Immunogenicity, Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00353288

First received: July 17, 2006

Last updated: October 9, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

July 17, 2006

Last Updated Date

October 9, 2008

Start Date ^ICMJE

March 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00353288 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Immunogenicity, Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™

Official Title ^ICMJE

Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-Mumps-Rubella Vaccine (Priorix™) co-Administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-Mumps-Rubella Vaccine

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Measles
Mumps
Rubella
Varicella

Intervention ^ICMJE

Biological: MeMuRu-OKA (study vacc)
Biological: MMR, Varicella vacc (control)
Other Names:
- MeMuRu-OKA (study vacc)
- MMR, Varicella vacc (control)

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

446

Completion Date

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children must be healthy to participate

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.

Gender

Both

Ages

15 Months to 6 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France, Germany, Italy

Administrative Information

NCT Number ^ICMJE

NCT00353288

Other Study ID Numbers ^ICMJE

105908

Has Data Monitoring Committee

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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