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

May 26, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarth, India, Oin-160 012
        • GSK Investigational Site
      • Kolkata, India, 700010
        • GSK Investigational Site
      • Pune, India, 411 011
        • GSK Investigational Site
      • Vellore,, India, 632002
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

"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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Fever, vomiting, diarrhea. Solicited symptoms. Unsolicited events. SAEs. Presence of rotavirus in GE stools.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 10, 2006

Study Completion (Actual)

September 8, 2006

Study Registration Dates

First Submitted

February 8, 2006

First Submitted That Met QC Criteria

February 8, 2006

First Posted (Estimate)

February 9, 2006

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103792

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: 103792
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: 103792
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 103792
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 103792
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: 103792
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: 103792
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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