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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01803425
Other study ID # 116290
Secondary ID
Status Withdrawn
Phase N/A
First received February 28, 2013
Last updated September 5, 2013
Start date April 2013
Est. completion date April 2014

Study information

Verified date September 2013
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Sri Lanka: Cosmetics, Devices and Drug Regulatory Authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Weeks to 5 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Immunisation Against Streptococcus Pneumoniae
  • Pneumonia

Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary Occurrence of unsolicited AEs During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall No
Primary 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 No