Last updated: 11/03/2018 08:46:14

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

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GSK study ID
106260
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Clinicaltrials.gov ID
NCT00396630
See results summary
EudraCT ID
2015-001542-29
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Presence of rotavirus vaccine strain in any stool sample from twin receiving placebo.

Timeframe: 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:

Duration of human rotavirus (HRV) shedding per study group.

Timeframe: 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.

Timeframe: 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.

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

Anti-rotavirus immunoglobulin A (IgA) antibody seroconversion.

Timeframe: At Visit 3 (Week 13).

Anti-rotavirus IgA antibody concentration.

Timeframe: At Visit 3 (Week 13).

Number of subjects with gastroenteritis (GE) and rotavirus gastroenteritis (RV GE) episodes.

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

Number of subjects reporting unsolicited adverse events (AEs).

Timeframe: Within 31 days after any doses.

Number of subjects reporting any Serious Adverse Events (SAEs).

Timeframe: Up to Visit 4.

Interventions:
  • Biological/vaccine: Rotarix
  • Biological/vaccine: Placebo
    • Enrollment:
    200
    Primary completion date:
    2008-23-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Rivera L et al. (2011) Horizontal transmission of a human rotavirus vaccine strain- a randomized, placebo-controlled study in twins. Vaccine. 29(51):9508-9513.
    Buyse H et al. (2013) The human rotavirus vaccine Rotarix™ in infants: An integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 10(1). [Epub ahead of print]
    Rivera L et al. (2011) Horizontal transmission of a human rotavirus vaccine strain-a randomized, placebo-controlled study in twins. Vaccine. 29(51):9508-9513.
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    January 2007 to February 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 14 weeks
    Accepts healthy volunteers
    Yes
    • 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,
    • 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).
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Santo Domingo, Dominican Republic
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-23-01
    Actual study completion date
    2008-13-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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