Pneumococcal DiseasesPhase 1NCT06970756
A Phase I Clinical Study to Evaluate the Safety of PCV26 in Individuals ≥60
A Phase 1 study testing 26-valent Pneumococcal Conjugate Vaccine and 13-valent Pneumococcal Conjugate Vaccine in people with Pneumococcal Diseases, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in Australia.
Trial summary
This Phase I, randomized, double-blind, parallel-controlled study is to be conducted in healthy adults aged 60 and above. Participants will be randomly assigned in a 1:1 ratio to receive either 26-valent Pneumococcal Conjugate Vaccine (PCV26) or the comparator (PCV13) on Day 1 (Visit 1). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Diseases
- What is being tested?
- 26-valent Pneumococcal Conjugate Vaccine and 13-valent Pneumococcal Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 27 May 2025to 10 Jul 2026
- Phase
- Phase 1
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 years or older at the time of enrollment.
- Evidence of a personally signed and dated ICF indicating that the participant has been informed of all pertinent aspects of the study.
- Able to comply with the protocol, and capable of using a thermometer, a ruler, and fill out the diary card and contact card as required.
- Negative pregnancy test (urine) for female participants of childbearing potential. Male and non-pregnant, non-lactating females must also meet one of the following criteria: a). Female participant of nonchildbearing potential; male participant not able to father children; b). Agrees to consistently practice contraception until at least 28 days after vaccination by one of the following methods: condoms, male or female, with or without spermicide; diaphragm or cervical cap with spermicide; intrauterine device; contraceptive pills or patch; Norplant, Depo-Provera, or other FDA approved contraceptive method; or a female participant with a male partner who has previously undergone a vasectomy.
Who cannot join
- Current febrile illness (oral temperature ≥100.4°F [≥38.0°C]) within 48 hours before vaccine administration.
- History of an infectious disease caused by Streptococcus pneumoniae confirmed by any modality of diagnosis within the last 3 years.
- History of any pneumococcal vaccination within the last 3 years.
- History of severe allergic reactions to any drug or vaccine, especially to any component of pneumococcal vaccines (including Pneumovax, any other tetanus toxoid-containing vaccine, or 13-valent pneumococcal conjugate vaccine), such as respiratory distress, angioedema, anaphylactic shock, allergic purpura, or thrombocytopenic purpura.
- History of any serious chronic disorder including respiratory diseases (eg., severe chronic obstructive pulmonary disease requiring supplemental oxygen, severe asthma), chronic hepatitis, chronic kidney disease (eg., end-stage renal disease with or without dialysis), clinically unstable cardiac diseases or cardiovascular diseases (eg., untreated or resistant hypertension [repeated office SBP >150 mmHg and/or DBP >95 mmHg], chronic cardiac insufficiency, coronary atherosclerotic heart disease), or clinically significant forms of drug or alcohol abuse or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
- Participants with known or suspected immunodeficiency or other conditions associated with immunosuppression, including, but not limited to, immunoglobulin class/subclass deficiencies, generalized malignancy, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, or organ or bone marrow transplant.
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- History of thrombocytopenia, any coagulation disorder, receiving anticoagulant therapy, or any condition contraindicating administration of intramuscular injections.
- History of asplenia, splenectomy, or functional asplenia for any reason.
- Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, or planned receipt within 28 days of vaccination. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before vaccination. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- Participants who has an acute illness or exacerbation of chronic illness ≤3 days before enrollment, or use of antipyretics, analgesics, and antihistamines (eg, acetaminophen, ibuprofen, aspirin) within this timeframe.
- Participants who have received any non-live vaccine ≤7 days before receipt of study vaccine; is scheduled to receive any non-live vaccine within 7 days (≤7 days) following receipt of the study vaccine; has received any live vaccine ≤14 days before receipt of the study vaccine; or is scheduled to receive any live vaccine within 7 days (≤7 days) following receipt of the study vaccine.
- Participation in other studies involving study drug(s), study vaccines, or study devices within 28 days prior to study enrollment and/or during study participation. Participation in purely observational studies is acceptable.
- Any ≥ Grade 2 laboratory abnormality or any lab abnormality that, in the opinion of the investigator, renders the participant unsuitable for enrollment.
- Planning to relocate before the end of the study or planning to be away from the local area for an extended period during the scheduled study visits.
- Any condition that, in the opinion of the investigator, may interfere with the assessment of the study objectives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Emeritus Research
Melbourne, Victoria, 3124
Paul Nygeun, +61-0415 252 595, feasibilities@emeritusresearch.com
About this study
Official title: A Phase I, Randomized, Double-blind, Parallel-controlled Clinical Study to Evaluate the Safety of a 26-valent Pneumococcal Conjugate Vaccine in Individuals Aged 60 and Above
This Phase I, randomized, double-blind, parallel-controlled study is to be conducted in healthy adults aged 60 and above. Participants will be randomly assigned in a 1:1 ratio to receive either 26-valent Pneumococcal Conjugate Vaccine (PCV26) or the comparator (PCV13) on Day 1 (Visit 1). Solicited adverse events (AEs) will be collected for 7 days post-vaccination and unsolicited AEs for 28 days post-vaccination, with safety data limited to serious adverse events (SAEs), and newly diagnosed chronic medical conditions (NDCMCs) collected up to 6 months post-vaccination.
- Conditions
- Pneumococcal Diseases
- Being tested
- 26-valent Pneumococcal Conjugate Vaccine, 13-valent Pneumococcal Conjugate Vaccine
- Keywords
- 26-valent Pneumococcal Conjugate 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.
26-valent Pneumococcal Conjugate VaccineBiological
Subjects were treated with a single intramuscular injection of 26-valent Pneumococcal Conjugate Vaccine.
13-valent Pneumococcal Conjugate VaccineBiological
Subjects were treated with a single intramuscular injection of 13-valent Pneumococcal Conjugate Vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine group | Experimental | 30 subjects aged ≥60 are enrolled in this group. Receives: Biological: 26-valent Pneumococcal Conjugate Vaccine |
| Active control group | Active comparator | 30 subjects aged ≥ 60 years are enrolled in this group. Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited AEs within 0-7 days after vaccination
The frequencies and percentages of participants reporting solicited AEs in injection within 7 days after vaccination in each group
Measured: Within 0-7 days after vaccination.
Solicited systemic AEs within 0-7 days after vaccination
The frequencies and percentages of participants reporting solicited systemic AEs within 7 days after vaccination in each group.
Measured: Within 0-7 days after vaccination.
Secondary outcomes (3)
Unsolicited AEs within 0-28 days after vaccination
The frequencies and percentages of participants reporting unsolicited AEs within 0-28 days after vaccination in each group.
Measured: Within 0-28 days after vaccination.
SAEs and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination
The frequencies and percentages of participants reporting SAEs and NDCMCs within 6 months after vaccination.
Measured: Within 0-6 months after vaccination.
Laboratory testing clinically abnormalities on the 7th day after vaccination
The frequencies and percentages of participants with laboratory testing clinically abnormalities on the 7th day after vaccination in each group.
Measured: On the 7th day after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start27 May 2025 (estimated)
- Primary completion27 Nov 2025 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseasesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- NCT06970756
- Sponsor's protocol ID
- 2024170A
- Status last verified
- Apr 2025
- First submitted
- 6 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Parallel-controlled Clinical Study to Evaluate the Safety of a 26-valent Pneumococcal Conjugate Vaccine in Individuals Aged 60 and Above
- ClinicalTrials.gov ID
- NCT06970756
- Acronym / sponsor ID
- 2024170A
- Conditions
- Pneumococcal Diseases
- Keywords
- 26-valent Pneumococcal Conjugate Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 May 2025 (estimated)
- Primary completion
- 27 Nov 2025 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 14 May 2025 (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 Phase I, randomized, double-blind, parallel-controlled study is to be conducted in healthy adults aged 60 and above. Participants will be randomly assigned in a 1:1 ratio to receive either 26-valent Pneumococcal Conjugate Vaccine (PCV26) or the comparator (PCV13) on Day 1 (Visit 1). Solicited adverse events (AEs) will be collected for 7 days post-vaccination and unsolicited AEs for 28 days post-vaccination, with safety data limited to serious adverse events (SAEs), and newly diagnosed chronic medical conditions (NDCMCs) collected up to 6 months post-vaccination.
