A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00432380
First received: February 6, 2007
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.


Condition Intervention Phase
Rotavirus Gastroenteritis
Biological: HRV liquid vaccine (GSK 357941A)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine (GSK 357941A) in Healthy Infants.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-rotavirus IgA antibody seroconversion at Month 3.

Secondary Outcome Measures:
  • Solicited symptoms (Day 0-7); unsolicited Adverse Events(Day 0-30); Serious Adverse Events(full study)
  • Presence of RV in gastroenteritis (GE) stools.

Estimated Enrollment: 375
Study Start Date: March 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: HRV liquid vaccine (GSK 357941A)
    Other Name: HRV liquid vaccine (GSK 357941A)
  Eligibility

Ages Eligible for Study:   5 Weeks to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo.
  • Birth weight of the subject should be > 2000 grams.
  • Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after. BCG is administered at birth according to the local EPI.
  • Concurrently participating in another clinical study, at any time during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432380

Locations
Philippines
GSK Investigational Site
Muntinlupa, Philippines
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00432380     History of Changes
Other Study ID Numbers: 109216
Study First Received: February 6, 2007
Last Updated: September 29, 2011
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by GlaxoSmithKline:
Placebo
Double blind
Gastroenteritis
Randomized
Oral live attenuated human rotavirus liquid vaccine

Additional relevant MeSH terms:
Gastroenteritis
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 21, 2014