UnknownPhase 3

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

Pakistan, Philippines4,500 participantsStarted 2023-09-22

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Has completed the written informed consent process. * For Singapore sites: age ≥21 and ≤ 65 years on Study Day 0; for other country sites: age ≥18 and ≤ 65 years on Screening. * Healthy males and females. * No history of rabies exposure, administration of rabies vaccination or rabies immunoglobulin. * Agree to refrain from blood donation during the course of the study. * Be able to commit to the vaccine schedule strictly. * Has the ability and commitment to comply with requirements of the study, such as completion of diary cards, return for follow-up visits, accessible by phone and reside within the study area for the duration of study. * For female subjects: agree to avoid pregnancy from Study Day 0 to Study Day 90 during the course of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide. Exclusion Criteria: * Pregnant and nursing female volunteers will be excluded from the study. * Previous exposure to a suspect rabid animal within the last 12 months. * Any subj…

What they're measuring

Primary Immunogenicity

Timeframe: 14 days post-vaccination

Primary Immunogenicity

Timeframe: 14 days post-vaccination

Co-primary Safety(solicited AEs)

Timeframe: 7 days after each vaccination.

Co-primary Safety(unsolicited AEs)

Timeframe: From day of first vaccination through 14 days after the last vaccination

Co-primary Safety(SAEs)

Timeframe: through study completion, an average of 1 year

Co-primary Safety

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05667974

SponsorYisheng Biopharma (Singapore) Pte. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-22

View on ClinicalTrials.gov More Rabies trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Primary Immunogenicity

Timeframe: 14 days post-vaccination

Primary Immunogenicity

Timeframe: 14 days post-vaccination

Co-primary Safety(solicited AEs)

Timeframe: 7 days after each vaccination.

Co-primary Safety(unsolicited AEs)

Timeframe: From day of first vaccination through 14 days after the last vaccination

Co-primary Safety(SAEs)

Timeframe: through study completion, an average of 1 year

Co-primary Safety

Timeframe: through study completion, an average of 1 year