Status:
COMPLETED
COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
Brief Summary
This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate vaccine (Synflorix ...
Detailed Description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The following vaccines will be offered by the sponsor: * Two doses of hepatitis A vaccine will be offere...
Eligibility Criteria
Inclusion
- A male or female between, and including, 6 and 16 weeks of age at the time of the first vaccination. Pre-term born infants can be included in the study starting from 8 weeks of chronological age at the time of first vaccination and up to 16 weeks of chronological age
- Subjects should be living in the area covered by the surveillance system for community acquired pneumonia (CAP), invasive disease and acute otitis media (AOM) •Written informed consent obtained from the parent or guardian of the subject.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
Exclusion
- Use of any investigational or non-registered drug or planned use during the study period.
- Use or planned use of any investigational or non-registered vaccine other than the study vaccine(s).
- Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A 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 .Other locally recommended vaccines are always allowed, even if concomitantly administered with the study vaccines. •Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar is not allowed. If Prevnar immunization needs to be initiated, due to the presence of a high risk disease for pneumococcal infections for which the Prevnar vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific Prevnar immunization program.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment
- For Colombia: infants with low birth weight ( less than (\<) 2.500 grams)
Key Trial Info
Start Date :
June 28 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2011
Estimated Enrollment :
23802 Patients enrolled
Trial Details
Trial ID
NCT00466947
Start Date
June 28 2007
End Date
July 28 2011
Last Update
July 16 2019
Active Locations (22)
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1
GSK Investigational Site
Godoy Cruz, Mendoza Province, Argentina
2
GSK Investigational Site
Las Heras, Mendoza Province, Argentina
3
GSK Investigational Site
Luján de Cuyo, Mendoza Province, Argentina
4
GSK Investigational Site
Villa Nueva, Mendoza Province, Argentina