Pneumococcal VaccinesPhase 1/2NCT06703203
Phase I/II Clinical Trial of 26-valent Pneumococcal Conjugate Vaccine
A Phase 1/2 study testing 26-Valent pneumococcal conjugate vaccine, 23-Valent pneumococcal polysaccharide vaccine and 13-Valent pneumococcal conjugate vaccine in people with Pneumococcal Vaccines, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this experiment is to evaluate the safety and immunogenicity of the 26 valent pneumococcal conjugate vaccine in the population aged 2 months and above. Read more about this study
- Who is it for?
- Ages 2 months and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Vaccines
- What is being tested?
- 26-Valent pneumococcal conjugate vaccine, 23-Valent pneumococcal polysaccharide vaccine and 13-Valent pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2025to 5 Feb 2026
- Phase
- Phase 1/2
- 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 2 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The subject is 2-3 months old (minimum 6 weeks old), 7 months old and above at the time of enrollment, and the legal guardian and/or the subject can provide legal identification certificate;
- The subjects themselves and/or their legal guardians understand the vaccination and trial procedures, voluntarily participate in the trial and sign the informed consent form;
- The subject and/or legal guardian can comply with the clinical trial protocol, have the ability to use thermometer, scale and fill in diary card and contact card as required;
- Female subjects of childbearing potential agree to take effective contraceptive measures from enrollment to 6 months after vaccination.
- For calibration group subjects: 18 to 55 years of age, ≥ 50 kg for males or ≥ 45 kg for females.
Who cannot join
- Axillary body temperature ≥ 37.3 ℃ on the day of enrollment;
- History of infectious diseases caused by Streptococcus pneumoniae confirmed by bacterial culture within 3 years;
- Have received or plan to receive a Streptococcus pneumoniae vaccine outside the trial protocol, including marketed or other investigational Streptococcus pneumoniae vaccines;
- Pregnant or lactating women; Previous history of severe allergy to any vaccine or drug, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock, Henoch-Schonlein purpura, thrombocytopenic purpura;
- Allergic to any component of the investigational vaccine;
- Suffering from severe respiratory diseases (such as severe asthma), heart diseases, liver diseases, kidney diseases, congenital malformations, developmental disorders and genetic defects (including but not limited to: down syndrome, thalassemia major, etc.) that may interfere with the conduct or completion of the trial;
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- Diagnosed with congenital or acquired immunodeficiency, or suspected to have serious chronic disease or systemic disease that may interfere with the conduct or completion of the trial, such as: active tuberculosis, human immunodeficiency virus (HIV) infection, etc.;
- Encephalopathy, uncontrolled epilepsy, convulsion and other progressive neurological diseases, or a history or family history of mental illness;
- Contraindications for intramuscular injection such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;
- Asplenia or splenectomy, functional asplenia due to any condition;
- Immunosuppressant therapy, cytotoxic therapy or corticosteroid therapy within 3 months prior to vaccination, such as systemic glucocorticoid therapy for more than 2 consecutive weeks, such as prednisone or similar drugs > 5 mg/day (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-complicated dermatitis);
- Received blood products or immunoglobulins within 3 months prior to enrollment (hepatitis B immunoglobulin is acceptable), or planned to be used during the trial (before the last immunogenicity blood sample collection);
- Within 3 days before the first dose of vaccine, the patient has acute illness or is in acute attack of chronic disease, or has used antipyretic, analgesic or anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, etc.);
- Received non-live vaccine within 7 days (≤ 7 days) or live attenuated vaccine within 14 days (≤ 14 days) prior to enrollment;
- Hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, applicable to adults);
- Abnormal and clinically significant laboratory test results, which are not suitable for enrollment as determined by the investigator (applicable to subjects aged 2 years and older in Phase I);
- Birth weight < 2.5 kg, premature delivery (gestational age < 37 weeks), history of abnormal labor process, history of asphyxia rescue, history of nerve organ damage, history of pathological jaundice confirmed by diagnosis;
- For Standardised Subjects:
- ① Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 50 U/L; Or hemoglobin ≤ 115 g/L (female)/120g/L (male); Any positive serology for hepatitis B, hepatitis C, HIV, or syphilis.
- Plans to move before the end of the trial or leave the area for an extended period of time during scheduled trial visits;
- Ongoing participation or planning to participate in other clinical trials (vaccines, drugs, medical devices, etc.) in the near future;
- Subject has any condition that, in the opinion of the investigator, may interfere with the evaluation of the objectives of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Provincial Center for Disease Control and Prevention
Shangqiu, Henan, 476700
About this study
Official title: A Single-center, Randomized, Double-blind, Active-controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of 26-valent Pneumococcal Conjugate Vaccine in People Aged 2 Months and Older
The purpose of this experiment is to evaluate the safety and immunogenicity of the 26 valent pneumococcal conjugate vaccine in the population aged 2 months and above.
