Safety Study of a Refrigerator-stable Formulation of VARIVAX®

March 10, 2017 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

500

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Amboise, France
  - Ancenis, France
  - Betton, France
  - Chateaubriant, France
  - Courbevoie, France
  - Essey les Nancy, France
  - Floirac, France
  - Fougères, France
  - Garches, France
  - Gradignan, France
  - Issy Les Moulineaux, France
  - Joué-les-Tours, France
  - Libourne, France
  - Lingolsheim, France
  - Merignac, France
  - Nancy, France
  - Paris, France
  - Rueil Malmaison, France
  - Strasbourg, France
  - Suresnes, France
  - Tours, France
  - Tresses, France
  - Vandoeuvre les Nancy, France
  - Villers les Nancy, France
Italy
- - Ragusa, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

Study Director: Anne FIQUET, MD, SPMSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ferrera G, Gajdos V, Thomas S, Tran C, Fiquet A. Safety of a refrigerator-stable varicella vaccine (VARIVAX) in healthy 12- to 15-month-old children: A randomized, double-blind, cross-over study. Hum Vaccin. 2009 Jul;5(7):455-60. doi: 10.4161/hv.8269. Epub 2009 Jul 23.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

February 7, 2007

First Submitted That Met QC Criteria

February 7, 2007

First Posted (Estimate)

February 8, 2007

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

V210-061
X04-VAR-402 (Other Identifier: MCMVaccBV (SPMSD) Secondary ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.