Respiratory Syncytial Virus (RSV)Phase 3NCT07908654
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
A Phase 3 study testing LYB005 in people with Respiratory Syncytial Virus (RSV) and Respiratory Syncytial Virus (RSV) Infection, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, observer-blinded, placebo-controlled Phase III clinical trial to evaluate efficacy, immunogenicity and safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in participants aged 60 years and older. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection, RSV Vaccine
- What is being tested?
- LYB005
- 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
- 1 siteChina
- Study dates
- Nov 2026to Dec 2027
- 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
- A male or female participant aged 60 years and above；
- Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form, and are able to attend all planned follow-up visits and comply with the protocol requirements；
- Axillary temperature ≤ 37.0°C on the day of enrollment;
- Female participants should have been menopausal or have undergone sterilization surgery; Menopause is defined as the absence of menstruation for at least 12 consecutive months without alternative medical measures; sterilization surgeries include bilateral tubal ligation or bilateral oophorectomy or hysterectomy; Male participants must not plan to father a child from the time of screening until 30 days after vaccination;
- Participants in the trial who were judged by the researchers to be healthy or have stable health conditions. [Stable health condition: This refers to having a chronic disease and maintaining a stable condition within the three months prior to enrollment irrespective of receipt of specific treatment, such as diabetes, hypertension, chronic obstructive pulmonary disease, and asthma. If the researcher determines that the condition is stable, participation in this trial will be permitted.].
Who cannot join
- Participants who are known to be allergic to any of the components contained in the test vaccine (e.g., sucrose, polysorbate 20, sodium dihydrogen phosphate dihydrate, and disodium hydrogen phosphate dihydrate.); A history of severe allergic reactions or serious adverse reactions to any vaccine;
- A confirmed diagnosis or etiological evidence of respiratory syncytial virus infection and related diseases caused by the infection within 12 months before enrollment (confirmed by RT-PCR, RSV-Ab, etc.);
- Have received or plan to receive any marketed or experimental RSV vaccine/RSV prophylactic medication;
- Has taken antipyretics, analgesics (except for medications used for underlying conditions that, in the investigator's judgment, are unlikely to affect study outcomes, such as enteric-coated aspirin for the prevention of cardiovascular and cerebrovascular diseases.) or anti-allergy drugs within 3 days before enrollment;
- Receipt of any non-live vaccine within 14 days prior to enrollment, or any live or nucleic acid vaccine within 28 days prior to enrollment;
- Any non-specific immunoglobulins and/or blood products containing non-specific immunoglobulins (such as whole blood, plasma) have been used within 3 months prior to enrollment or are planned to be used during the trial;
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- Individual with the following diseases: ①Has acute diseases or are in the acute exacerbation period of chronic diseases within 3 days before vaccination; ②Individual with active tuberculosis or currently undergoing treatment for tuberculosis; ③History of congenital or acquired immunodeficiency or autoimmune diseases; Chronic administration (≥14 consecutive days) of corticosteroids (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunomodulatory medications within the past 3 months, currently using or planning to use a long-acting immunomodulatory agent (e.g., infliximab), with the exception of inhaled or topical steroids, or short-term use (<14 consecutive days) of oral corticosteroids; ④Previous or current neurological disorders resulting in damage to brain nervous tissue (including seizures [specifically excluding simple febrile seizures in children], encephalopathy, etc.); or uncontrolled epilepsy with seizures occurring within 1 year prior to enrollment; or a history of psychotic disorders that affect normal behavior; ⑤Asplenia or functional asplenia; ⑥ Any cardiovascular, respiratory, hepatic, renal, metabolic, hematologic, or lymphatic disease deemed by the investigator to be unstable or uncontrolled (defined as requiring a major adjustment in treatment regimen within 3 months prior to enrollment, or hospitalization due to disease worsening; Individual with a history of lacunar cerebral infarction or cerebral infarction without residual sequelae can be enrolled if, after careful evaluation by the investigator, the condition has remained stable without recurrence for at least 5 years prior to enrollment); Individual with active malignancy or currently receiving antineoplastic therapy (excluding adjuvant endocrine therapy) are excluded (Certain malignancies, such as carcinoma in situ that has been clinically cured or papillary thyroid carcinoma, can be permitted following careful investigator assessment if there is no evidence of recurrence for ≥5 years prior to enrollment); ⑦Coagulation disorders (e.g., hemophilia or platelet count < 50 × 10⁹/L) that are contraindications for intramuscular injection; ⑧Uncontrolled hypertension as determined by the investigator (measured on-site: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg whether or not receiving medication); ⑨Arrhythmias that are newly diagnosed within 3 months prior to enrollment, not adequately controlled, or have required modification of treatment within 3 months prior to enrollment;
- Oxygen saturation (SpO₂) ≤ 90% as measured on site;
- History of major surgery within 6 months prior to enrollment (as determined by the investigator), or not fully recovered from the surgery, or having plans for major surgery during the study;
- A history of alcohol consumption and/or drug abuse that, in the investigator's judgment, may affect study assessments or participant compliance (Note: Within 3 months prior to enrollment, average weekly alcohol consumption exceeding 21 units for males or 14 units for females, where 1 unit = 360 mL of beer, 45 mL of spirits containing 40% alcohol, or 150 mL of wine. Drug abuse refers to the repeated and excessive use of drugs with dependence-producing properties or dependence potential, unrelated to recognized medical needs and for non-medical purposes);
- Individual who is currently participating in other clinical studies, or plan to participate in other clinical studies before the end of this clinical study;
- Other conditions that may impact the participant's safety or influence the assessment of vaccine response, as determined by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jiangsu Provincial Center for Disease Control and Prevention （Jiangsu Provincial Academy of Preventive Medicine）
Nanjing, Jiangsu
Hongxing Pan, 86-025-83759903, panhongxing@126.com
About this study
Official title: A Randomized, Observer-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, and Safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in Older Adults Aged 60 Years and Older
This is a randomized, observer-blinded, placebo-controlled Phase III clinical trial to evaluate efficacy, immunogenicity and safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in participants aged 60 years and older.
Read the detailed description
A randomized, observer-blinded, placebo-controlled trial will be conducted to observe efficacy, immunogenicity and safety of LYB005 in adults aged 60 years and older. A total of 25000 participants aged 60 years and older will be enrolled. All participants will randomly receive the investigational vaccine and the placebo in a 1:1 ratio.
- Conditions
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection, RSV Vaccine
- Being tested
- LYB005, Placebo
- Keywords
- Respiratory Syncytial Virus, Recombinant Respiratory Syncytial Virus Vaccine, RSV-associated lower respiratory tract disease (RSV-LRTD)
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYB005Biological
0.5 mL per dose.
PlaceboBiological
0.5 mL 0.9% sodium chloride (normal saline) injection per dose
| Study group | Role | What they receive |
|---|---|---|
| LYB005 | Experimental | Participant aged 60 years and older will be vaccinated with 1 dose of LYB005 at Day 0. Receives: Biological: LYB005 |
| Placebo | Placebo comparator | Participants aged 60 years and older will be vaccinated with 1 dose of placebo at Day 0. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) from 14 days post-vaccination through the end of the first RSV season
First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD from 14 days post-vaccination through the end of the first RSV season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.
Measured: From 14 days post-vaccination through the end of the first RSV season
Secondary outcomes (10)
Immediate adverse events (AEs) within 30 minutes after vaccination
The incidence, severity and causality of any AEs within 30 minutes after vaccination
Measured: 30 mins after vaccination
Solicited local and systemic AEs
The incidence, severity and causality of any solicited local and systemic AEs within 7 days after vaccination
Measured: Within 7 days after vaccination
Unsolicited AEs
The incidence, severity and causality of any unsolicited AEs within 30 days after vaccination.
Measured: Within 30 days after vaccination
Serious adverse events (SAEs) and adverse events of special interest (AESIs)
The incidence and causality of any SAEs and AESIs
Measured: 12 months after vaccination
Incidence of first episode of RSV-associated severe LRTD (RSV-sLRTD) from 14 days post-vaccination through the end of the first RSV season
RT-PCR-confirmed RSV A and/or RSV B-sLRTD is assessed.
Measured: From 14 days post-vaccination through the end of the first RSV season
Incidence of first episode of RT-PCR confirmed RSV A and/or B associated acute respiratory infections (ARI) from 14 days post-vaccination through the end of the first RSV season
RT-PCR-confirmed RSV A and/or RSV B-ARI is assessed.
Measured: From 14 days post-vaccination through the end of the first RSV season
The geometric mean titer (GMT) of Neutralizing Antibodies against RSV A and RSV B
Measured by microneutralization assay.
Measured: Before vaccination, 14 days, 30 days, 12 months and 24 months after vaccination
Geometric mean fold rise (GMFR) for Neutralizing Antibodies against RSV A and RSV B
Change from prevaccination in geometric mean fold rise of Neutralizing antibody titer against RSV A and RSV B
Measured: 14 days, 30 days, 12 months and 24 months after vaccination
The geometric mean concentration (GMC) for Pre-fusion Protein Specific Binding Antibodies
Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Before vaccination, 14 days, 30 days, 12 months and 24 months after vaccination
GMFR for Pre-fusion Protein Specific Binding Antibodies
Change from prevaccination in geometric mean fold rise of Pre-fusion Protein Specific Binding Antibodies
Measured: 14 days, 30 days, 12 months and 24 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 posted2 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908654
- Sponsor's protocol ID
- LYB005/CT-CHN-301
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, and Safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in Older Adults Aged 60 Years and Older
- ClinicalTrials.gov ID
- NCT07908654
- Acronym / sponsor ID
- LYB005/CT-CHN-301
- Conditions
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection, RSV Vaccine
- Keywords
- Respiratory Syncytial Virus, Recombinant Respiratory Syncytial Virus Vaccine, RSV-associated lower respiratory tract disease (RSV-LRTD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Nov 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 randomized, observer-blinded, placebo-controlled Phase III clinical trial to evaluate efficacy, immunogenicity and safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in participants aged 60 years and older.
