Last updated: 11/03/2018 09:39:31
Study of 2 doses of HRV vaccine given concomitantly or separately with routine vaccinations in healthy infants in USA
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: 2-dose oral live attenuated G1P[8] human rotavirus vaccine
Enrollment:
484
Observational study model:
Not applicable
Primary completion date:
2007-08-02
Time perspective:
Not applicable
Clinical publications:
Dennehy PH et al. (2008) 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. 122(5):e1062-1066.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
June 2006 to June 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 16 weeks
Accepts healthy volunteers
Yes
- Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.
- 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;
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.
Exclusion criteria:
- 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.
Trial location(s)
Location
GSK Investigational Site
Bryson, North Carolina, United States, 28713
Status
Study Complete
Location
GSK Investigational Site
South Jordan, Utah, United States, 84095
Status
Study Complete
Location
GSK Investigational Site
Benton, Arkansas, United States, 72015
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02903
Status
Study Complete
Location
GSK Investigational Site
Deerfield, North Carolina, United States, 28607
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
North Charleston, South Carolina, United States, 29405
Status
Study Complete
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Study Complete
Location
GSK Investigational Site
Clyde, North Carolina, United States, 28721
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22911
Status
Study Complete
Location
GSK Investigational Site
Youngstown, Ohio, United States, 44505
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Englewood, Colorado, United States, 80112
Status
Study Complete
Location
GSK Investigational Site
Youngstown, Ohio, United States, 44514
Status
Study Complete
Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
Status
Study Complete
Location
GSK Investigational Site
DeKalb, Illinois, United States, 60115
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Franklin, North Carolina, United States, 28734
Status
Study Complete
Location
GSK Investigational Site
Laurinburg, North Carolina, United States, 28352
Status
Study Complete
Location
GSK Investigational Site
Paramount, California, United States, 90723
Status
Study Complete
Location
GSK Investigational Site
Pasadena, California, United States, 91107
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29412
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66202
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84088
Status
Study Complete
Location
GSK Investigational Site
North Little Rock, Arkansas, United States, 72117
Status
Study Complete
Location
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Commerce Twp, Michigan, United States, 48382
Status
Study Complete
Location
GSK Investigational Site
Lakewood, California, United States, 90711
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2007-08-02
Actual study completion date
2007-17-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website