Safety Study of a Refrigerator-stable Formulation of VARIVAX®
NCT ID: NCT00432731
Last Updated: 2017-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
500 participants
INTERVENTIONAL
2004-12-31
2005-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DOUBLE
Interventions
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VARIVAX®
M-M-RTM II
Eligibility Criteria
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Inclusion Criteria
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
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
12 Months
15 Months
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Anne FIQUET, MD
Role: STUDY_DIRECTOR
SPMSD
Locations
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Amboise, , France
Ancenis, , France
Betton, , France
Châteaubriant, , France
Courbevoie, , France
Essey-lès-Nancy, , France
Floirac, , France
Fougères, , France
Garches, , France
Gradignan, , France
Issy-les-Moulineaux, , France
Joué-les-Tours, , France
Libourne, , France
Lingolsheim, , France
Mérignac, , France
Nancy, , France
Paris, , France
Rueil-Malmaison, , France
Strasbourg, , France
Suresnes, , France
Tours, , France
Tresses, , France
Vandœuvre-lès-Nancy, , France
Villers-lès-Nancy, , France
Ragusa, , Italy
Countries
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References
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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.
Other Identifiers
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X04-VAR-402
Identifier Type: OTHER
Identifier Source: secondary_id
V210-061
Identifier Type: -
Identifier Source: org_study_id
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