Immunisation Against Streptococcus Pneumoniae Clinical Trial
Official title:
Post-marketing Surveillance (PMS) of GlaxoSmithKline Biologicals' 10-valent Pneumococcal Conjugate Vaccine (Synflorix™) When Administered to Healthy Infants and Children According to the Prescribing Information in Sri Lanka
This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Weeks to 5 Years |
Eligibility |
Inclusion Criteria: - Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study. - Infants aged 6 weeks and above and children. - Written, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness. Note: Consent for this PMS study is solely for collection of safety and reactogenicity data and not for vaccination that is per routine practice. Data for demography, medical history and previous vaccination history, and concomitant medication/vaccination will also be collected. Exclusion Criteria: - Subjects with contraindications according to the locally approved PI. - Child in care. - Previous administration of three doses of Synflorix™. - Previous vaccination with a pneumococcal vaccine other than Synflorix™. - Planned administration of another pneumococcal vaccine other than Synflorix™ during the PMS study. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of solicited local (any intensity) and general (any intensity and causally related) adverse events (AEs) | During the 4-day follow-up period (Day 0 to Day 3) following any dose of Synflorix™ and overall | No | |
Primary | Occurrence of unsolicited AEs | During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall | No | |
Primary | Occurrence of Serious Adverse Events (SAEs) | Throughout the PMS study period, starting at Dose 1 (Visit 1) and ending 31 days (Day 0 to Day 30) after the last dose of Synflorix™ for each subject in the PMS study | No |