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RECRUITING
NCT07860216
PHASE3

Phase III Clinical Trial of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)

Sponsor: Beijing BeneWill Technology Development Co., Ltd

View on ClinicalTrials.gov

Summary

This is a phase III clinical trial with a multicenter, randomized, blinded, placebo-controlled design to evaluate the protective efficacy, safety, and immunogenicity of the recombinant respiratory syncytial virus (RSV) vaccine (CHO cell) in individuals aged 60 and above. Sample Size and Trial Grouping: This trial plans to enroll 25,000 trial participants aged ≥60 years (with approximately 30% aged 70 and above), with a relatively balanced gender distribution. Participants of each age group (60-69 years old, ≥70 years old) will be randomly assigned to the trial group and the placebo group in a 1:1 ratio. The sample size for the immunogenicity subgroup is not calculated based on statistical power. Referring to similar clinical trials of RSV vaccines and in conjunction with the immunogenicity observation objectives of this trial, the first 300 trial participants (including those from both age groups) from each site under the leading institution will be included in the immunogenicity subgroup, for a total of 1,200 participants.

Official title: Phase III Multicenter, Randomized, Blinded, Placebo-controlled Trial Assessing the Efficacy, Safety, and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged ≥60 Years

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25000

Start Date

2026-08-21

Completion Date

2028-12-31

Last Updated

2026-10-06

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Recombinant respiratory syncytial virus vaccine (CHO cell)

Test vaccine BW-201 (Adj 1): After mixing the "recombinant respiratory syncytial virus vaccine adjuvant injection" upside down, fully aspirate and inject it into the "RSV vaccine" lyophilized powder for re-dissolution. Slowly rotate the vial to mix, and use it after complete dissolution. After mixing the antigen and adjuvant, store them in a refrigerator at 2°C-8°C in the dark and use them within 4 hours. Before use, they need to be mixed again. If the mixture of antigen and adjuvant is left at room temperature (not exceeding 25°C), it needs to be used within 30 minutes. After mixing 1 bottle of adjuvant solution according to the above steps, aspirate the entire content and add it to the antigen, followed by mixing. Each person should receive 0.5mL per injection, administered intramuscularly into the deltoid muscle on the lateral side of the upper arm. Intravenous injection is strictly prohibited.

BIOLOGICAL

Sodium Chloride Injection 0.9%

The placebo is a 0.9% sodium chloride solution. Each person is to receive 0.5mL for intramuscular injection, with the injection site being the deltoid muscle on the lateral side of the upper arm. Intravenous injection is strictly prohibited. The remaining 0.9% sodium chloride solution (approximately 9.5mL) should be disposed of as waste.

Locations (7)

Guizhou Provincial Center for Disease Control and Prevention

GuiZhou, Guizhou, China

Hebei Provincial Center for Disease Control and Prevention

Hebei, Hebei, China

Hubei Provincial Center for Disease Control and Prevention

HuBei, Hubei, China

Hunan Province Center for Disease Control and Prevention

HuNan, Hunan, China

Shandong Provincial Center for Disease Control and Prevention

Shandong, Shandong, China

Shaanxi Provincial Center for Disease Control and Prevention

Shanxi, Shanxi, China

Baoshan Second People's Hospital in Yunnan Province

Baoshan, Yunnan, China