Safety Study of a Refrigerator-Stable Formulation of VARIVAX®
This study has been completed.
Sponsor:
Sanofi Pasteur MSD
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00432731
First received: February 7, 2007
Last updated: April 3, 2009
Last verified: April 2009
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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:
Eligibility| Ages Eligible for Study: | 12 Months to 15 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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:
|
Chickenpox Herpes Zoster Measles Mumps Rubella Herpesviridae Infections DNA Virus Infections Virus Diseases Morbillivirus Infections Paramyxoviridae Infections |
Mononegavirales Infections RNA Virus Infections Rubulavirus Infections Parotitis Parotid Diseases Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Rubivirus Infections Togaviridae Infections |
ClinicalTrials.gov processed this record on May 19, 2013