Pneumococcal Infectious DiseasePhase 2NCT06678620

Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine

A Phase 2 study testing Reinovax PCV24 formulation 1, Reinovax PCV24 formulation 2 and Reinovax PCV24 formulation 3 in people with Pneumococcal Infectious Disease, run by Reinovax Biologics Co., LTD at 2 sites 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

A phase II clinical trial of a 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The study's objective is to evaluate the safety and immunogenicity of PCV24. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infectious Disease
What is being tested?: Reinovax PCV24 formulation 1, Reinovax PCV24 formulation 2 and Reinovax PCV24 formulation 3
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 992 participants
Where: 2 sitesChina
Study dates: 20 Apr 2024to 12 Dec 2024
Phase: Phase 2
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Volunteers aged 18 and above on the day of screening, and can provide legal identification;
Informed consent must be obtained from the volunteer and signed informed consent form;
Volunteers are able and willing to comply with the requirements of the clinical trial protocol and can attend all visits;
Armpit body temperature ≤ 37.0 °C on the day of enrollment.

Who cannot join

Previous vaccination with pneumococcal conjugate vaccine, prior vaccination with pneumococcal polysaccharide vaccine for less than 3 years, or previous history of invasive disease caused by Streptococcus pneumoniae;
Have any history of severe allergies in the past, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Athus reaction), etc.;
Have been diagnosed with congenital or acquired immunodeficiency, or have recently received immunosuppressant therapy, such as systemic glucocorticoid therapy such as prednisone or similar drugs >5 mg/day for more than 2 consecutive weeks in 1 month prior to vaccination);
Suffering from more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg when measured on site);
Those who have acute febrile illness or acute infectious disease or have cold symptoms, advanced influenza and take medication;
History of nervous system damage, severe congenital malformations, severe developmental disorders, severe genetic defects, severe malnutrition, etc.;

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Have a history or family history of epilepsy, encephalopathy, or psychiatric disorders;
Those who have been diagnosed with thrombocytopenia, any abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities, etc.) or contraindications to intramuscular injection such as anticoagulant therapy;
asplenia, functional asplenia, and asplenia or splenectomy due to any cause;
Suffering from severe chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly;
Have received blood or blood-related products or immunoglobulins within 3 months;
Received live attenuated vaccine within 14 days;
Other vaccinations within 7 days;
Received other investigational drugs or vaccines within 1 month;
Is participating in or plans to participate in clinical studies of other drugs or vaccines during the study period;
Any other condition that, in the opinion of the investigator, may interfere with the study evaluation;
Exclusion Criteria for Partial Populations:
Females of childbearing potential (18~49 years old): positive urine pregnancy test on the day of enrollment, lactation, or pregnancy plans within 6 months.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Pizhou Center for Disease Control and Prevention
Pizhou, Jiangsu
Xuzhou Center for Disease Control and Prevention
Xuzhou, Jiangsu

Other trials in China

About this study

Official title: A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older

Read the detailed description

Phase II clinical trial of the 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The study's objective is to evaluate the safety and immunogenicity of PCV24. The active control vaccine is a 23-valent pneumococcal polysaccharide vaccine (23-valent pneumococcal polysaccharide vaccine, PPSV23) produced by the Chengdu Institute of Biological Products.

At least 992 participants will be enrolled, including 496 adults aged 18-60 and 496 elderly people aged ≥61. Participants will be randomized 1:1:1:1 to receive one dose of PCV24 formulation 1, PCV24 formulation 2, PCV24 formulation 3,or PPSV23.

Conditions: Pneumococcal Infectious Disease
Being tested: Reinovax PCV24 formulation 1, Reinovax PCV24 formulation 2, Reinovax PCV24 formulation 3, PPSV23
Medical subject headings: Pneumococcal Infections

What participants receive

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

Reinovax PCV24 formulation 1Biological
One dose of Reinovax PCV24 formulation 1（0.5mL）
Reinovax PCV24 formulation 2Biological
One dose of Reinovax PCV24 formulation 1（0.5mL）
Reinovax PCV24 formulation 3Biological
One dose of Reinovax PCV24 formulation 1（0.5mL）
PPSV23Biological
One dose of PPSV23 (0.5 mL) contains 1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F and33F saccharides.

Study groups in NCT06678620
Study group	Role	What they receive
Experimental group 1	Experimental	248 participants will be randomized to receive Reinovax PCV24 formulation 1. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose. Receives: Biological: Reinovax PCV24 formulation 1
Experimental group 2	Experimental	248 participants will be randomized to receive Reinovax PCV24 formulation 2. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose. Receives: Biological: Reinovax PCV24 formulation 2
Experimental group 3	Experimental	248 participants will be randomized to receive Reinovax PCV24 formulation 3. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose. Receives: Biological: Reinovax PCV24 formulation 3
Active control group	Active comparator	248 participants will be randomized to receive PPSV23. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose. Receives: Biological: PPSV23

What is being measured

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

incidence of adverse events
The incidence of adverse events within 30 days after vaccination.
Measured: 0~30 days after vaccination
Incidence of serious adverse events (SAE)
Incidence of SAE during the period of safety monitoring
Measured: 0-6 months after vaccination
Positive conversion rate of specific IgG antibodies by serotype
The positive conversion rate of IgG antibody of each serotype covered by pneumococcal vaccine detected by Enzyme linked immunosorbent assay (ELISA) 30 days after immunization in each group.
Measured: 0~30 days after vaccination

Secondary outcomes (1)

The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus
The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus in subjects 30 days after immunization in each group
Measured: 0~30 days after vaccination

Timeline

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

20 Apr 202412 Dec 2024

First posted7 Nov 2024
Study start20 Apr 2024
Primary completion12 Dec 2024
Study completion12 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pneumococcal Infectious DiseaseStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 992 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06678620
Sponsor's protocol ID: JSVCT183
Status last verified: Dec 2025
First submitted: 5 Nov 2024
Last updated: 17 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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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A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
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All Pneumococcal Infectious Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older
ClinicalTrials.gov ID: NCT06678620
Acronym / sponsor ID: JSVCT183
Conditions: Pneumococcal Infectious Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 992 participants (actual)
Lead sponsor: Reinovax Biologics Co., LTDIndustry (pharma, biotech, devices)
Study start: 20 Apr 2024 (actual)
Primary completion: 12 Dec 2024 (actual)
Study completion: 12 Dec 2024 (actual)
First posted: 7 Nov 2024 (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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Experimental group 1	Experimental	Biological: Reinovax PCV24 formulation 1248 participants will be randomized to receive Reinovax PCV24 formulation 1. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.
Experimental group 2	Experimental	Biological: Reinovax PCV24 formulation 2248 participants will be randomized to receive Reinovax PCV24 formulation 2. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.
Experimental group 3	Experimental	Biological: Reinovax PCV24 formulation 3248 participants will be randomized to receive Reinovax PCV24 formulation 3. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.
Active control group	Active comparator	Biological: PPSV23248 participants will be randomized to receive PPSV23. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Volunteers aged 18 and above on the day of screening, and can provide legal identification;
Informed consent must be obtained from the volunteer and signed informed consent form;
Volunteers are able and willing to comply with the requirements of the clinical trial protocol and can attend all visits;
Armpit body temperature ≤ 37.0 °C on the day of enrollment.

Key exclusion criteria (18 listed)

Previous vaccination with pneumococcal conjugate vaccine, prior vaccination with pneumococcal polysaccharide vaccine for less than 3 years, or previous history of invasive disease caused by Streptococcus pneumoniae;
Have any history of severe allergies in the past, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Athus reaction), etc.;
Have been diagnosed with congenital or acquired immunodeficiency, or have recently received immunosuppressant therapy, such as systemic glucocorticoid therapy such as prednisone or similar drugs >5 mg/day for more than 2 consecutive weeks in 1 month prior to vaccination);
Suffering from more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg when measured on site);
Those who have acute febrile illness or acute infectious disease or have cold symptoms, advanced influenza and take medication;

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
Reinovax PCV24 formulation 1One dose of Reinovax PCV24 formulation 1（0.5mL）	Biological	Experimental group 1
Reinovax PCV24 formulation 2One dose of Reinovax PCV24 formulation 1（0.5mL）	Biological	Experimental group 2
Reinovax PCV24 formulation 3One dose of Reinovax PCV24 formulation 1（0.5mL）	Biological	Experimental group 3
PPSV23One dose of PPSV23 (0.5 mL) contains 1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F and33F saccharides.	Biological	Active control group

Primary outcome

incidence of adverse events
Time frame: 0~30 days after vaccination
The incidence of adverse events within 30 days after vaccination.
Incidence of serious adverse events (SAE)
Time frame: 0-6 months after vaccination
Incidence of SAE during the period of safety monitoring
Positive conversion rate of specific IgG antibodies by serotype
Time frame: 0~30 days after vaccination
The positive conversion rate of IgG antibody of each serotype covered by pneumococcal vaccine detected by Enzyme linked immunosorbent assay (ELISA) 30 days after immunization in each group.

1 secondary outcome

The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus
Time frame: 0~30 days after vaccination

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 17 Aug 2026.
Individual participant dataSharing planned: No

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Active, not recruitingPhase 2
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RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
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Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
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Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 4 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

incidence of adverse events (time frame: 0~30 days after vaccination). The study lists 3 primary outcomes in all. 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 NCT06678620.

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 17 Aug 2026.