NCT07272434
Recruiting
Phase 3
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 Aears and Above
MAXVAX Biotechnology Limited Liability Company8 sites in 1 country25,000 target enrollmentStarted: October 22, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- MAXVAX Biotechnology Limited Liability Company
- Enrollment
- 25,000
- Locations
- 8
- Primary Endpoint
- The first-time incidence rate per person-year of Lower Respiratory Tract Disease (LRTD).
Overview
Brief Summary
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.
Detailed Description
A total of 25000 adults aged 60 years and above will be enrolled, stratified into 60-69 and ≥70 years of age. All Participants will randomly receive investigational vaccine or placebo at a ratio of 1:1. Efficacy and safety will be assessed in all Participants, while immunogenicity will be assessed in a subset of 1200 Participants in a selected trial site.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A male or female can provide legal identification at the time of enrollment, and is 60 years of age or older (women are required to be infertile).
- •(Note: Women with infertility include those who have been menopausal or have undergone sterilization (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, etc.)
- •Be able to understand the trial procedures, risks and benefits and voluntarily agree to participate in the study and sign an informed consent.
- •Be able to participate in all scheduled visits and comply with the protocol requirements
- •Participants with stable health conditions considered by the investigator. Stable health conditions refer to patients with chronic diseases whose conditions are stable (regardless of whether they have received specific treatment or not), such as diabetes, hypertension, chronic obstructive pulmonary disease, asthma, etc. If the researcher determines that the condition is stable, they may be allowed to participate in this trial.
Exclusion Criteria
- •Participants who meet any of the following exclusion criteria will not be allowed to enter the study (if the number of participants is not yet met, if the criteria described in "\*" are met during screening, repeated screening may be performed)
- •\*Axillary temperature\>37.3℃.
- •History of RSV infection within 6 months before enrollment.
- •\*New onsets of respiratory tract infection symptoms like cough, sputum, shortness of breath, wheezing, fever, runny nose or nasal congestion within 7 days before enrollment.
- •\*Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination.
- •\*Within 3 days before enrollment, antipyretic and analgesic drugs (except enteric-coated aspirin tablets for the prevention of cardiovascular and cerebrovascular diseases) and antihistamines were used
- •Those who are allergic to the known components in the test vaccine \[saponin (QS-21), dioleoyl phosphatidylcholine (DOPC), cholesterol, sucrose, sodium dihydrogen phosphate, anhydrous sodium dihydrogen phosphate, polysorbate 80, sodium chloride, hydrochloric acid and sodium hydroxide\] Those who have a history of severe allergies after any vaccination or medication use \[such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, etc.\] or serious adverse reactions.
- •Asplenia or functional asplenia, and any condition leading to asplenia or splenectomy.
- •Those who have had or are currently suffering from malignant tumors (except for clinically cured carcinoma in situ and papillary thyroid carcinoma).
- •Patients are diagnosed with autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease and autoimmune thyroid disease.
Arms & Interventions
Vaccine Group
Experimental
Participants will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell), by IM injection into the deltoid region of the arm.
Intervention: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) (Biological)
Placebo Group
Placebo Comparator
Participants will receive single dose of placebo, by IM injection into the deltoid region of the arm.
Intervention: Placebo (Saline solution) (Biological)
Outcomes
Primary Outcomes
The first-time incidence rate per person-year of Lower Respiratory Tract Disease (LRTD).
Time Frame: From 14 days after vaccination until the end of the first RSV epidemic season,assessed up to 12 months.
A case caused by RSV-A and/or RSV-B as confirmed by Reverse Transcription-Polymerase Chain Reaction（RT-PCR）.
Secondary Outcomes
- The first-time incidence rate per person-year of Acute Respiratory Illness (ARI).(From 14 days after vaccination until the end of the first RSV epidemic season,assessed up to 12 months.)
- The first-time incidence rate per person-year of Severe Lower Respiratory Tract Disease (sLRTD).(From 14 days after vaccination until the end of the first RSV epidemic season,assessed up to 12 months.)
- The first-time incidence rate per person-year of LRTD.(From 14 days after vaccination until the end of the second RSV epidemic season,assessed up to 24 months.)
- The first-time incidence rate per person-year of ARI.(From 14 days after vaccination until the end of the second RSV epidemic season,assessed up to 24 months.)
- The first-time incidence rate per person-year of sLRTD.(From 14 days after vaccination until the end of the second RSV epidemic season,assessed up to 24 months.)
- Geometric Mean Titers (GMT) of Neutralizing Antibody against RSV-serotype A and RSV-serotype B.(At 14 days,1,12,24 and 36 months after vaccination)
- Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A and RSV-serotype B(At 14 days,1,12,24 and 36 months after vaccination)
- Geometric Mean Concentrations (GMC) of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B(At 14 days,1,12,24 and 36 months after vaccination)
- GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B(At 14 days,1,12,24 and 36 months after vaccination)
- Incidence, Intensity and Causality of adverse events(AEs)(Within 30 days after vaccination)
- Incidence, Intensity and Causality of solicited AEs(Within 7 days after vaccination)
- Incidence, Intensity and Causality of unsolicited AEs(Within 30 days after vaccination)
- Incidence and Causality of Severe adverse events(SAEs)(Up to 12 months post vaccination)
- Incidence and Causality of Adverse event of special interest (AESI)(Up to 12 months post vaccination)
Investigators
Study Sites (8)
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