Pneumococcal DiseasePhase 3NCT06044077
A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People
A Phase 3 study testing 23-valent pneumococcal polysaccharide vaccine in people with Pneumococcal Disease, run by Aimei Vacin BioPharm (Zhejiang) Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- 23-valent pneumococcal polysaccharide vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,920 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2023to 31 Jul 2029
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy subjects who meet the observation age of this clinical trial (2 years old and above) and are determined based on medical history, physical examination and the researcher's judgment;
- Subjects who voluntarily participate and/or the subjects' legal guardians Or the entrusted person voluntarily agrees for his or her child to participate and signs an informed consent form (subjects aged 8-17 years old must also sign an informed notification form);
- The subject and/or the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol;
- *Axillary body temperature <37.3°C on the day of enrollment. For criteria marked with an asterisk (*), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.
Who cannot join
- Previous vaccination with marketed or experimental pneumococcal vaccines;
- Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria;
- History or family history of convulsions, epilepsy, encephalopathy, and mental illness;
- Have a history of severe allergy to any vaccination or drug in the past, be allergic to the ingredients of the experimental vaccine (mainly including pneumococcal polysaccharide, sodium dihydrogen phosphate, disodium hydrogen phosphate, and sodium chloride), and have a history of vaccination-related fever (39℃ or above );
- Known severe congenital malformations, developmental disabilities or clinically diagnosed serious chronic diseases (such as Down syndrome, diabetes that cannot be controlled by drugs, sickle cell anemia, Guillain-Barré syndrome);
- Known or suspected to have serious diseases including: severe respiratory diseases, severe digestive system diseases, severe endocrine system diseases, severe cardiovascular diseases, severe liver and kidney diseases, malignant tumors, severe skin diseases, etc.;
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- Known or suspected to be immune Academic functional defects include: immunosuppressant treatment (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc. within 6 months;
- Have received any treatment within 3 months before enrollment Blood products or globulin treatment, those who have used hepatitis B immune globulin are acceptable;
- Asplenia, functional asplenia or splenectomy;
- * In the acute infectious period (including recovery period) or acute exacerbation of chronic disease within 3 days before enrollment, or need or plan to use intravenous or oral steroids within 1 month after vaccination;
- * Antipyretic analgesics or anti-allergic drugs have been used within 3 days before enrollment;
- Women of childbearing age are pregnant ( Positive urine pregnancy test), breastfeeding or planning to prepare for pregnancy within six months; 13. *Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg in adults aged 18 years and above before enrollment;
- 14. Have received attenuated live vaccines within 14 days before vaccination, and received inactivated vaccines within 7 days; 15. Are participating in or plan to participate in clinical studies of other drugs or vaccines within 6 months after vaccination (immune persistence observation subjects in the vaccine who plan to vaccinate any marketed or unmarketed pneumococcal vaccine within 6 years after vaccination need to be excluded); 16. The investigators evaluate that they are not suitable for participating in the study.
- For criteria marked with an asterisk (), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.
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, 1 recruiting
- Recruiting
Sichuan Center For Disease Control and Prevention
Chengdu, Sichuan
Xuecheng LIU, +8618981958206
About this study
Official title: A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People Aged 2 Years and Above
This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.
- Conditions
- Pneumococcal Disease
- Being tested
- 23-valent pneumococcal polysaccharide vaccine, control pneumococcal polysaccharide vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23-valent pneumococcal polysaccharide vaccineBiological
23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
control pneumococcal polysaccharide vaccineBiological
23-valent pneumococcal polysaccharide vaccine from Merck Sharp \& Dohme Corp
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 1 dose vaccination of study vaccine Receives: Biological: 23-valent pneumococcal polysaccharide vaccine |
| Control Group | Other | 1 dose vaccination of control vaccine Receives: Biological: control pneumococcal polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
Measured: 30 days
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Measured: 30 days
Incidence of adverse reactions/events within 30 minutes of vaccination
Incidence of adverse reactions/events within 30 minutes of vaccination
Measured: 30 min after vaccination
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Measured: 7 days
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Measured: 30 days
Incidence of serious adverse events (SAE) within 6 months after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination
Measured: 6 months
Secondary outcomes (2)
Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination
Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination
Measured: 30 days
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination
Measured: 3, 6 years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 Sep 2023
- Primary completion8 Mar 2024 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044077
- Sponsor's protocol ID
- AM2022PPV23III
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People Aged 2 Years and Above
- ClinicalTrials.gov ID
- NCT06044077
- Acronym / sponsor ID
- AM2022PPV23III
- Conditions
- Pneumococcal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,920 participants (estimated)
- Lead sponsor
- Aimei Vacin BioPharm (Zhejiang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 8 Mar 2024 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 21 Sep 2023 (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 study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.
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 |
|---|---|---|
| Experimental Group | Experimental | Biological: 23-valent pneumococcal polysaccharide vaccine1 dose vaccination of study vaccine |
| Control Group | Other | Biological: control pneumococcal polysaccharide vaccine1 dose vaccination of control vaccine |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects who meet the observation age of this clinical trial (2 years old and above) and are determined based on medical history, physical examination and the researcher's judgment;
- Subjects who voluntarily participate and/or the subjects' legal guardians Or the entrusted person voluntarily agrees for his or her child to participate and signs an informed consent form (subjects aged 8-17 years old must also sign an informed notification form);
- The subject and/or the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol;
- *Axillary body temperature <37.3°C on the day of enrollment. For criteria marked with an asterisk (*), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.
Key exclusion criteria (14 listed)
- Previous vaccination with marketed or experimental pneumococcal vaccines;
- Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria;
- History or family history of convulsions, epilepsy, encephalopathy, and mental illness;
- Have a history of severe allergy to any vaccination or drug in the past, be allergic to the ingredients of the experimental vaccine (mainly including pneumococcal polysaccharide, sodium dihydrogen phosphate, disodium hydrogen phosphate, and sodium chloride), and have a history of vaccination-related fever (39℃ or above );
- Known severe congenital malformations, developmental disabilities or clinically diagnosed serious chronic diseases (such as Down syndrome, diabetes that cannot be controlled by drugs, sickle cell anemia, Guillain-Barré syndrome);
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 |
|---|---|---|
| 23-valent pneumococcal polysaccharide vaccine23-valent pneumococcal polysaccharide vaccine from Aimei Vacin BioPharm (Zhejiang) Co., Ltd. | Biological | Experimental Group |
| control pneumococcal polysaccharide vaccine23-valent pneumococcal polysaccharide vaccine from Merck Sharp \& Dohme Corp | Biological | Control Group |
Primary outcome
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
Time frame: 30 days
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Time frame: 30 days
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Incidence of adverse reactions/events within 30 minutes of vaccination
Time frame: 30 min after vaccination
Incidence of adverse reactions/events within 30 minutes of vaccination
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Time frame: 7 days
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Time frame: 30 days
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination
Time frame: 6 months
Incidence of serious adverse events (SAE) within 6 months after vaccination
2 secondary outcomes
Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination
Time frame: 30 days
GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination
Time frame: 3, 6 years 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 21 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.
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 23-valent pneumococcal polysaccharide vaccine in people with Pneumococcal Disease, run by Aimei Vacin BioPharm (Zhejiang) 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 4 inclusion and 14 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 21 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 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 Xuecheng LIU (+86 189 8195 8206, 534210793@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination, (time frame: 30 days). The study lists 6 primary outcomes in all. 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 21 Sep 2023.