Varicella Vaccine

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Henry R. Shinefield - One of the best experts on this subject based on the ideXlab platform.

  • Varicella Immunogenicity with 1- and 2-Dose Regimens of Measles-Mumps-Rubella-Varicella Vaccine
    The Journal of Infectious Diseases, 2008
    Co-Authors: Henry R. Shinefield, Steve Black, Barbara J. Kuter
    Abstract:

    A quadrivalent Vaccine combining measles, mumps, rubella, and Varicella antigens (MMRV) was developed to increase the coverage of Varicella Vaccine and reduce the number of injections children receive. Although the Varicella antigen is as immunogenic in the latest formulation of MMRV Vaccine as when it is administered alone, up to 14% of Vaccine recipients do not achieve protective levels of anti-Varicella antibodies after a single dose, which can result in breakthrough Varicella. A second dose of Varicella Vaccine raises response rates to 99% and was recently recommended by the Advisory Committee on Immunization Practices. Giving the second dose 3 months after the first (at approximately 15 months of age) would provide more protection against Varicella but would necessitate a change in the childhood vaccination schedule, which currently calls for a second dose of MMRV Vaccine between the ages of 4 and 6 years.

  • safety and immunogenicity of a combination measles mumps rubella and Varicella Vaccine proquad
    Human Vaccines, 2006
    Co-Authors: Barbara J. Kuter, Henry R. Shinefield, Steve Black, Wendy R Williams, Colin D. Marchant, Keith S. Reisinger, Jonathan Hartzel, Michelle L Brown, A Evesikaren, Bradley J Sullivan
    Abstract:

    Background: A combination measles, mumps, rubella, and Varicella Vaccine (ProQuad®, Merck & Co., Inc, West Point, PA) was evaluated in 5 clinical trials. Use of ProQuad® would result in fewer injections for children and would facilitate universal immunization against all 4 diseases. Objective: To describe the combined results obtained from the studies conducted during the clinical development program for ProQuad®. Methods: A total of 5833 healthy children, 12-23 months of age, and 399 healthy children, 4-6 years of age, received 1 or 2 doses of ProQuad® in 5 controlled clinical trials. M-M-R®II and VARIVAX® were used as the control for most studies. Safety was evaluated for 6 weeks postvaccination and immunogenicity was assessed 6 weeks after each dose by a sensitive assay (ELISA or gpELISA). Results: A single dose of ProQuad® in 12- to 23-month-old children was shown to be as immunogenic as a single dose of M-M-R®II and VARIVAX® and was generally well tolerated. ProQuad® can be used concomitantly with ot...

  • the safety and immunogenicity of a quadrivalent measles mumps rubella and Varicella Vaccine in healthy children a study of manufacturing consistency and persistence of antibody
    Pediatric Infectious Disease Journal, 2006
    Co-Authors: Jay M Lieberman, Henry R. Shinefield, Colin D. Marchant, Steven Black, Wendy Williams, Jacqueline M Miller, Frederick W Henderson, Alan Werzberger, Scott A Halperin, Jonathan Hartzel
    Abstract:

    BACKGROUND: This clinical trial was conducted to demonstrate that each of 3 consistency lots of a combined measles, mumps, rubella and Varicella Vaccine (MMRV) would be well tolerated, induce clinically acceptable and similar immune responses to each antigen and induce immune responses similar to measles, mumps and rubella Vaccine (MMR) administered concomitantly with Varicella Vaccine (V). An additional objective was to evaluate the persistence of antibodies 1 year postvaccination. METHODS: Study participants 12 to 23 months of age received a single injection of either one of 3 consistency lots of MMRV or MMR + V administered at separate injection sites. RESULTS: A total of 3,928 healthy children were enrolled at study sites in the United States and Canada. Immune responses to measles, mumps, rubella and Varicella in children immunized with each of 3 lots of MMRV were similar and the combined response to all 3 lots was comparable to that of the control group. The 1-year antibody persistence rates for measles, mumps, rubella and Varicella viruses were each greater than 95% and comparable among the recipients of the 3 consistency lots of MMRV and the control group. All Vaccines were generally well tolerated during the 42 days after vaccination and the overall incidence of adverse experiences was comparable between recipients of MMRV and MMR + V. Rates of fever (temperature >or=38.9 degrees C oral equivalent or tactile) were greater in recipients of MMRV than in recipients of MMR + V (39.1% versus 33.1%, P = 0.001). Fevers were transient and there was no difference in the incidence of febrile seizures. CONCLUSIONS: MMRV was generally well tolerated and had comparable immunogenicity and overall safety profiles to MMR + V administered concomitantly. Long-term persistence of antibodies after receipt of MMRV is expected based on similar antibody titers against all 4 antigens 1 year postvaccination compared with recipients of MMR and V.