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 |
|---|---|---|
| Vaccine group | Experimental | Biological: 26-valent Pneumococcal Conjugate Vaccine30 subjects aged ≥60 are enrolled in this group. |
| Active control group | Active comparator | Biological: 13-valent Pneumococcal Conjugate Vaccine30 subjects aged ≥ 60 years are enrolled in this group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60 years or older at the time of enrollment.
- Evidence of a personally signed and dated ICF indicating that the participant has been informed of all pertinent aspects of the study.
- Able to comply with the protocol, and capable of using a thermometer, a ruler, and fill out the diary card and contact card as required.
- Negative pregnancy test (urine) for female participants of childbearing potential. Male and non-pregnant, non-lactating females must also meet one of the following criteria: a). Female participant of nonchildbearing potential; male participant not able to father children; b). Agrees to consistently practice contraception until at least 28 days after vaccination by one of the following methods: condoms, male or female, with or without spermicide; diaphragm or cervical cap with spermicide; intrauterine device; contraceptive pills or patch; Norplant, Depo-Provera, or other FDA approved contraceptive method; or a female participant with a male partner who has previously undergone a vasectomy.
Key exclusion criteria (15 listed)
- Current febrile illness (oral temperature ≥100.4°F [≥38.0°C]) within 48 hours before vaccine administration.
- History of an infectious disease caused by Streptococcus pneumoniae confirmed by any modality of diagnosis within the last 3 years.
- History of any pneumococcal vaccination within the last 3 years.
- History of severe allergic reactions to any drug or vaccine, especially to any component of pneumococcal vaccines (including Pneumovax, any other tetanus toxoid-containing vaccine, or 13-valent pneumococcal conjugate vaccine), such as respiratory distress, angioedema, anaphylactic shock, allergic purpura, or thrombocytopenic purpura.
- History of any serious chronic disorder including respiratory diseases (eg., severe chronic obstructive pulmonary disease requiring supplemental oxygen, severe asthma), chronic hepatitis, chronic kidney disease (eg., end-stage renal disease with or without dialysis), clinically unstable cardiac diseases or cardiovascular diseases (eg., untreated or resistant hypertension [repeated office SBP >150 mmHg and/or DBP >95 mmHg], chronic cardiac insufficiency, coronary atherosclerotic heart disease), or clinically significant forms of drug or alcohol abuse or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
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 |
|---|---|---|
| 26-valent Pneumococcal Conjugate VaccineSubjects were treated with a single intramuscular injection of 26-valent Pneumococcal Conjugate Vaccine. | Biological | Vaccine group |
| 13-valent Pneumococcal Conjugate VaccineSubjects were treated with a single intramuscular injection of 13-valent Pneumococcal Conjugate Vaccine. | Biological | Active control group |
Primary outcome
Solicited AEs within 0-7 days after vaccination
Time frame: Within 0-7 days after vaccination.
The frequencies and percentages of participants reporting solicited AEs in injection within 7 days after vaccination in each group
Solicited systemic AEs within 0-7 days after vaccination
Time frame: Within 0-7 days after vaccination.
The frequencies and percentages of participants reporting solicited systemic AEs within 7 days after vaccination in each group.
3 secondary outcomes
Unsolicited AEs within 0-28 days after vaccination
Time frame: Within 0-28 days after vaccination.
SAEs and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination
Time frame: Within 0-6 months after vaccination.
Laboratory testing clinically abnormalities on the 7th day after vaccination
Time frame: On the 7th day 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 18 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 1 study testing 26-valent Pneumococcal Conjugate Vaccine and 13-valent Pneumococcal Conjugate Vaccine in people with Pneumococcal Diseases, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in Australia.
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 15 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: opening soon, as of the sponsor's last update on 18 May 2025. 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 Australia. 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?
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 Wenjian Fang (+86-18611630252, fangwenjian@zhifeishengwu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited AEs within 0-7 days after vaccination (time frame: Within 0-7 days after vaccination.). The study lists 2 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 18 May 2025.