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Trial record 1 of 5 for:    varivax | Chicken Pox | merck | Phase 4
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Safety Study of a Refrigerator-stable Formulation of VARIVAX®

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
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : March 14, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

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

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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

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

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

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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
Ragusa, Italy
Sponsors and Collaborators
Merck Sharp & Dohme LLC
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Study Director: Anne FIQUET, MD SPMSD
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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:
Prevention of : Varicella
Additional relevant MeSH terms:
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Varicella Zoster Virus Infection
Herpes Zoster
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections