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

NCT07272434 | Recruiting Phase 3 DMC

• 1 other identifier: MKKCT-900-002
• Study Type: interventional
• Target: 25,000
• Locations: 1 country
• Sites: 8

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.

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (1)

• The first-time incidence rate per person-year of Lower Respiratory Tract Disease (LRTD).

  A case caused by RSV-A and/or RSV-B as confirmed by Reverse Transcription-Polymerase Chain Reaction（RT-PCR）.

  From 14 days after vaccination until the end of the first RSV epidemic season,assessed up to 12 months.

Secondary Outcomes (17)

• 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.

  After vaccination, during the second RSV epidemic season,assessed up to 12 months.

• The first-time incidence rate per person-year of ARI.

  After vaccination, during the second RSV epidemic season,assessed up to 12 months.

• The first-time incidence rate per person-year of sLRTD.

  After vaccination, during the second RSV epidemic season,assessed up to 12 months.

Study Arms (2)

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.

Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)

Placebo Group

PLACEBO COMPARATOR

Participants will receive single dose of placebo, by IM injection into the deltoid region of the arm.

Biological: Placebo (Saline solution)

Interventions

Placebo (Saline solution) BIOLOGICAL

0.5 mL per dose

Placebo Group

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) BIOLOGICAL

0.5 mL per dose

Vaccine Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \*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.
• Persons with known or suspected immunodeficiency disorders \[e.g. primary or secondary immunodeficiency, or diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus infection or immunosuppressive/cytotoxic agent therapy (e.g. cancer chemotherapy, organ transplantation or autoimmune disease treatment) resulting in confirmed or suspected immunosuppression or immunodeficiency\].
• According to the investigator's assessment,there is any disease that may make intramuscular injections unsafe, such as a history of thrombocytopenia or other coagulation disorders.
• Those who have a history or are currently suffering from severe clinical diseases that have not been cured (such as severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory system diseases, diabetes with complications, major surgeries, etc.) and may affect the evaluation of the trial.
• Those who have had or are currently suffering from thrombotic diseases.
• Patients with a history of untreated TB or active TB at enrollment.
• \*Hypertension with poor medication control (on-site blood pressure measurement before vaccination: systolic blood pressure≥150mmHg and/or diastolic blood pressure≥100mmHg).

Sponsors & Collaborators

• Hunan Provincial Center for Disease Control and Prevention: collaborator
• Hubei Provincial Center for Disease Control and Prevention: collaborator
• Shaanxi Provincial Center for Disease Control and Prevention: collaborator
• Guangdong Center for Disease Prevention and Control: collaborator
• Shandong Province Centers for Disease Control and Prevention: collaborator
• Sichuan Center for Disease Control and Prevention: collaborator
• Hebei CDC ,China: collaborator
• MAXVAX Biotechnology Limited Liability Company: lead
• Henan Center for Disease Control and Prevention: collaborator

Study Sites (8)

Guangdong Provincial Center for Disease Control and Prevention

Guangzhou, Guangdong, 511400, China

NOT YET RECRUITING

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, 050021, China

ACTIVE NOT RECRUITING

Henan Center for Disease Control and Prevention

Zhengzhou, Henan, 450016, China

RECRUITING

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, 430079, China

RECRUITING

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, 410005, China

RECRUITING

Shaanxi Provincial Center for Disease Control and Prevention

Xi'an, Shaanxi, 710054, China

RECRUITING

Shandong Province Centers for Disease Control and Prevention

Jinan, Shandong, 250014, China

ACTIVE NOT RECRUITING

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yanxia Wang

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LiangHao Zhang

CONTACT

+86 18971498772; lianghao.zhang@maxvax.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 9, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)