Clinical trial NCT01803425: Post-marketing Safety Study of GlaxoSmithKline (GSK) Biologicals' Synflorix™ Vaccine, in Healthy Infants and Children in Sri Lanka
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Immunisation Against Streptococcus Pneumoniae
Keywords: Post-marketing surveillance
Prescribing Information (PI)
Healthy infants and children
Streptococcus pneumoniae
Synflorix™
Sri Lanka
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Sri Lankan infants aged 6 weeks and above and children

Brief summary: 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.

Detailed description: The participating physicians (investigators) will be asked to enrol only those subjects to whom they administer Synflorix™ in the course of their normal clinical practice according to the locally approved Prescribing Information.

Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of solicited local (any intensity) and general (any intensity and causally related) adverse events (AEs)
timeFrame: During the 4-day follow-up period (Day 0 to Day 3) following any dose of Synflorix™ and overall
measure: Occurrence of unsolicited AEs
timeFrame: During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall
measure: Occurrence of Serious Adverse Events (SAEs)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: