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A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults

NCT05469802 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-03-13

No results posted yet for this study

Summary

The purpose of this study is to describe the side effects and immune response of a candidate vaccine that might protect against Zika. The vaccine called PIZV (purified inactivated Zika virus vaccine) is given by injection in two doses that are 28 days apart in healthy adults. Participants will receive PIZV or placebo and will be followed for 7 days after each dose and up to 6 months after dose 2.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

Purified Inactivated Zika Virus Vaccine (PIZV)

PIZV vaccine with aluminium hydroxide adjuvant IM injection.

OTHER

Placebo

Placebo (normal saline (0.9% NaCl) IM injection.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2024-07-05
Completion
2024-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05469802 on ClinicalTrials.gov