Safety Study of a Refrigerator-stable Formulation of VARIVAX®

A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00432731

Enrollment

500

Registered

2007-02-08

Start date

2004-12-31

Completion date

2005-09-30

Last updated

2017-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicella, Measles, Mumps, Rubella

Keywords

Prevention of : Varicella, Measles, Mumps, Rubella

Brief summary

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

Interventions

BIOLOGICALVARIVAX®

BIOLOGICALM-M-RTM II

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Months to 15 Months

Healthy volunteers

Yes

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

Countries

France, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026