Safety, tolerability and immunogenicity of VAQTA given concomitantly versus nonconcomitantly with other pediatric vaccines in healthy 12-month-old children

Fernando A. Guerra, Jacqueline Gress, Alan Werzberger, Keith Reisinger, Emmanuel Walter, Hassan Lakkis, Anthony D. Grosso, Carolee Welebob, Barbara J. Kuter, Stan Block, Stephen Chartrand, Archana Chatterjee, Mathuram Santosham, Dean Blumberg, James A. Taylor, Harry Keyserling, Malcolm J. Sperling, Joseph Bocchini, Donald Murphey, Samantha BostrumW. Malcolm Gooch

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The objective of this study is to assess whether hepatitis A vaccine is immunogenic and well tolerated when administered to 12-month-old children alone or concomitantly with other routinely administered pediatric vaccines. METHODS: Six hundred seventeen healthy 12-month-old children were randomized to receive dose 1 of hepatitis A vaccine given alone or concomitantly with measles-mumps-rubella vaccine and varicella vaccine and dose 2 of hepatitis A vaccine given alone or concomitantly with diphtheria-tetanus- acellular pertussis vaccine and optionally with oral or inactivated poliovirus vaccine. Participants were followed for clinical adverse experiences and serologic responses to all vaccine antigens. Antibody responses were compared with historical controls for some indices. RESULTS: The safety profile was generally comparable whether hepatitis A vaccine was administered alone or concomitantly with other vaccines. When administered alone, the hepatitis A seropositivity rate was 98.3% and 100% for dose 1 and dose 2, respectively, and after dose 2 was similar to historical rates and the geometric mean titers were similar between initially seropositive and initially seronegative subjects (6207 and 6810 mIU/mL, respectively). After concomitant administration with hepatitis A vaccine, antibody responses to measles, mumps, rubella, diphtheria, tetanus and filamentous hemagglutinin (98.8%, 99.6%, 100%, 98.6%, 100% and 83.3%, respectively) were similar to historical controls and response to poliovirus was demonstrated, but immune responses to varicella zoster virus (79%) and pertussis toxoid (76%) were inferior to historical controls. CONCLUSIONS: Hepatitis A vaccine is highly immunogenic and generally well tolerated when administered to healthy children as young as 12 months of age regardless of initial hepatitis A serostatus and can be administered concomitantly with measles-mumps-rubella vaccine and oral or inactivated poliovirus vaccine.

Original languageEnglish (US)
Pages (from-to)912-919
Number of pages8
JournalPediatric Infectious Disease Journal
Volume25
Issue number10
DOIs
StatePublished - Oct 2006
Externally publishedYes

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Hepatitis A Vaccines
Vaccines
Pediatrics
Safety
Inactivated Poliovirus Vaccine
Oral Poliovirus Vaccine
Measles-Mumps-Rubella Vaccine
Hepatitis A
Antibody Formation
Diphtheria-Tetanus-acellular Pertussis Vaccines
Chickenpox Vaccine
Hepatitis A Antibodies
Mumps
Human Herpesvirus 3
Diphtheria
Poliovirus
Rubella
Tetanus
Measles
Hemagglutinins

Keywords

  • Hepatitis A vaccine
  • Immunization
  • Immunogenic
  • Pediatric vaccines

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)

Cite this

Safety, tolerability and immunogenicity of VAQTA given concomitantly versus nonconcomitantly with other pediatric vaccines in healthy 12-month-old children. / Guerra, Fernando A.; Gress, Jacqueline; Werzberger, Alan; Reisinger, Keith; Walter, Emmanuel; Lakkis, Hassan; Grosso, Anthony D.; Welebob, Carolee; Kuter, Barbara J.; Block, Stan; Chartrand, Stephen; Chatterjee, Archana; Santosham, Mathuram; Blumberg, Dean; Taylor, James A.; Keyserling, Harry; Sperling, Malcolm J.; Bocchini, Joseph; Murphey, Donald; Bostrum, Samantha; Gooch, W. Malcolm.

