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 Singapore
The aim of the study was to assess and describe the booster effect of a tetravalent CYD dengue vaccine dose administered about 5 years or more after the completion of a 3-dose vaccination schedule in Singapore. 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 CYD28 trial (participants from Group 1 only). Secondary Objectives: - If the primary objective of non-inferiority 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 CYD28 trial (participants from Group 1 only). - To describe the immune responses elicited by the CYD dengue vaccine booster or placebo injection in participants who received three doses of the CYD dengue vaccine in the CYD28 trial in all participants. - To describe the neutralizing antibody levels of each dengue serotype Post Dose 3 (CYD28 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 study participants. - To evaluate the safety of booster vaccination with CYD dengue vaccine in all participants.
Healthy adolescents and adults received 3 doses of the tetravalent dengue vaccine 5-6 years earlier in a previous CYD dengue vaccine trial (CYD28 - NCT00880893) received either a booster injection of 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
|