Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes

Phase 3

Completed

• Conditions: Measles; Mumps; Rubella; Varicella

• Registration Number: NCT00351923
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-07-12
• Study First Submitted QC: 2006-07-12
• Study First Posted: 2006-07-13
• Study Completion: 2006-12
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-09
• Last Update Posted: 2008-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Children must be healthy and have a birth weight > 2000 g to participate

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Exclusion Criteria

• confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
• Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
• Children must have received one dose (but not more) of MMR and of varicella 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 within 30 days before vaccination.
• Children must not have had measles, mumps, rubella or varicella/zoster, 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
Seroconversion rates after vaccination

Secondary Outcome Measures

Name	Time	Method
Antibody titres; safety: solicited local/ general, unsolicited AEs (42 days), SAEs (whole study)

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Worms, Rheinland-Pfalz, Germany