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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorMAXVAX Biotechnology Limited Liability Company

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

*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.

Trial design

Treatments tested in this trial

  • Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)
  • Placebo (Saline solution)

Treatment groups

25,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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