Safety Study of a Refrigerator-Stable Formulation of VARIVAX®

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00432731
First received: February 7, 2007
Last updated: April 3, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Varicella
Measles
Mumps
Rubella
Biological: VARIVAX®
Biological: M-M-RTM II
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Estimated Enrollment: 500
Study Start Date: December 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432731

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
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD SPMSD
  More Information

No publications provided by Sanofi Pasteur MSD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00432731     History of Changes
Other Study ID Numbers: X04-VAR-402
Study First Received: February 7, 2007
Last Updated: April 3, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency

Keywords provided by Sanofi Pasteur MSD:
Prevention of : Varicella
Measles
Mumps
Rubella

Additional relevant MeSH terms:
Rubella
Rubivirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 15, 2014