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

NCT00396630 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 106260
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Rotavirus

Keywords

Transmission; Gastroenteritis; Shedding; rotavirus; HRV vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (8)

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

  From Day 0 up to Week 13.

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

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

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

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

• Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.

  At Visit 3 (Week 13).

• Anti-rotavirus IgA Antibody Concentration.

  At Visit 3 (Week 13).

Study Arms (2)

Rotarix Group

EXPERIMENTAL

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).

Biological: Rotarix

Placebo Group

PLACEBO COMPARATOR

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).

Biological: Rotarix; Biological: Placebo

Interventions

Rotarix BIOLOGICAL

Two-dose oral vaccination.

Placebo Group; Rotarix Group

Placebo BIOLOGICAL

Two-dose oral administration.

Placebo Group

Eligibility Criteria

• Age: 6 Weeks - 14 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Santo Domingo, Dominican Republic

Location

Related Publications (1)

• 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.

  PMID: 22008819 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Rotavirus Infections; Gastroenteritis

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 7, 2006
• Study Start: January 23, 2007
• Primary Completion: January 23, 2008
• Study Completion: February 13, 2008
• Last Updated: February 6, 2018
• Results First Posted: March 13, 2009

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

DO (1)