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 range

12 Months – 17 Months

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

12 Months – 17 Months

Sex

ALL

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