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NCT00406211
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®.
Phase 3 trial testing MMRV in Rubella in 398 participants. Completed in 1 December 2004.
1 December 2004
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 398 |
| Start date | 1 July 2004 |
| Primary completion | 1 December 2004 |
| Estimated completion | 1 December 2004 |
| Sites | 41 locations across Austria, Germany |
Drugs / interventions tested
- MMRV — full drug profile →
- MMR (Priorix®) — full drug profile →
- Varicella (Varilrix®) — full drug profile →
Conditions studied
- Rubella — all drugs for Rubella →
- Varicella — all drugs for Varicella →
- Mumps — all drugs for Mumps →
- Measles — all drugs for Measles →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 12 Months to 18 Months, any sex, with Rubella or Varicella. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- 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
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children.
Knuf M, Zepp F, Helm K, Maurer H, et al · · 2012 · cited 14× · PMID 21935584 · DOI 10.1007/s00431-011-1569-4
Verify or expand the search:
- PubMed search for NCT00406211
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MMRV
Trials testing the same drug.
- NCT07406360 — A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, · Phase 3 · not yet recruiting
Other recruiting trials for Rubella
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00406211 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 14 September 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00406211.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing