Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00406211
First received: December 1, 2006
Last updated: November 8, 2012
Last verified: November 2012
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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 3 |
| 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:
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, 24937 | |
| GSK Investigational Site | |
| Flensburg, Schleswig-Holstein, Germany, 24943 | |
| 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.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| 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: | November 8, 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 May 16, 2013