Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01839188
Status:
COMPLETED
Last Update Posted:
2019-02-25
First Post:
2013-04-19
Brief Title:
Spanish Mixed HEXAPENTAHEXA Schedule V419-010
Sponsor:
MCM Vaccines BV
Organization:
MCM Vaccines BV
Study Overview
Official Title:
A Phase 3 Open-label Study to Evaluate the Immunogenicity and Safety of a Mixed HEXAPENTAHEXA Primary Series Schedule That Includes V419 PR5I at 2 and 6 Months of Age and Pediacel at 4 Months of Age
Status:
COMPLETED
Status Verified Date:
2019-02
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:
To evaluate the immune response and the safety of a primary series schedule that includes V419 PR5I at 2 and 6 months of age and Pediacel at 4 months of age
Primary objectives
To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B HB one month after completion of the mixed schedule
To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b Hib one month after completion of the mixed schedule
Secondary objectives
To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule
To describe the antibody response to meningococcal serogroup C MCC conjugate vaccine one month after the second dose of MenC vaccine
To describe the safety profile after each dose of study vaccines administered
Primary objectives
To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B HB one month after completion of the mixed schedule
To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b Hib one month after completion of the mixed schedule
Secondary objectives
To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule
To describe the antibody response to meningococcal serogroup C MCC conjugate vaccine one month after the second dose of MenC vaccine
To describe the safety profile after each dose of study vaccines administered
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 |
|---|---|---|---|
| V419-010 | OTHER | Merck Protocol Number | None |
| 2012-004221-25 | EUDRACT_NUMBER | None | None |
| PRI02C | OTHER | None | None |