  • the safety and immunogenicity of a quadrivalent measles mumps rubella and Varicella Vaccine in healthy children a study of manufacturing consistency and persistence of antibody
    Pediatric Infectious Disease Journal, 2006
    Co-Authors: Jay M Lieberman, Henry R. Shinefield, Wendy R Williams, Colin D. Marchant, Steven Black, Jacqueline M Miller, Frederick W Henderson, Alan Werzberger, Scott A Halperin, Jonathan Hartzel
    Abstract:

    Background:This clinical trial was conducted to demonstrate that each of 3 consistency lots of a combined measles, mumps, rubella and Varicella Vaccine (MMRV) would be well tolerated, induce clinically acceptable and similar immune responses to each antigen and induce immune responses similar to mea

  • safety and immunogenicity of a measles mumps rubella and Varicella Vaccine given with combined haemophilus influenzae type b conjugate hepatitis b Vaccines and combined diphtheria tetanus acellular pertussis Vaccines
    Pediatric Infectious Disease Journal, 2006
    Co-Authors: Henry R. Shinefield, Steve Black, Keith S. Reisinger, Jonathan Hartzel, Laura Digilio, Edward P Rothstein, Marci Thear, Daniel L Coury, Barbara Evans, Florian Schodel
    Abstract:

    Background A study was conducted to assess administration of a combination measles, mumps, rubella and Varicella Vaccine (MMRV) with other childhood Vaccines. Methods In this open, multicenter trial, 1915 healthy children ages 12-15 months were randomized into 3 groups: group 1, MMRV, combined Haemophilus influenzae type b conjugate-hepatitis B Vaccines (Hib/HepB) and combined diphtheria-tetanus-acellular pertussis Vaccines (DTaP) concomitantly; group 2, MMRV followed by Hib/HepB and DTaP 42 days later; group 3, MMR and Varicella Vaccine followed by Hib/HepB and DTaP 42 days later. Results Antibody responses to measles, mumps, rubella, Varicella, Hib, HepB, diphtheria and tetanus were similar between groups 1 and 2 (all >95%, except Varicella, 89.7% in group 1 and 90.9% in group 2). Pertussis toxin and filamentous hemagglutinin responses were significantly lower in group 1 than in group 2 (group 1, 74.1 and 67.1%; group 2, 90.4 and 86.8%, respectively). An exploratory analysis suggested that the difference in and pertussis toxin and filamentous hemagglutinin responses was likely the result of study design rather than interference among Vaccine components because the groups differed in age of receipt of DTaP (group 1, approximately 12 months; group 2, approximately 13.5 months). When the groups were matched for age, sample size was sufficient for comparison only in children > or =13.5 months old. Pertussis toxin and filamentous hemagglutinin responses were similar in these children. The safety profiles for each vaccination regimen were comparable. Conclusions The immunogenicity data support concomitant administration of MMRV with Hib/HepB. Limited data from an exploratory analysis indicate that MMRV can be administered concomitantly with DTaP. Concomitant administration of MMRV, Hib/HepB and DTaP is well-tolerated.

Martine Douha - One of the best experts on this subject based on the ideXlab platform.

