Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™

Phase 2

Completed

• Conditions: Varicella; Measles; Mumps; Rubella

• Registration Number: NCT00353288
• Lead Sponsor: GlaxoSmithKline

Brief Summary

As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-18
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

• Children must be healthy to participate

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Exclusion Criteria

• Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
• Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study.
• They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
• Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination.
• Children must not have been vaccinated against varicella.
• They must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start.
• New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Varicella seroconversion and MMR titres at 42-56 days after first vaccination

Secondary Outcome Measures

Name	Time	Method
Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)

Trial Locations

Locations (1)

GSK Investigational Site; 🇮🇹 Sassari, Sardegna, Italy