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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00396630
First received: November 6, 2006
Last updated: November 3, 2016
Last verified: November 2016
  Purpose
The aim of this study is to explore horizontal transmission of the 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
Infections, Rotavirus
Biological: Rotarix
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:


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. ]
    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. [ Time Frame: From Day 0 up to Week 13 ]
    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.

  • Analysis by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission. [ Time Frame: During the entire study period. ]
  • Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission. [ Time Frame: During the entire study period. ]
  • Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion. [ Time Frame: At Visit 3 (Week 13). ]
    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. [ Time Frame: At Visit 3 (Week 13). ]
    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. [ Time Frame: Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE. ]

    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). [ Time Frame: Within 31 days after any doses. ]
    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). [ Time Frame: Up to Visit 4. ]

    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.



Enrollment: 200
Study Start Date: January 2007
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).

Biological: Rotarix
Two-dose oral vaccination.
Placebo Comparator: 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).

Biological: Placebo
Two-dose oral administration.

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   (Child)
Sexes Eligible for Study:   All
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 106260
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 106260
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 106260
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 106260
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 106260
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 106260
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 106260
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
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: November 3, 2016
Individual Participant Data  
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
Transmission
Gastroenteritis
Shedding
rotavirus
HRV vaccine

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 20, 2017