Safety & Immunogenicity of Three Formulations of Takeda's Tetravalent

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the equivalence of the lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of TDV.

Clinical Trial Description

The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). This study is designed to determine whether the lyophilized formulation provides equivalent safety and immunogenicity as the original liquid formulation. An exploratory analysis has been added for the purpose of understanding whether there is a manufacturing or formulation effect on the vaccine.

The study will enroll approximately 1000 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four study groups—which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

- Group A: TDV Liquid Formulation 1, subcutaneous (SC) injection on Day 1 and placebo (dummy) SC at Month 3 - this is a liquid that looks like the study drug but has no active ingredient

- Group B: TDV Liquid Formulation 1, SC injection Day 1 and Month 3

- Group C: TDV Liquid Formulation 2, SC injection Day 1 and Month 3

- Group D: TDV Lyophilized formulation SC injection Day 1 and Month 3

In order to keep the treatment arms undisclosed to the participant and the doctor, participants will receive a placebo injection at any study visit where TDV is not being administered (Month 3). Participants will be asked to record any adverse events that may be related to the vaccine or the injection in a diary card for 28 days after each vaccination.

This multi-center trial will be conducted in the United States. The overall time to participate in this study is up to 10 months. Participants will make 9 visits to the clinic including a final visit 1 month after last dose of study drug for a follow-up assessment. A follow up phone call will be done 6 months after the last dose to assess serious adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02193087
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 2
Start date	August 6, 2014
Completion date	May 19, 2015

View Details

See also
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms