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

NCT ID: NCT00729001

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

529 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2002-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infections, Rotavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A

Human Rotavirus Vaccine - Formulation 1

Group Type EXPERIMENTAL

Human Rotavirus Vaccine - two different formulations

Intervention Type BIOLOGICAL

Two oral doses

Prevnar

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (US subjects only)

IPOL

Intervention Type BIOLOGICAL

Two-dose intramuscular injection (US subjects only)

Infanrix

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (US subjects only)

OmniHIB

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (US subjects only)

Pentacel

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (Canada only)

Group B

Human Rotavirus Vaccine - Formulation 2

Group Type EXPERIMENTAL

Human Rotavirus Vaccine - two different formulations

Intervention Type BIOLOGICAL

Two oral doses

Prevnar

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (US subjects only)

IPOL

Intervention Type BIOLOGICAL

Two-dose intramuscular injection (US subjects only)

Infanrix

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (US subjects only)

OmniHIB

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (US subjects only)

Pentacel

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (Canada only)

Group C

Group Type PLACEBO_COMPARATOR

Prevnar

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (US subjects only)

IPOL

Intervention Type BIOLOGICAL

Two-dose intramuscular injection (US subjects only)

Infanrix

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (US subjects only)

OmniHIB

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (US subjects only)

Pentacel

Intervention Type BIOLOGICAL

Three-dose intramuscular injection (Canada only)

Interventions

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Human Rotavirus Vaccine - two different formulations

Two oral doses

Intervention Type BIOLOGICAL

Prevnar

Three-dose intramuscular injection (US subjects only)

Intervention Type BIOLOGICAL

IPOL

Two-dose intramuscular injection (US subjects only)

Intervention Type BIOLOGICAL

Infanrix

Three-dose intramuscular injection (US subjects only)

Intervention Type BIOLOGICAL

OmniHIB

Three-dose intramuscular injection (US subjects only)

Intervention Type BIOLOGICAL

Pentacel

Three-dose intramuscular injection (Canada only)

Intervention Type BIOLOGICAL

Other Intervention Names

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ActHIB

Eligibility Criteria

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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.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* 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.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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Dennehy PH; North American Human Rotavirus Vaccine Study Group. A short report on the highlights of world-wide development of RIX4414: a North American experience comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine (RIX4414) in infants in the United States and Canada. Vaccine. 2006 May 1;24(18):3780-1. doi: 10.1016/j.vaccine.2005.07.030. Epub 2005 Aug 1.

Reference Type BACKGROUND
PMID: 16111790 (View on PubMed)

Dennehy PH, Brady RC, Halperin SA, Ward RL, Alvey JC, Fischer FH Jr, Innis BL, Rathfon H, Schuind A, De Vos B; North American Human Rotavirus Vaccine Study Group. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infect Dis J. 2005 Jun;24(6):481-8. doi: 10.1097/01.inf.0000164763.55558.71.

Reference Type BACKGROUND
PMID: 15933555 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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444563/005

Identifier Type: -

Identifier Source: org_study_id

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