Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
- Conditions
- Hepatitis A Virus
- Registration Number
- NCT00312858
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella \[Oka/Merck\] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.
- Detailed Description
Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTA™) administered with Measles, Mumps, Rubella and Varicella Vaccine (ProQuad™) and Pneumococcal 7-Valent Conjugate Vaccine (Prevnar™) will have a Duration of Treatment: 2 Doses, 6 months apart.
Vaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 653
- 12- to 15-month-old males and females with no active liver disease
- A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster
- Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine
- Any immune deficiency
- History of allergy to any of the vaccine components
- History of any seizure disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Antibody Response to Hepatitis A - Participants With a Serological Response 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
Antibody Response to Varicella - Participants With a Serological Response 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) Participants with varicella baseline antibody titer \<1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay
Participants With 1 or More Systemic Adverse Experience 4 weeks post dose 2 Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.
Participants With 1 or More Systemic Adverse Experience. 6 months Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart
Participants With 1 or More Injection-site Adverse Experience 6 months Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Participants With Elevated Temperature (≥102.2F/ ≥39.0C) 6 months Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Participants With 1 or More Serious Vaccine-related Adverse Experience 6 months Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
- Secondary Outcome Measures
Name Time Method