An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 653
- Primary Endpoint
- Antibody Response to Hepatitis A - Participants With a Serological Response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 12 Months to 15 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
1
Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.
Intervention: Comparator: VAQTA™ (Hepatitis A vaccine) (Biological)
1
Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.
Intervention: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine) (Biological)
1
Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.
Intervention: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine) (Biological)
2
Arm 2: ProQuad™ 0.5 mL injection (2 doses ~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.
Intervention: Comparator: VAQTA™ (Hepatitis A vaccine) (Biological)
2
Arm 2: ProQuad™ 0.5 mL injection (2 doses ~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.
Intervention: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine) (Biological)
2
Arm 2: ProQuad™ 0.5 mL injection (2 doses ~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.
Intervention: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine) (Biological)
Outcomes
Primary Outcomes
Antibody Response to Hepatitis A - Participants With a Serological Response
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Participants With 1 or More Systemic Adverse Experience
Time Frame: 6 weeks post dose 1
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 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.
Participants With 1 or More Injection-site Adverse Experience
Time Frame: 6 weeks post dose 1
Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Time Frame: 6 weeks post dose 1
Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Time Frame: 4 weeks post dose 2
Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Participants With 1 or More Injection-site Adverse Experience
Time Frame: 4 weeks post dose 2
Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Participants With 1 or More Serious Vaccine-related Adverse Experience
Time Frame: 6 weeks post dose 1
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
Participants With 1 or More Serious Vaccine-related Adverse Experience
Time Frame: 4 weeks post dose 2
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 Outcomes
No secondary outcomes reported