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COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine

NCT00466947 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23802

Last updated 2019-07-16

Study results available
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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 vaccine, or GSK1024850A) to prevent cases of pneumonia (lung infection) likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of otitis media (ear infection) in children under 3 years old.

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine GSK1024850A

Intramuscular injection, 4 doses

BIOLOGICAL

Havrix

Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group

BIOLOGICAL

Engerix-B

Intramuscular injection, 3 doses

BIOLOGICAL

Infanrix hexa

Intramuscular injection,3 doses

BIOLOGICAL

GSK Biologicals' DTPa-IPV/Hib vaccine

Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-28
Primary Completion
2010-08-31
Completion
2011-07-28

Countries

  • Argentina
  • Colombia
  • Panama

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00466947 on ClinicalTrials.gov