Assessing the Effectiveness of Vaccines in Preventing Adult RSV-caused Lower Respiratory Tract Disease (LRTD)Phase 3NCT07860216
Phase III Clinical Trial of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)
A Phase 3 study testing Recombinant respiratory syncytial virus vaccine (CHO cell) and Sodium Chloride Injection 0.9% in people with Assessing the Effectiveness of Vaccines in Preventing Adult RSV-caused Lower Respiratory Tract Disease (LRTD), run by Beijing BeneWill Technology Development Co., Ltd at 7 sites in China.
Trial summary
This is a phase III clinical trial with a multicenter, randomized, blinded, placebo-controlled design to evaluate the protective efficacy, safety, and immunogenicity of the recombinant respiratory syncytial virus (RSV) vaccine (CHO cell) in individuals aged 60 and above. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Assessing the Effectiveness of Vaccines in Preventing Adult RSV-caused Lower Respiratory Tract Disease (LRTD)
- What is being tested?
- Recombinant respiratory syncytial virus vaccine (CHO cell) and Sodium Chloride Injection 0.9%
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25,000 participants
- Where
- 7 sitesChina
- Study dates
- 21 Aug 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (In cases where the required number of participants has not been met, if the criteria described in the "" option are not met during screening, the visit can be rescheduled)
- *At the time of enrollment, participants must be aged 60 or above, of either gender, and able to provide legal identification;
- Have the ability to understand the clinical trial procedures, voluntarily agree to participate, and sign the informed consent form;
- Be able to cooperate and participate in all scheduled follow-ups as required by the protocol;
- Female trial participants should have undergone menopause or sterilization surgery; [Menopause is defined as continuous cessation of menstruation for ≥12 months without alternative medical measures; sterilization surgery includes bilateral tubal ligation, bilateral oophorectomy, or hysterectomy].
- Trial participants who are judged by the researchers to have stable health conditions. [Stable health conditions refer to those with chronic diseases that have been stable for the past 3 months prior to enrollment, such as diabetes, hypertension, chronic obstructive pulmonary disease, and asthma. If the researchers judge the condition to be stable, the participant is allowed to participate in this trial].
Who cannot join
- (If the enrollment requirement is not met, and the criteria described in the "" option are met during screening, the visit can be rescheduled)
- *On the day before vaccination, the on-site measured temperature is >37.0℃ (axillary temperature);
- *Upon research, the on-site measured blood oxygen saturation (SpO2) is ≤90%;
- Have previously received or plan to receive any marketed or experimental RSV vaccine/RSV monoclonal antibody;
- A history of RSV infection confirmed within 6 months prior to enrollment;
- *Having used or planning to use any non-specific immunoglobulin and/or blood products containing non-specific immunoglobulin (such as whole blood, plasma) within 3 months before enrollment or during the trial period;
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- *Have used other investigational or unregistered products (drugs or vaccines) within one month before enrollment, or are currently participating in other clinical trials or plan to participate in other clinical trials during the trial period;
- *Having used immunosuppressants or other immunomodulatory drugs for a prolonged period (continuous use ≥14 days) within 3 months before enrollment or during the planned trial period [such as systemic glucocorticoids for ≥14 days, with a dose ≥2mg/kg/day or ≥20mg/day of prednisone or equivalent to prednisone; however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are allowed, and the dose of topical medications must not exceed the recommended dose as stated in the instructions];
- *Having received a live attenuated vaccine within 30 days before enrollment or planning to receive one within 30 days after enrollment, or having received any non-live vaccine other than the trial vaccine within 14 days before enrollment or planning to receive one within 14 days after enrollment;
- *Having an acute disease or being in an acute exacerbation phase of a chronic disease within 3 days before enrollment, or using antipyretic analgesics (excluding medications used to control current diseases and which, in the investigator's judgment, are not expected to affect the interpretation of trial results, such as aspirin used for the treatment of coronary heart disease) or antiallergic medications (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
- Individuals with a history of severe allergic reactions requiring medical intervention to any vaccine or medication [such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction), etc.] or known allergies to any component of the trial vaccine [citric acid, sodium citrate, sodium chloride, sucrose, polysorbate 80 (II), mannitol, squalene, sorbitan trioleate (Span 85), water for injection];
- Previous or current congenital or acquired immune deficiency diseases (such as AIDS), human immunodeficiency virus (HIV) infection, systemic lupus erythematosus, or other autoimmune diseases that may affect the trial evaluation as assessed by the investigator (such as a history of inflammatory demyelinating neuropathy like Guillain-Barré syndrome); other diseases affecting immune function (such as asplenia or functional asplenia);
- Previous or current severe or uncontrollable cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory system diseases, diabetes with complications, malignant tumors [for patients with lacunar cerebral infarction or cerebral infarction without sequelae, or certain malignant tumors (such as papillary thyroid carcinoma, early-stage cervical cancer, basal cell carcinoma, and squamous cell carcinoma of the skin), those who have been stable and relapse-free for 5 years prior to enrollment after careful assessment by the researchers are allowed to be enrolled];
- Currently suffering from or having previously suffered from convulsions, epilepsy (specifically other convulsions and epilepsy other than febrile seizures in children), acute disseminated encephalomyelitis, or other neurological diseases; or having a history of mental illness affecting normal behavior, or a family history of the aforementioned diseases with a genetic predisposition;
- Suffering from thrombocytopenia, coagulation dysfunction, or any condition that may constitute a contraindication to intramuscular injection;
- *Elevated blood pressure (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg, regardless of medication use) measured through on-site physical examination;
- Individuals with alcoholism or alcohol dependence (such as an inability to control drinking behavior, and a dependency on alcohol) or drug abuse;
- Other conditions that researchers consider unsuitable for participation in clinical trials.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Baoshan Second People's Hospital in Yunnan Province
Baoshan, Yunnan
Yanhong Jiang, 18725329929, 18725329929@139.com
- Recruiting
Guizhou Provincial Center for Disease Control and Prevention
GuiZhou, Guizhou
Kuihu Guan, 13087815811, 522649392@qq.com
- Recruiting
Hebei Provincial Center for Disease Control and Prevention
Hebei, Hebei
Zhao Gao, Master of Medicine, +86 177 9691 5780, gaozhao123000@163.com
- Not yet recruiting
Hubei Provincial Center for Disease Control and Prevention
HuBei, Hubei
YeQing Tong, 13971078410, 63382251@qq.com
- Recruiting
Hunan Province Center for Disease Control and Prevention
HuNan, Hunan
JunShi Zhao, 17788903138, E-mail：ymlc02@hncdc.con
- Not yet recruiting
Shandong Provincial Center for Disease Control and Prevention
Shandong, Shandong
Li Zhang, 18853165191, zltrial@vip.163.com
- Not yet recruiting
Shaanxi Provincial Center for Disease Control and Prevention
Shanxi, Shanxi
XiaoYu Liu, 18629031661, liuxiaoyu594230@163.com
About this study
Official title: Phase III Multicenter, Randomized, Blinded, Placebo-controlled Trial Assessing the Efficacy, Safety, and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged ≥60 Years
This is a phase III clinical trial with a multicenter, randomized, blinded, placebo-controlled design to evaluate the protective efficacy, safety, and immunogenicity of the recombinant respiratory syncytial virus (RSV) vaccine (CHO cell) in individuals aged 60 and above.
Sample Size and Trial Grouping: This trial plans to enroll 25,000 trial participants aged ≥60 years (with approximately 30% aged 70 and above), with a relatively balanced gender distribution. Participants of each age group (60-69 years old, ≥70 years old) will be randomly assigned to the trial group and the placebo group in a 1:1 ratio. The sample size for the immunogenicity subgroup is not calculated based on statistical power. Referring to similar clinical trials of RSV vaccines and in conjunction with the immunogenicity observation objectives of this trial, the first 300 trial participants (including those from both age groups) from each site under the leading institution will be included in the immunogenicity subgroup, for a total of 1,200 participants.
Read the detailed description
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.
- Being tested
- Recombinant respiratory syncytial virus vaccine (CHO cell), Sodium Chloride Injection 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant respiratory syncytial virus vaccine (CHO cell)Biological
Test vaccine BW-201 (Adj 1): After mixing the "recombinant respiratory syncytial virus vaccine adjuvant injection" upside down, fully aspirate and inject it into the "RSV vaccine" lyophilized powder for re-dissolution. Slowly rotate the vial to mix, and use it after complete dissolution.
After mixing the antigen and adjuvant, store them in a refrigerator at 2°C-8°C in the dark and use them within 4 hours. Before use, they need to be mixed again. If the mixture of antigen and adjuvant is left at room temperature (not exceeding 25°C), it needs to be used within 30 minutes.
After mixing 1 bottle of adjuvant solution according to the above steps, aspirate the entire content and add it to the antigen, followed by mixing. Each person should receive 0.5mL per injection, administered intramuscularly into the deltoid muscle on the lateral side of the upper arm. Intravenous injection is strictly prohibited.
Sodium Chloride Injection 0.9%Biological
Also called normal saline
The placebo is a 0.9% sodium chloride solution. Each person is to receive 0.5mL for intramuscular injection, with the injection site being the deltoid muscle on the lateral side of the upper arm. Intravenous injection is strictly prohibited. The remaining 0.9% sodium chloride solution (approximately 9.5mL) should be disposed of as waste.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant respiratory syncytial virus vaccine (CHO cells) | Experimental | Antigen: white or almost white powder or cake-like substance. MF59 adjuvant: milky white liquid. Vaccination procedure and dosage: Administer one dose on Day 0. Before use, mix the adjuvant solution thoroughly. Pipette up the entire solution and add it to the antigen, mixing well. Each individual receives 0.5 mL for intramuscular injection, with the injection site being the lateral deltoid muscle of the upper arm. Intravenous injection is strictly prohibited. Receives: Biological: Recombinant respiratory syncytial virus vaccine (CHO cell) |
| Sodium chloride injection | Placebo comparator | Appearance: colorless and clear liquid Vaccination procedure and dosage: One dose is administered on Day 0, with 0.5 mL per person for intramuscular injection. The injection site is the deltoid muscle on the lateral side of the upper arm. Intravenous injection is strictly prohibited. Receives: Biological: Sodium Chloride Injection 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first-time incidence rate per person-year of Lower Respiratory Tract Disease (LRTD).
The yearly rate of first-time RSV-LRTD confirmed by RT-PCR from 14 days after vaccination until the end of S1.
Measured: From 14 days after vaccination until the end of S1, the evaluation period can last up to 12 months.
Secondary outcomes (15)
The first time someone gets severe lower respiratory tract disease (sLRTD) each year per person.
The annual incidence rate per person for the first occurrence of RSV-sLRTD confirmed by RT-PCR from 14 days after vaccination until the end of S1.
Measured: From 14 days after vaccination until the end of S1, the evaluation period can last up to 12 months.
The first occurrence rate of acute respiratory infections (ARI) per person per year.
The annual incidence rate of first-time RSV-ARI confirmed by RT-PCR occurring from 14 days after vaccination until the end of S1.
Measured: From 14 days after vaccination until the end of S1, the evaluation period can last up to 12 months.
The incidence of the first occurrence of LRTD per person per year.
The annual incidence per person of first-time, RT-PCR-confirmed RSV A or RSV B subtype-related LRTD from 14 days after vaccination until the end of S1;
Measured: From 14 days after vaccination to the end of S1, the assessment period can last up to 12 months.
The incidence of the first occurrence of sLRTD per person per year.
