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A Study to Evaluate a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried

NCT05667974 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4500

Last updated 2024-07-23

No results posted yet for this study

Summary

This is a phase III, randomized, comparator-controlled, double-blind, multicenter study to evaluate lot-to-lot consistency of three lots of a PIKA Rabies Vaccine, immunogenicity and safety in healthy adults using a post-exposure prophylaxis schedule. It is also the aim of this study to evaluate non-inferiority and superiority of the PIKA Rabies Vaccine compared to the rabies vaccine comparator ChiroRab.

Conditions

  • Rabies
  • Prevention

Interventions

BIOLOGICAL

PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried

PIKA rabies vaccine

BIOLOGICAL

Chirorab

Active Comparator

Sponsors & Collaborators

  • Yisheng Biopharma (Singapore) Pte. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2024-03-22
Completion
2025-02-21

Countries

  • Pakistan
  • Philippines

Study Locations

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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 NCT05667974 on ClinicalTrials.gov