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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01803425
Recruitment Status : Withdrawn (Lack of clarity regarding the PMS study requirement from the RA and Ethics committee hence it was concluded GSK will submit local PSURs.)
First Posted : March 4, 2013
Last Update Posted : September 9, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Immunisation Against Streptococcus Pneumoniae 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
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : April 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

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.

Primary Outcome Measures :
  1. Occurrence of solicited local (any intensity) and general (any intensity and causally related) adverse events (AEs) [ Time Frame: During the 4-day follow-up period (Day 0 to Day 3) following any dose of Synflorix™ and overall ]
  2. Occurrence of unsolicited AEs [ Time Frame: During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall ]
  3. Occurrence of Serious Adverse Events (SAEs) [ Time Frame: 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Sri Lankan infants aged 6 weeks and above and children

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01803425

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT01803425     History of Changes
Other Study ID Numbers: 116290
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013

Keywords provided by GlaxoSmithKline:
Post-marketing surveillance
Prescribing Information (PI)
Healthy infants and children
Streptococcus pneumoniae
Sri Lanka

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections