NCT02993757

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil®

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil® in Healthy Subjects Aged 9 to 13 Years in Malaysia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 528 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Years – 13 Years
• Healthy volunteers: Accepted

Summary

The aim of the study was to assess the safety and immunogenicity of the CYD dengue vaccine and Gardasil (Human Papillomavirus Quadrivalent \[Types 6, 11, 16, and 18\] Vaccine, Recombinant) when administered concomitantly or sequentially. Primary objectives: * To demonstrate that the humoral immune response (in terms of geometric mean titers \[GMTs\]) to Gardasil after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil. * To demonstrate that the humoral immune response to the CYD dengue vaccine after concomitant administration was non-inferior to sequential administration with Gardasil 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 Gardasil vaccine after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil. * To describe the humoral immune response to Gardasil at baseline and after each dose of Gardasil 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 Gardasil and the CYD dengue vaccine after each and any dose in each group.

Detailed description

Participants received 3 doses of CYD dengue vaccine and 2 doses of Gardasil administered either concomitantly or sequentially. The study activities were put on hold for several months (up to 6 months for some participants) to obtain the approval of Protocol Amendment 1 by the competent authorities and completed the associated logistic tasks. Due to this protocol amendment as per Independent Data Monitoring Committee recommendation, only previously dengue immune participants (seropositive for dengue before vaccination) were eligible to complete the vaccination schedule. Dengue non-immune participants (seronegative for dengue before vaccination) did not receive any additional CYD dengue vaccine injections, but were followed for safety up to 6 months after the last injection. Due to the change in amendment 1, the number of evaluable dengue immune participants at baseline did not meet the predefined number of participants that would have allowed for a global power of at least 80% for non-inferiority testing of Gardasil vaccine and CYD dengue vaccine (121 per group for the co-primary objectives and 194 per group for the secondary objectives). All participants were assessed for immunogenicity and safety. Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events (AEs) within 28 days after each injection, non-serious AEs of Special Interests (AESIs) within 7 days after each injection, and serious adverse events including AESI and hospitalized virologically-confirmed dengue cases during the study period.

Conditions

• Dengue Fever
• Dengue Hemorrhagic Fever
• Human Papillomavirus Disease

Interventions

Type	Name	Description
BIOLOGICAL	CYD Dengue Vaccine	0.5 mL, SC injection at Day 0, Month 6 and 12, respectively.
BIOLOGICAL	CYD Dengue Vaccine	0.5 mL, SC injection at Month 1, 7 and 13, respectively.
BIOLOGICAL	Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant.	0.5 mL, IM injection at Day 0 and Month 6, respectively.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-05-27
• Completion: 2019-05-27
• First posted: 2016-12-15
• Last updated: 2022-03-25
• Results posted: 2020-06-11

Locations

5 sites across 1 country: Malaysia

Regulatory

• FDA-regulated drug study