Phase 4
N=1,800
Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
Hepatitis A · Measles · Mumps · Rubella · Chickenpox
Bottom Line
View on ClinicalTrials.gov: NCT00326183 ↗Enrolled (actual)
1,800
Serious AEs
—
Results posted
Nov 2008
Primary outcome: Primary: Participants With 1 or More Serious Vaccine-Related Adverse Experiences — 0; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- VAQTA® (Biological); ProQuad (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With 1 or More Serious Vaccine-Related Adverse Experiences |
0; 1 | — |
| PRIMARY Participants With 1 or More Injection-Site Adverse Experiences |
701; 164 | — |
| PRIMARY Participants With Measles-Like Rash After First Vaccination |
13 | — |
| PRIMARY Participants With Measles-Like Rash After Second Vaccination |
5 | — |
| PRIMARY Participants With Mumps-Like Symptoms After First Vaccination |
— | — |
| PRIMARY Participants With Mumps-Like Symptoms After Second Vaccination |
— | — |
| PRIMARY Participants With Rubella-Like Rash After First Vaccination |
1 | — |
| PRIMARY Participants With Rubella-Like Rash After Second Vaccination |
— | — |
| PRIMARY Participants With Varicella/Zoster-Like Rash After First Vaccination |
— | — |
| PRIMARY Participants With Varicella/Zoster-Like Rash After Second Vaccination |
— | — |
| PRIMARY Participants With Elevated Temperature (>=102.2F/39.0C) |
56; 13 | — |
| SECONDARY Participants With 1 or More Systemic Adverse Experiences |
782; 197 | — |
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.
Eligibility Criteria
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 ( 100.3 degrees F [>37.9 degrees C] oral equivalent) prior to study vaccination.
Data sourced from ClinicalTrials.gov (NCT00326183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.