Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

September 15, 2016 updated by: GlaxoSmithKline

Phase II, Double-blind, Randomized, Placebo-controlled Study of 2 Doses of GSK Biologicals' Live Attenuated Human Rotavirus Vaccine at Different Virus Concentrations (10 5.2 and 10 6.4 Ffu) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.

This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All subjects enrolled from Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset).

The third dose of IPV vaccine (IPOL) may be given at visit 3, 4 or another time, at the investigator's discretion.

Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of Comvax administered according to the prescribing information.

Study Type

Interventional

Enrollment (Actual)

529

Phase

  • Phase 2

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 child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parents or guardians of the subject.
  • Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
  • Planned administration of a vaccine (including routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of vaccine(s) and ending 14 days after. Hepatitis B vaccine given concomitantly or within 14 days before and after vaccination is not an exclusion criteria.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • History of diphtheria, tetanus, pertussis, polio, Hib disease and/or invasive pneumococcal infection. History of invasive pneumococcal infection is not an exclusion criteria for Canadian subjects.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and/or Streptococcus pneumoniae. Previous vaccination against Streptococcus pneumoniae is not an exclusion criteria for Canadian subjects.
  • Use of antibiotics within 7 days preceding dose 1.
  • 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.
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
  • Acute disease at time of enrollment.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Household contact with an immunosuppressed individual or pregnant women.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  • Previous confirmed occurrence of rotavirus gastroenteritis.
  • Inability to contact parents/guardians of the subject by telephone.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group C
Biological: Prevnar
Three-dose intramuscular injection (US subjects only)
Biological: IPOL
Two-dose intramuscular injection (US subjects only)
Biological: Infanrix
Three-dose intramuscular injection (US subjects only)
Biological: OmniHIB
Three-dose intramuscular injection (US subjects only)
Other Names:
  • ActHIB
Biological: Pentacel
Three-dose intramuscular injection (Canada only)
Experimental: Group A
Human Rotavirus Vaccine - Formulation 1
Biological: Human Rotavirus Vaccine - two different formulations
Two oral doses
Biological: Prevnar
Three-dose intramuscular injection (US subjects only)
Biological: IPOL
Two-dose intramuscular injection (US subjects only)
Biological: Infanrix
Three-dose intramuscular injection (US subjects only)
Biological: OmniHIB
Three-dose intramuscular injection (US subjects only)
Other Names:
  • ActHIB
Biological: Pentacel
Three-dose intramuscular injection (Canada only)
Experimental: Group B
Human Rotavirus Vaccine - Formulation 2
Biological: Human Rotavirus Vaccine - two different formulations
Two oral doses
Biological: Prevnar
Three-dose intramuscular injection (US subjects only)
Biological: IPOL
Two-dose intramuscular injection (US subjects only)
Biological: Infanrix
Three-dose intramuscular injection (US subjects only)
Biological: OmniHIB
Three-dose intramuscular injection (US subjects only)
Other Names:
  • ActHIB
Biological: Pentacel
Three-dose intramuscular injection (Canada only)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with vaccine take
Time Frame: Two months after the second dose
Two months after the second dose
Occurrence of any grade 2 or 3 fever, vomiting or diarrhea
Time Frame: Within the 15-day solicited follow-up period after any dose of study vaccine.
Within the 15-day solicited follow-up period after any dose of study vaccine.

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of each type of solicited symptoms
Time Frame: Within the 15-day solicited follow-up period after any dose of study vaccine
Within the 15-day solicited follow-up period after any dose of study vaccine
Occurrence of unsolicited symptoms according to WHO classification.
Time Frame: Within 42 days after dose 1 and dose 2
Within 42 days after dose 1 and dose 2
Occurrence of serious adverse events
Time Frame: Throughout the entire study period
Throughout the entire study period
Serum rotavirus immunoglobulin A (IgA) antibody titers
Time Frame: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
Rotavirus seropositivity status
Time Frame: Before dose 1 and at the end of the study
Before dose 1 and at the end of the study
Vaccine take (for pilot efficacy subset only)
Time Frame: 2 months after dose 1
2 months after dose 1
Anti- polyribosyl-ribitol phosphate (PRP), anti-diphtheria and anti-tetanus toxoids, anti- pertussis toxoid (PT), anti- filamentous haemagglutinin (FHA), anti- pertactin (PRN), anti-polio type 1, 2 and 3 antibody concentrations
Time Frame: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Antibody concentrations to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Time Frame: Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
Anti-PRP, anti-diphtheria, anti-tetanus, anti-polio type 1, 2 and 3 seroprotection status.
Time Frame: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Anti-PT, anti-FHA, anti-PRN, pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (only in US subjects) seropositivity status.
Time Frame: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Seropositivity status and Geometric mean titres (GMTs) of rotavirus IgA for breast fed infants compared with formula fed infants
Time Frame: Two months after dose 2.
Two months after dose 2.
Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects)
Time Frame: Two weeks after dose 2 until the end of the rotavirus season following vaccination.
Two weeks after dose 2 until the end of the rotavirus season following vaccination.

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

November 1, 2000

Primary Completion (Actual)

September 1, 2002

Study Completion (Actual)

September 1, 2002

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 444563/005

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. Dataset Specification
    Information identifier: 444563/005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: 444563/005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 444563/005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 444563/005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: 444563/005
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: 444563/005
    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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