Trial record 1 of 5 for:
varivax | Chicken Pox | merck | Phase 4
Safety Study of a Refrigerator-stable Formulation of VARIVAX®
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00432731 |
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Recruitment Status :
Completed
First Posted : February 8, 2007
Last Update Posted : March 14, 2017
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Varicella Measles Mumps Rubella | Biological: VARIVAX® Biological: M-M-RTM II | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double |
| 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. |
| Study Start Date : | December 2004 |
| Actual Primary Completion Date : | September 2005 |
| Actual Study Completion Date : | September 2005 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Shingles
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Months to 15 Months (Child) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Anne FIQUET, MD | SPMSD |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT00432731 |
| Other Study ID Numbers: |
V210-061 X04-VAR-402 ( Other Identifier: MCMVaccBV (SPMSD) Secondary ID ) |
| First Posted: | February 8, 2007 Key Record Dates |
| Last Update Posted: | March 14, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Merck Sharp & Dohme LLC:
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Prevention of : Varicella Measles Mumps Rubella |
Additional relevant MeSH terms:
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Chickenpox Varicella Zoster Virus Infection Measles Herpes Zoster Rubella Morbillivirus Infections Paramyxoviridae Infections Mononegavirales Infections |
RNA Virus Infections Virus Diseases Infections Herpesviridae Infections DNA Virus Infections Rubivirus Infections Togaviridae Infections |