Phase 3
N=200
A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
Infections, Rotavirus
Bottom Line
View on ClinicalTrials.gov: NCT00396630 ↗Enrolled (actual)
200
Serious AEs
5.5%
Results posted
Mar 2009
Primary outcome: Primary: Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. — 15 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rotarix (Biological); Placebo (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. |
15 | — |
| SECONDARY Duration of Human Rotavirus (HRV) Shedding Per Study Group. |
17; 7; 13; 1 | — |
| SECONDARY Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission. |
0; 0 | — |
| SECONDARY Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission. |
3 | — |
| SECONDARY Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion. |
50; 17 | — |
| SECONDARY Anti-rotavirus IgA Antibody Concentration. |
78.6; 20.5 | — |
| SECONDARY Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes. |
32; 31; 10; 6 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs). |
69; 71 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs). |
5; 6 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00396630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.