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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infections, Streptococcal

Intervention / Treatment
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* Biological: Synflorix™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Synflorix Group<br>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™<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal vaccine