Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine - Full Text View

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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 [ Designated as safety issue: No ]
Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination [ Designated as safety issue: No ]

Enrollment:	398
Study Start Date:	July 2004
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

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

Locations

Austria
GSK Investigational Site
Klagenfurt, Austria, A-9020
GSK Investigational Site
Neufeld/Leitha, Austria, A 2491
GSK Investigational Site
Salzburg, Austria, A-5020
GSK Investigational Site
Villach, Austria, A-9500
Germany
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
GSK Investigational Site
Marktredwitz, Bayern, Germany, 95615
GSK Investigational Site
Olching, Bayern, Germany, 82140
GSK Investigational Site
Tegernsee, Bayern, Germany, 83684
GSK Investigational Site
Tutzing, Bayern, Germany, 82327
GSK Investigational Site
Bad Camberg, Hessen, Germany, 65520
GSK Investigational Site
Fulda, Hessen, Germany, 36037
GSK Investigational Site
Hochheim, Hessen, Germany, 65239
GSK Investigational Site
Marburg/Lahn, Hessen, Germany, 35039
GSK Investigational Site
Nidderau, Hessen, Germany, 61130
GSK Investigational Site
Ruesselsheim, Hessen, Germany, 65428
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65205
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33332
GSK Investigational Site
Kirchlengern, Nordrhein-Westfalen, Germany, 32278
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48159
GSK Investigational Site
Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
GSK Investigational Site
Bad Sobernheim, Rheinland-Pfalz, Germany, 55566
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Gau-Algesheim, Rheinland-Pfalz, Germany, 55435
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
GSK Investigational Site
Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
GSK Investigational Site
Altenholz, Schleswig-Holstein, Germany, 24161
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
GSK Investigational Site
Brunsbuettel, Schleswig-Holstein, Germany, 25541
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
GSK Investigational Site
Neumuenster, Schleswig-Holstein, Germany, 24534

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

Zepp F et al. Persistence of Functional Antibodies against Mumps Remains High One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella (MMRV) Vaccine in the Second Year of Life. Presented at 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.

Knuf M, Faber J, Barth I, Habermehl P. A combination vaccine against measles, mumps, rubella and varicella. Drugs Today (Barc). 2008 Apr;44(4):279-92. Review.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00406211 History of Changes
Other Study ID Numbers:	208136/039, 208136/040, 208136/041
Study First Received:	December 1, 2006
Last Updated:	January 12, 2012
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

Rubella
Varicella
Measles

Mumps
Germany
Austria

Additional relevant MeSH terms:

Chickenpox
Herpes Zoster
Measles
Mumps
Parotitis
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections

Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on February 09, 2012