ClinicalTrials.Veeva

Menu

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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Terminated

Conditions

Infections, Streptococcal

Treatments

Biological: Synflorix™

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

6 weeks to 5 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

28 participants in 1 patient group

Synflorix Group
Description:
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.
Treatment:
Biological: Synflorix™

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems