Healthy VolunteersPhase 3NCT06314867
Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23
A Phase 3 study testing 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1), 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) and 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1), 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) and 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 990 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2023to 30 Jun 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 18-59;
- Voluntarily participate and sign an informed consent form;
- Subjects are able to comply with the requirements of the clinical study protocol and complete the prescribed follow-up;
- Has not received pneumococcal vaccine or any other preventive products recently (has not received attenuated live vaccine within 14 days, has not received inactivated vaccine within 7 days);
- Underarm temperature ≤ 37.0 ℃;
- Female participants of childbearing age agree to take effective contraceptive measures within 3 months from the start of the study until the full vaccination period.
Who cannot join
- Subjects with a history or family history of progressive neurological disorders such as epilepsy, encephalopathy, and mental illness;
- Has a history of severe allergies to any drugs or vaccines in the past;
- Has a allergy history to any component of the experimental vaccine (the main components of the vaccine include type 23 pneumococcal polysaccharides, sodium chloride, sodium dihydrogen phosphate, and sodium dihydrogen phosphate);
- Suffering from severe cardiovascular diseases (heart disease, pulmonary heart disease, pulmonary edema, drug-resistant hypertension (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg)); drug-resistant diabetes;
- Subjects with a history of thrombocytopenia or other coagulation disorders that may cause contraindications for subcutaneous injection;
- Subjects with known immunological dysfunction or low levels, or HIV infection;
Show all 12Show fewer
- Any situation leading to splenomegaly, splenectomy, or functional splenomegaly;
- Malignant tumors, active or treated tumors that have not been clearly cured, or are likely to recur during the study period;
- Anti tuberculosis prevention or treatment is under way;
- Subjects who are participating in or planning to participate in clinical trials of other drugs or vaccine clinical trials throughout the entire observation period;
- Women of childbearing age are in pregnancy (positive urine pregnancy test) or lactation period;
- Any situation that the researcher believes may affect the evaluation of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, 610041
About this study
Official title: A Single Center, Randomized, Double-blind, and Intergroup Control Clinical Study to Evaluation on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of 23 Valent Pneumococcal Polysaccharide Vaccine
The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine.
Read the detailed description
This study adopted a randomized, double-blind, equivalency design with different batches of experimental vaccine. 990 individuals aged 18-59 were included and divided into three groups at a ratio of 1:1:1, with 330 individuals in each group receiving three batches of experimental vaccines, respectively. All subjects were vaccinated with 1 dose of 0.5ml, intramuscularly injected into the lateral deltoid muscle of the upper arm.
- Conditions
- Healthy Volunteers
- Being tested
- 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1), 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2), 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)
- Keywords
- 23 Valent Pneumococcal Polysaccharide Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)Biological
All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112011), intramuscularly injected into the lateral deltoid muscle of the upper arm.
23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)Biological
All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112012), intramuscularly injected into the lateral deltoid muscle of the upper arm.
23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)Biological
All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112013), intramuscularly injected into the lateral deltoid muscle of the upper arm.
| Study group | Role | What they receive |
|---|---|---|
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) | Experimental | Batch number: Y202112011 Receives: Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) |
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) | Experimental | Batch number: Y202112012 Receives: Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) |
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) | Experimental | Batch number: Y202112013 Receives: Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean concentration (GMC) levels
Geometric mean concentration (GMC) levels of 23 serotype specific IgG antibodies
Measured: 30 days after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start30 Jan 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 990 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Du, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314867
- Sponsor's protocol ID
- 20220231
- Status last verified
- Feb 2024
- First submitted
- 11 Mar 2024
- Last updated
- 4 Apr 2024
- 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind, and Intergroup Control Clinical Study to Evaluation on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of 23 Valent Pneumococcal Polysaccharide Vaccine
- ClinicalTrials.gov ID
- NCT06314867
- Acronym / sponsor ID
- 20220231
- Conditions
- Healthy Volunteers
- Keywords
- 23 Valent Pneumococcal Polysaccharide Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 990 participants (actual)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Mar 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.
The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine.
Detailed description
This study adopted a randomized, double-blind, equivalency design with different batches of experimental vaccine. 990 individuals aged 18-59 were included and divided into three groups at a ratio of 1:1:1, with 330 individuals in each group receiving three batches of experimental vaccines, respectively. All subjects were vaccinated with 1 dose of 0.5ml, intramuscularly injected into the lateral deltoid muscle of the upper arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) | Experimental | Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)Batch number: Y202112011 |
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) | Experimental | Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)Batch number: Y202112012 |
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) | Experimental | Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)Batch number: Y202112013 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy volunteers aged 18-59;
- Voluntarily participate and sign an informed consent form;
- Subjects are able to comply with the requirements of the clinical study protocol and complete the prescribed follow-up;
- Has not received pneumococcal vaccine or any other preventive products recently (has not received attenuated live vaccine within 14 days, has not received inactivated vaccine within 7 days);
- Underarm temperature ≤ 37.0 ℃;
Key exclusion criteria (12 listed)
- Subjects with a history or family history of progressive neurological disorders such as epilepsy, encephalopathy, and mental illness;
- Has a history of severe allergies to any drugs or vaccines in the past;
- Has a allergy history to any component of the experimental vaccine (the main components of the vaccine include type 23 pneumococcal polysaccharides, sodium chloride, sodium dihydrogen phosphate, and sodium dihydrogen phosphate);
- Suffering from severe cardiovascular diseases (heart disease, pulmonary heart disease, pulmonary edema, drug-resistant hypertension (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg)); drug-resistant diabetes;
- Subjects with a history of thrombocytopenia or other coagulation disorders that may cause contraindications for subcutaneous injection;
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 Vaccine (lot 1)All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112011), intramuscularly injected into the lateral deltoid muscle of the upper arm. | Biological | 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) |
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112012), intramuscularly injected into the lateral deltoid muscle of the upper arm. | Biological | 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) |
| 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112013), intramuscularly injected into the lateral deltoid muscle of the upper arm. | Biological | 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) |
Primary outcome
Geometric mean concentration (GMC) levels
Time frame: 30 days after immunization
Geometric mean concentration (GMC) levels of 23 serotype specific IgG antibodies
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 4 Apr 2024.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Lin Du study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
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 (lot 1), 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) and 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical 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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2024. 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?
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?
Geometric mean concentration (GMC) levels (time frame: 30 days after immunization). 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 4 Apr 2024.