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

Primary Purpose

Infections, Rotavirus

Status

Completed

Phase

Phase 3

Locations

Dominican Republic

Study Type

Interventional

Intervention

Rotarix

Placebo

About this trial

This is an interventional prevention trial for Infections, Rotavirus focused on measuring Transmission, Gastroenteritis, Shedding, rotavirus, HRV vaccine

Eligibility Criteria

6 Weeks - 14 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rotarix Group

Placebo Group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.

Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.

Secondary Outcome Measures

Duration of Human Rotavirus (HRV) Shedding Per Study Group.

Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.

Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.

Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences.

Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.

Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission.

Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.

Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.

Anti-rotavirus IgA Antibody Concentration.

Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.

Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.

GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting. RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA).

Number of Subjects Reporting Unsolicited Adverse Events (AEs).

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Number of Subjects Reporting Any Serious Adverse Events (SAEs).

A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Full Information

NCT ID

NCT00396630

First Posted

November 6, 2006

Last Updated

January 9, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00396630

Brief Title

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

Official Title

A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

January 23, 2007 (Actual)

Primary Completion Date

January 23, 2008 (Actual)

Study Completion Date

February 13, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Rotavirus

Keywords

Transmission, Gastroenteritis, Shedding, rotavirus, HRV vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rotarix Group

Arm Type

Experimental

Arm Description

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Rotarix

Intervention Description

Two-dose oral vaccination.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Two-dose oral administration.

Primary Outcome Measure Information:

Title

Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.

Description

Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.

Time Frame

On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.

Secondary Outcome Measure Information:

Title

Duration of Human Rotavirus (HRV) Shedding Per Study Group.

Description

Time Frame

From Day 0 up to Week 13.

Title

Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.

Description

Time Frame

During the entire study period (up to Visit 4, Week 17).

Title

Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.

Description

Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission.

Time Frame

During the entire study period (up to Visit 4, Week 17).

Title

Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.

Description

Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.

Time Frame

At Visit 3 (Week 13).

Title

Anti-rotavirus IgA Antibody Concentration.

Description

Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.

Time Frame

At Visit 3 (Week 13).

Title

Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.

Description

Time Frame

Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.

Title

Number of Subjects Reporting Unsolicited Adverse Events (AEs).

Description

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time Frame

Within 31 days after any doses.

Title

Number of Subjects Reporting Any Serious Adverse Events (SAEs).

Description

Time Frame

Up to Visit 4.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

14 Weeks

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Santo Domingo

Country

Dominican Republic

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

22008819

Citation

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.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106260

Available IPD/Information Comments

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

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106260

Available IPD/Information Comments

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

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106260

Available IPD/Information Comments

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

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106260

Available IPD/Information Comments

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

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106260

Available IPD/Information Comments

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

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106260

Available IPD/Information Comments

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

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

106260

Available IPD/Information Comments

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

Learn more about this trial

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

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