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

Merck Sharp & Dohme LLC1,800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,800

Conditions

Hepatitis A Measles Mumps Rubella Chickenpox

Interventions

VAQTA®BIOLOGICAL

0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.

ProQuadBIOLOGICAL

0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 17 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Participants With 1 or More Serious Vaccine-Related Adverse Experiences

Time frame: Days 1 to 14 after any vaccination

Participants With 1 or More Injection-Site Adverse Experiences

Time frame: Days 1 to 14 after any vaccination

Participants With Measles-Like Rash After First Vaccination

Time frame: Days 1 to 28 After First Vaccination

Participants With Measles-Like Rash After Second Vaccination

Time frame: Days 1 to 28 After Second Vaccination

Participants With Mumps-Like Symptoms After First Vaccination

Time frame: Days 1 to 28 After First Vaccination

Participants With Mumps-Like Symptoms After Second Vaccination

Time frame: Days 1 to 28 After Second Vaccination

Participants With Rubella-Like Rash After First Vaccination

Time frame: Days 1 to 28 After First Vaccination

Participants With Rubella-Like Rash After Second Vaccination

Time frame: Days 1 to 28 After Second Vaccination

Participants With Varicella/Zoster-Like Rash After First Vaccination

Time frame: Days 1 to 28 After First Vaccination

Participants With Varicella/Zoster-Like Rash After Second Vaccination

Time frame: Days 1 to 28 After Second Vaccination

Participants With Elevated Temperature (>=102.2F/39.0C)

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes