Pneumococcal InfectionsPhase 1NCT05092386

Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

A Phase 1 study testing Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine in people with Pneumococcal Infections, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research \& Development Co., Ltd. Read more about this study

Who is it for?: Ages 6 weeks to 49 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 310 participants
Where: 1 siteChina
Study dates: 3 Jan 2023to 28 May 2024
Phase: Phase 1
Are there results?: None posted in the registry

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 6 weeks to 49 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy infants aged 2 months (minimum 6 weeks), healthy infants aged 3 months, healthy infants aged 7 ~ 11 months, healthy infants aged 12~ 23 months, healthy children aged 2~ 5 years, healthy adolescent and children aged 6~ 17 years, healthy adults aged 18~ 49 years；
Proven legal identification and vaccination certificate (vaccination certificate is required for those aged 5 and below)；
The subject and/or guardian can understand and voluntarily sign the informed consent form.

Who cannot join

Have received pneumococcal polysaccharide vaccine or pneumococcal polysaccharide conjugate vaccine;
Have Bacterial pneumonia or invasive pneumococcal infectious disease (IPD) caused by pneumococcus confirmed by sputum culture;
History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
Autoimmune disease or immunodeficiency / immunosuppression;
Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;

Show all 18Show fewer

Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
History of thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy due to any circumstance;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
History of alcohol or drug abuse;
Receipt of blood products within in the past 3 months;
Receipt of other investigational drugs in the past 30 days;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
Axillary temperature >37.0°C;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Henan Center for Diseases Control and Prevention
Zhengzhou, Henan

Other trials in China

About this study

Official title: An Open-label Combined Randomized Double-blind, Positive Control Clinical Trial in Subjects Aged 2 Months (Minimum 6 Weeks) and Above to Preliminary Evaluate the Safety and Immunogenicity of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

Read the detailed description

This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial in subjects aged 2 months (minimum 6 weeks) and above. The experimental vaccine was manufactured by Sinovac Research \& Development Co., Ltd. .And one of the positive control vaccine was manufactured by WALVAX Biotechnology Co., Ltd( WALVAX PCV13) ,the other manufactured by Pfizer(Pfizer PCV13).A total of 310 subjects including 20 adults aged 18-49 years,20 adolescents and children aged 6~7 years ,60 children aged 2-5 years,60 infants aged 12~23 months,60 infants aged 7 ~11 months,60 infants aged 2 months (minimum 6 weeks), and 30 infants aged 3 months will be enrolled.Subjects will be assigned to receive one dose , two doses ,three doses or four doses of experimental vaccine or different positive control vaccines . Subjects aged 18-49 years will receive one dose of experimental vaccine.Subjects aged 6~17 years will receive one dose of experimental vaccine.Subjects aged 2~5 years will be randomly divided into two groups in a ratio of 1:1,and each group will receive one dose of experimental vaccine or control vaccine(WALVAX PCV13）.Subjects aged 7 ~ 11 months and subjects aged 12 ~23 months will be randomly divided into two groups in a 1:1 ratio,the subjects aged 12 ~ 23 months will receive two doses of experimental vaccine or control vaccine on the schedule of month 0,2 .Subjects aged 7 ~11 months will receive 3 doses of experimental vaccine or control vaccine (WALVAX PCV13）on the immunization schedule of month 0,2,4.Subjects aged 3 months will receive 4 doses of experimental vaccine.Subjects aged 2 months will be randomly divided into 2 groups in a 1:1 ratio and each group will receive 4 doses of experimental vaccine or control vaccine (Pfizer PCV13).

Conditions: Pneumococcal Infections
Being tested: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine, Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13), Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational 13-valent Pneumococcal Polysaccharide Conjugate VaccineBiological
The investigational vaccine was manufactured by Sinovac Research \& Development Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and diphtheria CRM197 in 0·5 mL of aluminum phosphate ,sodium chloride,polysorbate 80 and succinic acid per injection.
Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)Biological
The control vaccine was manufactured by WALVAX Biotechnology Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,disodium hydrogen phosphate and sodium dihydrogen phosphate per injection.
Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)Biological
The control vaccine was manufactured by Pfizer. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,sodium chloride ,succinic acid ,polysorbate 80 and water for injection per injection.

Study groups in NCT05092386
Study group	Role	What they receive
Experimental Group of One Dose	Experimental	110 Participants (including 20 subjects aged 18~49 years, 20 subjects aged 6~17 years , 30 subjects aged2-5 years) will receive one dose of experimental vaccine Receives: Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Experimental Group of Two Doses	Experimental	30 Participants aged 12~23 months will receive two doses of experimental vaccine on the schedule of month 0,2. Receives: Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Experimental Group of Three Doses	Experimental	30 Participants aged 7~11 months will receive two doses of experimental vaccine on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months . Receives: Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Experimental Group of Four Doses	Experimental	30 Participants aged 3 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,1,2 and one dose of booster immunization during the participants aged 12~15 months ; 30 Participants aged 2 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months Receives: Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Control Group of One Dose With WALVAX PCV13	Active comparator	30 Participants aged 2-5 years will receive one dose of control vaccine (WALVAX PCV13) Receives: Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
Control Group of Two Doses With WALVAX PCV13	Active comparator	30 Participants aged 12~23 months will receive two doses of control vaccine(WALVAX PCV13) on the schedule of month 0,2. Receives: Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
Control Group of Three Doses With WALVAX PCV13	Active comparator	30 Participants aged 7~11 months will receive two doses of control vaccine(WALVAX PCV13) on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months . Receives: Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
Control Group of Three Doses With Pfizer PCV13	Active comparator	30 Participants aged 2 months will receive three doses of control vaccine(Pfizer PCV13 on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months Receives: Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)

What is being measured

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

Safety index-incidence of adverse reactions
Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine
Measured: Day 0-30 after each dose of experimental vaccine

Secondary outcomes (9)

Safety index-incidence of adverse reactions
Incidence of adverse reactions 0 to 7 days after each dose of experimental vaccine
Measured: Day 0-7 after each dose of experimental vaccine
Safety index-incidence of abnormal indicators
Incidence of abnormal indicators of Blood routine, blood biochemistry and urine routine 3 days after vaccination in subjects aged 2 years and older
Measured: Day 3 after vaccination after each dose of experimental vaccine
Safety index-Incidence of serious adverse events during the safety observation period
Incidence of serious adverse events during the safety observation period, including 1 month after vaccination in subject aged 6 years and older, and 6 months after primary immunization and 1 month after booster immunization in subject aged 2 months (minimum 6 weeks) to 5 years(if any)
Measured: 1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization
Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype
Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype at 30 days after vaccination in subjects of all age groups
Measured: Day 30 after vaccination
Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype
Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype at 30 days after vaccination in subjects of all age groups
Measured: Day 30 after vaccination
Immunogenicity index-Seropositive rates，GMCs and GMI of serum specific antibody
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMCs) and GMI of serum specific antibody at 30 days after primary immunization in subjects of all age groups
Measured: Day 30 after vaccination
Immunogenicity index-Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)
Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)in subjects of all age groups at 30 days after primary immunization
Measured: Day 30 after vaccination
Immunogenicity index-Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC)
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC) in subjects aged 2 months (Minimum 6 weeks), 3 months and 7 ~ 11 months at 30 days before and after booster immunization
Measured: Day 30 before and after booster immunization
Immunogenicity index-Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT)
Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT) in subjects aged 2 months (Minimum 6 weeks), 3 months, and 7~ 11 months at 30 days before and after booster immunization
Measured: Day 30 before and after booster immunization

