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

GlaxoSmithKline (GSK)

Status: Withdrawn

Conditions: Immunisation Against Streptococcus Pneumoniae

Treatments: Other: Synflorix™ data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01803425

116290

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 6 weeks to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Synflorix™ cohort

Description:

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.

Treatment:

Other: Synflorix™ data collection