Status:
COMPLETED
Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Streptococcus Pneumoniae Vaccines
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, ...
Eligibility Criteria
Inclusion
- Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Written and signed or thumb-printed informed consent obtained from the parent(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
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Acute disease and/or fever at the time of enrolment.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
- Hypersensitivity to latex.
- Previous vaccination against diphtheria, tetanus, pertussis, Hemophilus influenzae type b and/or Streptococcus pneumoniae. Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine is administered. Other locally recommended vaccines are allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
Key Trial Info
Start Date :
February 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2011
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01153841
Start Date
February 17 2011
End Date
July 26 2011
Last Update
January 2 2020
Active Locations (1)
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1
GSK Investigational Site
Ho Chi Minh City, Vietnam