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

This study has been completed.

First Received: December 1, 2006 Last Updated: October 9, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00406211

Purpose

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.

Condition	Intervention	Phase
Measles Mumps Rubella Varicella	Biological: MMRV Biological: MMR (Priorix®) Biological: Varicella (Varilrix®)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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®.

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Measles Mumps Rubella Shingles

Drug Information available for: Measles-Mumps-Rubella Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Estimated Enrollment:	480
Study Start Date:	July 2003
Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	12 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406211

Show 40 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	208136/039, 208136/040, 208136/041
Study First Received:	December 1, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00406211 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

Measles
Mumps
Rubella

Varicella
Germany
Austria

Additional relevant MeSH terms:

Mouth Diseases
Herpes Zoster
RNA Virus Infections
Morbillivirus Infections
Paramyxoviridae Infections
Measles
Rubulavirus Infections
Chickenpox
Rubella
Togaviridae Infections

Herpesviridae Infections
Virus Diseases
Rubivirus Infections
Parotid Diseases
DNA Virus Infections
Stomatognathic Diseases
Salivary Gland Diseases
Parotitis
Mumps
Mononegavirales Infections

ClinicalTrials.gov processed this record on February 08, 2010