Timeline

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

3 Jan 202328 May 2024

First posted25 Oct 2021
Study start3 Jan 2023
Primary completion26 May 2024
Study completion28 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pneumococcal InfectionsStudies 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 310 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05092386
Sponsor's protocol ID: PRO-PCV-1001
Status last verified: Jan 2026
First submitted: 13 Oct 2021
Last updated: 28 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Combined Randomized Double-blind, Positive Control Clinical Trial in Subjects Aged 2 Months (Minimum 6 Weeks) and Above to Preliminary Evaluate the Safety and Immunogenicity of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
ClinicalTrials.gov ID: NCT05092386
Acronym / sponsor ID: PRO-PCV-1001
Conditions: Pneumococcal Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 310 participants (actual)
Lead sponsor: Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
Study start: 3 Jan 2023 (actual)
Primary completion: 26 May 2024 (actual)
Study completion: 28 May 2024 (actual)
First posted: 25 Oct 2021 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Experimental Group of One Dose	Experimental	Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine110 Participants (including 20 subjects aged 18~49 years, 20 subjects aged 6~17 years , 30 subjects aged2-5 years) will receive one dose of experimental vaccine
Experimental Group of Two Doses	Experimental	Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine30 Participants aged 12~23 months will receive two doses of experimental vaccine on the schedule of month 0,2.
Experimental Group of Three Doses	Experimental	Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine30 Participants aged 7~11 months will receive two doses of experimental vaccine on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months .
Experimental Group of Four Doses	Experimental	Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine30 Participants aged 3 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,1,2 and one dose of booster immunization during the participants aged 12~15 months ; 30 Participants aged 2 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months
Control Group of One Dose With WALVAX PCV13	Active comparator	Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)30 Participants aged 2-5 years will receive one dose of control vaccine (WALVAX PCV13)
Control Group of Two Doses With WALVAX PCV13	Active comparator	Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)30 Participants aged 12~23 months will receive two doses of control vaccine(WALVAX PCV13) on the schedule of month 0,2.
Control Group of Three Doses With WALVAX PCV13	Active comparator	Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)30 Participants aged 7~11 months will receive two doses of control vaccine(WALVAX PCV13) on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months .
Control Group of Three Doses With Pfizer PCV13	Active comparator	Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)30 Participants aged 2 months will receive three doses of control vaccine(Pfizer PCV13 on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months

Who may qualify

Ages: 6 weeks to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Healthy infants aged 2 months (minimum 6 weeks), healthy infants aged 3 months, healthy infants aged 7 ~ 11 months, healthy infants aged 12~ 23 months, healthy children aged 2~ 5 years, healthy adolescent and children aged 6~ 17 years, healthy adults aged 18~ 49 years；
Proven legal identification and vaccination certificate (vaccination certificate is required for those aged 5 and below)；
The subject and/or guardian can understand and voluntarily sign the informed consent form.

Key exclusion criteria (18 listed)

Have received pneumococcal polysaccharide vaccine or pneumococcal polysaccharide conjugate vaccine;
Have Bacterial pneumonia or invasive pneumococcal infectious disease (IPD) caused by pneumococcus confirmed by sputum culture;
History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
Autoimmune disease or immunodeficiency / immunosuppression;

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
Investigational 13-valent Pneumococcal Polysaccharide Conjugate VaccineThe investigational vaccine was manufactured by Sinovac Research \& Development Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and diphtheria CRM197 in 0·5 mL of aluminum phosphate ,sodium chloride,polysorbate 80 and succinic acid per injection.	Biological	Experimental Group of Four Doses, Experimental Group of One Dose, Experimental Group of Three Doses, Experimental Group of Two Doses
Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)The control vaccine was manufactured by WALVAX Biotechnology Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,disodium hydrogen phosphate and sodium dihydrogen phosphate per injection.	Biological	Control Group of One Dose With WALVAX PCV13, Control Group of Three Doses With WALVAX PCV13, Control Group of Two Doses With WALVAX PCV13
Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)The control vaccine was manufactured by Pfizer. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,sodium chloride ,succinic acid ,polysorbate 80 and water for injection per injection.	Biological	Control Group of Three Doses With Pfizer PCV13

Primary outcome

Safety index-incidence of adverse reactions
Time frame: Day 0-30 after each dose of experimental vaccine
Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine

9 secondary outcomes

Safety index-incidence of adverse reactions
Time frame: Day 0-7 after each dose of experimental vaccine
Safety index-incidence of abnormal indicators
Time frame: Day 3 after vaccination after each dose of experimental vaccine
Safety index-Incidence of serious adverse events during the safety observation period
Time frame: 1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization
Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype
Time frame: Day 30 after vaccination
Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype
Time frame: Day 30 after vaccination
Immunogenicity index-Seropositive rates，GMCs and GMI of serum specific antibody
Time frame: Day 30 after vaccination
Immunogenicity index-Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)
Time frame: Day 30 after vaccination
Immunogenicity index-Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC)
Time frame: Day 30 before and after booster immunization
Immunogenicity index-Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT)
Time frame: Day 30 before and after booster immunization

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.

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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. This study is not recruiting at the moment.

Yanxia Wang, Master principal investigator

Henan Provincial Center for Disease Prevention and Control

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine in people with Pneumococcal Infections, run by Sinovac Life Sciences 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 3 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: finished, as of the sponsor's last update on 28 Jan 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety index-incidence of adverse reactions (time frame: Day 0-30 after each dose of experimental vaccine). 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 NCT05092386.

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 28 Jan 2026.