Last updated: 07/17/2024 15:12:12
Efficacy, safety, reactogenicity & immunogenicity of the Rotarix vaccine in Japanese infants
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Efficacy, safety, reactogenicity and immunogenicity study of the lyophilised formulation of Rotarix vaccine in healthy Japanese infants
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects reporting any rotavirus (RV) gastroenteritis (GE) leading to medical intervention and caused by the circulating wild-type RV strains
Timeframe: From 2 weeks after Dose 2 up to 2 years of age
Secondary outcomes:
Number of subjects reporting severe rotavirus (RV) gastroenteritis (GE) leading to medical intervention and caused by the circulating wild-type RV strains
Timeframe: From 2 weeks after Dose 2 up to 2 years of age
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
Timeframe: From 2 weeks after Dose 2 up to 2 years of age
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
Timeframe: From 2 weeks after Dose 2 up to 2 years of age
Number of subjects hospitalized due to rotavirus (RV) gastroenteritis (GE) caused by the circulating wild-type RV strains
Timeframe: From 2 weeks after Dose 2 up to 2 years of age
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
Timeframe: From Dose 1 up to 2 years of age
Serum anti-rotavirus immunoglobulin A (IgA) antibody concentration
Timeframe: 2 months after Dose 2
Number of subjects seroconverted for anti-rotavirus immunoglobulin A (IgA) antibodies
Timeframe: 2 months after Dose 2
Number of subjects reporting solicited symptoms
Timeframe: During the 8-day follow-up period after each dose
Number of subjects reporting unsolicited adverse events (AEs)
Timeframe: During the 31-day follow-up period after each dose
Number of subjects reporting serious adverse events (SAEs)
Timeframe: Up to 2 years of age
Interventions:
Biological/vaccine: Rotarix
Biological/vaccine: Placebo
Enrollment:
765
Observational study model:
Not applicable
Primary completion date:
2009-31-03
Time perspective:
Not applicable
Clinical publications:
Kawamura N et al. (2011) Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life. Vaccine. 29(37):6335-6341.
Kawamura N et al. Efficacy of Human Rotavirus (G1P[8] strain) Vaccine (HRV) RIX4414 in Japanese Infants during the Two-year Efficacy Follow-up Period. Abstract presented at the 114th Annual Meeting of Japan Pediatric Society (JPS). Tokyo, Japan, 12-14 August 2011.
Kawamura N et al. Efficacy of human rotavirus vaccine RIX4414 in Japanese infants from 2 weeks post dose 2 up to data lock point. Abstract presented at the 28th meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.
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]
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
June 2007 to November 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 14 weeks
Accepts healthy volunteers
Yes
- 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
- 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.
Inclusion and exclusion 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.
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
2009-31-03
Actual study completion date
2009-21-11
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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