Hepatitis A
Conditions
Keywords
Prophylaxis pneumococcal vaccine
Brief summary
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).
Interventions
BIOLOGICALundecavalent pneumococcal-protein D conjugate vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 27 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by vaccine-type pneumococcus in fully vaccinated children less than 2 years of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by NTHI in fully vaccinated children less than 2 years of age. | — |
Countries
Czechia, Slovakia
Outcome results
None listed