Detailed description
A randomized, observer-blinded, placebo-controlled trial will be conducted to observe efficacy, immunogenicity and safety of LYB005 in adults aged 60 years and older. A total of 25000 participants aged 60 years and older will be enrolled. All participants will randomly receive the investigational vaccine and the placebo in a 1:1 ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LYB005 | Experimental | Biological: LYB005Participant aged 60 years and older will be vaccinated with 1 dose of LYB005 at Day 0. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants aged 60 years and older will be vaccinated with 1 dose of placebo at Day 0. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A male or female participant aged 60 years and above；
- Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form, and are able to attend all planned follow-up visits and comply with the protocol requirements；
- Axillary temperature ≤ 37.0°C on the day of enrollment;
- Female participants should have been menopausal or have undergone sterilization surgery; Menopause is defined as the absence of menstruation for at least 12 consecutive months without alternative medical measures; sterilization surgeries include bilateral tubal ligation or bilateral oophorectomy or hysterectomy; Male participants must not plan to father a child from the time of screening until 30 days after vaccination;
- Participants in the trial who were judged by the researchers to be healthy or have stable health conditions. [Stable health condition: This refers to having a chronic disease and maintaining a stable condition within the three months prior to enrollment irrespective of receipt of specific treatment, such as diabetes, hypertension, chronic obstructive pulmonary disease, and asthma. If the researcher determines that the condition is stable, participation in this trial will be permitted.].
Key exclusion criteria (12 listed)
- Participants who are known to be allergic to any of the components contained in the test vaccine (e.g., sucrose, polysorbate 20, sodium dihydrogen phosphate dihydrate, and disodium hydrogen phosphate dihydrate.); A history of severe allergic reactions or serious adverse reactions to any vaccine;
- A confirmed diagnosis or etiological evidence of respiratory syncytial virus infection and related diseases caused by the infection within 12 months before enrollment (confirmed by RT-PCR, RSV-Ab, etc.);
- Have received or plan to receive any marketed or experimental RSV vaccine/RSV prophylactic medication;
- Has taken antipyretics, analgesics (except for medications used for underlying conditions that, in the investigator's judgment, are unlikely to affect study outcomes, such as enteric-coated aspirin for the prevention of cardiovascular and cerebrovascular diseases.) or anti-allergy drugs within 3 days before enrollment;
- Receipt of any non-live vaccine within 14 days prior to enrollment, or any live or nucleic acid vaccine within 28 days 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 |
|---|---|---|
| LYB0050.5 mL per dose. | Biological | LYB005 |
| Placebo0.5 mL 0.9% sodium chloride (normal saline) injection per dose | Biological | Placebo |
Primary outcome
Incidence of first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) from 14 days post-vaccination through the end of the first RSV season
Time frame: From 14 days post-vaccination through the end of the first RSV season
First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD from 14 days post-vaccination through the end of the first RSV season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.
10 secondary outcomes
Immediate adverse events (AEs) within 30 minutes after vaccination
Time frame: 30 mins after vaccination
Solicited local and systemic AEs
Time frame: Within 7 days after vaccination
Unsolicited AEs
Time frame: Within 30 days after vaccination
Serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: 12 months after vaccination
Incidence of first episode of RSV-associated severe LRTD (RSV-sLRTD) from 14 days post-vaccination through the end of the first RSV season
Time frame: From 14 days post-vaccination through the end of the first RSV season
Incidence of first episode of RT-PCR confirmed RSV A and/or B associated acute respiratory infections (ARI) from 14 days post-vaccination through the end of the first RSV season
Time frame: From 14 days post-vaccination through the end of the first RSV season
The geometric mean titer (GMT) of Neutralizing Antibodies against RSV A and RSV B
Time frame: Before vaccination, 14 days, 30 days, 12 months and 24 months after vaccination
Geometric mean fold rise (GMFR) for Neutralizing Antibodies against RSV A and RSV B
Time frame: 14 days, 30 days, 12 months and 24 months after vaccination
The geometric mean concentration (GMC) for Pre-fusion Protein Specific Binding Antibodies
Time frame: Before vaccination, 14 days, 30 days, 12 months and 24 months after vaccination
GMFR for Pre-fusion Protein Specific Binding Antibodies
Time frame: 14 days, 30 days, 12 months and 24 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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LYB005 in people with Respiratory Syncytial Virus (RSV) and Respiratory Syncytial Virus (RSV) Infection, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site 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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Hongxing Pan (86-025-83759903, panhongxing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) from 14 days post-vaccination through the end of the first RSV season (time frame: From 14 days post-vaccination through the end of the first RSV season). 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 3 Nov 2026.