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.
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).
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.
*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.
Parallel
Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)
Biological/Vaccine0.5 mL per dose
Placebo (Saline solution)
Biological/Vaccine0.5 mL per dose
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）.
The first-time incidence rate per person-year of Acute Respiratory Illness (ARI).
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
The first-time incidence rate per person-year of Severe Lower Respiratory Tract Disease (sLRTD).
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
The first-time incidence rate per person-year of LRTD.
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
The first-time incidence rate per person-year of ARI.
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
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MAXVAX Biotechnology Limited Liability Company
Lead sponsor
Henan Center for Disease Control and Prevention
Collaborator
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
