Last updated: 07/17/2024 15:22:14
Study to evaluate immunogenicity, reactogenicity and safety of Rotarix™ vaccine in Korean infants
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Immunogenicity, reactogenicity and safety study to evaluate two doses of the lyophilised formulation of the human rotavirus (HRV) vaccine when administered to healthy Korean infants previously uninfected with HRV
Trial description: The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects seroconverted for anti-rotavirus immunoglobulin A
Timeframe: One month after the second vaccine dose
Secondary outcomes:
Serum anti-rotavirus immunoglobulin A antibody concentrations
Timeframe: One month after the second vaccine dose
Number of subjects reporting solicited symptoms
Timeframe: During the 8-day (Day 0 – Day 7) follow-up period after each vaccine dose.
Number of subjects reporting unsolicited adverse events (AEs)
Timeframe: During the 31-day (Day 0 – Day 30) follow-up period after each vaccine dose
Number of subjects reporting serious adverse events (SAEs)
Timeframe: Throughout the study period (2-3 months).
Number of subjects reporting rotavirus gastroenteritis episode(s)
Timeframe: From Dose 1 up to 1 month after Dose 2.
Interventions:
Enrollment:
684
Primary completion date:
2010-23-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kim JS et al. (2012) Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized, double-blind, placebo-controlled, phase IV study. Hum Vaccin Immunother. 8(6):806-812.
Kim JS et al. Assessment of immunogenicity, reactogenicity and safety of human rotavirus vaccine RIX4414 in Korean infants. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Autumn Conference (KSPID). Seoul, S Korea, 12-15 November 2011.
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)
August 2009 to July 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- 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 to 12 weeks of age at the time of the first dose of the vaccination.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female between, and including, 6 to 12 weeks of age at the time of the first dose of the vaccination.
- Written informed consent obtained from the parents or guardians of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive.
- Subjects for whom the vaccination history is available from vaccination diary cards or medical charts.
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.
Exclusion criteria:
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant vaccines.
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Gastroenteritis (GE) within 7 days preceding the study vaccine administration.
- Previous confirmed occurrence of RV GE.
- Previous vaccination with rotavirus vaccine or planned use during the study period.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Trial location(s)
Showing 1 - 6 of 11 Results
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
Study complete
Actual primary completion date
2010-23-07
Actual study completion date
2010-23-07
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.
Additional information about the trial
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