Infections, Streptococcal
Conditions
Keywords
Pneumococcal vaccine
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.
Interventions
BIOLOGICALSynflorix™
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.
Sponsors
GlaxoSmithKline
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 5 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of grade 3 unsolicited adverse events. | Within 31 days (Day 0 - Day 30) after each vaccination. |
Secondary
| 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. |
Countries
Philippines
Outcome results
None listed