Dengue Fever Clinical Trial
Official title:
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil® in Healthy Subjects Aged 9 to 13 Years in Malaysia
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04514107 -
A Cluster-randomized Trial to EValuate the Efficacy of Wolbachia-InfecTed Aedes Aegypti Mosquitoes in Reducing the Incidence of Arboviral Infection in Brazil (EVITA Dengue)
|
N/A | |
Completed |
NCT00788151 -
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
|
Phase 2 | |
Completed |
NCT02510638 -
The Clinical Epidemiology of Hospitalized Dengue Cases in Malaysia
|
N/A | |
Completed |
NCT01666652 -
A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults
|
Phase 1 | |
Completed |
NCT01477671 -
Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children
|
N/A | |
Completed |
NCT01443247 -
Role of Andi-d in Dengue Fever: a Pilot Study
|
N/A | |
Completed |
NCT00831012 -
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3delta30/31‐7164) in Healthy Adults
|
Phase 1 | |
Completed |
NCT00089908 -
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults
|
Phase 1 | |
Completed |
NCT01983553 -
Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
|
||
Completed |
NCT01134263 -
Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
|
Phase 3 | |
Completed |
NCT02741128 -
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
|
Phase 2 | |
Completed |
NCT03620487 -
Detection of Dengue Virus in Plasma of Patients in Nepal
|
||
Recruiting |
NCT02608047 -
Studies on the Pathogen, Vector Control and Clinical Treatment of Dengue Fever in Guangzhou
|
N/A | |
Completed |
NCT02510690 -
Factors Associated With Poor Dengue Outcomes in Malaysia
|
N/A | |
Completed |
NCT01550016 -
International Research Consortium on Dengue Risk Assessment, Management, and Surveillance
|
N/A | |
Completed |
NCT01421732 -
Laboratory Diagnosis and Prognosis of Severe Dengue
|
N/A | |
Completed |
NCT00993447 -
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
|
Phase 2 | |
Completed |
NCT01224639 -
Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever
|
Phase 1 | |
Completed |
NCT01943825 -
Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine
|
Phase 2 | |
Active, not recruiting |
NCT03465254 -
Dengue Serostatus Study in the Philippines
|