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
Completed
Completed
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:
Biological/vaccine: Rotarix ™
Biological/vaccine: Placebo
Enrollment:
684
Observational study model:
Not applicable
Primary completion date:
2010-23-07
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)
Location
GSK Investigational Site
Suwon, Kyonggi-do, South Korea, 443-721
Status
Study Complete
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
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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