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A double-blind, randomised, controlled, multi-centre safety study of a refrigerator-stable formulation of VARIVAX® in healthy 12 to 15 month-old infants.

A double-blind, randomised, controlled, multi-centre safety study of a refrigerator-stable formulation of VARIVAX® in healthy 12 to 15 month-old infants.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002669-19-IT
Enrollment
Unknown
Registered
2005-06-07
Start date
2004-12-23
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active immunisation against varicella MedDRA version: 6.1 Level: PT Classification code 10046980

Interventions

Trade Name: VARIVAX*SC 1 FL 0,5ML+1F SOL Product Name: NA Product Code: NA Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Varicella, live attenuated Concentr

Sponsors

AVENTIS PASTEUR MSD S.P.A.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026