Lower respiratory tract disease caused by respiratory syncytial virus infection
Conditions
Interventions
Vaccine Group:Participants will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells), by IM injection into the deltoid region of the arm.
Placebo Group:Participants will receive single dose of placebo, by IM injection into the deltoid region of the arm.
Sponsors
Henan Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.*A male or female is able to 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.); 2.Be able to understand the trial procedures, risks and benefits and voluntarily agree to participate in the study and signed an informed consent; 3.Be able to participate in all scheduled visits and comply with the protocol requirements; 4.Participants with stable health conditions considered by the investigator; Stable health condition refers 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
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) 1.*Axillary temperature>37.3?; 2.History of RSV infection within 6 months before enrollment; 3.*New onset of respiratory tract infection symptoms like cough, sputum, shortness of breath, wheezing, fever, runny nose or nasal congestion within 7 days before enrollment; 4.*Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination; 5.*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; 6.Those who are allergic to the known components in the test vaccine [saponin (QS-21), dioleyl 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; 7.Anplenia or functional anplenia, and any condition leading to anplenia or splenectomy ; 8.Those who have had or are currently suffering from malignant tumors (except for clinically cured carcinoma in situ and papillary thyroid carcinoma) 9.Patients diagnosed with autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease and autoimmune thyroid disease; 10.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] 11.According to the investigator's assessment,there is any disease that may make intramuscular injection unsafe, such as a history of thrombocytopenia or other coagulation disorders; 12.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; 13.Those who have had or are currently suffering from thrombotic diseases; 14.Patients with a history of untreated TB or active TB at enrollment; 15.*Hypertension with poor medication control (on-site blood pressure measurement before vaccination: systolic blood pressure=150mmHg and/or diastolic blood pressure>=100mmHg); 16.Those with severe arrhythmias (such as atrial fibrillation) 17.Those with a history or family history of convulsions, epilepsy, congenital brain hypoplasia, mental illness, etc., or a history of brain nerve tissue damage caused by other serious neurological diseases (such as brain tumors, cerebral hemorrhage, brain infections, chemical drug poisoning, etc.) 18.Use of any experimental or unmarketed product (drug, vaccine or medical device) other than the vaccine used
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A case caused by RSV-A and/or RSV-B as confirmed by Reverse Transcription-Polymerase Chain Reaction(RT-PCR).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titer (GMT) and geometric mean fold rise (GMFR) of serum neutralizing antibodies against respiratory syncytial virus subtype A (RSV-A) and subtype B (RSV-B).;Geometric mean concentration (GMC) and geometric mean fold rise (GMFR) of serum IgG binding antibodies against respiratory syncytial virus (RSV) prefusion F protein (RSV-pre-F) for subtypes A (RSV-A) and B (RSV-B);The incidence, severity distribution, and relationship to vaccination of all adverse events (AEs);The incidence, severity and relationship to vaccination of solicited local adverse events(AE);The incidence, severityand relationship to vaccination of solicited systemic AEs;The incidence, severity, and relationship to vaccination of non-solicited AEs;The incidence and relationship to vaccination of SAE;The incidence and relationship to vaccination of AESI;The first-time incidence rate per person-year of Acute Respiratory Illness (ARI).;The first-time incidence rate per person-year of Severe Lower Respiratory Tract Disease (sLRTD).; | — |
Countries
China
Contacts
Public ContactYanxia Wang
Henan Center for Disease Control and Prevention
Outcome results
None listed