Trial intelligence / Profile preview

RotaTeq in healthy infants in India

NCT00496054Phase 3Completed

Sponsor
Merck & Co.
Start
May 2008
Primary completion
Oct 2008
Modality
Live Biotherapeutic Products, Vaccines & Immunotherapeutics
01

Overview

Phase 3, open-label, single-arm trial of rotavirus vaccine, live, oral, pentavalent in rotavirus gastroenteritis, sponsored by Merck & Co. Primary endpoints: Percentage of Participants Who Exhibit a 3 Fold Rise or Greater in Rotavirus Specific Serum IgA at 6 months, Percentage of Participants Who Exhibit 3 Fold Rise Responses or Greater in G1 Serum Neutralizing Antibodies at 6 months and 10 more. Started May 2008; status: completed.

02

Drugs

rotavirus vaccine, live, oral, pentavalent
03

Conditions

rotavirus gastroenteritis

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