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: September 4, 2014
Last verified: September 2014
  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 Phase
Infections, Streptococcal
Biological: Synflorix™
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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)
Arms Assigned Interventions
Experimental: Synflorix Group
Subjects receiving Synflorix™ according to local Prescribing Information.
Biological: Synflorix™
Intramuscular administration of 1, 2, 3 doses or a booster dose according to local prescribing information

  Eligibility

Ages Eligible for Study:   6 Weeks and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01046097     History of Changes
Other Study ID Numbers: 113381
Study First Received: January 7, 2010
Last Updated: September 4, 2014
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

ClinicalTrials.gov processed this record on October 23, 2014