Read the detailed description
A single-center, randomized, double-blind, active-controlled trial design (Phase I/II) was used. In addition, according to the requirements in the approval letter of this product (2024LP01053), serum standards need to be established for the newly added types (24F, 35B). Therefore, a calibration group is set and an open study design is adopted.
- Conditions
- Pneumococcal Vaccines
- Being tested
- 26-Valent pneumococcal conjugate vaccine, 23-Valent pneumococcal polysaccharide vaccine, 13-Valent pneumococcal conjugate vaccine
- Keywords
- 26 valent pneumococcal conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
26-Valent pneumococcal conjugate vaccineBiological
As an experimental group. The active ingredient of 26-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 26 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time.
23-Valent pneumococcal polysaccharide vaccineBiological
As a control group. The effective ingredients of 23-valent pneumococcal polysaccharide vaccine are 23 serotypes of pneumococcal capsular polysaccharides. Administer one dose of 0.5mL each time.
13-Valent pneumococcal conjugate vaccineBiological
As a control group. The active ingredient of 13-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 13 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time.
| Study group | Role | What they receive |
|---|---|---|
| ≥60 years old age group (for phase Ⅰ) | Other | There are 30 subjects in ≥60 years old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. Receives: Biological: 26-Valent pneumococcal conjugate vaccine; Biological: 23-Valent pneumococcal polysaccharide vaccine |
| 18-59 years old age group (for phase Ⅰ) | Other | There are total 40 subjects in 18-59 age group. Among them, 30 subjects were randomly assigned to the experimental group and the control group in a 2:1 ratio. In addition, other 10 subjects aged 18-55 to receive the experimental vaccine as the serum calibration test population. Receives: Biological: 26-Valent pneumococcal conjugate vaccine; Biological: 23-Valent pneumococcal polysaccharide vaccine |
| 6-17 years old age group (for phase Ⅰ) | Other | There are 30 subjects in 6-17 years old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. Receives: Biological: 26-Valent pneumococcal conjugate vaccine; Biological: 23-Valent pneumococcal polysaccharide vaccine |
| 2-5 years old age group (for phase Ⅰ/Ⅱ) | Other | There are total 230 people in 2-5 years old age group. Among them, there were 30 subjects included in the phase Ⅰ clinical trial and were randomly assigned to the experimental group and the control group in a 2:1 ratio. And the other 200 people were included for phase Ⅱ and were randomly assigned to the experimental group and the control group in a 1:1 ratio. Receives: Biological: 26-Valent pneumococcal conjugate vaccine; Biological: 13-Valent pneumococcal conjugate vaccine |
| 13-23 months old age group (for phase Ⅰ) | Other | There are 30 subjects in 13-23 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. Receives: Biological: 26-Valent pneumococcal conjugate vaccine; Biological: 13-Valent pneumococcal conjugate vaccine |
| 7-11 months old age group (for phase Ⅰ) | Other | There are 30 subjects in 7-11 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. Receives: Biological: 26-Valent pneumococcal conjugate vaccine; Biological: 13-Valent pneumococcal conjugate vaccine |
| 3 months old age group (for phase Ⅰ) | Other | There are 30 subjects in 3 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. Receives: Biological: 26-Valent pneumococcal conjugate vaccine; Biological: 13-Valent pneumococcal conjugate vaccine |
| 2 months old age group （for phase Ⅰ） | Other | There are 30 subjects in 2 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. Receives: Biological: 26-Valent pneumococcal conjugate vaccine; Biological: 13-Valent pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
All AE occurrences within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination)
Measured: 30 day after each vaccination
Solicited AE occurrences within 0-30 minutes after each dose of vaccination (for phase Ⅰ/Ⅱ）
The occurrence of Solicited adverse events (AE) within 0-30 minutes after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination)
Measured: 30 minutes after each vaccination
Solicited AE occurrences within 0-7 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
The occurrence of solicited adverse events (AE) within 0-7 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination);
Measured: 0-7 days after each vaccination
Unsolicited AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
The occurrence of unsolicited adverse events (AE) within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination);
Measured: 0-30 days after each vaccination
Grade 3 and above AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
The occurrence of grade 3 and above adverse events within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination).
