Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
Assess the Immunogenicity of 3 Doses of Pediarix®, Prevnar® & ActHIB® Given to Healthy Infants When Administered With GSK Biologicals' 2 Dose Oral Live Attenuated Human Rotavirus Vaccine Given During the Same Vaccination Visit or Separately
1 other identifier
interventional
484
1 country
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2006
Shorter than P25 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 7, 2006
CompletedFirst Posted
Study publicly available on registry
June 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedNovember 4, 2016
November 1, 2016
8 months
June 7, 2006
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
Secondary Outcomes (1)
Assess immunogenicity and safety of HRV vaccine.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Benton, Arkansas, 72015, United States
GSK Investigational Site
Cabot, Arkansas, 72023, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
North Little Rock, Arkansas, 72117, United States
GSK Investigational Site
Lakewood, California, 90711, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
Pasadena, California, 91107, United States
GSK Investigational Site
Englewood, Colorado, 80112, United States
GSK Investigational Site
DeKalb, Illinois, 60115, United States
GSK Investigational Site
Overland Park, Kansas, 66202, United States
GSK Investigational Site
Commerce Twp, Michigan, 48382, United States
GSK Investigational Site
Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
Bryson City, North Carolina, 28713, United States
GSK Investigational Site
Clyde, North Carolina, 28721, United States
GSK Investigational Site
Deerfield, North Carolina, 28607, United States
GSK Investigational Site
Franklin, North Carolina, 28734, United States
GSK Investigational Site
Laurinburg, North Carolina, 28352, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Akron, Ohio, 44304, United States
GSK Investigational Site
Boardman, Ohio, 44512, United States
GSK Investigational Site
Dayton, Ohio, 45406, United States
GSK Investigational Site
Youngstown, Ohio, 44505, United States
GSK Investigational Site
Youngstown, Ohio, 44514, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
East Providence, Rhode Island, 02914, United States
GSK Investigational Site
Providence, Rhode Island, 02903, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Charleston, South Carolina, 29412, United States
GSK Investigational Site
North Charleston, South Carolina, 29405, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Bryan, Texas, 77802, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Ogden, Utah, 84405, United States
GSK Investigational Site
Orem, Utah, 84057, United States
GSK Investigational Site
Provo, Utah, 84604, United States
GSK Investigational Site
South Jordan, Utah, 84095, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
Charlottesville, Virginia, 22911, United States
GSK Investigational Site
Marshfield, Wisconsin, 54449, United States
Related Publications (1)
Dennehy PH, Bertrand HR, Silas PE, Damaso S, Friedland LR, Abu-Elyazeed R. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics. 2008 Nov;122(5):e1062-6. doi: 10.1542/peds.2008-1059.
PMID: 18977955BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2006
First Posted
June 8, 2006
Study Start
June 1, 2006
Primary Completion
February 1, 2007
Study Completion
June 1, 2007
Last Updated
November 4, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.