Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00289172
First received: February 8, 2006
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of the first dose.


Condition Intervention Phase
Rotavirus Gastroenteritis
Biological: Live attenuated human rotavirus vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Multicenter Study of the Immunogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (RIX4414) as Primary Dosing of Healthy Infants in India Aged Approximately 8 Wks at the Time of the First Dose

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.

Secondary Outcome Measures:
  • Fever, vomiting, diarrhea. Solicited symptoms. Unsolicited events. SAEs. Presence of rotavirus in GE stools.

Estimated Enrollment: 360
Study Start Date: February 2006
Study Completion Date: September 2006
Intervention Details:
    Biological: Live attenuated human rotavirus vaccine
    Other Name: Live attenuated human rotavirus vaccine
Detailed Description:

The study consists of two groups of children to be recruited in different centers in India. One group will receive the HRV vaccine and one group will receive the placebo. The vaccine or placebo will be administered starting at 8-12 weeks of age, according to a two dose schedule (0, 1 months schedule). The study will consist of three visits. A 8-day (Day 0 - 7) follow-up period will be observed for general symptoms solicited in the study. A 31-day (Day 0 - 30) follow-up will be observed for other unsolicited symptoms. Serious adverse events (SAEs) will be followed-up throughout the study. A stool sample will be collected from the child at any point during the study if he/ she develops any GE.

  Eligibility

Ages Eligible for Study:   8 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

"Inclusion criteria:

  • A male or female between, and including, 8 and 10 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • The subjects should have been administered the first dose of DTP/ OPV/ hepatitis B vaccines as per the local universal immunization program at 6 weeks of age.

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine or the routine UIP vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
  • Any chronic drug therapy to be continued during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 6 weeks of the first dose of vaccine or planned administration during the study of a vaccine not foreseen by the study protocol, with the exception of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), OPV and vaccination against tuberculosis, which can be given with at least two weeks separation from the first and subsequent dose of the study vaccine.
  • Prior administration of experimental rotavirus vaccine.
  • History of confirmed rotavirus gastroenteritis.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection based on physical examination (no laboratory testing is required).
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Gastroenteritis (diarrhea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins via breastfeeding is allowed.
  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: NCT00289172

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00289172     History of Changes
Other Study ID Numbers: 103792
Study First Received: February 8, 2006
Last Updated: October 14, 2010
Health Authority: India: Drugs Controller General of India (DCGI)

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014