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Respiratory Syncytial Virus (RSV)Phase 3NCT07272434

Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell)

A Phase 3 study testing Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in people with Respiratory Syncytial Virus (RSV), run by MAXVAX Biotechnology Limited Liability Company at 8 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… 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)
What is being tested?
Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25,000 participants
Where
8 sitesChina
Study dates
22 Oct 2025to 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

  • 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.

Who cannot join

  • 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)
  • *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
Show all 27Show fewer
  • 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, 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.
  • 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 immunosuppressive/cytotoxic agent therapy (e.g. cancer chemotherapy, organ transplantation or autoimmune disease treatment) resulting in confirmed or suspected immunosuppression or immunodeficiency].
  • 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 diseases, diabetes with complications, major surgeries, etc.) and may affect the evaluation of the trial.
  • 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 tumors, cerebral hemorrhage, brain infections, chemical drug poisoning, etc.).
  • 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 period.
  • *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 use of systemic glucocorticoids for ≥ 14 days, with a dose of ≥ 20mg/day prednisone or equivalent prednisone dose; local medications are allowed, such as ointments, eye drops, inhalants or nasal sprays, but the local medication dosage must not exceed the recommended dosage in the instructions)
  • 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 week, and women had an average of more than 7 standard drinks per week; 1 standard drink contained 14g of alcohol, such as 360mL of beer or 45mL of 40% alcohol spirit or 150ml of wine.) Drug abuse refers to the repeated and excessive use of drugs with dependent characteristics or potential for dependence, which is not related to recognized medical needs and falls under non-medical purpose drug use.
  • 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.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

LiangHao Zhang contact

+86 18971498772

lianghao.zhang@maxvax.cn

8 sites in 1 country

China8 sites, 6 recruiting

  • Hunan Provincial Center for Disease Control and Prevention

    Changsha, Hunan, 410005

    Junshi Zhao, +86 17788903138, ymlc02@hncdc.com

    Recruiting

  • Sichuan Center for Disease Control and Prevention

    Chengdu, Sichuan, 610041

    Ting Huang, +86 13330993324, cocoht@163.com

    Recruiting

  • Guangdong Provincial Center for Disease Control and Prevention

    Guangzhou, Guangdong, 511400

    Zhuhang Huang, +86 13602438596, gdsjkzx_sws_sps@gd.gov.cn

    Not yet recruiting

  • Shandong Province Centers for Disease Control and Prevention

    Jinan, Shandong, 250014

    Active, not recruiting

  • Hebei Provincial Center for Disease Control and Prevention

    Shijiazhuang, Hebei, 050021

    Active, not recruiting

  • Hubei Provincial Center for Disease Control and Prevention

    Wuhan, Hubei, 430079

    Yeqing Tong, +86 13971078410, 63382251@qq.com

    Recruiting

  • Shaanxi Provincial Center for Disease Control and Prevention

    Xi'an, Shaanxi, 710054

    Weijun Hu, +86 15291916996, sxlchu801@163.com

    Recruiting

  • Henan Center for Disease Control and Prevention

    Zhengzhou, Henan, 450016

    Yanxia Wang, +86 13613816598, wangyanxia99@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Adults Aged 60 Aears and Above

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.

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), Placebo (Saline solution)

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

    0.5 mL per dose

  • Placebo (Saline solution)Biological

    0.5 mL per dose

Study groups in NCT07272434
Study groupRoleWhat they receive
Vaccine GroupExperimentalParticipants will receive single dose of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell), by IM injection into the deltoid region of the arm.
Receives: Biological: Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell)
Placebo GroupPlacebo comparatorParticipants will receive single dose of placebo, by IM injection into the deltoid region of the arm.
Receives: Biological: Placebo (Saline solution)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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）.

    Measured: From 14 days after vaccination until the end of the first RSV epidemic season,assessed up to 12 months.

Secondary outcomes (17)

  1. 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.

    Measured: From 14 days after vaccination until the end of the first RSV epidemic season,assessed up to 12 months.

  2. The first-time incidence rate per person-year of Severe Lower Respiratory Tract Disease (sLRTD).

    A case caused by RSV-A and/or RSV-B as confirmed by RT-PCR.

    Measured: From 14 days after vaccination until the end of the first RSV epidemic season,assessed up to 12 months.

  3. 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.

    Measured: After vaccination, during the second RSV epidemic season,assessed up to 12 months.

  4. 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.

    Measured: After vaccination, during the second RSV epidemic season,assessed up to 12 months.

  5. 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.

    Measured: After vaccination, during the second RSV epidemic season,assessed up to 12 months.

  6. 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.

    Measured: From 14 days after vaccination until the end of the second RSV epidemic season,assessed up to 24 months.

  7. 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.

    Measured: From 14 days after vaccination until the end of the second RSV epidemic season,assessed up to 24 months.

  8. 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.

    Measured: From 14 days after vaccination until the end of the second RSV epidemic season,assessed up to 24 months.

  9. Geometric Mean Titers (GMT) of Neutralizing Antibody against RSV-serotype A and RSV-serotype B.

    Measured by Virus Neutralization Test.

    Measured: At 14 days,1,12,24 and 36 months after vaccination

  10. Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A and RSV-serotype B

    Measured by Virus Neutralization Test.

    Measured: At 14 days,1,12,24 and 36 months after vaccination

  11. Geometric Mean Concentrations (GMC) of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B

    Measured by ELISA.

    Measured: At 14 days,1,12,24 and 36 months after vaccination

  12. GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A and RSV-serotype B

    Measured by ELISA.

    Measured: At 14 days,1,12,24 and 36 months after vaccination

  13. 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.

    Measured: Within 30 days after vaccination

  14. 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.

    Measured: Within 7 days after vaccination

  15. 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.

    Measured: Within 30 days after vaccination

  16. 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.

    Measured: Up to 12 months post vaccination

  17. Incidence and Causality of Adverse event of special interest (AESI)

    Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation.

    Measured: Up to 12 months post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start22 Oct 2025
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07272434
Sponsor's protocol ID
MKKCT-900-002
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in people with Respiratory Syncytial Virus (RSV), run by MAXVAX Biotechnology Limited Liability Company at 8 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 5 inclusion and 27 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 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 LiangHao Zhang (+86 18971498772, lianghao.zhang@maxvax.cn), 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 the first RSV epidemic season,assessed up to 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07272434.

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 9 Dec 2025.

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