A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

NCT ID: NCT00396630

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-23
• Study Completion Date: 2008-02-13

Brief Summary

The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator.

One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study.

The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo.

The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.

Conditions

Infections, Rotavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Rotarix Group

All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).

Group Type: EXPERIMENTAL

Rotarix

Intervention Type: BIOLOGICAL

Two-dose oral vaccination.

Placebo Group

All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).

Group Type: PLACEBO_COMPARATOR

Rotarix

Intervention Type: BIOLOGICAL

Two-dose oral vaccination.

Placebo

Intervention Type: BIOLOGICAL

Two-dose oral administration.

Interventions

Rotarix

Two-dose oral vaccination.

Intervention Type: BIOLOGICAL

Placebo

Two-dose oral administration.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects with a live twin living in the same household who is also enrolled in this study.
• Born after a gestation period of ≥32 weeks,
• Discharged from hospital neonatal care stay,
• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 6 and 14 weeks of age at the time of the first study vaccination.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Written informed consent obtained from the parent or guardian of the subjects.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Any clinically significant history of chronic gastrointestinal disease.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at time of enrolment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Contact with an immunosuppressed individual.
• 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 of immunosuppressants since birth.
• Gastroenteritis within 7 days preceding the first study vaccine administration.
• Documented HIV-positive subject.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 14 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Santo Domingo, , Dominican Republic

Countries

Dominican Republic

References

Rivera L, Pena LM, Stainier I, Gillard P, Cheuvart B, Smolenov I, Ortega-Barria E, Han HH. Horizontal transmission of a human rotavirus vaccine strain--a randomized, placebo-controlled study in twins. Vaccine. 2011 Nov 28;29(51):9508-13. doi: 10.1016/j.vaccine.2011.10.015. Epub 2011 Oct 18.

Reference Type: BACKGROUND

PMID: 22008819 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

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

View Document

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: Statistical Analysis Plan

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: Annotated Case Report Form

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

View Document

Related Links

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

106260

Identifier Type: -

Identifier Source: org_study_id