Clinical trial NCT00326183: Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis A
Measles
Mumps
Rubella
Chickenpox
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-05-16
Enrollment: 1800
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 (\<72 hours) febrile illness (\>100.3 degrees F \[\>37.9 degrees C\] oral equivalent) prior to study vaccination.

Primary outcomes:
measure: Participants With 1 or More Serious Vaccine-Related Adverse Experiences
timeFrame: Days 1 to 14 after any vaccination
measure: Participants With 1 or More Injection-Site Adverse Experiences
timeFrame: Days 1 to 14 after any vaccination
measure: Participants With Measles-Like Rash After First Vaccination
timeFrame: Days 1 to 28 After First Vaccination
measure: Participants With Measles-Like Rash After Second Vaccination
timeFrame: Days 1 to 28 After Second Vaccination
measure: Participants With Mumps-Like Symptoms After First Vaccination
timeFrame: Days 1 to 28 After First Vaccination
measure: Participants With Mumps-Like Symptoms After Second Vaccination
timeFrame: Days 1 to 28 After Second Vaccination
measure: Participants With Rubella-Like Rash After First Vaccination
timeFrame: Days 1 to 28 After First Vaccination
measure: Participants With Rubella-Like Rash After Second Vaccination
timeFrame: Days 1 to 28 After Second Vaccination
measure: Participants With Varicella/Zoster-Like Rash After First Vaccination
timeFrame: Days 1 to 28 After First Vaccination
measure: Participants With Varicella/Zoster-Like Rash After Second Vaccination
timeFrame: Days 1 to 28 After Second Vaccination
measure: Participants With Elevated Temperature (>=102.2F/39.0C)
timeFrame: Days 1 to 5 After Any Vaccination
Secondary outcomes:
measure: Participants With 1 or More Systemic Adverse Experiences
timeFrame: Days 1 to 14 After Any Vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Petrecz M, Acosta CJ, Klopfer SO, Kuter BJ, Goveia MG, Stek JE, Schodel FP, Lee AW. Safety and immunogenicity of VAQTA(R) in children 12-to-23 months of age with and without administration of other US pediatric vaccines. Hum Vaccin Immunother. 2019;15(2):426-432. doi: 10.1080/21645515.2018.1530934. Epub 2018 Nov 15.