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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 4

Conditions

Rubella

Hepatitis A

Mumps

Measles

Chickenpox

Treatments

Biological: ProQuad

Biological: VAQTA®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00326183

V251-066

2006_023

Details and patient eligibility

About

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.

Enrollment

1,800 patients

Sex

All

Ages

12 to 17 months old

Volunteers

Accepts Healthy Volunteers

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.