Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT02979535
Status:
COMPLETED
Last Update Posted:
2022-03-25
First Post:
2016-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix®
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix® in Healthy Female Subjects Aged 9 to 14 Years in Mexico
Status:
COMPLETED
Status Verified Date:
2022-03
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 aim of this study was to investigate the immunogenicity and safety of CYD dengue vaccine and Cervarix when administered concomitantly or sequentially in healthy female participants aged 9-14 years of age.
Primary objectives:
* To demonstrate that the humoral immune response (in terms of geometric mean titers \[GMTs\]) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of GMTs) after sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix.
* To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after concomitant administration with Cervarix is non-inferior to the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after sequential administration with Cervarix measured 28 days after the last dose of the CYD dengue vaccine.
Secondary Objectives:
* To demonstrate that the humoral immune response (in terms of seroconversion) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of seroconversion) to Cervarix sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix.
* To describe the humoral immune response to Cervarix at baseline and after each dose of Cervarix in each and any group.
* To describe the humoral immune response to the CYD dengue vaccine at baseline and after each dose of the CYD dengue vaccine, in each and any group.
* To describe the safety of Cervarix and CYD dengue vaccine after each and any dose in each group.
Primary objectives:
* To demonstrate that the humoral immune response (in terms of geometric mean titers \[GMTs\]) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of GMTs) after sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix.
* To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after concomitant administration with Cervarix is non-inferior to the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after sequential administration with Cervarix measured 28 days after the last dose of the CYD dengue vaccine.
Secondary Objectives:
* To demonstrate that the humoral immune response (in terms of seroconversion) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of seroconversion) to Cervarix sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix.
* To describe the humoral immune response to Cervarix at baseline and after each dose of Cervarix in each and any group.
* To describe the humoral immune response to the CYD dengue vaccine at baseline and after each dose of the CYD dengue vaccine, in each and any group.
* To describe the safety of Cervarix and CYD dengue vaccine after each and any dose in each group.
Detailed Description:
Participants received 3 doses of the CYD dengue vaccine and 2 doses of Cervarix administered either concomitantly or sequentially. Due to a protocol amendment, only previously dengue exposed participants (seropositive for dengue before vaccination) were eligible to complete the vaccination schedule and be assessed for CYD immunogenicity and human papilloma virus (HPV) immunogenicity. Dengue unexposed participants (seronegative for dengue before vaccination) did not receive the third CYD dengue vaccine injection, but were followed for safety up to 6 months after the last injection.
Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period. All participants were included in the assessment of safety up to 6 months after the last injection.
Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period. All participants were included in the assessment of safety up to 6 months after the last injection.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: