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

Phase 4

Completed

• Conditions: Measles; Mumps; Chickenpox; Hepatitis A; Rubella
• Interventions: Biological: VAQTA®; Biological: ProQuad

• Registration Number: NCT00326183
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-12
• Study First Submitted QC: 2006-05-15
• Study First Posted: 2006-05-16
• Study Start: 2007-03-26
• Primary Completion: 2008-01-15
• Study Completion: 2008-01-15
• Results First Submitted: 2008-10-21
• Results First Submitted QC: 2008-11-18
• Results First Posted: 2008-11-20
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1800

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	VAQTA®	Arm 1: vaccine
2	VAQTA®	Arm 2: Active comparator
2	ProQuad	Arm 2: Active comparator

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Participants With 1 or More Systemic Adverse Experiences	Days 1 to 14 After Any Vaccination