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

• Occurrence of unsolicited adverse events. [ Time Frame: During 31 days (Day 0 - Day 30) follow-up period after each vaccination/vaccine dose. ] [ Designated as safety issue: No ]
• Occurrence of serious adverse events. [ Time Frame: From the Dose 1 up to study end. ] [ Designated as safety issue: No ]

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.

Inclusion Criteria:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Filipino male or female subjects whose age at the first vaccination with Synflorix is not lesser than 6 weeks of age.
• For subjects who will receive vaccination on the second dose or third dose onwards, administration of the second dose or third dose of Synflorix as part of the post-marketing surveillance study should be according to the local Prescribing Information. Subjects who will complete their primary vaccination series either starting at first, second or third dose of Synflorix, booster dose will no longer be within the scope of the post-marketing surveillance for these subjects even if return for the booster dose and if they follow up.
• Subjects will be enrolled in booster dose visit only if this is their first visit or first dose of Synflorix in the post-marketing surveillance. For subjects who will receive Synflorix as a booster dose to a primary vaccination series of a pneumococcal vaccine other than Synflorix, there should be an interval of at least 6 months from the last dose of primary vaccination.
• Written, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s)/LAR of the child. Where parent(s)/guardian(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 on axillary, infrared or tympanic setting.
• Subjects with a minor illness 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.
• Any contraindications as stated in the Prescribing Information.