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 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
25,000
0.5 mL per dose
0.5 mL per dose
Guangdong Provincial Center for Disease Control and Prevention
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGHebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
ACTIVE_NOT_RECRUITINGHenan Center for Disease Control and Prevention
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).
Time frame: 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 Acute Respiratory Illness (ARI).
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
Time frame: 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).
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
Time frame: 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.
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
Time frame: After vaccination, during the second RSV epidemic season,assessed up to 12 months.
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.
Time frame: After vaccination, during the second RSV epidemic season,assessed up to 12 months.
The first-time incidence rate per person-year of sLRTD.
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
Time frame: After vaccination, during the second RSV epidemic season,assessed up to 12 months.
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Zhengzhou, Henan, China
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
RECRUITINGHunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
RECRUITINGShaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi, China
RECRUITINGShandong Province Centers for Disease Control and Prevention
Jinan, Shandong, China
ACTIVE_NOT_RECRUITINGSichuan Center for Disease Control and Prevention
Chengdu, Sichuan, China
RECRUITINGThe first-time incidence rate per person-year of LRTD.
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
Time frame: 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.
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
Time frame: 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.
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.
Time frame: 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.
Measured by Virus Neutralization Test.
Time frame: 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
Measured by Virus Neutralization Test.
Time frame: 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
Measured by ELISA.
Time frame: 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
Measured by ELISA.
Time frame: At 14 days,1,12,24 and 36 months after vaccination
Incidence, Intensity and Causality of adverse events(AEs)
An AE includes any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Within 30 days after vaccination
Incidence, Intensity and Causality of solicited AEs
Solicited AEs include solicited local and general symptoms; Assessed solicited local AEs at injection site are pain, erythema, swelling, induration and itching; Assessed solicited general symptoms include fever, fatigue, headache, myalgia, nausea, vomiting, diarrhea, arthralgia and hypersensitivity.
Time frame: Within 7 days after vaccination
Incidence, Intensity and Causality of unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within 30 days after vaccination
Incidence and Causality of Severe adverse events(SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability/incapacity or are congenital anomaly/birth defect.
Time frame: Up to 12 months post vaccination
Incidence and Causality of Adverse event of special interest (AESI)
Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation.
Time frame: Up to 12 months post vaccination