Post-marketing Surveillance Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Philippines

Post-marketing Surveillance Study of GSK Biologicals' Pneumococcal Conjugate Vaccine, Synflorix, When Administered According to the Local Prescribing Information in Philippines

The purpose of this post-marketing surveillance study is to evaluate the safety of Synflorix™ when administered according to the local Prescribing Information to healthy Filipino infants.

Study Overview

• Status: Terminated
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Biological: Synflorix™

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Philippines
  • Quezon City, Philippines, 1113
    • GSK Investigational Site
  • Sta. Mesa, Manila, Philippines
    • GSK Investigational Site

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 Filipino infants and children aged 6 weeks of age to 5 years of age who will receive Synflorix™ as a part of routine practice as per the Prescribing Information in Philippines.

Description

Inclusion Criteria:

• Subjects who the investigator believes that their parents/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
• Filipino male or female subjects whose age at the first vaccination with Synflorix™ in this PMS should not be less than 6 weeks of age.
• Filipino male or female subjects who enter the PMS at the second dose should not be less than 10 weeks of age.
• Filipino male or female subjects who enter the PMS at the third dose should not be less than 14 weeks of age.
• Filipino male or female subjects who enter the PMS at the booster dose (i.e. if they have received Synflorix™ in the previous dose/s outside the PMS) should not be less than 10 months of age. The time interval between the primary vaccination and booster dose should be at least 6 months. For the booster dose, subjects who received PCV-7/-13 or Synflorix™ in their primary vaccination series will be allowed to take part in the PMS.
• Written and signed informed consent obtained from the parents/LAR(s) of the child. Where parents/LAR(s) are illiterate, the consent form will be countersigned by a witness.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Acute disease and/or fever at the time of vaccine administration.
• Fever is defined as temperature ≥ 37.5°C (99.5°F) on axillary, infrared or tympanic setting.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• History of chronic condition(s) requiring treatment such as cancer or autoimmune diseases.
• Hypersensitivity to latex (found in syringe-tip cap and plunger).
• Any contraindications as stated in the Prescribing Information.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Synflorix Group; Subjects receiving Synflorix™ according to local Prescribing Information. Subjects were administered with Synflorix by investigators in the course of their normal clinical practice. The vaccination schedule consisted of three doses/two doses/one dose or the booster dose of 10Pn-PD-DiT to be administered as per the local PI. First dose of the vaccine could be administered to infants as early as 6 weeks of age and minimum interval between subsequent primary doses was 4 weeks.

Biological: Synflorix™; Intramuscular administration of three doses/two doses/one dose of primary vaccination/the booster dose/ catch-up dose(s) of Synflorix according to local prescribing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of grade 3 unsolicited adverse events.	Within 31 days (Day 0 - Day 30) after each vaccination.

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of unsolicited adverse events.	During 31 days (Day 0 - Day 30) follow-up period after each vaccination/vaccine dose.
Occurrence of serious adverse events.	From the Dose 1 up to study end.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 7, 2010
• First Submitted That Met QC Criteria: January 7, 2010
• First Posted (Estimate): January 11, 2010

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Pneumococcal vaccine
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections
• Other Study ID Numbers: 113381