Post-marketing Surveillance Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Philippines
Terminated
- Conditions
- Infections, Streptococcal
- Interventions
- Biological: Synflorix™
- Registration Number
- NCT01046097
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Synflorix Group Synflorix™ 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.
- Primary Outcome Measures
Name Time Method Occurrence of grade 3 unsolicited adverse events. Within 31 days (Day 0 - Day 30) after each vaccination.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇭Sta. Mesa, Manila, Philippines