  • safety and immunogenicity of a measles mumps rubella Varicella Vaccine given as a second dose in children up to six years of age
    Vaccine, 2009
    Co-Authors: Scott A Halperin, Martine Douha, Giuseppe Ferrera, David W Scheifele, Gerald Predy, Giuseppe Stella, Mario Cuccia, Paul Willems
    Abstract:

    Abstract Two doses of measles–mumps–rubella Vaccine (MMR) are widely recommended and consideration is being given to a similar schedule for Varicella Vaccine. A combined measles–mumps–rubella–Varicella Vaccine (MMRV) could be considered for this second dose in children previously vaccinated separately with MMR and Varicella Vaccines. Healthy children ( N  = 390) aged 15–75 months (median 54 months) previously immunized with MMR and Varicella Vaccines were randomly allocated to receive MMRV or separate injections of MMR and Varicella Vaccines. Before administration of study Vaccines, seropositivity rates were 96.4% for measles, 94.3% for mumps, 99.5% for rubella, and 97.9% for Varicella. Post-immunization, seropositivity rates were 99.5% for measles and mumps and 100% for rubella and Varicella in the MMR + Varicella group and 100% for all four antigens in the MMRV group; a 26.2- and 27.2-fold increase in Varicella titer was observed in the MMR + Varicella Vaccine and MMRV groups, respectively. Except for more frequent pain in the MMRV group (33.3% vs. 23.7%, p  = 0.043), there were no differences in the incidence of local and solicited symptoms between groups. In children primed with MMR and Varicella Vaccine, MMRV had non-inferior immunogenicity and similar safety profiles as a second dose of licensed MMR and Varicella Vaccine administered concomitantly.

  • 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, Ulrich Behre, X. Lanse, Susanna Esposito, N. Meister, Maria Giuseppina Desole, 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

  • 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.
    Vaccine, 2008
    Co-Authors: Y. Gillet, G.c. Steri, Ulrich Behre, J.p. Arsène, X. Lanse, Klaus F. Helm, Susanna Esposito, N. Meister, Maria Giuseppina Desole, 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, MMRV group) or concomitant MMR and Varicella Vaccines (Priorix and Varilrix, MMR+V group), followed 42-56 days later by another dose of Varicella Vaccine (Varilrix) 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: > or =97.6% (MMRV), > or =96.6% (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 39.5 degrees C (rectal temperature) within 15 days was < or =2.8% (MMRV) and < or =2.6% (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.

  • Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-Varicella Vaccine in healthy children during the second year of life.
    The Pediatric infectious disease journal, 2008
    Co-Authors: Volker Schuster, Klaus Kindler, Walter Otto, Lothar Maurer, Patricia Tcherepnine, Ulrich Pfletschinger, Peter Soemantri, Uta Walther, Ute Macholdt, Martine Douha
    Abstract:

    Background Measles, mumps, and rubella (MMR) and Varicella (V) Vaccines are often coadministered at 1 clinic visit. This study (104389/NCT00127023) was undertaken to assess the immunogenicity and safety of a new refrigerator-stable tetravalent MMRV Vaccine after 1 dose and after 2 doses administered during the second year of life. Methods Nine hundred seventy healthy children aged 10-21 months received 2 doses of MMRV Vaccine (Priorix-Tetra; GlaxoSmithKline Biologicals, Rixensart, Belgium) 42 days apart (MMRV group; N = 732) or 1 dose of MMR Vaccine (Priorix) coadministered with Varicella Vaccine (Varilrix) followed by a second dose of only MMR Vaccine 42 days later (MMR + V group; N = 238). Results Observed seroconversion rates for measles, mumps, rubella, and Varicella antibodies 42 days postdose 1 were 94.5%, 96.1%, 99.7%, 95.5% in the MMRV group and 93.4%, 93.6%, 98.1%, 95.6% in the MMR + V group. Respective seroconversion rates postdose 2 were 98.3%, 99.4%, 99.7%, 99.7% in the MMRV group and 97.6%, 99.5%, 100%, 97.5% in the MMR + V group. Observed antimeasles and antimumps geometric mean titers (GMTs) were higher after each dose in the MMRV group than in the MMR + V group. AntiVaricella GMT increased 21-fold in the MMRV group postdose 2, and was markedly higher than in the MMR + V group who did not receive a second dose of Varicella (1903.3 and 80.3 dilution, respectively). Both Vaccine regimens were generally well-tolerated in terms of local reactions, fever >39.5 degrees C, and Vaccine-related rashes. Conclusions Both after 1 dose and after 2 doses, the MMRV Vaccine was at least as immunogenic as concomitant MMR and Varicella vaccination suggesting that it could be suitable for use according to current vaccination schedules.

