Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Dengue FeverDengue Hemorrhagic FeverThe purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia. Primary Objectives: To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD dengue vaccine in all participants after each injection. To describe the antibody response to each dengue virus serotype post-injection 2 and post-injection 3.
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially...
Dengue FeverDengue Hemorrhagic Fever1 moreThe 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.
Evaluation of the Safety and Immune Response of Five Admixtures of a Tetravalent Dengue Virus Vaccine...
DengueDengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will evaluate the safety and immune responses of five formulations of a tetravalent dengue virus vaccine in healthy adults.
Efficacy and Safety of Dengue Vaccine in Healthy Children
Dengue VirusDengue Fever2 moreThe primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion. Secondary objectives included to assess: Vaccine efficacy against severe VCD cases Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine Immune response to CYD dengue vaccine Safety profile of CYD dengue vaccine. Safety assessments include 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. Other objectives included: Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine Vaccine efficacy against VCD cases due to each serotype Participants with clinical signs and symptoms for VCD
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to...
Dengue FeverDengue Hemorrhagic Fever1 moreThis study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6. The secondary objectives were: To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine. To describe the neutralizing antibody responses to each of the 3 vaccine formulations. To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.
Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults...
Dengue VirusDengue Fever2 moreThis is part of an ongoing effort to develop a satisfactory dengue vaccine: Primary objective: To describe the safety after each vaccination with bivalent and tetravalent formulations of dengue vaccine candidates. To describe the immune response after each vaccination of dengue vaccine.
Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years...
Dengue FeverDengue Hemorrhagic Fever1 moreThe aim of the study was to assess the efficacy of Sanofi Pasteur's CYD dengue vaccine in preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of Latin America. Primary Objective: To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children and adolescents aged 9 to 16 years at the time of inclusion. Secondary Objectives: To describe the efficacy of CYD dengue vaccine in preventing symptomatic VCD cases after the third dose to the end of the Active Phase, after at least 1 dose, and after 2 doses. To describe the occurrence of hospitalized VCD cases and the occurrence of severe (clinically severe or as per World Health Organization (WHO) criteria) VCD cases, throughout the Surveillance Expansion Period (SEP) and throughout the trial (from Day 0 until the end of the study). To describe the antibody response to each dengue serotype after Dose 2, after Dose 3, and 1 and 5 years after Dose 3. To describe the occurrence of serious adverse events (SAEs), including SAEs of special interest in all participants throughout the trial period.
A Phase I/II Trial of Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naive Infants...
DengueThe main target populations for the tetravalent live attenuated dengue virus vaccine are indigenous populations, especially infants less than 2 years old, residing in areas of the world endemic for dengue and at risk of developing dengue hemorrhagic fever (DHF). The presence of maternal dengue antibody during the first year of life makes it unlikely that a vaccine given during that time will have long-term efficacy, as the vaccine virus would likely be neutralized prior to necessary replication. Children older than 18 months may have preexisting flavivirus antibody. Therefore, vaccination of infants living in Thailand early in the second year of life (between the ages of 12 and 18 months) seems most beneficial. The aim of this trial is to evaluate the safety and immunogenicity of a two-dose schedule of a tetravalent live attenuated dengue vaccine in flavivirus antibody naïve infants beginning at 12-15 months of age. To assess the kinetics of dengue neutralizing antibodies to each dengue virus serotype one and four years following dose 2 of dengue/control vaccination in the setting of potential wild-type dengue virus exposure. To assess the immunogenicity, the safety and reactogenicity of a booster dose of dengue vaccine administered at Year 3 following primary vaccination.
Safety and Immunogenicity of Various Formulations of Live Attenuated Tetravalent Dengue Vaccine...
DengueThis descriptive study will evaluate the safety and immunogenicity of 3 different formulations of the WRAIR dengue vaccine compared to a placebo.
Study of HBV-001 D1 in Healthy Adults
Dengue FeverThis is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects.