Last updated: 11/04/2018 02:34:30
A Efficacy Against Otitis Media in Children with 11 Valent Pneumococcal Vaccine
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: Assess, in young children, the efficacy in preventing acute otitis media (AOM) of GSK Biologicals undecavalent pneumococcal-protein D conjugate vaccine, when administered as a three dose primary vaccination course during the first year of life with a booster dose in the second year of life.
Trial description: The purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza, following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life, with booster dose in the second year of life. Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo (hepatitis A vaccine).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: undecavalent pneumococcal-protein D conjugate vaccine
Enrollment:
5000
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Poolman J et al. (2009) Pneumococcal serotype 3 otitis media, limited effect of polysaccharide conjugate immunisation and strain characteristics. Vaccine. 27(24):3213-3222.
Poolman J et al. (2011) Impact of the conjugation method on the immunogenicity of Streptococcus pneumoniae serotype 19F polysaccharide in conjugate vaccines. Clin Vaccine Immunol. 18(2):327-336.
Prymula R et al. (2006) Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pnuemoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet. 367(9512): 740-748.
Prymula R et al. (2008) Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered hexavalent diphtheria, tetanus, cellular pertussis, hepatitis B, inactivated polio virus, Haemophilus influenzae type b and control hepatitis A vaccines. Vaccine. 26(35):4563-4570.
Schuerman L et al. (2007) ELISA IgG concentrations and opsonophagocytic activity following pneumococcal protein D conjugate vaccination and relationship to efficacy against acute otitis media. Vaccine. 25(11):1962-1968.
Schuerman L et al. (2007) Kinetics of the immune response following pneumococcal PD conjugate vaccination. Vaccine 25(11):1953–1961.
Schuerman L et al. (2009) Prevention of otitis media: Now a reality? Vaccine. 27(42):5748-5754.
Medical condition
Hepatitis A
Product
SB347414
Collaborators
Not applicable
Study date(s)
October 2000 to June 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 weeks - 27 months
Accepts healthy volunteers
Yes
- Male or female between 6 weeks and 5 months (42-152 days) of age at the time of first vaccination.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female between 6 weeks and 5 months (42-152 days) of age at the time of first vaccination.
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Trial location(s)
Location
GSK Investigational Site
Havlickuv Brod, Czech Republic, 580 22
Status
Study Complete
Location
GSK Investigational Site
Ceske Budejovice, Czech Republic, 370 71
Status
Study Complete
Location
GSK Investigational Site
Usti nad Labem, Czech Republic, 400 01
Status
Study Complete
Location
GSK Investigational Site
Hlinsko v Cechach, Czech Republic, 539 01
Status
Study Complete
Location
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 377 01
Status
Study Complete
Location
GSK Investigational Site
Nove Mesto nad Vahom, Slovakia, 915 01
Status
Study Complete
Location
GSK Investigational Site
Usti nad Labem, Czech Republic, 400 78
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2004-30-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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