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

Infections, Streptococcal Clinical Trial

Official title:

Post-marketing Surveillance Study of GSK Biologicals' Pneumococcal Conjugate Vaccine, Synflorix, When Administered According to the Local Prescribing Information in Philippines

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01046097
• Other study ID #: 113381
• Status: Terminated
• Phase: N/A
• First received: January 7, 2010
• Last updated: May 12, 2016
• Start date: May 2010
• Est. completion date: July 2013

Study information

• Verified date: May 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 5 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infections, Streptococcal
• Streptococcal Infections

Intervention

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.

Locations

Country	Name	City	State
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Sta. Mesa, Manila

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of grade 3 unsolicited adverse events.		Within 31 days (Day 0 - Day 30) after each vaccination.	No
Secondary	Occurrence of unsolicited adverse events.		During 31 days (Day 0 - Day 30) follow-up period after each vaccination/vaccine dose.	No
Secondary	Occurrence of serious adverse events.		From the Dose 1 up to study end.	No