Phase 4
N=684
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
Infections, Rotavirus · Rotavirus Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT00969228 ↗Enrolled (actual)
684
Serious AEs
4.4%
Results posted
Nov 2011
Primary outcome: Primary: Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A — 280; 5 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rotarix ™ (Biological); Placebo (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A |
280; 5 | — |
| SECONDARY Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations |
208.5; NA | — |
| SECONDARY Number of Subjects Reporting Solicited Symptoms |
180; 66; 20; 7; 290; 106 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
148; 59 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
17; 13 | — |
| SECONDARY Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s) |
0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT00969228). 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.