Phase I/II Clinical Trial of 26-valent Pneumococcal Conjugate Vaccine

NCT06703203 | Completed Phase 1

• 1 other identifier: 202417AB
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumococcal Vaccines

Keywords

26 valent pneumococcal conjugate vaccine

Outcome Measures

Primary Outcomes (7)

• 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)

  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)

  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);

  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);

  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).

  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)

  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

  30 day after vaccination

Secondary Outcomes (3)

• All SAE in the population aged ≥12 months during 0-6 months after vaccination （for phase Ⅰ）

  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）

  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）

  30 day after vaccination

Study Arms (8)

≥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.

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.

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.

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.

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.

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.

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.

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.

Biological: 26-Valent pneumococcal conjugate vaccine; Biological: 13-Valent pneumococcal conjugate vaccine

Interventions

23-Valent pneumococcal polysaccharide vaccine BIOLOGICAL

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.

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 vaccine BIOLOGICAL

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.

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)

26-Valent pneumococcal conjugate vaccine BIOLOGICAL

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.

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)

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Henan Provincial Center for Disease Control and Prevention

Shangqiu, Henan, 476700, China

Location

MeSH Terms

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: July 17, 2025
• Primary Completion: August 5, 2025
• Study Completion: February 5, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-10

Locations

CN (1)