Clinical trial NCT00432731: Safety Study of a Refrigerator-stable Formulation of VARIVAX®
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Varicella
Measles
Mumps
Rubella
Keywords: Prevention of : Varicella
Measles
Mumps
Rubella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-02-08
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Amboise
country: France
city: Ancenis
country: France
city: Betton
country: France
city: Chateaubriant
country: France
city: Courbevoie
country: France
city: Essey les Nancy
country: France
city: Floirac
country: France
city: Fougères
country: France
city: Garches
country: France
city: Gradignan
country: France
city: Issy Les Moulineaux
country: France
city: Joué-les-Tours
country: France
city: Libourne
country: France
city: Lingolsheim
country: France
city: Merignac
country: France
city: Nancy
country: France
city: Paris
country: France
city: Rueil Malmaison
country: France
city: Strasbourg
country: France
city: Suresnes
country: France
city: Tours
country: France
city: Tresses
country: France
city: Vandoeuvre les Nancy
country: France
city: Villers les Nancy
country: France
city: Ragusa
country: Italy
Study officials:
affiliation: SPMSD
name: Anne FIQUET, MD
role: STUDY_DIRECTOR
References:
citation: 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.