Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

September 20, 2016 updated by: GlaxoSmithKline

Compare the Immunogenicity, Reactogenicity & Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine Given as a Two-dose Primary Vaccination in Healthy Infants Previously Uninfected With HRV

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. A new formulation of the vaccine, with an alternative buffer, was developed. This study will be conducted to evaluate the new formulation compared to the existing formulation of the HRV vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consists of four groups of children recruited in different centers in Finland. One group of children will receive the existing formulation of HRV vaccine and one group will receive the new formulation of the HRV vaccine. The other two groups will receive the placebo for existing formulation or the new formulation based on the allocation. The vaccine or placebo will be administered starting at 6 - 12 weeks of age according to 0, 1 month schedule. Routine childhood vaccinations are allowed according to local practice, but at least 14 days apart from each dose of study vaccine. The duration of the study will be approximately 2 months per child.

Study Type

Interventional

Enrollment

250

Phase

  • Phase 2

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

  • Finland
      • Lahti, Finland, 15140
        • GSK Investigational Site
      • Oulu, Finland, 90100
        • GSK Investigational Site
      • Pori, Finland, 28120
        • GSK Investigational Site
      • Tampere, Finland, 33200
        • GSK Investigational Site
      • Turku, Finland, 20520
        • 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:

  • Subjects with parents/guardians who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
  • Males or females between, and including, 6 and 12 weeks (42 - 90 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parents or guardians of the subjects.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of 36 to 42 weeks inclusive.

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.
  • Planned administration of a vaccine (including routine paediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device)
  • 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 clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition, as determined by the investigator.
  • History of allergic diseases or reactions likely to be exacerbated by any component of the vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
  • Major congenital defects or serious chronic illnesses.
  • Acute disease at time of enrolment. (Acute disease is defined as the presence of moderate or severe illness with or without fever, i.e. temperature >= 37.5°C as measured by an axillary thermometer or >= 38.0°C as measured by a rectal thermometer.) Temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  • Gastroenteritis (GE) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
  • Household contact with an immunosuppressed individual or pregnant woman.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  • Previous confirmed occurrence of RV GE.
  • History of neurological disorders or seizures.

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
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Endpoint: immunogenicity and reactogenicity
Proportion of subjects with vaccine take

Secondary Outcome Measures

Outcome Measure
Proportion of seroconverters
RV-IgA concentration
Occurrence of solicited symptoms: loss of appetite, fussiness/irritability, fever, diarrhea, vomiting, cough/runny nose
Unsolicited symptoms and serious adverse events (SAEs)

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

August 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104480 (Other Identifier: GSK)

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. Informed Consent Form
    Information identifier: 104480
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: 104480
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: 104480
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 104480
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: 104480
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: 104480
    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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