CompletedPhase 4

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

1,800 participantsStarted 2007-03-26

Plain-language 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.

Who can participate

Age range12 Months – 17 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Participants With 1 or More Serious Vaccine-Related Adverse Experiences

Timeframe: Days 1 to 14 after any vaccination

Participants With 1 or More Injection-Site Adverse Experiences

Timeframe: Days 1 to 14 after any vaccination

Participants With Measles-Like Rash After First Vaccination

Timeframe: Days 1 to 28 After First Vaccination

Participants With Measles-Like Rash After Second Vaccination

Timeframe: Days 1 to 28 After Second Vaccination

Participants With Mumps-Like Symptoms After First Vaccination

Timeframe: Days 1 to 28 After First Vaccination

Participants With Mumps-Like Symptoms After Second Vaccination

Timeframe: Days 1 to 28 After Second Vaccination

Participants With Rubella-Like Rash After First Vaccination

Timeframe: Days 1 to 28 After First Vaccination

Participants With Rubella-Like Rash After Second Vaccination

Trial details

NCT IDNCT00326183

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01-15

Results submitted2008-10-21

View on ClinicalTrials.gov More Hepatitis A trials

Who can participate

Age range12 Months – 17 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Participants With 1 or More Serious Vaccine-Related Adverse Experiences

Timeframe: Days 1 to 14 after any vaccination

Participants With 1 or More Injection-Site Adverse Experiences

Timeframe: Days 1 to 14 after any vaccination

Participants With Measles-Like Rash After First Vaccination

Timeframe: Days 1 to 28 After First Vaccination

Participants With Measles-Like Rash After Second Vaccination

Timeframe: Days 1 to 28 After Second Vaccination

Participants With Mumps-Like Symptoms After First Vaccination

Timeframe: Days 1 to 28 After First Vaccination

Participants With Mumps-Like Symptoms After Second Vaccination

Timeframe: Days 1 to 28 After Second Vaccination

Participants With Rubella-Like Rash After First Vaccination

Timeframe: Days 1 to 28 After First Vaccination

Participants With Rubella-Like Rash After Second Vaccination