Dengue Fever Clinical Trial
Official title:
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Given as a Booster Injection in Adolescents and Adults Who Previously Completed the 3-dose Schedule in a Study Conducted in Latin America
The aim of the study was to assess and describe the booster effect of a CYD dengue vaccine dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule. Primary Objective - To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 - NCT00993447 and CYD30 - NCT01187433 trials (participants from Group 1 only). Secondary Objectives: - If the primary objective of non-inferiority was achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 and CYD30 trials. - To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13 and CYD30 trials in all participants. - To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13 and CYD30 participants) and immediately prior to booster or placebo injection in all participants. - To describe the neutralizing antibody persistence 6 months, 1 year, and 2 years post booster or placebo injection in all participants. - To evaluate the safety of booster vaccination with the CYD dengue vaccine in all participants.
Healthy adolescents and adults who received 3 doses of the tetravalent dengue vaccine 4 to 5 years earlier in previous CYD dengue vaccine trials (CYD13 and CYD30) received either a booster dose CYD dengue vaccine or a placebo on Day 0. They were evaluated for safety and antibody persistence of the booster injection up to 2 years post-vaccination. ;
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
|