Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)

Study Overview
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Brief Summary
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Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data will be collected following each vaccination.

Official Title
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An Open, Multicenter Study of the Safety and Tolerability of VAQTA(TM) and ProQuad(TM) in Healthy Children 12 to 23 Months of Age

Conditions
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Hepatitis A, Measles, Mumps, Rubella, Chickenpox

Intervention / Treatment
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* Biological: VAQTA®
* Biological: ProQuad


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Negative clinical history of hepatitis A, measles, mumps, rubella, varicella (chickenpox), and/or zoster No other vaccinations scheduled to be administered at the time of the first or second doses of VAQTA(TM) and ProQuad(TM) Exclusion Criteria: Previously vaccinated with any hepatitis A vaccine, measles, mumps, rubella, and/or varicella vaccine either alone or in any combination History of allergy to any vaccine component History of seizure disorder Immunosuppressed including congenial and acquired conditions and immunosuppressive therapy Known severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injections Recent (<72 hours) febrile illness (>100.3 degrees F [>37.9 degrees C] oral equivalent) prior to study vaccination.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 17 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: vaccine | Biological: VAQTA®<br>* 0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.<br>* Other names: V251;|
| Active Comparator: 2<br>Arm 2: Active comparator | Biological: VAQTA®<br>* 0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.<br>* Other names: V251;Biological: ProQuad<br>* 0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With 1 or More Serious Vaccine-Related Adverse Experiences |  | Days 1 to 14 after any vaccination | 
| Participants With 1 or More Injection-Site Adverse Experiences |  | Days 1 to 14 after any vaccination | 
| Participants With Measles-Like Rash After First Vaccination |  | Days 1 to 28 After First Vaccination | 
| Participants With Measles-Like Rash After Second Vaccination |  | Days 1 to 28 After Second Vaccination | 
| Participants With Mumps-Like Symptoms After First Vaccination |  | Days 1 to 28 After First Vaccination | 
| Participants With Mumps-Like Symptoms After Second Vaccination |  | Days 1 to 28 After Second Vaccination | 
| Participants With Rubella-Like Rash After First Vaccination |  | Days 1 to 28 After First Vaccination | 
| Participants With Rubella-Like Rash After Second Vaccination |  | Days 1 to 28 After Second Vaccination | 
| Participants With Varicella/Zoster-Like Rash After First Vaccination |  | Days 1 to 28 After First Vaccination | 
| Participants With Varicella/Zoster-Like Rash After Second Vaccination |  | Days 1 to 28 After Second Vaccination | 
| Participants With Elevated Temperature (>=102.2F/39.0C) |  | Days 1 to 5 After Any Vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With 1 or More Systemic Adverse Experiences |  | Days 1 to 14 After Any Vaccination |