Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine

NCT05731115 | Completed Phase 4

• 1 other identifier: PRO-PPV-4003
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (1)

• Immunogenicity index-Geometric Mean Concentration (GMC)

  GMC for serotype-specific pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.

  30 days after vaccination

Secondary Outcomes (5)

• Immunogenicity index-Geometric Mean Increase (GMI)

  30 days after vaccination

• Immunogenicity index-Seroconversion rate (2-fold increase rate)

  30 days after vaccination

• Safety index-Incidence of adverse reactions

  Within 30 days after vaccination

• Safety index-Incidence of adverse reactions

  Within 7 days after vaccination

• Safety index-Incidence of serious adverse events

  Within 30 days after vaccination

Study Arms (3)

Experimental Vaccine-lot 1

EXPERIMENTAL

Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 1.

Biological: Experimental 23-valent Pneumococcal

Experimental Vaccine-lot 2

EXPERIMENTAL

Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 2.

Biological: Experimental 23-valent Pneumococcal

Experimental Vaccine-lot 3

EXPERIMENTAL

Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 3.

Biological: Experimental 23-valent Pneumococcal

Interventions

Experimental 23-valent Pneumococcal BIOLOGICAL

The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B,17F,18C, 19A, 19F, 20, 22F, 23F, and 33F in 0.5 mL of sodium chloride mixture per injection.

Experimental Vaccine-lot 1; Experimental Vaccine-lot 2; Experimental Vaccine-lot 3

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 40-65 years in stable health;
• The subjects can understand and voluntarily sign the informed consent form;
• Proven legal identity.

You may not qualify if:

• Have received any pneumococcal vaccine;
• History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture;
• Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
• History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
• Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
• Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
• Autoimmune disease or immune deficiency/immunosuppression;
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
• A long history of alcohol or drug abuse;
• Receipt of blood products within in the past 3 months;
• Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
• Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days;
• Receipt of inactivated or subunit vaccines in the past 7 days;
• Onset of various acute or chronic diseases within 7 days prior to the study;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (2)

The First People's Hospital of Yuanping Medical Group

Yuanping, Shanxi, 034199, China

Location

Salt Lake District Center for Disease Control and Prevention

Yuncheng, Shanxi, 044000, China

Location

Related Publications (1)

• Zhang Y, Shi G, Zhou S, Zhao W, Wang L, Li J, Zhao Z, Li G, Geng J, Chen Z, Zhao H, Li Y, Xu L, Wang B, Jiao P, Li G. Lot-to-lot consistency, immunogenicity, and safety of a 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy adults aged 40-65 years: A randomized, double-blind, controlled, phase IV clinical trial. Hum Vaccin Immunother. 2025 Dec;21(1):2579366. doi: 10.1080/21645515.2025.2579366. Epub 2025 Oct 30.

  PMID: 41165164 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Yunong Zhang

  Shanxi Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: February 27, 2023
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-02

Locations

CN (2)