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.
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2008-23-01
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:
- 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.
Subjects with a live twin living in the same household who is also enrolled in this study.
Exclusion criteria:
- 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.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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.
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