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Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A

NCT00839254 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6181

Last updated 2020-12-17

Study results available
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Summary

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. These data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442.

The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.

Conditions

  • Infections, Streptococcal
  • Streptococcus Pneumoniae

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine Synflorix (GSK1024850A)

2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

BIOLOGICAL

GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)

3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children \< 12 months of age at the time of first study vaccination.

BIOLOGICAL

GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)

2 Intramuscular injections only for children \>= 12 months of age at the time of first study vaccination.

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
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-18
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Finland

Study Locations

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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 NCT00839254 on ClinicalTrials.gov