Chikungunya

  • STATUS
    Recruiting
  • sponsor
    Emergent BioSolutions
Updated on 18 April 2022
hysterectomy
bilateral tubal ligation

Summary

The goal of this multi-center, randomized, double blind, placebo controlled study is to evaluate the safety and immunogenicity of PXVX0317 in healthy adult and adolescent subjects.

Description

  • Condition: Chikungunya
  • Clinical Trial Identifier: NCT05072080
  • Sponsor: Emergent BioSolutions
Looking for participants within a 35 mile radius of the study site.

Details
Condition Vaccines
Clinical Study IdentifierTX290673
SponsorEmergent BioSolutions
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males or females, 12 to <65 years of age
Generally healthy, in the opinion of the Investigator, based on medical history, physical examination, and screening laboratory assessments
Women who are either: (i) Not of childbearing potential (CBP): pre-menarche, surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or post-menopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment) or (ii) Meeting all the below criteria: Negative serum pregnancy test at screening visit, Negative urine pregnancy test immediately prior to dosing at Day 1, Using an acceptable method of contraception (if women of CBP) for the duration of participation, such as hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior to dosing, intrauterine device (IUD) inserted ≥30 days prior to dosing, double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap)

Exclusion Criteria

Currently pregnant, breastfeeding, or planning to become pregnant during the study
History of severe allergic reaction or anaphylaxis to any component of the vaccine
History of any known congenital or acquired immunodeficiency that could impact response to vaccination (e.g., leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis)
Prior receipt of an investigational CHIKV vaccine/product
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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