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

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.

Study Overview

• Status: Withdrawn
• Conditions: Immunisation Against Streptococcus Pneumoniae
• Intervention / Treatment: Other: Synflorix™ data collection

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Sri Lankan infants aged 6 weeks and above and children

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Synflorix™ cohort; 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.	Other: Synflorix™ data collection; Safety monitoring and evaluation: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact. Recording of SAEs throughout the study period for each subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: February 28, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimate): March 4, 2013

Study Record Updates

• Last Update Posted (Estimate): September 9, 2013
• Last Update Submitted That Met QC Criteria: September 5, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Post-marketing surveillance; Streptococcus pneumoniae; Sri Lanka; Prescribing Information (PI); Healthy infants and children; Synflorix™
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia; Pneumonia, Pneumococcal
• Other Study ID Numbers: 116290