Safety Study of a Refrigerator-stable Formulation of VARIVAX®

Measles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432731
• Other study ID #: V210-061
• Secondary ID: X04-VAR-402
• Status: Completed
• Phase: Phase 4
• First received: February 7, 2007
• Last updated: March 10, 2017
• Start date: December 2004
• Est. completion date: September 2005

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 15 Months

Eligibility

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Measles
• Mumps
• Rubella
• Varicella

Intervention

Biological:
• VARIVAX®

• M-M-RTM II

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

France,  Italy,