12 months of age, waning titres were boosted by a fourth dose, such that 95–100% of children had hSBA titres of 5 or more for all antigens, with or without concomitant MMRV. Immune responses to routine Vaccines were much the same with or without concomitant 4CMenB, but concomitant vaccination was associated with increased reactogenicity. 77% (1912 of 2478) of infants had fever of 38·5°C or higher after any 4CMenB dose, compared with 45% (295 of 659) after routine Vaccines alone and 47% (228 of 490) with MenC, but only two febrile seizures were deemed probably related to 4CMenB. Interpretation 4CMenB is immunogenic in infants and children aged 12 months with no clinically relevant interference with routine Vaccines, but increases reactogenicity when administered concomitantly with routine Vaccines. This breakthrough Vaccine offers an innovative solution to the major remaining cause of bacterial meningitis in infant and toddlers. Funding Novartis Vaccines and Diagnostics.

  • Booster vaccination of pre-school children with reduced-antigen-content diphtheria-tetanus-acellular pertussis-inactivated poliovirus Vaccine co-administered with measles-mumps-rubella-varicella Vaccine: a randomized, controlled trial in children pri
    Human vaccines & immunotherapeutics, 2012
    Co-Authors: Giuseppe Ferrera, Susanna Esposito, M. Cuccia, G. Mereu, G. Icardi, G. Bona, M. Messier, S. Kuriyakose, Federico Marchetti, K. Hardt
    Abstract:

    Background: Pertussis occurs in older children, adolescents and adults due to waning immunity after primary vaccination. Booster vaccination for pre-school children has been recommended in Italy since 1999. In this study (NCT00871000), the immunogenicity, safety and reactogenicity of a booster dose of reduced-antigen content diphtheria-tetanus-acellular pertussis-inactivated poliovirus Vaccine (dTpa-IPV; GSK Biologicals Boostrix™-Polio; 3-component pertussis) vs. full-strength DTPa-IPV Vaccine (sanofi-pasteur—MSD Tetravac™; 2-component pertussis) was evaluated in pre-school Italian children.   Methods: Healthy children aged 5–6 y primed in a routine vaccination setting with three doses of DTPa-based Vaccines were enrolled and randomized (1:1) in this phase IIIb, booster study to receive a single dose of dTpa-IPV or DTPa-IPV; the MMRV Vaccine was co-administered. Antibody concentrations/titers against diphtheria, tetanus, pertussis and poliovirus 1–3 were measured before and one month post-booster. Reactogenicity and safety was assessed. Results: 305 subjects were enrolled of whom 303 (dTpa-IPV = 151; DTPa-IPV = 152) received booster vaccination. One month post-booster, all subjects were seroprotected/seropositive for anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-poliovirus 1–3; 99.3% of dTpa-IPV and 60.4% of DTPa-IPV subjects were seropositive for anti-PRN; 98–100% of subjects were seropositive against MMRV antigens post-booster. Pain at the injection site (dTpa-IPV: 63.6%; DTPa-IPV: 63.2%) and fatigue (dTpa-IPV: 26.5%; DTPa-IPV: 23.7%) were the most commonly reported solicited local and general symptoms, during the 4-d follow-up period. No SAEs or fatalities were reported. Conclusions: The reduced-antigen-content dTpa-IPV Vaccine was non-inferior to full-strength DTPa-IPV Vaccine with respect to immunogenicity. The Vaccine was well-tolerated and can be confidently used as a booster dose in pre-school children.

  • A combined measles, mumps, rubella and varicella Vaccine (Priorix-Tetra™): Immunogenicity and safety profile
    Vaccine, 2009
    Co-Authors: Hanna Czajka, Susanna Esposito, Martine Douha, Volker Schuster, Fred Zepp, Paul Willems
    Abstract:

    Priorix-Tetra (GlaxoSmithKline Biologicals) is a combined measles, mumps, rubella and varicella (MMRV) Vaccine. Eight studies involving more than 3000 children were reviewed. Compared with co-administration of MMR (Priorix) and varicella (Varilrix) Vaccines, the MMRV Vaccine showed: similar immunogenicity, with immunity shown up to 3 years post-vaccination; a higher rate of fever after the first dose; a slight increase in mild local reactions after the second dose. This MMRV Vaccine can be used either as a two-dose Vaccine or as a second dose in children primed with separate MMR and/or varicella Vaccines, offering a convenient way to introduce varicella vaccination into routine vaccination programmes.

  • Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) Vaccine followed by one dose of varicella Vaccine in children aged 15 months–2 years or 2–6 years primed with measles-mumps-rubella (MMR) Vaccine
    'Elsevier BV', 2009
    Co-Authors: Y. Gillet, G.c. Steri, X. Lanse, Susanna Esposito, N. Meister, Maria Giuseppina Desole, U. Behre, J.p. Ars&#232, K. Helm, Martine Douha
    Abstract:

    In this open, randomized, comparative study (105908/NCT00353288), 458 age-stratified children (15 months-2 years and 2-6 years) previously primed with MMR received one dose of either a combined MMRV Vaccine (Priorix-Tetra\u2122, MMRV group) or concomitant MMR and varicella Vaccines (Priorix\u2122 and Varilrix\u2122, MMR + V group), followed 42-56 days later by another dose of varicella Vaccine (Varilrix\u2122) in both groups. Post-vaccination measles, mumps and rubella seropositivity rates and antibody geometric mean titers (GMTs) were high (99.5% for anti-measles and 100% for anti-mumps and anti-rubella) in both Vaccine groups. In the two age strata, varicella seroconversion rates were, post-dose 1: 6597.6% (MMRV), 6596.6% (MMR + V) and, post-dose 2: 100% in both groups. Post-dose 2, anti-varicella GMTs increased respectively 14.1- and 12.6-fold (MMRV), and 9.8- and 13.1-fold (MMR + V). Both Vaccine regimens were well-tolerated. Post-dose 1, the incidence of any solicited local symptom during the 4-days follow-up was 6428.2% (MMRV) and 6419.8% (MMR + V) and the incidence of fever >39.5 \ub0C (rectal temperature) within 15 days was 642.8% (MMRV) and 642.6% (MMR + V). This MMRV Vaccine appears an immunogenic and safe substitute for a second dose of MMR Vaccine in young children. The increase in anti-varicella antibodies observed after a second dose of varicella Vaccine supports a two-dose schedule for varicella-containing Vaccine