Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live Safety Study
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis A; Measles; Mumps; Rubella; Chickenpox
Intervention: VAQTA® (Biological); ProQuad (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
Official title: An Open, Multicenter Study of the Safety and Tolerability of VAQTA(TM) and ProQuad(TM) in Healthy Children 12 to 23 Months of Age
Study design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Primary outcome: vaccine-related serious adverse experiences, injection-site adverse experiences (redness, swelling, pain, rash), measles-like rash, mumps-like symptoms, rubella-like rash, & varicella/zoster-like rash, distribution of maximum temperature postvaccination.
Secondary outcome: all other systemic adverse experiences & injection-site adverse experiences.
Eligibility
Minimum age: 12 Months.
Maximum age: 17 Months.
Gender(s): Both.
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 (<72 hours) febrile illness (>100. 3 degrees F [>37. 9 degrees C] oral
equivalent) prior to study vaccination.
Locations and Contacts
Additional Information
Starting date: May 2006
Ending date: October 2007
Last updated: December 20, 2007
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