Post-marketing Safety Study of GlaxoSmithKline (GSK) Biologicals' Synflorix™ Vaccine, in Healthy Infants and Children in Sri Lanka

Withdrawn

• Conditions: Immunisation Against Streptococcus Pneumoniae
• Interventions: Other: Synflorix™ data collection

• Registration Number: NCT01803425
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-04
• Study Start: 2013-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-05
• Last Update Posted: 2013-09-09
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Synflorix™ cohort	Synflorix™ data collection	Only those subjects to whom Synflorix™ will be administered as per normal clinical practice, according to the locally approved PI, will be included in the study.

Primary Outcome Measures

Name	Time	Method
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
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
Occurrence of unsolicited AEs	During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall