Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378417
Status:
COMPLETED
Last Update Posted:
2006-09-20
First Post:
2006-09-19
Brief Title:
Efficacy Trial of Two Pneumococcal Conjugate Vaccines PncCRM and PncOMPC for Prevention of Acute Otitis Media Due to Vaccine Serotypes
Sponsor:
Finnish Institute for Health and Welfare
Organization:
Finnish Institute for Health and Welfare
Study Overview
Official Title:
Efficacy Trial in Finnish Children of Two Pneumococcal Conjugate Vaccines PncCRM and PncOMPC for Prevention of Acute Otitis Media Due to Pneumococcal Serotypes in the Vaccines
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a randomized double-blinded multicenter cohort study of Finnish children aged 2 to 24 months The study was designed to evaluate the efficacy of two 7-valent pneumococcal conjugate vaccines PncCRM and PncOMPC parallelly both vaccines compared with the same control vaccine hepatitis B vaccine
The primary endpoint was culture-confirmed pneumococcal acute otitis media AOM episodes due to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis was that compared to the control vaccine group the pneumococcal conjugate vaccine would protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated
The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine at the age of 2 4 6 and 12 months and followed at study clinics established specifically for the purpose from 2 to 24 months of age Whenever AOM was diagnosed during the follow-up middle ear fluid was aspirated for bacterial culture
The primary endpoint was culture-confirmed pneumococcal acute otitis media AOM episodes due to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis was that compared to the control vaccine group the pneumococcal conjugate vaccine would protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated
The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine at the age of 2 4 6 and 12 months and followed at study clinics established specifically for the purpose from 2 to 24 months of age Whenever AOM was diagnosed during the follow-up middle ear fluid was aspirated for bacterial culture
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PNC95KTL | None | None | None |