Actively Recruiting
Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell)
Led by MAXVAX Biotechnology Limited Liability Company · Updated on 2025-12-09
25000
Participants Needed
8
Research Sites
166 weeks
Total Duration
On this page
Sponsors
M
MAXVAX Biotechnology Limited Liability Company
Lead Sponsor
H
Henan Center for Disease Control and Prevention
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will evaluate the efficacy of the Recombinant RSV vaccine(CHO cell) vaccine in preventing lower respiratory tract diseases(LRTD) caused by RSV in adults≥ 60 years of following a single dose of the RSV vaccine(CHO cell) vaccine .This study will also assess if the vaccine is safe and induces an immune response.
CONDITIONS
Official Title
Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 60 years or older who can provide legal identification
- Women must be infertile (menopausal or surgically sterilized)
- Able to understand study procedures and voluntarily consent
- Able to attend all scheduled visits and follow study rules
- Stable health conditions as determined by the investigator, including controlled chronic diseases such as diabetes, hypertension, COPD, or asthma
You will not qualify if you...
- Fever with axillary temperature above 37.3°C
- History of RSV infection within 6 months before enrollment
- New respiratory symptoms (cough, sputum, shortness of breath, wheezing, fever, runny nose, or nasal congestion) within 7 days before enrollment
- Acute illness or worsening of chronic disease within 3 days before vaccination
- Use of antipyretic, analgesic (except aspirin for cardiovascular prevention), or antihistamines within 3 days before enrollment
- Allergies to vaccine components or history of severe allergic reactions
- Asplenia or functional asplenia
- Current or past malignant tumors (except cured carcinoma in situ and papillary thyroid carcinoma)
- Diagnosed autoimmune diseases
- Known or suspected immunodeficiency disorders or immunosuppressive treatments
- Conditions making intramuscular injections unsafe, such as coagulation disorders
- Severe clinical diseases that may affect study evaluation
- Thrombotic diseases history or current
- Untreated or active tuberculosis
- Poorly controlled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg before vaccination)
- Severe arrhythmias
- History or family history of convulsions, epilepsy, brain hypoplasia, mental illness, or serious neurological diseases
- Use of experimental or unapproved products within 30 days before or during the trial
- Vaccination with non-live vaccines within 14 days or live/nucleic acid vaccines within 28 days prior to enrollment
- Previous RSV vaccination
- Use of immunoglobulins or blood products within 3 months prior or planned during trial
- Use of immunosuppressive or immunomodulatory drugs within 3 months prior or planned during trial
- Use of long-acting immunomodulatory drugs within 6 months prior or planned during trial
- Drinking or drug abuse history affecting study assessment
- Planned relocation preventing study completion
- Any condition deemed by the investigator to affect safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Guangdong Provincial Center for Disease Control and Prevention
Guangzhou, Guangdong, China, 511400
Not Yet Recruiting
2
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China, 050021
Active, Not Recruiting
3
Henan Center for Disease Control and Prevention
Zhengzhou, Henan, China, 450016
Actively Recruiting
4
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China, 430079
Actively Recruiting
5
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China, 410005
Actively Recruiting
6
Shaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi, China, 710054
Actively Recruiting
7
Shandong Province Centers for Disease Control and Prevention
Jinan, Shandong, China, 250014
Active, Not Recruiting
8
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
L
LiangHao Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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