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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Vaccines
• Intervention / Treatment: Biological: 26-Valent pneumococcal conjugate vaccine; Biological: 23-Valent pneumococcal polysaccharide vaccine; Biological: 13-Valent pneumococcal conjugate vaccine

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 Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Shangqiu, Henan, China, 476700
      • Henan Provincial Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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);
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ≥60 years old age group (for phase Ⅰ); 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; 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.; Biological: 23-Valent pneumococcal polysaccharide vaccine; 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.
Other: 18-59 years old age group (for phase Ⅰ); 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; 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.; Biological: 23-Valent pneumococcal polysaccharide vaccine; 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.
Other: 6-17 years old age group (for phase Ⅰ); 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; 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.; Biological: 23-Valent pneumococcal polysaccharide vaccine; 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.
Other: 2-5 years old age group (for phase Ⅰ/Ⅱ); 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; 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.; Biological: 13-Valent pneumococcal conjugate vaccine; 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.
Other: 13-23 months old age group (for phase Ⅰ); 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; 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.; Biological: 13-Valent pneumococcal conjugate vaccine; 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.
Other: 7-11 months old age group (for phase Ⅰ); 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; 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.; Biological: 13-Valent pneumococcal conjugate vaccine; 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.
Other: 3 months old age group (for phase Ⅰ); 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; 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.; Biological: 13-Valent pneumococcal conjugate vaccine; 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.
Other: 2 months old age group （for phase Ⅰ）; 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; 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.; Biological: 13-Valent pneumococcal conjugate vaccine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	30 day after vaccination

Collaborators and Investigators

• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2025
• Primary Completion (Actual): August 5, 2025
• Study Completion (Actual): February 5, 2026

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: 26 valent pneumococcal conjugate vaccine
• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; 23-valent pneumococcal capsular polysaccharide vaccine
• Other Study ID Numbers: 202417AB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No