Scott A Halperin - One of the best experts on this subject based on the ideXlab platform.

  • safety and immunogenicity of a measles mumps rubella Varicella Vaccine given as a second dose in children up to six years of age
    Vaccine, 2009
    Co-Authors: Scott A Halperin, Martine Douha, Giuseppe Ferrera, David W Scheifele, Gerald Predy, Giuseppe Stella, Mario Cuccia, Paul Willems
    Abstract:

    Abstract Two doses of measles–mumps–rubella Vaccine (MMR) are widely recommended and consideration is being given to a similar schedule for Varicella Vaccine. A combined measles–mumps–rubella–Varicella Vaccine (MMRV) could be considered for this second dose in children previously vaccinated separately with MMR and Varicella Vaccines. Healthy children ( N  = 390) aged 15–75 months (median 54 months) previously immunized with MMR and Varicella Vaccines were randomly allocated to receive MMRV or separate injections of MMR and Varicella Vaccines. Before administration of study Vaccines, seropositivity rates were 96.4% for measles, 94.3% for mumps, 99.5% for rubella, and 97.9% for Varicella. Post-immunization, seropositivity rates were 99.5% for measles and mumps and 100% for rubella and Varicella in the MMR + Varicella group and 100% for all four antigens in the MMRV group; a 26.2- and 27.2-fold increase in Varicella titer was observed in the MMR + Varicella Vaccine and MMRV groups, respectively. Except for more frequent pain in the MMRV group (33.3% vs. 23.7%, p  = 0.043), there were no differences in the incidence of local and solicited symptoms between groups. In children primed with MMR and Varicella Vaccine, MMRV had non-inferior immunogenicity and similar safety profiles as a second dose of licensed MMR and Varicella Vaccine administered concomitantly.

  • the epidemiology of children hospitalized with herpes zoster in canada immunization monitoring program active impact 1991 2005
    Pediatric Infectious Disease Journal, 2008
    Co-Authors: Susan H Wootton, David W Scheifele, Michelle Mozel, Scott A Halperin
    Abstract:

    Background: Varicella zoster virus causes Varicella (chickenpox) and can reactivate to cause herpes zoster (HZ). In Canada, live attenuated Varicella Vaccine was recommended for routine use among healthy susceptible children age 1 year and older, in 1999. Varicella Vaccine has had a profound impact on the incidence of Varicella; however the impact on HZ remains uncertain. Methods: Surveillance for HZ admissions was conducted by the Immunization Monitoring Program, Active (IMPACT) surveillance network comprising 12 centers representing over 90% of pediatric tertiary care beds in Canada. Active surveillance for HZ was undertaken in 1991-1996 and reintroduced in 1999. A clinical diagnosis was accepted, with or without laboratory confirmation. For each case, a detailed case report form was completed. Results: In total, 648 children were admitted with HZ; 342 (52.8%) were boys and the mean age was 9.9 ± 4.4 years. Five hundred seventy-seven (89.0%) were immunocompromised and 71 immunocompetent (10.8%). Five hundred seventy-one (88.1%) had a history of Varicella zoster virus infection. Varicella vaccination was documented in 4 children before admission. Most (85.5%) presented with localized disease. Immunocompetent children were more likely than immunocompromised children to be hospitalized with ophthalmic disease (odds ratio 5.1, P < 0.001) or with at least 1 complication (odds ratio 3.0, P < 0.001). Only 1 death was attributable to HZ. Conclusions: Immunocompromised children represented the overwhelming majority of IMPACT hospitalized cases. Complications directly resulting from HZ were common in immunocompetent children. As Varicella Vaccine use becomes more widespread, the IMPACT network will continue to play an important role in monitoring the changing epidemiology of HZ in children.

