Seamless Controlled Trial To Evaluate Safety And Immunogenicity of Chikungunya Vaccine in LatinAm… (NCT04566484) | Clinical Trial Compass
TerminatedPhase 2/3
Seamless Controlled Trial To Evaluate Safety And Immunogenicity of Chikungunya Vaccine in LatinAmerica and Asia
Stopped: The founder has decided to discontinue the study for Part C. This decision is not related to any safety concerns, adverse event findings or manufacturing process changes. There were multiple delays in initiating part C
Colombia, Costa Rica, Guatemala3,210 participantsStarted 2021-08-01
Plain-language summary
This study has a Phase II with part A and part B and a Phase III with part C. This Adaptive seamless design will prospectively include planned modifications and incorporate both dose selection (parts A and B) and confirmation of the selected dose (part C) based on the accumulation of subjects' data within the entire study period as shown below. Part C will be randomized for immunogenicity subset and will be open label for safety cohort. The participants assigned to the control group from all parts (i.e, Part A, B and C) will be continuously followed up from the enrollment until the end of the study.
Who can participate
Age range12 Years – 65 Years
SexALL
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Inclusion criteria
âś“. Part A first component : Healthy participants 18 to 65 years of age at enrollment. Good health is based on medical history and physical examination Part A second component, Part B and Part C: Healthy participants 12 to 65 years of age at enrollment. Good health is based on medical history and physical examination
âś“. Participants/Parent(s)/LAR who have voluntarily signed and dated informed consent/assent based on local regulation. In case of a public health emergency in which site visits is not permitted, the informed consent can be obtained in accordance with the local IRB/EC or local regulatory agency guidelines.
âś“. Participants/Parent(s)/LAR who are able to attend all scheduled visits and to comply with all trial procedures Criteria applicable to women and adolescents of childbearing potential
âś“. Negative result on a pregnancy test (urine/serum) on day of enrollment before receiving study products.
âś“. Agree to use effective birth control\^ methods (or abstinence) during the duration of the study.
Exclusion criteria
âś•. Any current or pre-existing health conditions (e.g., any major congenital defects, etc) which in the opinion of the investigator may affect the safety of the subject or the study endpoints.
What they're measuring
1
Geometric mean titers (GMT) of neutralization antibody
Timeframe: 28 days post second dose
2
Proportion of participants with treatment emergent adverse events (TEAEs)