Not Signed In -
Barotitis media |
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Clinical Trial: Efficacy Against Otitis Media in Children with 11 Valent Pneumococcal Vaccine
This study has been completed.
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Otitis Media | Vaccine: undecavalent pneumococcal-protein D conjugate vaccine | Phase III |
MedlinePlus related topics: Ear Infections
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Phase III, Double Blind Randomized, Controlled Study to Assess, in Young Children, the Efficacy in Preventing Acute Otitis Media 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
Further Study Details:
Primary Outcomes: 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 Outcomes: 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.
Expected Total Enrollment: 5000
Secondary Outcomes: 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.
Expected Total Enrollment: 5000
Eligibility
Ages Eligible for Study: 6 Weeks - 27 Months, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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.
Location Information
Czech Republic
NA, HRADEC KRALOVE, Czech Republic
Study chairs or principal investigators
Roman Prymula, Professor, Principal Investigator, unaffiliated
More Information
Study ID Numbers: 347414/010
Last Updated: August 1, 2005
Record first received: July 14, 2005
ClinicalTrials.gov Identifier: NCT00119743
Health Authority: Czech Republic: State Institute for Drug Control
ClinicalTrials.gov processed this record on 2005-08-02
Last Updated: August 1, 2005
Record first received: July 14, 2005
ClinicalTrials.gov Identifier: NCT00119743
Health Authority: Czech Republic: State Institute for Drug Control
ClinicalTrials.gov processed this record on 2005-08-02
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- Airplane Ear (MayoClinic)
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