Pneumococcal InfectionsPhase 4NCT05477693
Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine
A Phase 4 study testing Experimental 23-valent PPV in people with Pneumococcal Infections, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Experimental 23-valent PPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2022to 10 Apr 2023
- Phase
- Phase 4
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children aged 2 years and above in stable health;
- The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form.If the subject aged 16 to 17 years with full capacity for civil conduct and his/her labor income is his/her main source of living, the informed consent can be signed only by the subject himself/herself);
- Proven legal identity.
Who cannot join
- Have received any pneumococcal vaccine;
- History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture.
- Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
- History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
- Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
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- 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;
- A long history of alcohol or drug abuse;
- Receipt of blood products within in the past 3 months;
- Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
- Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Onset of various acute or chronic diseases within 3 days prior to the study;
- Underarm body temperature before vaccination>37.0°C;
- The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials within 1 months;
- 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
Linwei District Center for Disease Control and Prevention
Weinan, Shanxi, 710000
About this study
Official title: A Randomized, Double-blind, Positive-controlled Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Population Aged 2 Years and Older
This is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.
Read the detailed description
This study is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Merck Sharp \& Dohme.A total of 1800 subjects including 900 subjects aged 2~17 years,360 subjects aged 18~59 years and 540 subjects aged 60 years and above will be enrolled.Subjects in each age group will be randomly divided into two groups according to the ratio of 2:1, and received one dose of experimental vaccine or control vaccine.
- Conditions
- Pneumococcal Infections
- Being tested
- Experimental 23-valent PPV, Control 23-valent PPV
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental 23-valent PPVBiological
The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B,17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0.5 mL of sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection.
Control 23-valent PPVBiological
The control vaccine was manufactured by Merck Sharp \& Dohme, Ltd. Purified capsular polysaccharides from 23 Streptococcus in 0.5 mL of pneumoniae types 0.25% phenol and sodium chloride.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 1200 participants(including 600 subjects aged 2~17 years,240 subjects aged 18~59 years and 360 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd Receives: Biological: Experimental 23-valent PPV |
| Control Group | Active comparator | 600 participants(including 300 subjects aged 2~17 years,120 subjects aged 18~59 years and 180 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Merck Sharp \& Dohme. Receives: Biological: Control 23-valent PPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity index-Seroconversion rate (2-fold increase rate)
Seroconversion rate (2-fold increase rate)for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.
Measured: 30 days after vaccination
Secondary outcomes (8)
Immunogenicity index-Geometric Mean Concentration (GMC)
Geometric Mean Concentration (GMC) for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal IgG antibody 30 days after vaccination.
Measured: 30 days after vaccination
Immunogenicity index-Geometric Mean Increase (GMI)
Geometric Mean Increase (GMI) for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal IgG antibody 30 days after vaccination.
Measured: 30 days after vaccination
Immunogenicity index-Seroconversion rate
Seroconversion rate for serotype specificity （1、2、4、5、7F、8、9N、9V、10A、11A、12F、15B、17F、18C、20、22F and 33F）of pneumococcal IgG antibody 30 days after vaccination.
Measured: 30 days after vaccination
Immunogenicity index-GMC
Geometric Mean Concentration (GMC) for serotype specificity （1、2、4、5、7F、8、9N、9V、10A、11A、12F、15B、17F、18C、20、22F and 33F）of pneumococcal IgG antibody 30 days after vaccination.
Measured: 30 days after vaccination
Immunogenicity index-GMI
Geometric Mean Increase (GMI) for serotype specificity （1、2、4、5、7F、8、9N、9V、10A、11A、12F、15B、17F、18C、20、22F and 33F）of pneumococcal IgG antibody 30 days after vaccination.
Measured: 30 days after vaccination
Safety index-Incidence of adverse reactions
Incidence of adverse reactions within 30 days after vaccination.
Measured: Within 30 days after vaccination
Safety index-incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
Measured: Within 7 days after vaccination
Safety index-Incidence of serious adverse events
Incidence of serious adverse events within 30 days after vaccination.
Measured: Within 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.
- First posted28 Jul 2022
- Study start25 Oct 2022
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
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.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weijun Hu, Principal investigator, Shanxi Provincial Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477693
- Sponsor's protocol ID
- PRO-PPV-4002
- Status last verified
- Apr 2022
- First submitted
- 26 Jul 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Positive-controlled Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Population Aged 2 Years and Older
- ClinicalTrials.gov ID
- NCT05477693
- Acronym / sponsor ID
- PRO-PPV-4002
- Conditions
- Pneumococcal Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 28 Jul 2022 (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, double-blind, positive-controlled phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.
Detailed description
This study is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Merck Sharp \& Dohme.A total of 1800 subjects including 900 subjects aged 2~17 years,360 subjects aged 18~59 years and 540 subjects aged 60 years and above will be enrolled.Subjects in each age group will be randomly divided into two groups according to the ratio of 2:1, and received one dose of experimental vaccine or control vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Experimental 23-valent PPV1200 participants(including 600 subjects aged 2~17 years,240 subjects aged 18~59 years and 360 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd |
| Control Group | Active comparator | Biological: Control 23-valent PPV600 participants(including 300 subjects aged 2~17 years,120 subjects aged 18~59 years and 180 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Merck Sharp \& Dohme. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Children aged 2 years and above in stable health;
- The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form.If the subject aged 16 to 17 years with full capacity for civil conduct and his/her labor income is his/her main source of living, the informed consent can be signed only by the subject himself/herself);
- Proven legal identity.
Key exclusion criteria (17 listed)
- Have received any pneumococcal vaccine;
- History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture.
- Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
- History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
- Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
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 |
|---|---|---|
| Experimental 23-valent PPVThe investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B,17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0.5 mL of sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection. | Biological | Experimental Group |
| Control 23-valent PPVThe control vaccine was manufactured by Merck Sharp \& Dohme, Ltd. Purified capsular polysaccharides from 23 Streptococcus in 0.5 mL of pneumoniae types 0.25% phenol and sodium chloride. | Biological | Control Group |
Primary outcome
Immunogenicity index-Seroconversion rate (2-fold increase rate)
Time frame: 30 days after vaccination
Seroconversion rate (2-fold increase rate)for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.
8 secondary outcomes
Immunogenicity index-Geometric Mean Concentration (GMC)
Time frame: 30 days after vaccination
Immunogenicity index-Geometric Mean Increase (GMI)
Time frame: 30 days after vaccination
Immunogenicity index-Seroconversion rate
Time frame: 30 days after vaccination
Immunogenicity index-GMC
Time frame: 30 days after vaccination
Immunogenicity index-GMI
Time frame: 30 days after vaccination
Safety index-Incidence of adverse reactions
Time frame: Within 30 days after vaccination
Safety index-incidence of adverse reactions
Time frame: Within 7 days after vaccination
Safety index-Incidence of serious adverse events
Time frame: Within 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 18 Sep 2023.
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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.
Weijun Hu principal investigator
Shanxi 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 4 study testing Experimental 23-valent PPV in people with Pneumococcal Infections, run by Sinovac 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 3 inclusion and 17 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 18 Sep 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Immunogenicity index-Seroconversion rate (2-fold increase rate) (time frame: 30 days after vaccination). 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 18 Sep 2023.