In: Pediatric Infectious Disease Journal, Vol. 25, No. 10, 10.2006, p. 912-919.

Research output: Contribution to journalArticle

Guerra, FA, Gress, J, Werzberger, A, Reisinger, K, Walter, E, Lakkis, H, Grosso, AD, Welebob, C, Kuter, BJ, Block, S, Chartrand, S, Chatterjee, A, Santosham, M, Blumberg, D, Taylor, JA, Keyserling, H, Sperling, MJ, Bocchini, J, Murphey, D, Bostrum, S & Gooch, WM 2006, 'Safety, tolerability and immunogenicity of VAQTA given concomitantly versus nonconcomitantly with other pediatric vaccines in healthy 12-month-old children', Pediatric Infectious Disease Journal, vol. 25, no. 10, pp. 912-919. https://doi.org/10.1097/01.inf.0000238135.01287.b9
Guerra, Fernando A. ; Gress, Jacqueline ; Werzberger, Alan ; Reisinger, Keith ; Walter, Emmanuel ; Lakkis, Hassan ; Grosso, Anthony D. ; Welebob, Carolee ; Kuter, Barbara J. ; Block, Stan ; Chartrand, Stephen ; Chatterjee, Archana ; Santosham, Mathuram ; Blumberg, Dean ; Taylor, James A. ; Keyserling, Harry ; Sperling, Malcolm J. ; Bocchini, Joseph ; Murphey, Donald ; Bostrum, Samantha ; Gooch, W. Malcolm. / Safety, tolerability and immunogenicity of VAQTA given concomitantly versus nonconcomitantly with other pediatric vaccines in healthy 12-month-old children. In: Pediatric Infectious Disease Journal. 2006 ; Vol. 25, No. 10. pp. 912-919.
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abstract = "BACKGROUND: The objective of this study is to assess whether hepatitis A vaccine is immunogenic and well tolerated when administered to 12-month-old children alone or concomitantly with other routinely administered pediatric vaccines. METHODS: Six hundred seventeen healthy 12-month-old children were randomized to receive dose 1 of hepatitis A vaccine given alone or concomitantly with measles-mumps-rubella vaccine and varicella vaccine and dose 2 of hepatitis A vaccine given alone or concomitantly with diphtheria-tetanus- acellular pertussis vaccine and optionally with oral or inactivated poliovirus vaccine. Participants were followed for clinical adverse experiences and serologic responses to all vaccine antigens. Antibody responses were compared with historical controls for some indices. RESULTS: The safety profile was generally comparable whether hepatitis A vaccine was administered alone or concomitantly with other vaccines. When administered alone, the hepatitis A seropositivity rate was 98.3{\%} and 100{\%} for dose 1 and dose 2, respectively, and after dose 2 was similar to historical rates and the geometric mean titers were similar between initially seropositive and initially seronegative subjects (6207 and 6810 mIU/mL, respectively). After concomitant administration with hepatitis A vaccine, antibody responses to measles, mumps, rubella, diphtheria, tetanus and filamentous hemagglutinin (98.8{\%}, 99.6{\%}, 100{\%}, 98.6{\%}, 100{\%} and 83.3{\%}, respectively) were similar to historical controls and response to poliovirus was demonstrated, but immune responses to varicella zoster virus (79{\%}) and pertussis toxoid (76{\%}) were inferior to historical controls. CONCLUSIONS: Hepatitis A vaccine is highly immunogenic and generally well tolerated when administered to healthy children as young as 12 months of age regardless of initial hepatitis A serostatus and can be administered concomitantly with measles-mumps-rubella vaccine and oral or inactivated poliovirus vaccine.",
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AU - Guerra, Fernando A.

AU - Gress, Jacqueline

AU - Werzberger, Alan

AU - Reisinger, Keith

AU - Walter, Emmanuel

AU - Lakkis, Hassan

AU - Grosso, Anthony D.

AU - Welebob, Carolee

AU - Kuter, Barbara J.

