Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine

NCT05477693 | Completed Phase 4

• 1 other identifier: PRO-PPV-4002
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, positive-controlled 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 immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (1)

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

  Seroconversion rate (2-fold increase rate)for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.

  30 days after vaccination

Secondary Outcomes (8)

• Immunogenicity index-Geometric Mean Concentration (GMC)

  30 days after vaccination

• Immunogenicity index-Geometric Mean Increase (GMI)

  30 days after vaccination

• Immunogenicity index-Seroconversion rate

  30 days after vaccination

• Immunogenicity index-GMC

  30 days after vaccination

• Immunogenicity index-GMI

  30 days after vaccination

Study Arms (2)

Experimental Group

EXPERIMENTAL

1200 participants(including 600 subjects aged 2\~17 years,240 subjects aged 18\~59 years and 360 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd

Biological: Experimental 23-valent PPV

Control Group

ACTIVE COMPARATOR

600 participants(including 300 subjects aged 2\~17 years,120 subjects aged 18\~59 years and 180 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Merck Sharp \& Dohme.

Biological: Control 23-valent PPV

Interventions

Experimental 23-valent PPV 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, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection.

Experimental Group

Control 23-valent PPV BIOLOGICAL

The control vaccine was manufactured by Merck Sharp \& Dohme, Ltd. Purified capsular polysaccharides from 23 Streptococcus in 0.5 mL of pneumoniae types 0.25% phenol and sodium chloride.

Control Group

Eligibility Criteria

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

You may qualify if:

• Children aged 2 years and above in stable health;
• The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form.If the subject aged 16 to 17 years with full capacity for civil conduct and his/her labor income is his/her main source of living, the informed consent can be signed only by the subject himself/herself);
• 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;
• 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 3 days prior to the study;
• Underarm body temperature before vaccination\>37.0°C;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Linwei District Center for Disease Control and Prevention

Weinan, Shanxi, 710000, China

Location

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Weijun Hu

  Shanxi Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: October 25, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: September 18, 2023

Record last verified: 2022-04

Locations

CN (1)