Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343889
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
2006-06-21
Brief Title:
Comparison of DTaP-HB-PRPT Combined Vaccine to Tritanrix-HepBHib Both Given Concomitantly With Oral Polio Vaccine
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix-HepBHib Both Given Concomitantly With the Oral Polio Vaccine at 6 10 and 14 Weeks of Age in Healthy Infants in the Philippines
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRPT vaccine in countries that follow the World Health Organization-Expanded Program of Immunization WHO-EPI schedule
The primary objective is
To demonstrate that the pentavalent DTaP-HB-PRPT combined vaccine does not induce a lower immune response than Tritanrix-HepBHib in terms of the seroprotection rate to hepatitis B HB one month after a 3-dose primary series at 6 10 and 14 weeks of age
The secondary objectives are
To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6 10 and 14 weeks of age and
To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial
The primary objective is
To demonstrate that the pentavalent DTaP-HB-PRPT combined vaccine does not induce a lower immune response than Tritanrix-HepBHib in terms of the seroprotection rate to hepatitis B HB one month after a 3-dose primary series at 6 10 and 14 weeks of age
The secondary objectives are
To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6 10 and 14 weeks of age and
To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial
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