Safety Study of a Refrigerator-stable Formulation of VARIVAX®

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: VARIVAX®; Biological: M-M-RTM II

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432731

V210-061

X04-VAR-402 (Other Identifier)

Details and patient eligibility

About

Primary objective:

To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.

Secondary objectives: NA

Sex: All

Ages: 12 to 15 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy infants from 12 months of age to 15 months of age.
2. Consent form signed by both parents or by the legal representative(s), properly informed about the study,
3. Parent(s) able to understand the protocol requirements and to fill in the Diary Card.

Exclusion criteria

1. Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
2. Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
3. Any known recent (≤30 days) exposure to measles, mumps or rubella,
4. Any known recent (≤30 days) exposure to varicella or zoster involving:
5. Any recent (≤3 days) history of febrile illness (rectal temperature ≥38.0°C),
6. Active untreated tuberculosis,
7. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
8. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
9. Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 3,
10. Any recent receipt of an inactivated or a live vaccine (≤ 30 days) or scheduled vaccination through visit 3