  • the safety and immunogenicity of a quadrivalent measles mumps rubella and Varicella Vaccine in healthy children a study of manufacturing consistency and persistence of antibody
    Pediatric Infectious Disease Journal, 2006
    Co-Authors: Jay M Lieberman, Henry R. Shinefield, Colin D. Marchant, Steven Black, Wendy Williams, Jacqueline M Miller, Frederick W Henderson, Alan Werzberger, Scott A Halperin, Jonathan Hartzel
    Abstract:

    BACKGROUND: This clinical trial was conducted to demonstrate that each of 3 consistency lots of a combined measles, mumps, rubella and Varicella Vaccine (MMRV) would be well tolerated, induce clinically acceptable and similar immune responses to each antigen and induce immune responses similar to measles, mumps and rubella Vaccine (MMR) administered concomitantly with Varicella Vaccine (V). An additional objective was to evaluate the persistence of antibodies 1 year postvaccination. METHODS: Study participants 12 to 23 months of age received a single injection of either one of 3 consistency lots of MMRV or MMR + V administered at separate injection sites. RESULTS: A total of 3,928 healthy children were enrolled at study sites in the United States and Canada. Immune responses to measles, mumps, rubella and Varicella in children immunized with each of 3 lots of MMRV were similar and the combined response to all 3 lots was comparable to that of the control group. The 1-year antibody persistence rates for measles, mumps, rubella and Varicella viruses were each greater than 95% and comparable among the recipients of the 3 consistency lots of MMRV and the control group. All Vaccines were generally well tolerated during the 42 days after vaccination and the overall incidence of adverse experiences was comparable between recipients of MMRV and MMR + V. Rates of fever (temperature >or=38.9 degrees C oral equivalent or tactile) were greater in recipients of MMRV than in recipients of MMR + V (39.1% versus 33.1%, P = 0.001). Fevers were transient and there was no difference in the incidence of febrile seizures. CONCLUSIONS: MMRV was generally well tolerated and had comparable immunogenicity and overall safety profiles to MMR + V administered concomitantly. Long-term persistence of antibodies after receipt of MMRV is expected based on similar antibody titers against all 4 antigens 1 year postvaccination compared with recipients of MMR and V.

  • the safety and immunogenicity of a quadrivalent measles mumps rubella and Varicella Vaccine in healthy children a study of manufacturing consistency and persistence of antibody
    Pediatric Infectious Disease Journal, 2006
    Co-Authors: Jay M Lieberman, Henry R. Shinefield, Wendy R Williams, Colin D. Marchant, Steven Black, Jacqueline M Miller, Frederick W Henderson, Alan Werzberger, Scott A Halperin, Jonathan Hartzel
    Abstract:

    Background:This clinical trial was conducted to demonstrate that each of 3 consistency lots of a combined measles, mumps, rubella and Varicella Vaccine (MMRV) would be well tolerated, induce clinically acceptable and similar immune responses to each antigen and induce immune responses similar to mea

  • the immunization monitoring program active impact prospective five year study of canadian children hospitalized for chickenpox or an associated complication
    Pediatric Infectious Disease Journal, 2000
    Co-Authors: Noni Macdonald, Scott A Halperin, David W Scheifele, Pierre Dery, Taj Jadavji, Marc H Lebel, Elaine L Mills, R Morris, Wendy Vaudry, Ron Gold
    Abstract:

    Background. Varicella Vaccine was approved for use in Canada in 1998. A major goal of universal Varicella Vaccine programs is to reduce severe infection and associated complications. Baseline data are essential against which to judge the effectiveness of routine childhood immunization. Objective. To describe morbidity and mortality among children hospitalized for chickenpox. Methods. From January 1, 1991, to March 31, 1996, chickenpox admissions to 11 pediatric referral centers were actively identified. Patient and illness characteristics were compared for 3 subgroups defined by prior health: healthy; unhealthy but immunocompetent; immunocompromised. Results. Of 861 cases 488 (56.7%) were healthy, 75(8.7%) were unhealthy and 298 (34.6%) were immunocompromised. The immunocompromised children differed from healthy/unhealthy cases in mean age (6.4 vs. 4.0/4.6 years, respectively, P < 0.0001); median interval from rash onset to admission (2 vs. 5/5 days, P < 0.0001); complication rate (20% vs. 90%/79%; P = 0.001); and rate of acyclovir therapy (98% vs. 24%/39%; P = 0.001). Unhealthy vs. healthy cases had a higher frequency (P < 0.01) of intensive care (13.3% vs. 4.7%), ventilation (9.3% vs. 2.0%) and death (4% vs. 0.2%). Conclusion. These data provide a baseline for morbidity/mortality resulting from chickenpox before Varicella Vaccine use in Canada.

