Phase 3
N=765
Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
Infections, Rotavirus · Rotavirus Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT00480324 ↗Enrolled (actual)
765
Serious AEs
15.2%
Results posted
Nov 2010
Primary outcome: Primary: Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains — 14; 34 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
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains |
14; 34 | — |
| SECONDARY Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains |
2; 12 | — |
| SECONDARY Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type |
4; 13; 1; 6 | — |
| SECONDARY Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types |
10; 21; 1; 6 | — |
| SECONDARY Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains |
1; 2 | — |
| SECONDARY Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains |
14; 36; 2; 13 | — |
| SECONDARY Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration |
217.0; 0 | — |
| SECONDARY Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies |
29; 1 | — |
| SECONDARY Number of Subjects Reporting Solicited Symptoms |
184; 92; 43; 14; 62; 22 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
279; 144 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
72; 44 | — |
Summary
This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
- 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
- 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 subject.
- Born between a gestation period of 36 and 42 weeks inclusive.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
- History of use of experimental rotavirus vaccine.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- 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).
- Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Previous confirmed occurrence of RV GE.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
- A family history of congenital or hereditary immunodeficiency.
- Acute disease at the time of enrolment.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT00480324). 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.