Measured: 0-30 days after each vaccination
All SAE occurrences within 0-6 months after vaccination (for Phase Ⅱ)
The occurrence of all serious adverse reactions within 6 months after vaccination (number of cases, incidence rate, and relationship with vaccination)
Measured: 0-6 months after each vaccination
Positive rate of serotype-specific pneumococcal IgG antibody on the 30th day after immunization in subjects aged 2-5 years （for phase Ⅱ）
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 μg/ml on Day 30 after vaccination in subjects aged 2-5 years
Measured: 30 day after vaccination
Secondary outcomes (3)
All SAE in the population aged ≥12 months during 0-6 months after vaccination （for phase Ⅰ）
All SAE in the population aged 12 months and older from the first dose to 6 months after the full course of vaccination
Measured: 0-6 months after vaccination
All SAE in the population aged <12 months from the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster（for phase Ⅰ）
All SAE from the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster in the population less than 12 months of age.
Measured: From the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster
Proportion of IgG antibodies ≥ 1.0 µg/mL and GMC results on Day 30 post-immunization（for phase Ⅱ）
Proportion of subjects with serotype-specific pneumococcal IgG antibodies ≥ 1.0 µg/mL and GMC results on Day 30 post-immunization in subjects 2 to 5 years of age.
Measured: 30 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 posted25 Nov 2024
- Study start17 Jul 2025
- Primary completion5 Aug 2025
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal VaccinesStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703203
- Sponsor's protocol ID
- 202417AB
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2024
- Last updated
- 30 Mar 2026
- 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Active-controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of 26-valent Pneumococcal Conjugate Vaccine in People Aged 2 Months and Older
- ClinicalTrials.gov ID
- NCT06703203
- Acronym / sponsor ID
- 202417AB
- Conditions
- Pneumococcal Vaccines
- Keywords
- 26 valent pneumococcal conjugate vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 25 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.
The purpose of this experiment is to evaluate the safety and immunogenicity of the 26 valent pneumococcal conjugate vaccine in the population aged 2 months and above.
Detailed description
A single-center, randomized, double-blind, active-controlled trial design (Phase I/II) was used. In addition, according to the requirements in the approval letter of this product (2024LP01053), serum standards need to be established for the newly added types (24F, 35B). Therefore, a calibration group is set and an open study design is adopted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ≥60 years old age group (for phase Ⅰ) | Other | Biological: 26-Valent pneumococcal conjugate vaccine, Biological: 23-Valent pneumococcal polysaccharide vaccineThere are 30 subjects in ≥60 years old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| 18-59 years old age group (for phase Ⅰ) | Other | Biological: 26-Valent pneumococcal conjugate vaccine, Biological: 23-Valent pneumococcal polysaccharide vaccineThere are total 40 subjects in 18-59 age group. Among them, 30 subjects were randomly assigned to the experimental group and the control group in a 2:1 ratio. In addition, other 10 subjects aged 18-55 to receive the experimental vaccine as the serum calibration test population. |
| 6-17 years old age group (for phase Ⅰ) | Other | Biological: 26-Valent pneumococcal conjugate vaccine, Biological: 23-Valent pneumococcal polysaccharide vaccineThere are 30 subjects in 6-17 years old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| 2-5 years old age group (for phase Ⅰ/Ⅱ) | Other | Biological: 26-Valent pneumococcal conjugate vaccine, Biological: 13-Valent pneumococcal conjugate vaccineThere are total 230 people in 2-5 years old age group. Among them, there were 30 subjects included in the phase Ⅰ clinical trial and were randomly assigned to the experimental group and the control group in a 2:1 ratio. And the other 200 people were included for phase Ⅱ and were randomly assigned to the experimental group and the control group in a 1:1 ratio. |
| 13-23 months old age group (for phase Ⅰ) | Other | Biological: 26-Valent pneumococcal conjugate vaccine, Biological: 13-Valent pneumococcal conjugate vaccineThere are 30 subjects in 13-23 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| 7-11 months old age group (for phase Ⅰ) | Other | Biological: 26-Valent pneumococcal conjugate vaccine, Biological: 13-Valent pneumococcal conjugate vaccineThere are 30 subjects in 7-11 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| 3 months old age group (for phase Ⅰ) | Other | Biological: 26-Valent pneumococcal conjugate vaccine, Biological: 13-Valent pneumococcal conjugate vaccineThere are 30 subjects in 3 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. |
| 2 months old age group （for phase Ⅰ） | Other | Biological: 26-Valent pneumococcal conjugate vaccine, Biological: 13-Valent pneumococcal conjugate vaccineThere are 30 subjects in 2 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio. |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is 2-3 months old (minimum 6 weeks old), 7 months old and above at the time of enrollment, and the legal guardian and/or the subject can provide legal identification certificate;
- The subjects themselves and/or their legal guardians understand the vaccination and trial procedures, voluntarily participate in the trial and sign the informed consent form;
- The subject and/or legal guardian can comply with the clinical trial protocol, have the ability to use thermometer, scale and fill in diary card and contact card as required;
- Female subjects of childbearing potential agree to take effective contraceptive measures from enrollment to 6 months after vaccination.