Florian Schodel - One of the best experts on this subject based on the ideXlab platform.

  • safety and immunogenicity of a measles mumps rubella and Varicella Vaccine given with combined haemophilus influenzae type b conjugate hepatitis b Vaccines and combined diphtheria tetanus acellular pertussis Vaccines
    Pediatric Infectious Disease Journal, 2006
    Co-Authors: Henry R. Shinefield, Steve Black, Keith S. Reisinger, Jonathan Hartzel, Laura Digilio, Edward P Rothstein, Marci Thear, Daniel L Coury, Barbara Evans, Florian Schodel
    Abstract:

    Background A study was conducted to assess administration of a combination measles, mumps, rubella and Varicella Vaccine (MMRV) with other childhood Vaccines. Methods In this open, multicenter trial, 1915 healthy children ages 12-15 months were randomized into 3 groups: group 1, MMRV, combined Haemophilus influenzae type b conjugate-hepatitis B Vaccines (Hib/HepB) and combined diphtheria-tetanus-acellular pertussis Vaccines (DTaP) concomitantly; group 2, MMRV followed by Hib/HepB and DTaP 42 days later; group 3, MMR and Varicella Vaccine followed by Hib/HepB and DTaP 42 days later. Results Antibody responses to measles, mumps, rubella, Varicella, Hib, HepB, diphtheria and tetanus were similar between groups 1 and 2 (all >95%, except Varicella, 89.7% in group 1 and 90.9% in group 2). Pertussis toxin and filamentous hemagglutinin responses were significantly lower in group 1 than in group 2 (group 1, 74.1 and 67.1%; group 2, 90.4 and 86.8%, respectively). An exploratory analysis suggested that the difference in and pertussis toxin and filamentous hemagglutinin responses was likely the result of study design rather than interference among Vaccine components because the groups differed in age of receipt of DTaP (group 1, approximately 12 months; group 2, approximately 13.5 months). When the groups were matched for age, sample size was sufficient for comparison only in children > or =13.5 months old. Pertussis toxin and filamentous hemagglutinin responses were similar in these children. The safety profiles for each vaccination regimen were comparable. Conclusions The immunogenicity data support concomitant administration of MMRV with Hib/HepB. Limited data from an exploratory analysis indicate that MMRV can be administered concomitantly with DTaP. Concomitant administration of MMRV, Hib/HepB and DTaP is well-tolerated.

  • a combination measles mumps rubella and Varicella Vaccine proquad given to 4 to 6 year old healthy children vaccinated previously with m m rii and varivax
    Pediatrics, 2006
    Co-Authors: Keith S. Reisinger, Jacqueline Gress, Michelle L Brown, Florian Schodel, Bradley J Sullivan, Gary S Marshall, Beth Nauert, David O Matson, Peter E Silas, Barbara J. Kuter
    Abstract:

    BACKGROUND. In the United States, children receive primary doses of M-M-RII (Merck & Co, Inc, West Point, PA) and Varivax (Merck & Co, Inc) beginning at 12 months, often at the same health care visit. Currently a second dose of M-M-RII is given to 4- to 6-year-old children, to increase vaccination rates and to reduce the number of individuals without detectable antibodies. A second dose of a Varicella-containing Vaccine may result in similar benefits. OBJECTIVES. To demonstrate that ProQuad (measles, mumps, rubella, and Varicella virus Vaccine live; Merck & Co, Inc) may be given in place of a second dose of M-M-RII or second doses of M-M-RII and Varivax for 4- to 6-year-old children. METHODS. Four- to 6-year-old children who had been immunized previously with M-M-RII and Varivax were assigned randomly to receive either ProQuad and placebo (N = 399), M-M-RII and placebo (N = 195), or M-M-RII and Varivax (N = 205) and were then monitored for safety and immunogenicity. RESULTS. ProQuad was generally well tolerated. Similarity (noninferiority) was demonstrated in postvaccination antibody responses to measles, mumps, and rubella between recipients of ProQuad and all recipients of M-M-RII and in responses to Varicella between recipients of ProQuad and recipients of Varivax. Postvaccination seropositivity rates for antibodies against all 4 viruses were nearly 100% in all 3 groups. Small fold increases were observed for measles, mumps, and rubella antibody titers. In contrast, substantial boosts in Varicella antibody titers were observed among recipients of a second dose of Varicella Vaccine, administered as ProQuad or Varivax. CONCLUSIONS. ProQuad may be used in place of a second dose of M-M-RII or second doses of M-M-RII and Varivax for 4- to 6-year-old children.

  • evaluation of a quadrivalent measles mumps rubella and Varicella Vaccine in healthy children
    Pediatric Infectious Disease Journal, 2005
    Co-Authors: Henry R. Shinefield, Steve Black, Keith S. Reisinger, Stephanie O. Klopfer, Laura Digilio, Mark M Blatter, Jacqueline Gress, Michelle L Brown, Karen Eves, Florian Schodel
    Abstract:

    Background:A quadrivalent measles, mumps, rubella and Varicella Vaccine would facilitate universal immunization against all 4 diseases, improve compliance and immunization rates and decrease the number of injections given to children and visits to physicians' offices.Objectives:To evaluate 1- and 2-

Keith S. Reisinger - One of the best experts on this subject based on the ideXlab platform.

  • safety and immunogenicity of a combination measles mumps rubella and Varicella Vaccine proquad
    Human Vaccines, 2006
    Co-Authors: Barbara J. Kuter, Henry R. Shinefield, Steve Black, Wendy R Williams, Colin D. Marchant, Keith S. Reisinger, Jonathan Hartzel, Michelle L Brown, A Evesikaren, Bradley J Sullivan
    Abstract:

    Background: A combination measles, mumps, rubella, and Varicella Vaccine (ProQuad®, Merck & Co., Inc, West Point, PA) was evaluated in 5 clinical trials. Use of ProQuad® would result in fewer injections for children and would facilitate universal immunization against all 4 diseases. Objective: To describe the combined results obtained from the studies conducted during the clinical development program for ProQuad®. Methods: A total of 5833 healthy children, 12-23 months of age, and 399 healthy children, 4-6 years of age, received 1 or 2 doses of ProQuad® in 5 controlled clinical trials. M-M-R®II and VARIVAX® were used as the control for most studies. Safety was evaluated for 6 weeks postvaccination and immunogenicity was assessed 6 weeks after each dose by a sensitive assay (ELISA or gpELISA). Results: A single dose of ProQuad® in 12- to 23-month-old children was shown to be as immunogenic as a single dose of M-M-R®II and VARIVAX® and was generally well tolerated. ProQuad® can be used concomitantly with ot...

  • safety and immunogenicity of a measles mumps rubella and Varicella Vaccine given with combined haemophilus influenzae type b conjugate hepatitis b Vaccines and combined diphtheria tetanus acellular pertussis Vaccines
    Pediatric Infectious Disease Journal, 2006
    Co-Authors: Henry R. Shinefield, Steve Black, Keith S. Reisinger, Jonathan Hartzel, Laura Digilio, Edward P Rothstein, Marci Thear, Daniel L Coury, Barbara Evans, Florian Schodel
    Abstract:

    Background A study was conducted to assess administration of a combination measles, mumps, rubella and Varicella Vaccine (MMRV) with other childhood Vaccines. Methods In this open, multicenter trial, 1915 healthy children ages 12-15 months were randomized into 3 groups: group 1, MMRV, combined Haemophilus influenzae type b conjugate-hepatitis B Vaccines (Hib/HepB) and combined diphtheria-tetanus-acellular pertussis Vaccines (DTaP) concomitantly; group 2, MMRV followed by Hib/HepB and DTaP 42 days later; group 3, MMR and Varicella Vaccine followed by Hib/HepB and DTaP 42 days later. Results Antibody responses to measles, mumps, rubella, Varicella, Hib, HepB, diphtheria and tetanus were similar between groups 1 and 2 (all >95%, except Varicella, 89.7% in group 1 and 90.9% in group 2). Pertussis toxin and filamentous hemagglutinin responses were significantly lower in group 1 than in group 2 (group 1, 74.1 and 67.1%; group 2, 90.4 and 86.8%, respectively). An exploratory analysis suggested that the difference in and pertussis toxin and filamentous hemagglutinin responses was likely the result of study design rather than interference among Vaccine components because the groups differed in age of receipt of DTaP (group 1, approximately 12 months; group 2, approximately 13.5 months). When the groups were matched for age, sample size was sufficient for comparison only in children > or =13.5 months old. Pertussis toxin and filamentous hemagglutinin responses were similar in these children. The safety profiles for each vaccination regimen were comparable. Conclusions The immunogenicity data support concomitant administration of MMRV with Hib/HepB. Limited data from an exploratory analysis indicate that MMRV can be administered concomitantly with DTaP. Concomitant administration of MMRV, Hib/HepB and DTaP is well-tolerated.

