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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00839254 |
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.
Condition | Intervention | Phase |
---|---|---|
Haemophilus Influenzae Infections Pneumococcal Disease |
Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine) Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Impact on Nasopharyngeal Carriage, Acute Otitis Media, Immunogenicity and Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A. |
Estimated Enrollment: | 7000 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Control 2+1: Active Comparator
Children receiving the control vaccine: Hepatitis B vaccine for children < 12 months of age at the time of first vaccination or Hepatitis A vaccine for children >= 12 months of age at the time of first study vaccination. Children within the first 7 months of life enrolled in this group of clusters receive a 2-dose primary vaccination schedule.
|
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.
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.
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Control 3+1: Active Comparator
Children receiving the control vaccine: Hepatitis B vaccine for children < 12 months of age at the time of first vaccination or Hepatitis A vaccine for children >= 12 months of age at the time of first study vaccination. Children within the first 7 months of life enrolled in this group of clusters receive a 3-dose primary vaccination schedule.
|
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.
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.
|
Pn 2+1: Experimental
Children receiving the pneumococcal conjugate vaccine 1024850A. Children within the first 7 months of life enrolled in this group of clusters receive a 2-dose primary vaccination schedule.
|
Biological: Pneumococcal conjugate vaccine GSK1024850A
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
|
Pn 3+1: Experimental
Children receiving the pneumococcal conjugate vaccine 1024850A. Children within the first 7 months of life enrolled in this group of clusters receive a 3-dose primary vaccination schedule.
|
Biological: Pneumococcal conjugate vaccine GSK1024850A
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination
|
Ages Eligible for Study: | 6 Weeks to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Finland | |
GSK Investigational Site | Recruiting |
Vantaa, Finland, 01600 | |
GSK Investigational Site | Recruiting |
Pori, Finland, 28100 | |
GSK Investigational Site | Recruiting |
Espoo, Finland, 02100 | |
GSK Investigational Site | Recruiting |
Oulu, Finland, 90220 | |
GSK Investigational Site | Recruiting |
Jarvenpaa, Finland, 04400 | |
GSK Investigational Site | Recruiting |
Seinajoki, Finland, 60100 | |
GSK Investigational Site | Recruiting |
Vantaa, Finland, 01300 | |
GSK Investigational Site | Recruiting |
Tampere, Finland, 33100 | |
GSK Investigational Site | Recruiting |
Kuopio, Finland, 70100 | |
GSK Investigational Site | Recruiting |
Turku, Finland, 20520 | |
GSK Investigational Site | Recruiting |
Helsinki, Finland, 00100 | |
GSK Investigational Site | Recruiting |
Kotka, Finland, 48600 | |
GSK Investigational Site | Recruiting |
Kokkola, Finland, 67100 | |
GSK Investigational Site | Recruiting |
Helsinki, Finland, 00930 | |
GSK Investigational Site | Recruiting |
Lahti, Finland, 15140 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 112595 |
Study First Received: | February 5, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00839254 History of Changes |
Health Authority: | Finland: National Agency for Medicines |
Pneumococcal conjugate vaccine Streptococcus pneumoniae Haemophilus influenzae invasive disease |
nasopharyngeal carriage acute otitis media immunogenicity |
Haemophilus Infections Bacterial Infections Otorhinolaryngologic Diseases Haemophilus Influenzae Otitis Media Orthomyxoviridae Infections Ear Diseases |
Gram-Negative Bacterial Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Otitis Influenza, Human Pneumonia |
Bacterial Infections Haemophilus Infections Pasteurellaceae Infections RNA Virus Infections Otorhinolaryngologic Diseases Otitis Media Orthomyxoviridae Infections Infection |
Ear Diseases Gram-Negative Bacterial Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Otitis Influenza, Human |