Long-Term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Long-Term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine

Official Title ^†

Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-Dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.

Brief Summary

Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany & Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination

Secondary Outcome Measure ^†

Condition ^†

Measles
Mumps
Rubella
Varicella

Intervention ^†

Biological: MMRV
Biological: MMR (Priorix®)
Biological: Varicella (Varilrix®)

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

480

Start Date ^†

July 2003

Completion Date

December 2006

Eligibility Criteria ^†

Inclusion Criteria:

Written informed consent from the parents/guardians of the child before participating in the long-term follow-up.
Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study.
Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.

Exclusion Criteria:

Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.

Gender

Both

Ages

12 Months to 18 Months

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Austria, Germany

Administrative Information Fields

NCT ID ^†

NCT00406211

Organization ID

208136/039

Secondary IDs ^††

208136/040, 208136/041

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

First Received Date ^†

December 1, 2006

Last Updated Date

October 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.