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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00396630
First received: November 6, 2006
Last updated: April 1, 2009
Last verified: March 2009
History of Changes
  Purpose

The aim of this study is to explore horizontal transmission of the human rotavirus (HRV) 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.


Condition Intervention Phase
Rotavirus Gastroenteritis
 Biological: Rotarix
Biological: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis
Drug Information available for: Rotarix
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. [ 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Human Rotavirus (HRV) Shedding Per Study Group. [ Time Frame: From Day 0 up to Week 13 ] [ Designated as safety issue: No ]
  • Analysis by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission. [ Time Frame: During the entire study period. ] [ Designated as safety issue: No ]
  • Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission. [ Time Frame: During the entire study period. ] [ Designated as safety issue: No ]
  • Anti-Rotavirus Immunoglobulin A (IgA) Antibody Seroconversion. [ Time Frame: At Visit 3 (Week 13). ] [ Designated as safety issue: No ]
  • Anti-Rotavirus IgA Antibody Concentration. [ Time Frame: At Visit 3 (Week 13). ] [ Designated as safety issue: No ]
  • Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes. [ Time Frame: Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE. ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: Within 31 days after any doses. ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Any Serious Adverse Events (SAEs). [ Time Frame: Up to Visit 4. ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group B Biological: Placebo
Two-dose oral administration.
Experimental: Group A Biological: Rotarix
Two-dose oral vaccination.

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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 14 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 enrollment.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396630

Locations
Dominican Republic
GSK Investigational Site
Santo Domingo, Dominican Republic
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00396630     History of Changes
Other Study ID Numbers: 106260
Study First Received: November 6, 2006
Results First Received: February 13, 2009
Last Updated: April 1, 2009
Health Authority: Dominican Republic: Secretaria de Estado de Salud Pública y Asistencia Social (SESPAS)
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
rotavirus
Gastroenteritis
HRV vaccine
Shedding
Transmission

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013