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> Web page: https://trialight.com/data/trial/a-phase-iii-clinical-trial-on-immunogenicity-and-safety-of-d9ec5663-1799-48d8-9385-a30dc31a8ecc
> Record changed: 2026-10-13

# A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)

NCT07500207

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

Recruitment status

Enrolling by invitation

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

Participants

3,000

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

Lead sponsor

Changchun BCHT Biotechnology Co.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

Start date

2026-03-04

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Title and summary

**Summary**

Neutralizing antibody seroconversion rate and geometric mean concentration in seronegative participants of each group at 14 days after the first dose of immunization. The seroconversion rate of neutralizing antibodies 42 days after the first dose among seronegative participants before vaccination in each group

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Short title**

A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Official title**

A Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Lyophilized Human Rabies Vaccine (Human Diploid Cell) Administered Via Different Immunization Schedules Using a Randomized, Blinded, Positive-Controlled Design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Recruitment status**

Enrolling by invitation

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Dates

**Completion date**

2027-03-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**First posted**

2026-03-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Registry last updated**

2026-03-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Primary completion date**

2026-05-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Start date**

2026-03-04

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Size and sites

**Participants**

3,000

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Planned participants**

3,000

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Lead sponsor**

Changchun BCHT Biotechnology Co.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Identifiers

**Registry ID**

NCT07500207

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**ClinicalTrials.gov ID**

NCT07500207

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Single masking

**Masked roles**

Participants

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Outcomes

### Primary outcomes

1. neutralizing antibodies after the first dose  
Timeframe: 14 days and 42 day after the first dose  
Seroconversion rate and geometric mean concentration of neutralizing antibodies

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Eligibility

**Sex**

All

**Age groups**

Children, Adults

**Minimum age**

10 Years

**Maximum age**

60 Years

**Healthy volunteers**

Yes

### Inclusion criteria

- Participants aged 10 to 60 years old;
- Able to obtain informed consent from the participants themselves and/or their guardians;
- The participants themselves and/or their guardians are able to comply with the requirements of the clinical trial protocol.

### Exclusion criteria

- Axillary temperature >37.0°C on the day of vaccination;
- History of rabies vaccination or administration of rabies virus passive immunization preparations;
- History of bites or scratches (with broken skin) by dogs or other mammals within 1 year before the first vaccination;
- Suffering from an acute illness or acute exacerbation of a chronic disease within 3 days before the first vaccination;
- Positive urine pregnancy test result or lactation in female participants of childbearing age, or pregnancy planning for female participants of childbearing age, male participants and their female sexual partners from the start of the trial until 6 months after the completion of the full vaccination course;
- History of severe allergies requiring medical intervention or severe adverse reactions to vaccines (such as severe urticaria, anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrotizing reaction (Arthus reaction), angioedema, etc.), or allergy to any component of the investigational vaccine, such as human albumin, dextran 40, sucrose, glycine, disodium hydrogen phosphate, potassium dihydrogen phosphate;
- Known or suspected malignant tumor, autoimmune disease, immunodeficiency or immunosuppression (e.g., human immunodeficiency virus (HIV) infection, organ transplantation, systemic lupus erythematosus (SLE), rheumatoid arthritis, etc.);
- Use of immunosuppressive agents and/or immunomodulators (e.g., systemic glucocorticoids, targeted immunomodulators used continuously for more than 14 days), cytotoxic therapy, etc., within 6 months before the first vaccination or planned long-term use thereof;
- Congenital malformations or developmental disorders affecting organ function, hypertension not effectively controlled by medication (only for those aged 18-60 years) \[systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite maintenance medication\], severe liver and kidney diseases (severe cases, e.g., complicated with diabetes), etc.;
- Contraindications to intramuscular injection, such as local infection or skin lesions at the injection site, severe thrombocytopenia, abnormal coagulation function or history of coagulation disorders;
- History or family history of mental and neurological diseases such as convulsions, epilepsy, encephalopathy and psychosis;
- Received blood products or immunoglobulin products within the past 3 months or planned to use them during the trial;
- Received other investigational medicinal products within 1 month before administration of the investigational vaccine or are currently participating in other clinical trials;
- Received live attenuated vaccines within 14 days before enrollment, or subunit or inactivated vaccines within 7 days before enrollment;
- Other conditions that the investigator considers may affect the trial.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Sites

- sichuan CDCNeijiang, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07500207)

## Related records

### Drugs (2)

- [Iron isomaltoside 1000](https://trialight.com/data/asset/iron-isomaltoside-1000-8f78d416-6b53-49f1-8d80-ded37eeb0ccf.md)
- [Sintilimab](https://trialight.com/data/asset/sintilimab-e2618eaf-967e-401c-aed4-7546875a6d3e.md)

### Lead sponsors (1)

- [Changchun BCHT Biotechnology Co.](https://trialight.com/data/company/changchun-bcht-biotechnology-co-2f38a069-5e9a-44f3-93e1-84ac3c4da340.md)

### Targets (1)

- [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md)

---

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