Clinical trial NCT01046097: Post-marketing Surveillance Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Philippines
Official title: Post-marketing Surveillance Study of GSK Biologicals' Pneumococcal Conjugate Vaccine, Synflorix, When Administered According to the Local Prescribing Information in Philippines
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infections, Streptococcal
Keywords: Pneumococcal vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of grade 3 unsolicited adverse events.
timeFrame: Within 31 days (Day 0 - Day 30) after each vaccination.
Secondary outcomes:
measure: Occurrence of unsolicited adverse events.
timeFrame: During 31 days (Day 0 - Day 30) follow-up period after each vaccination/vaccine dose.
measure: Occurrence of serious adverse events.
timeFrame: From the Dose 1 up to study end.
Other outcomes:
Locations:
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Sta. Mesa, Manila
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: