Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Adults Aged 60 Years and Above
Led by MAXVAX Biotechnology Limited Liability Company · Updated on 2025-12-09
25000
Participants Needed
8
Research Sites
126 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
Researchers are evaluating the effectiveness of a Recombinant Respiratory Syncytial Virus (RSV) vaccine made from CHO cells in preventing lower respiratory tract diseases caused by RSV in adults aged 60 years and older. This Phase III trial aims to assess if a single dose of this vaccine is safe and stimulates an immune response. The study involves a large group of 25,000 participants divided into two age groups: 60-69 years and 70 years or older. Participants will be randomly assigned to receive either the investigational RSV vaccine or a placebo injection, with each participant receiving a single intramuscular dose into the arm. The vaccine dose is 0.5 mL, and the placebo consists of saline solution. Researchers will monitor safety, immune response, and vaccine effectiveness over time, including a subgroup of 1,200 participants for detailed immune response testing. Throughout the study, participants will be followed for up to two RSV epidemic seasons, with evaluations starting 14 days after vaccination and continuing for up to 36 months. The research team will track the occurrence of respiratory illnesses, measure immune responses through blood tests at multiple time points, and monitor adverse events and safety. Participants will have scheduled visits to assess health, immune markers, and any side effects related to the vaccine or placebo.
CONDITIONS
Brief 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 the study procedures and voluntarily sign informed consent
- Able to attend all scheduled visits and follow the study protocol
- Have stable health conditions as judged by the investigator, including stable chronic diseases like diabetes, hypertension, COPD, or asthma
You will not qualify if you...
- Axillary temperature above 37.3°C at screening
- History of RSV infection within 6 months before enrollment
- New respiratory symptoms like cough, fever, or nasal congestion within 7 days before enrollment
- Acute illness or flare-up of chronic disease within 3 days before vaccination
- Use of antipyretic, analgesic, or antihistamine drugs within 3 days before enrollment (except low-dose aspirin)
- Allergy to vaccine components or history of severe allergic reactions to vaccines or medications
- Asplenia or functional asplenia
- Current or past malignant tumors, except cured carcinoma in situ or papillary thyroid carcinoma
- Autoimmune diseases such as lupus, rheumatoid arthritis, inflammatory bowel disease, or autoimmune thyroid disease
- Known or suspected immunodeficiency or immunosuppressive treatments
- Conditions making intramuscular injection unsafe, including bleeding disorders
- Severe clinical diseases not cured that may affect the study evaluation
- History or current thrombotic diseases
- Untreated or active tuberculosis
- Poorly controlled hypertension (blood pressure ≥150/100 mmHg before vaccination)
- Severe arrhythmias like atrial fibrillation
- History or family history of seizures, neurological disorders, or serious brain diseases
- Use of experimental drugs or participation in other trials within 30 days before enrollment
- Recent live or non-live vaccinations within specified timeframes before enrollment
- Prior RSV vaccination
- Use of immunoglobulin or blood products within 3 months before enrollment
- Use of immunosuppressive or immunomodulatory drugs within 3 months or planned during the trial
- Use of long-acting immunomodulatory drugs within 6 months before enrollment
- Alcohol or drug abuse affecting trial assessment
- Planned relocation preventing trial completion
- Any condition deemed unsafe or interfering by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single dose of the recombinant respiratory syncytial virus vaccine or placebo by intramuscular injection in the deltoid region of the arm.
1 vaccination visit (in-person)
Duration - Up to 36 months
Participants are monitored for safety and efficacy outcomes, including respiratory illness incidence and antibody response, up to 36 months after vaccination.
Multiple follow-up visits at 14 days, 1, 12, 24, and 36 months post-vaccination
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
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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