Last updated: 02/23/2021 08:00:08
To evaluate safety & reactogenicity of GSK Bio’s human rotavirus (HRV) vaccine in Filipino infants at least 6 weeks of age at first vaccination
EudraCT ID
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Open, multicentric, post-marketing surveillance study to evaluate safety and reactogenicity of GSK Bio's live attenuated oral Human Rotavirus (HRV) vaccine, Rotarix when administered according to Prescribing Information, in Filipino subjects aged at least 6 weeks of age at the time of first vaccination
Trial description: GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects reporting grade 2 or 3. Grade 2 : An AE which was sufficiently discomforting to interfere with normal everyday activities. Grade 3: an unsolicited AE that prevented normal everyday activity.
Timeframe: During 15 days after each vaccine dose
Secondary outcomes:
Number of subjects reporting solicited symptoms
Timeframe: During 15 days after each vaccine dose
Number of subjects reporting unsolicited adverse events (AE)
Timeframe: During 31 days after each vaccine dose
Number of subjects reporting serious adverse events (SAE)
Timeframe: Throughout the study period
Interventions:
Biological/vaccine: Rotarix
Other: Data collection
Enrollment:
1439
Observational study model:
Cohort
Primary completion date:
2010-31-03
Time perspective:
Prospective
Clinical publications:
Bravo L et al. (2014) Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 10(8):2276-2283.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
November 2006 to July 2010
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
6 - 24 weeks
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- A Filipino male or female aged at least 6 weeks at the time of the first vaccination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.
Inclusion and exclusion criteria
Inclusion criteria:
- A Filipino male or female aged at least 6 weeks at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
Exclusion criteria:
- Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.
- Any contraindications as stated in the Prescribing Information.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Trial location(s)
Location
GSK Investigational Site
Alabang, Muntinlupa City, Philippines, 1780
Status
Study Complete
Location
GSK Investigational Site
Pasig City, Metro Manila, Philippines, 1600
Status
Study Complete
Location
GSK Investigational Site
Talaba IV, Bacoor, Cavite, Philippines
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
Finalized
Actual primary completion date
2010-31-03
Actual study completion date
2010-17-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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