Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA

Completed · Phase 3

Conditions studied: Infections, Rotavirus

In brief

The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.

Key facts

Study ID

NCT00334607

Run by

GlaxoSmithKline

People needed

484

Starts

2006-06-01

Expected to finish

2007-06-01

Last updated by the study team

2016-11-04

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

You may not qualify if…

• Allergic reaction to vaccine components;
• clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
• immunocompromised.

Where it is running

• GSK Investigational Site — Benton, Arkansas, United States
• GSK Investigational Site — Cabot, Arkansas, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — North Little Rock, Arkansas, United States
• GSK Investigational Site — Lakewood, California, United States
• GSK Investigational Site — Paramount, California, United States
• GSK Investigational Site — Pasadena, California, United States
• GSK Investigational Site — Englewood, Colorado, United States
• GSK Investigational Site — DeKalb, Illinois, United States
• GSK Investigational Site — Overland Park, Kansas, United States
• GSK Investigational Site — Commerce Twp, Michigan, United States
• GSK Investigational Site — Lebanon, New Hampshire, United States
• GSK Investigational Site — Bryson City, North Carolina, United States
• GSK Investigational Site — Clyde, North Carolina, United States
• GSK Investigational Site — Deerfield, North Carolina, United States
• GSK Investigational Site — Franklin, North Carolina, United States
• GSK Investigational Site — Laurinburg, North Carolina, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Akron, Ohio, United States
• GSK Investigational Site — Boardman, Ohio, United States
• GSK Investigational Site — Dayton, Ohio, United States
• GSK Investigational Site — Youngstown, Ohio, United States
• GSK Investigational Site — Youngstown, Ohio, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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