- For calibration group subjects: 18 to 55 years of age, ≥ 50 kg for males or ≥ 45 kg for females.
Key exclusion criteria (22 listed)
- Axillary body temperature ≥ 37.3 ℃ on the day of enrollment;
- History of infectious diseases caused by Streptococcus pneumoniae confirmed by bacterial culture within 3 years;
- Have received or plan to receive a Streptococcus pneumoniae vaccine outside the trial protocol, including marketed or other investigational Streptococcus pneumoniae vaccines;
- Pregnant or lactating women; Previous history of severe allergy to any vaccine or drug, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock, Henoch-Schonlein purpura, thrombocytopenic purpura;
- Allergic to any component of the investigational vaccine;
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 vaccineAs an experimental group. The active ingredient of 26-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 26 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time. | Biological | 13-23 months old age group (for phase Ⅰ), 18-59 years old age group (for phase Ⅰ), 2 months old age group （for phase Ⅰ）, 2-5 years old age group (for phase Ⅰ/Ⅱ), 3 months old age group (for phase Ⅰ), 6-17 years old age group (for phase Ⅰ), 7-11 months old age group (for phase Ⅰ), ≥60 years old age group (for phase Ⅰ) |
| 23-Valent pneumococcal polysaccharide vaccineAs a control group. The effective ingredients of 23-valent pneumococcal polysaccharide vaccine are 23 serotypes of pneumococcal capsular polysaccharides. Administer one dose of 0.5mL each time. | Biological | 18-59 years old age group (for phase Ⅰ), 6-17 years old age group (for phase Ⅰ), ≥60 years old age group (for phase Ⅰ) |
| 13-Valent pneumococcal conjugate vaccineAs a control group. The active ingredient of 13-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 13 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time. | Biological | 13-23 months old age group (for phase Ⅰ), 2 months old age group （for phase Ⅰ）, 2-5 years old age group (for phase Ⅰ/Ⅱ), 3 months old age group (for phase Ⅰ), 7-11 months old age group (for phase Ⅰ) |
Primary outcome
AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
Time frame: 30 day after each vaccination
All AE occurrences within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination)
Solicited AE occurrences within 0-30 minutes after each dose of vaccination (for phase Ⅰ/Ⅱ）
Time frame: 30 minutes after each vaccination
The occurrence of Solicited adverse events (AE) within 0-30 minutes after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination)
Solicited AE occurrences within 0-7 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
Time frame: 0-7 days after each vaccination
The occurrence of solicited adverse events (AE) within 0-7 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination);
Unsolicited AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
Time frame: 0-30 days after each vaccination
The occurrence of unsolicited adverse events (AE) within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination);
Grade 3 and above AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
Time frame: 0-30 days after each vaccination
The occurrence of grade 3 and above adverse events within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination).
All SAE occurrences within 0-6 months after vaccination (for Phase Ⅱ)
Time frame: 0-6 months after each vaccination
The occurrence of all serious adverse reactions within 6 months after vaccination (number of cases, incidence rate, and relationship with vaccination)
Positive rate of serotype-specific pneumococcal IgG antibody on the 30th day after immunization in subjects aged 2-5 years （for phase Ⅱ）
Time frame: 30 day after vaccination
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 μg/ml on Day 30 after vaccination in subjects aged 2-5 years
3 secondary outcomes
All SAE in the population aged ≥12 months during 0-6 months after vaccination （for phase Ⅰ）
Time frame: 0-6 months after vaccination
All SAE in the population aged <12 months from the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster（for phase Ⅰ）
Time frame: From the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster
Proportion of IgG antibodies ≥ 1.0 µg/mL and GMC results on Day 30 post-immunization（for phase Ⅱ）
Time frame: 30 day 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 30 Mar 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 26-Valent pneumococcal conjugate vaccine, 23-Valent pneumococcal polysaccharide vaccine and 13-Valent pneumococcal conjugate vaccine in people with Pneumococcal Vaccines, 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 5 inclusion and 22 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 30 Mar 2026. 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 combined 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.
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?
AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ） (time frame: 30 day after each vaccination). The study lists 7 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 30 Mar 2026.