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

NCT01046097 | Terminated

• 1 other identifier: 113381
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Infections, Streptococcal

Keywords

Pneumococcal vaccine

Outcome Measures

Primary Outcomes (1)

• Occurrence of grade 3 unsolicited adverse events.

  Within 31 days (Day 0 - Day 30) after each vaccination.

Secondary Outcomes (2)

• Occurrence of unsolicited adverse events.

  During 31 days (Day 0 - Day 30) follow-up period after each vaccination/vaccine dose.

• Occurrence of serious adverse events.

  From the Dose 1 up to study end.

Study Arms (1)

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™

Interventions

Synflorix™ BIOLOGICAL

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

Eligibility Criteria

• Age: 6 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Quezon City, 1113, Philippines

Location

GSK Investigational Site

Santa Mesa, Manila, Philippines

Location

MeSH Terms

Conditions

Streptococcal Infections

Interventions

PHiD-CV vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 11, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

PH (2)