AU - Block, Stan

AU - Chartrand, Stephen

AU - Chatterjee, Archana

AU - Santosham, Mathuram

AU - Blumberg, Dean

AU - Taylor, James A.

AU - Keyserling, Harry

AU - Sperling, Malcolm J.

AU - Bocchini, Joseph

AU - Murphey, Donald

AU - Bostrum, Samantha

AU - Gooch, W. Malcolm

PY - 2006/10

Y1 - 2006/10

N2 - BACKGROUND: The objective of this study is to assess whether hepatitis A vaccine is immunogenic and well tolerated when administered to 12-month-old children alone or concomitantly with other routinely administered pediatric vaccines. METHODS: Six hundred seventeen healthy 12-month-old children were randomized to receive dose 1 of hepatitis A vaccine given alone or concomitantly with measles-mumps-rubella vaccine and varicella vaccine and dose 2 of hepatitis A vaccine given alone or concomitantly with diphtheria-tetanus- acellular pertussis vaccine and optionally with oral or inactivated poliovirus vaccine. Participants were followed for clinical adverse experiences and serologic responses to all vaccine antigens. Antibody responses were compared with historical controls for some indices. RESULTS: The safety profile was generally comparable whether hepatitis A vaccine was administered alone or concomitantly with other vaccines. When administered alone, the hepatitis A seropositivity rate was 98.3% and 100% for dose 1 and dose 2, respectively, and after dose 2 was similar to historical rates and the geometric mean titers were similar between initially seropositive and initially seronegative subjects (6207 and 6810 mIU/mL, respectively). After concomitant administration with hepatitis A vaccine, antibody responses to measles, mumps, rubella, diphtheria, tetanus and filamentous hemagglutinin (98.8%, 99.6%, 100%, 98.6%, 100% and 83.3%, respectively) were similar to historical controls and response to poliovirus was demonstrated, but immune responses to varicella zoster virus (79%) and pertussis toxoid (76%) were inferior to historical controls. CONCLUSIONS: Hepatitis A vaccine is highly immunogenic and generally well tolerated when administered to healthy children as young as 12 months of age regardless of initial hepatitis A serostatus and can be administered concomitantly with measles-mumps-rubella vaccine and oral or inactivated poliovirus vaccine.

AB - BACKGROUND: The objective of this study is to assess whether hepatitis A vaccine is immunogenic and well tolerated when administered to 12-month-old children alone or concomitantly with other routinely administered pediatric vaccines. METHODS: Six hundred seventeen healthy 12-month-old children were randomized to receive dose 1 of hepatitis A vaccine given alone or concomitantly with measles-mumps-rubella vaccine and varicella vaccine and dose 2 of hepatitis A vaccine given alone or concomitantly with diphtheria-tetanus- acellular pertussis vaccine and optionally with oral or inactivated poliovirus vaccine. Participants were followed for clinical adverse experiences and serologic responses to all vaccine antigens. Antibody responses were compared with historical controls for some indices. RESULTS: The safety profile was generally comparable whether hepatitis A vaccine was administered alone or concomitantly with other vaccines. When administered alone, the hepatitis A seropositivity rate was 98.3% and 100% for dose 1 and dose 2, respectively, and after dose 2 was similar to historical rates and the geometric mean titers were similar between initially seropositive and initially seronegative subjects (6207 and 6810 mIU/mL, respectively). After concomitant administration with hepatitis A vaccine, antibody responses to measles, mumps, rubella, diphtheria, tetanus and filamentous hemagglutinin (98.8%, 99.6%, 100%, 98.6%, 100% and 83.3%, respectively) were similar to historical controls and response to poliovirus was demonstrated, but immune responses to varicella zoster virus (79%) and pertussis toxoid (76%) were inferior to historical controls. CONCLUSIONS: Hepatitis A vaccine is highly immunogenic and generally well tolerated when administered to healthy children as young as 12 months of age regardless of initial hepatitis A serostatus and can be administered concomitantly with measles-mumps-rubella vaccine and oral or inactivated poliovirus vaccine.

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KW - Immunization

KW - Immunogenic

KW - Pediatric vaccines

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