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

This study has been terminated.
(Local authorities no longer require routine PMS studies;GSK does not believe the study would add meaningfully to the safety data already available for Synflorix)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01046097
First received: January 7, 2010
Last updated: May 12, 2016
Last verified: May 2016

January 7, 2010
May 12, 2016
May 2010
July 2013   (final data collection date for primary outcome measure)
Occurrence of grade 3 unsolicited adverse events. [ Time Frame: Within 31 days (Day 0 - Day 30) after each vaccination. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01046097 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Post-marketing Surveillance Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Philippines
Post-marketing Surveillance Study of GSK Biologicals' Pneumococcal Conjugate Vaccine, Synflorix, When Administered According to the Local Prescribing Information in Philippines
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Infections, Streptococcal
Biological: Synflorix™
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.
Synflorix Group
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.
Intervention: Biological: Synflorix™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
28
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 5 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01046097
113381
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP