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
  Purpose
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.

Condition Intervention
Infections, Streptococcal
Biological: Synflorix™

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Post-marketing Surveillance Study of GSK Biologicals' Pneumococcal Conjugate Vaccine, Synflorix, When Administered According to the Local Prescribing Information in Philippines

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of grade 3 unsolicited adverse events. [ Time Frame: Within 31 days (Day 0 - Day 30) after each vaccination. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: May 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046097

Locations
Philippines
GSK Investigational Site
Quezon City, Philippines, 1113
GSK Investigational Site
Sta. Mesa, Manila, Philippines
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01046097     History of Changes
Other Study ID Numbers: 113381 
Study First Received: January 7, 2010
Last Updated: May 12, 2016
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by GlaxoSmithKline:
Pneumococcal vaccine

Additional relevant MeSH terms:
Streptococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016