Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
72 participants
INTERVENTIONAL
2021-04-06
2022-02-14
Brief Summary
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Detailed Description
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This is a Phase 1, randomized, double blind, active-controlled sequential-group study, designed to evaluate the safety, tolerability, and immunogenicity of the combination of TQL1055 and acellular pertussis vaccine. The dose of TQL1055 will increase by group.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
DOUBLE
Study Groups
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TQL1055
TQL1055 + acellular pertussis vaccine
TQL1055
Semisynthetic saponin adjuvant
Acellular pertussis vaccine
Acellular pertussis vaccine
Acellular pertussis vaccine
Acellular pertussis vaccine
Acellular pertussis vaccine
Acellular pertussis vaccine
Interventions
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TQL1055
Semisynthetic saponin adjuvant
Acellular pertussis vaccine
Acellular pertussis vaccine
Eligibility Criteria
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Inclusion Criteria
* General good health
* BMI between 17 and 35 kg/m2
* Not of childbearing potential OR using adequate contraception
Exclusion Criteria
* Prior medical condition that could adversely affect subject safety
* Clinically significant abnormal laboratory parameter
* Current acute febrile illness
* Contraindication to intramuscular injection
* Contraindication to pertussis vaccination
* Received pertussis vaccine within 3 years
18 Years
50 Years
ALL
Yes
Sponsors
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Adjuvance Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sean R Bennett, MD PhD
Role: STUDY_DIRECTOR
Adjuvance Technologies, Inc.
Locations
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Q-Pharm
Brisbane, , Australia
Countries
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Other Identifiers
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V1.1-101
Identifier Type: -
Identifier Source: org_study_id
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