WHO ICTRP trial

A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the…

EUCTR2006-006204-11-PL · EU Clinical Trials Register

Key facts

Trial ID EUCTR2006-006204-11-PL
Public title A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine - Manufacturing scale study
Scientific title A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine - Manufacturing scale study
Primary sponsor Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Registry EU Clinical Trials Register
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Poland
Conditions Healthy infants
Interventions Product Name: 13vPnC pilot scale Product Code: 6096A1 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Pneumococcal polysaccharide serotype 1 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal…
Registration date Dec 4, 2007
Secondary IDs 6096A1-3000;N/A
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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