Trials / Completed
CompletedNCT00839254
Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
Impact on Nasopharyngeal Carriage, Acute Otitis Media, Immunogenicity and Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 6,181 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 18 Months
- Healthy volunteers
- Accepted
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.
Detailed description
The protocol posting has been updated with regards to the outcome measures following Protocol amendment 4, 12 August 2011.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2009-02-18
- Primary completion
- 2012-01-31
- Completion
- 2012-01-31
- First posted
- 2009-02-09
- Last updated
- 2020-12-17
- Results posted
- 2020-07-27
Locations
15 sites across 1 country: Finland
Source: ClinicalTrials.gov record NCT00839254. Inclusion in this directory is not an endorsement.