Last updated: 11/03/2018 15:13:38
Study to assess the safety of GSK Biologicals’ liquid human rotavirus vaccine in healthy infants
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated liquid human rotavirus (HRV) vaccine 444563, in healthy infants
Trial description: The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals’ liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Occurrence of grade 3 solicited adverse events.
Timeframe: Within the 8-day (Day 0 – 7) follow-up period after each vaccine dose.
Secondary outcomes:
Occurrence of each solicited adverse event.
Timeframe: Within the 8-day (Day 0 – 7) follow-up period after each vaccine dose.
Occurrence of unsolicited adverse events.
Timeframe: Within the 31-day (Day 0 – 30) follow-up period after any vaccine dose.
Occurrence of serious adverse events.
Timeframe: Throughout the study period (Day 0 to Month 2).
Interventions:
Enrollment:
50
Primary completion date:
2010-28-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Li RC et al. (2013) Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: Randomized, double-blind, placebo-controlled Phase I studies. Hum Vaccin Immunother. 9(8). [Epub ahead of print]
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
April 2010 to June 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
6 - 16 weeks
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
Exclusion criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth (for corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations.
- Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment..
- History of confirmed rotavirus gastroenteritis.
- Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
- Previous vaccination with rotavirus vaccine or planned to use during the study period.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- 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.
Child in care.
Trial location(s)
Location
GSK Investigational Site
Liucheng County, Guangxi, China, 545200
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2010-28-06
Actual study completion date
2010-28-06
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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Additional information
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