The incidence rate per person-year of first-time RSV A and RSV B related sLRTD confirmed by RT-PCR from 14 days after vaccination until the end of S1;
Measured: From 14 days after vaccination to the end of S1, the assessment period can last up to 12 months.
The incidence rate of the first ARI each year per person.
The incidence rate per person-year of RSV A and RSV B related ARI confirmed by RT-PCR, occurring for the first time from 14 days after vaccination until the end of S1.
Measured: From 14 days after vaccination to the end of S1, the assessment period can last up to 12 months.
Occurrence of adverse events (AEs)
The occurrence of adverse events (AE) within 30 days after vaccination
Measured: Within 30 days after vaccination
Occurrence of solicited adverse events
Occurrence of solicited AEs within 7 days after vaccination
Measured: Within 7 days after vaccination
Occurrence of unsolicited AEs
Occurrence of unsolicited AEs within 30 days after vaccination
Measured: Within 30 days after vaccination
How often serious adverse events (SAEs) and adverse events of special interest (AESIs) happen
The occurrence of serious adverse events (SAE) and adverse events of special interest (AESI) within 12 months after vaccination.
Measured: Within 12 months after vaccination
Immunogenicity (Immunogenicity Subgroup)
Geometric mean titers (GMT) of neutralizing antibodies against RSV A and RSV B subtypes
Measured: 30 days and 12 months after vaccination.
Immunogenicity (Immunogenicity Subgroup)
Geometric mean fold increase (GMFR) of neutralizing antibodies for RSV A and RSV B subtypes.
Measured: 30 days and 12 months after vaccination
Immunogenicity (Immunogenicity Subgroup)
Serum response rate (SRR) for neutralizing antibodies against RSV A and RSV B subtypes
Measured: 30 days and 12 months after vaccination.
Immunogenicity (Immunogenicity Subgroup)
Geometric mean concentration (GMC) of pre-fusion F protein (preF) specific IgG antibodies.
Measured: 30 days and 12 months after vaccination.
Immunogenicity (Immunogenicity Subgroup)
Geometric mean fold rise (GMFR) of pre-fusion F protein (preF) specific IgG antibodies
Measured: 30 days and 12 months after vaccination.
Immunogenicity (Immunogenicity Subgroup)
Geometric mean concentration (SRR) of pre-fusion F protein (preF) specific IgG antibodies
Measured: 30 days and 12 months after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start21 Aug 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessing the Effectiveness of Vaccines in Preventing Adult RSV-caused Lower Respiratory Tract Disease (LRTD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sample size considerations: Given that a comprehensive and functional infection surveillance network for RSV has not yet been established domestically, the incidence rate of LRTD caused by RSV infection in this trial is unpredictable. This trial reviewed randomized controlled trials of commercially available RSV vaccines abroad, where the incidence rate in the placebo group ranged from 0.35% to 0.8%. Based on the estimated incidence rate of RSV-LRTD in similar clinical trials, this trial assumes an incidence rate of approximately 0.35% during the first epidemic season. It is expected that the vaccine will achieve a protective efficacy of 70% 14 days after one dose of the trial vaccine in individuals aged 60 and above. The ratio of the test group to the control group is 1:1, and the total type I error rate is set at one-sided α=0.025. An interim analysis will be considered when at least two-thirds of the primary efficacy endpoint cases of RSV-LRTD are observed during the first epidemic
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing BeneWill Technology Development Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhao Gao, Master of Medicine, Study director, Hebei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860216
- Sponsor's protocol ID
- RSV-201-CT3
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Multicenter, Randomized, Blinded, Placebo-controlled Trial Assessing the Efficacy, Safety, and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged ≥60 Years
- ClinicalTrials.gov ID
- NCT07860216
- Acronym / sponsor ID
- RSV-201-CT3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Beijing BeneWill Technology Development Co., LtdUniversity, hospital or other
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III clinical trial with a multicenter, randomized, blinded, placebo-controlled design to evaluate the protective efficacy, safety, and immunogenicity of the recombinant respiratory syncytial virus (RSV) vaccine (CHO cell) in individuals aged 60 and above.
Sample Size and Trial Grouping: This trial plans to enroll 25,000 trial participants aged ≥60 years (with approximately 30% aged 70 and above), with a relatively balanced gender distribution. Participants of each age group (60-69 years old, ≥70 years old) will be randomly assigned to the trial group and the placebo group in a 1:1 ratio. The sample size for the immunogenicity subgroup is not calculated based on statistical power. Referring to similar clinical trials of RSV vaccines and in conjunction with the immunogenicity observation objectives of this trial, the first 300 trial participants (including those from both age groups) from each site under the leading institution will be included in the immunogenicity subgroup, for a total of 1,200 participants.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sample size considerations: Given that a comprehensive and functional infection surveillance network for RSV has not yet been established domestically, the incidence rate of LRTD caused by RSV infection in this trial is unpredictable. This trial reviewed randomized controlled trials of commercially available RSV vaccines abroad, where the incidence rate in the placebo group ranged from 0.35% to 0.8%. Based on the estimated incidence rate of RSV-LRTD in similar clinical trials, this trial assumes an incidence rate of approximately 0.35% during the first epidemic season. It is expected that the vaccine will achieve a protective efficacy of 70% 14 days after one dose of the trial vaccine in individuals aged 60 and above. The ratio of the test group to the control group is 1:1, and the total type I error rate is set at one-sided α=0.025. An interim analysis will be considered when at least two-thirds of the primary efficacy endpoint cases of RSV-LRTD are observed during the first epidemic
| Arm | Type | Receives |
|---|---|---|
| Recombinant respiratory syncytial virus vaccine (CHO cells) | Experimental | Biological: Recombinant respiratory syncytial virus vaccine (CHO cell)Antigen: white or almost white powder or cake-like substance. MF59 adjuvant: milky white liquid. Vaccination procedure and dosage: Administer one dose on Day 0. Before use, mix the adjuvant solution thoroughly. Pipette up the entire solution and add it to the antigen, mixing well. Each individual receives 0.5 mL for intramuscular injection, with the injection site being the lateral deltoid muscle of the upper arm. Intravenous injection is strictly prohibited. |
| Sodium chloride injection | Placebo comparator | Biological: Sodium Chloride Injection 0.9%Appearance: colorless and clear liquid Vaccination procedure and dosage: One dose is administered on Day 0, with 0.5 mL per person for intramuscular injection. The injection site is the deltoid muscle on the lateral side of the upper arm. Intravenous injection is strictly prohibited. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (In cases where the required number of participants has not been met, if the criteria described in the "" option are not met during screening, the visit can be rescheduled)
- *At the time of enrollment, participants must be aged 60 or above, of either gender, and able to provide legal identification;
- Have the ability to understand the clinical trial procedures, voluntarily agree to participate, and sign the informed consent form;
- Be able to cooperate and participate in all scheduled follow-ups as required by the protocol;
- Female trial participants should have undergone menopause or sterilization surgery; [Menopause is defined as continuous cessation of menstruation for ≥12 months without alternative medical measures; sterilization surgery includes bilateral tubal ligation, bilateral oophorectomy, or hysterectomy].
