Safety Study of a Refrigerator-stable Formulation of VARIVAX®
A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.
2 other identifiers
interventional
500
2 countries
25
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2004
Shorter than P25 for phase_4
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 7, 2007
CompletedFirst Posted
Study publicly available on registry
February 8, 2007
CompletedMarch 14, 2017
March 1, 2017
9 months
February 7, 2007
March 10, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Amboise, France
Unknown Facility
Ancenis, France
Unknown Facility
Betton, France
Unknown Facility
Châteaubriant, France
Unknown Facility
Courbevoie, France
Unknown Facility
Essey-lès-Nancy, France
Unknown Facility
Floirac, France
Unknown Facility
Fougères, France
Unknown Facility
Garches, France
Unknown Facility
Gradignan, France
Unknown Facility
Issy-les-Moulineaux, France
Unknown Facility
Joué-les-Tours, France
Unknown Facility
Libourne, France
Unknown Facility
Lingolsheim, France
Unknown Facility
Mérignac, France
Unknown Facility
Nancy, France
Unknown Facility
Paris, France
Unknown Facility
Rueil-Malmaison, France
Unknown Facility
Strasbourg, France
Unknown Facility
Suresnes, France
Unknown Facility
Tours, France
Unknown Facility
Tresses, France
Unknown Facility
Vandœuvre-lès-Nancy, France
Unknown Facility
Villers-lès-Nancy, France
Unknown Facility
Ragusa, Italy
Related Publications (1)
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.
PMID: 19305145DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anne FIQUET, MD
SPMSD
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2007
First Posted
February 8, 2007
Study Start
December 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
March 14, 2017
Record last verified: 2017-03