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NCT00432731
A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.
Phase 4 trial testing VARIVAX® in Varicella in 500 participants. Completed in 1 September 2005.
1 September 2005
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Enrollment | 500 |
| Start date | 1 December 2004 |
| Primary completion | 1 September 2005 |
| Estimated completion | 1 September 2005 |
| Sites | 25 locations across France, Italy |
Drugs / interventions tested
- VARIVAX®
- M-M-RTM II — full drug profile →
Conditions studied
- Varicella — all drugs for Varicella →
- Measles — all drugs for Measles →
- Mumps — all drugs for Mumps →
- Rubella — all drugs for Rubella →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
Adults 12 Months to 15 Months, any sex, with Varicella or Measles. Healthy volunteers can join.
Sponsor's own description
Primary objective: To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination. Secondary objectives: NA
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00432731
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of VARIVAX®
Trials testing the same drug.
- NCT00197015 — Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children · Phase 3 · completed
Other recruiting trials for Varicella
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT05669625 — A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine · Phase 3 · active not recruiting
- NCT04471493 — Pediatric and Ambulatory Research in Infectious Diseases · recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
- NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
- NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
- NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
- NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
- NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · 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 NCT00432731 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
- Last refreshed: 10 March 2017
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/NCT00432731.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing