Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00334607
First received: June 7, 2006
Last updated: February 2, 2012
Last verified: January 2012
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Purpose
Detailed 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.
Condition | Intervention | Phase |
---|---|---|
Rotavirus Gastroenteritis |
Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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 |
Resource links provided by NLM:
MedlinePlus related topics:
Gastroenteritis
Drug Information available for:
Rotarix
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
Secondary Outcome Measures:
- Assess immunogenicity and safety of HRV vaccine.
Enrollment: | 484 |
Study Start Date: | June 2006 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals' two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age).
Eligibility
Ages Eligible for Study: | 6 Weeks to 16 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334607
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Show 42 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
Publications:
Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
ClinicalTrials.gov Identifier: | NCT00334607 History of Changes |
Other Study ID Numbers: | 107531 |
Study First Received: | June 7, 2006 |
Last Updated: | February 2, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
HRV vaccine diarrhoea rotavirus |
Additional relevant MeSH terms:
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on October 16, 2012