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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hepatitis A Virus

Intervention / Treatment
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* Biological: Comparator: VAQTA™ (Hepatitis A vaccine)
* Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
* Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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. | Biological: Comparator: VAQTA™ (Hepatitis A vaccine)<br>* VAQTA™ 0.5 mL injection<br>Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)<br>* ProQuad™ 0.5 mL injection<br>Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)<br>* Prevnar™ 0.5 mL injection<br>|
| Active Comparator: 2<br>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. | Biological: Comparator: VAQTA™ (Hepatitis A vaccine)<br>* VAQTA™ 0.5 mL injection<br>Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)<br>* ProQuad™ 0.5 mL injection<br>Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)<br>* Prevnar™ 0.5 mL injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Response to Hepatitis A - Participants With a Serological Response | Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus | 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) | 
| Antibody Response to Varicella - Participants With a Serological Response | 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) | 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) | 
| Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers | Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay | 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) | 
| Participants With 1 or More Systemic Adverse Experience | 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. | 6 weeks post dose 1 | 
| Participants With 1 or More Systemic Adverse Experience | 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. | 4 weeks post dose 2 | 
| Participants With 1 or More Systemic Adverse Experience. | 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 | 6 months | 
| Participants With 1 or More Injection-site Adverse Experience | 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. | 6 weeks post dose 1 | 
| Participants With 1 or More Injection-site Adverse Experience | 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. | 4 weeks post dose 2 | 
| Participants With 1 or More Injection-site Adverse Experience | 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. | 6 months | 
| Participants With Elevated Temperature (≥102.2F/ ≥39.0C) | 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. | 6 weeks post dose 1 | 
| Participants With Elevated Temperature (≥102.2F/ ≥39.0C) | 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. | 4 weeks post dose 2 | 
| Participants With Elevated Temperature (≥102.2F/ ≥39.0C) | 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. | 6 months | 
| Participants With 1 or More Serious Vaccine-related Adverse Experience | 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 | 6 weeks post dose 1 | 
| Participants With 1 or More Serious Vaccine-related Adverse Experience | 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 | 4 weeks post dose 2 | 
| Participants With 1 or More Serious Vaccine-related Adverse Experience | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis A Virus