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

NCT01803425 | Withdrawn

• 1 other identifier: 116290
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immunisation Against Streptococcus Pneumoniae

Keywords

Post-marketing surveillance; Prescribing Information (PI); Healthy infants and children; Streptococcus pneumoniae; Synflorix™; Sri Lanka

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Synflorix™ data collection OTHER

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.

Synflorix™ cohort

Eligibility Criteria

• Age: 6 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Sri Lankan infants aged 6 weeks and above and children

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 4, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 9, 2013

Record last verified: 2013-09