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New treatment option for Respiratory Syncytial Virus (RSV)
Official title Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell)
ClinicalTrials.gov ID: NCT07272434
What this study is testing
What is Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)?
Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) is an investigational medicine, being studied as a potential treatment for respiratory syncytial virus (rsv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- \ 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...
- \ Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination.
- \ Within 3 days before enrollment, antipyretic and analgesic drugs (except enteric-coated aspirin tablets for the prevention of cardiovascular and...
See the full eligibility 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...
- 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...
- 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...
- \ 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.
- \ 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
- Those who are allergic to the known components in the test vaccine [saponin (QS-21), dioleoyl phosphatidylcholine (DOPC), cholesterol, sucrose, sodium dihydrogen phosphate, anhydrous sodium dihydrogen phosphate...
- Asplenia or functional asplenia, and any condition leading to asplenia or splenectomy.
- Those who have had or are currently suffering from malignant tumors (except for clinically cured carcinoma in situ and papillary thyroid carcinoma).
- Patients are diagnosed with autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease and autoimmune thyroid disease.
- 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...
- According to the investigator's assessment,there is any disease that may make intramuscular injections unsafe, such as a history of thrombocytopenia or other coagulation disorders.
- 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...
- Those who have had or are currently suffering from thrombotic diseases.
- Patients with a history of untreated TB or active TB at enrollment.
- \ Hypertension with poor medication control (on-site blood pressure measurement before vaccination: systolic blood pressure≥150mmHg and/or diastolic blood pressure≥100mmHg).
- Those with severe arrhythmias (such as atrial fibrillation).
- 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...
- Use of any experimental or unapproved product (drug, vaccine or medical device) other than the vaccine used in this trial or participate in other clinical trials within 30 days prior to enrollment or during the trial...
- \ Within 14 days prior to enrollment, any non-live vaccine has been administered, or within 28 days, a live vaccine or nucleic acid vaccine has been administered.
- Has received the RSV vaccine before.
- Use of immunoglobulin and/or any blood preparation or plasma derivative, such as gamma globulin or intravenous human immunoglobulin, within 3 months prior to enrollment or plan to use during the trial
- Within the 3 months prior to enrollment or if it is expected to be used for a long period during the trial (continuous for more than 14 days), immunosuppressive agents or other immunomodulatory drugs (such as long-term...
- Long-acting immunomodulatory drugs (such as infliximab) were used within 6 months before enrollment or during the planned trial period.
- The researchers determined that the drinking behavior and/or drug abuse history that might affect the assessment of the trial (Note: within the last three months, men had an average of more than 14 standard drinks per...
- Planned move to a location that will prohibit participating in the trial until study end;
- Any condition that, in the opinion of the investigator, may affect the safety of the participant or the evaluation of the study results.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Xi'an, Shaanxi, China
- Jinan, Shandong, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Shijiazhuang, Hebei, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Changsha, Hunan, China; Xi'an, Shaanxi, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.