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

NCT ID: NCT01046097

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-07-31

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

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Synflorix™

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Santa Mesa, Manila, , Philippines

Countries

Philippines

Other Identifiers

113381

Identifier Type: -

Identifier Source: org_study_id