Key exclusion criteria (18 listed)
- (If the enrollment requirement is not met, and the criteria described in the "" option are met during screening, the visit can be rescheduled)
- *On the day before vaccination, the on-site measured temperature is >37.0℃ (axillary temperature);
- *Upon research, the on-site measured blood oxygen saturation (SpO2) is ≤90%;
- Have previously received or plan to receive any marketed or experimental RSV vaccine/RSV monoclonal antibody;
- A history of RSV infection confirmed within 6 months prior to enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant respiratory syncytial virus vaccine (CHO cell)Test vaccine BW-201 (Adj 1): After mixing the "recombinant respiratory syncytial virus vaccine adjuvant injection" upside down, fully aspirate and inject it into the "RSV vaccine" lyophilized powder for re-dissolution. Slowly rotate the vial to mix, and use it after complete dissolution. After mixing the antigen and adjuvant, store them in a refrigerator at 2°C-8°C in the dark and use them within 4 hours. Before use, they need to be mixed again. If the mixture of antigen and adjuvant is left at room temperature (not exceeding 25°C), it needs to be used within 30 minutes. After mixing 1 bottle of adjuvant solution according to the above steps, aspirate the entire content and add it to the antigen, followed by mixing. Each person should receive 0.5mL per injection, administered intramuscularly into the deltoid muscle on the lateral side of the upper arm. Intravenous injection is strictly prohibited. | Biological | Recombinant respiratory syncytial virus vaccine (CHO cells) |
| Sodium Chloride Injection 0.9%Also: normal salineThe placebo is a 0.9% sodium chloride solution. Each person is to receive 0.5mL for intramuscular injection, with the injection site being the deltoid muscle on the lateral side of the upper arm. Intravenous injection is strictly prohibited. The remaining 0.9% sodium chloride solution (approximately 9.5mL) should be disposed of as waste. | Biological | Sodium chloride injection |
Primary outcome
The first-time incidence rate per person-year of Lower Respiratory Tract Disease (LRTD).
Time frame: From 14 days after vaccination until the end of S1, the evaluation period can last up to 12 months.
The yearly rate of first-time RSV-LRTD confirmed by RT-PCR from 14 days after vaccination until the end of S1.
15 secondary outcomes
The first time someone gets severe lower respiratory tract disease (sLRTD) each year per person.
Time frame: From 14 days after vaccination until the end of S1, the evaluation period can last up to 12 months.
The first occurrence rate of acute respiratory infections (ARI) per person per year.
Time frame: From 14 days after vaccination until the end of S1, the evaluation period can last up to 12 months.
The incidence of the first occurrence of LRTD per person per year.
Time frame: From 14 days after vaccination to the end of S1, the assessment period can last up to 12 months.
The incidence of the first occurrence of sLRTD per person per year.
Time frame: From 14 days after vaccination to the end of S1, the assessment period can last up to 12 months.
The incidence rate of the first ARI each year per person.
Time frame: From 14 days after vaccination to the end of S1, the assessment period can last up to 12 months.
Occurrence of adverse events (AEs)
Time frame: Within 30 days after vaccination
Occurrence of solicited adverse events
Time frame: Within 7 days after vaccination
Occurrence of unsolicited AEs
Time frame: Within 30 days after vaccination
How often serious adverse events (SAEs) and adverse events of special interest (AESIs) happen
Time frame: Within 12 months after vaccination
Immunogenicity (Immunogenicity Subgroup)
Time frame: 30 days and 12 months after vaccination.
Immunogenicity (Immunogenicity Subgroup)
Time frame: 30 days and 12 months after vaccination
Immunogenicity (Immunogenicity Subgroup)
Time frame: 30 days and 12 months after vaccination.
Immunogenicity (Immunogenicity Subgroup)
Time frame: 30 days and 12 months after vaccination.
Immunogenicity (Immunogenicity Subgroup)
Time frame: 30 days and 12 months after vaccination.
Immunogenicity (Immunogenicity Subgroup)
Time frame: 30 days and 12 months after vaccination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhao Gao, Master of Medicine study director
Hebei Provincial Center for Disease Control and Prevention
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant respiratory syncytial virus vaccine (CHO cell) and Sodium Chloride Injection 0.9% in people with Assessing the Effectiveness of Vaccines in Preventing Adult RSV-caused Lower Respiratory Tract Disease (LRTD), run by Beijing BeneWill Technology Development Co., Ltd at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao Gao, Master of Medicine (+86 177 9691 5780, gaozhao123000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first-time incidence rate per person-year of Lower Respiratory Tract Disease (LRTD). (time frame: From 14 days after vaccination until the end of S1, the evaluation period can last up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.