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| Name | Class |
|---|---|
| Henan Center for Disease Control and Prevention | OTHER_GOV |
| Hunan Provincial Center for Disease Control and Prevention | OTHER |
| Hubei Provincial Center for Disease Control and Prevention | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo Group | Placebo Comparator | Participants will receive single dose of placebo, by IM injection into the deltoid region of the arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) | Biological | 0.5 mL per dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LiangHao Zhang | Contact | +86 18971498772 | lianghao.zhang@maxvax.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanxia Wang | Henan Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Center for Disease Control and Prevention | Not yet recruiting | Guangzhou | Guangdong | 511400 | China |
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| Shaanxi Provincial Center for Disease Control and Prevention | OTHER |
| Guangdong Center for Disease Prevention and Control | OTHER_GOV |
| Shandong Province Centers for Disease Control and Prevention | OTHER |
| Sichuan Center for Disease Control and Prevention | OTHER_GOV |
| Hebei CDC ,China | UNKNOWN |
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| Placebo (Saline solution) |
| Biological |
0.5 mL per dose |
|
A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR. |
| 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. | 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. | 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. | After vaccination, during the second 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 12 months post vaccination |
| Hebei Provincial Center for Disease Control and Prevention | Active, not recruiting | Shijiazhuang | Hebei | 050021 | China |
| Henan Center for Disease Control and Prevention | Recruiting | Zhengzhou | Henan | 450016 | China |
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| Hubei Provincial Center for Disease Control and Prevention | Recruiting | Wuhan | Hubei | 430079 | China |
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| Hunan Provincial Center for Disease Control and Prevention | Recruiting | Changsha | Hunan | 410005 | China |
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| Shaanxi Provincial Center for Disease Control and Prevention | Recruiting | Xi'an | Shaanxi | 710054 | China |
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| Shandong Province Centers for Disease Control and Prevention | Active, not recruiting | Jinan | Shandong | 250014 | China |
| Sichuan Center for Disease Control and Prevention | Recruiting | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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