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

NCT ID: NCT00406211

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2004-12-31

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.

Conditions

Rubella; Varicella; Mumps; Measles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

MMRV

Intervention Type: BIOLOGICAL

MMR (Priorix®)

Intervention Type: BIOLOGICAL

Varicella (Varilrix®)

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Klagenfurt, , Austria

GSK Investigational Site

Neufeld/Leitha, , Austria

GSK Investigational Site

Salzburg, , Austria

GSK Investigational Site

Villach, , Austria

GSK Investigational Site

Bindlach, Bavaria, Germany

GSK Investigational Site

Marktredwitz, Bavaria, Germany

GSK Investigational Site

Olching, Bavaria, Germany

GSK Investigational Site

Tegernsee, Bavaria, Germany

GSK Investigational Site

Tutzing, Bavaria, Germany

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

GSK Investigational Site

Bad Camberg, Hesse, Germany

GSK Investigational Site

Fulda, Hesse, Germany

GSK Investigational Site

Hochheim am Main, Hesse, Germany

GSK Investigational Site

Marburg/Lahn, Hesse, Germany

GSK Investigational Site

Nidderau, Hesse, Germany

GSK Investigational Site

Rüsselsheim am Main, Hesse, Germany

GSK Investigational Site

Wiesbaden, Hesse, Germany

GSK Investigational Site

Salzgitter, Lower Saxony, Germany

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

GSK Investigational Site

Detmold, North Rhine-Westphalia, Germany

GSK Investigational Site

Gütersloh, North Rhine-Westphalia, Germany

GSK Investigational Site

Kirchlengern, North Rhine-Westphalia, Germany

GSK Investigational Site

Löhne, North Rhine-Westphalia, Germany

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

GSK Investigational Site

Bad Kreuznach, Rhineland-Palatinate, Germany

GSK Investigational Site

Bad Sobernheim, Rhineland-Palatinate, Germany

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

GSK Investigational Site

Gau-Algesheim, Rhineland-Palatinate, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Schoeneberg - Kuebelberg, Rhineland-Palatinate, Germany

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

GSK Investigational Site

Altenholz, Schleswig-Holstein, Germany

GSK Investigational Site

Bredstedt, Schleswig-Holstein, Germany

GSK Investigational Site

Brunsbüttel, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Husum, Schleswig-Holstein, Germany

GSK Investigational Site

Neumünster, Schleswig-Holstein, Germany

Countries

Austria; Germany

References

Habermehl P, Zepp F, Sänger R, Otto W, Helm K, Meister N, Knuf M, Kindler K, Willems P. Assessment of Varicella Breakthrough Cases One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella Vaccine in the Second Year of Life. Abstract presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.

Reference Type: BACKGROUND

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. doi: 10.1358/dot.2008.44.4.1210755.

Reference Type: BACKGROUND

PMID: 18536786 (View on PubMed)

Knuf M, Zepp F, Helm K, Maurer H, Prieler A, Kieninger-Baum D, Douha M, Willems P. Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Eur J Pediatr. 2012 Mar;171(3):463-70. doi: 10.1007/s00431-011-1569-4. Epub 2011 Sep 21.

Reference Type: BACKGROUND

PMID: 21935584 (View on PubMed)

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.

Reference Type: BACKGROUND

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

208136/040

Identifier Type: -

Identifier Source: secondary_id

208136/041

Identifier Type: -

Identifier Source: secondary_id

208136/039

Identifier Type: -

Identifier Source: org_study_id