  • a combination measles mumps rubella and Varicella Vaccine proquad given to 4 to 6 year old healthy children vaccinated previously with m m rii and varivax
    Pediatrics, 2006
    Co-Authors: Keith S. Reisinger, Jacqueline Gress, Michelle L Brown, Florian Schodel, Bradley J Sullivan, Gary S Marshall, Beth Nauert, David O Matson, Peter E Silas, Barbara J. Kuter
    Abstract:

    BACKGROUND. In the United States, children receive primary doses of M-M-RII (Merck & Co, Inc, West Point, PA) and Varivax (Merck & Co, Inc) beginning at 12 months, often at the same health care visit. Currently a second dose of M-M-RII is given to 4- to 6-year-old children, to increase vaccination rates and to reduce the number of individuals without detectable antibodies. A second dose of a Varicella-containing Vaccine may result in similar benefits. OBJECTIVES. To demonstrate that ProQuad (measles, mumps, rubella, and Varicella virus Vaccine live; Merck & Co, Inc) may be given in place of a second dose of M-M-RII or second doses of M-M-RII and Varivax for 4- to 6-year-old children. METHODS. Four- to 6-year-old children who had been immunized previously with M-M-RII and Varivax were assigned randomly to receive either ProQuad and placebo (N = 399), M-M-RII and placebo (N = 195), or M-M-RII and Varivax (N = 205) and were then monitored for safety and immunogenicity. RESULTS. ProQuad was generally well tolerated. Similarity (noninferiority) was demonstrated in postvaccination antibody responses to measles, mumps, and rubella between recipients of ProQuad and all recipients of M-M-RII and in responses to Varicella between recipients of ProQuad and recipients of Varivax. Postvaccination seropositivity rates for antibodies against all 4 viruses were nearly 100% in all 3 groups. Small fold increases were observed for measles, mumps, and rubella antibody titers. In contrast, substantial boosts in Varicella antibody titers were observed among recipients of a second dose of Varicella Vaccine, administered as ProQuad or Varivax. CONCLUSIONS. ProQuad may be used in place of a second dose of M-M-RII or second doses of M-M-RII and Varivax for 4- to 6-year-old children.

  • evaluation of a quadrivalent measles mumps rubella and Varicella Vaccine in healthy children
    Pediatric Infectious Disease Journal, 2005
    Co-Authors: Henry R. Shinefield, Steve Black, Keith S. Reisinger, Stephanie O. Klopfer, Laura Digilio, Mark M Blatter, Jacqueline Gress, Michelle L Brown, Karen Eves, Florian Schodel
    Abstract:

    Background:A quadrivalent measles, mumps, rubella and Varicella Vaccine would facilitate universal immunization against all 4 diseases, improve compliance and immunization rates and decrease the number of injections given to children and visits to physicians' offices.Objectives:To evaluate 1- and 2-

  • Dose-response study of a quadrivalent measles, mumps, rubella and Varicella Vaccine in healthy children.
    The Pediatric infectious disease journal, 2005
    Co-Authors: Henry R. Shinefield, H. Cody Meissner, Steve Black, Wendy R Williams, Colin D. Marchant, Keith S. Reisinger, Tracy Stewart, Juan Guerrero, Stephanie O. Klopfer
    Abstract:

    Background:A combined measles, mumps, rubella and Varicella (MMRV) Vaccine would facilitate universal immunization against 4 diseases by decreasing the number of injections and thus enhancing compliance and coverage rates. If a second dose of Varicella Vaccine were to be recommended, MMRV could be u

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