Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23

A Single Center, Randomized, Double-blind, and Intergroup Control Clinical Study to Evaluation on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of 23 Valent Pneumococcal Polysaccharide Vaccine

The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1); Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2); Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)

Detailed Description

This study adopted a randomized, double-blind, equivalency design with different batches of experimental vaccine. 990 individuals aged 18-59 were included and divided into three groups at a ratio of 1:1:1, with 330 individuals in each group receiving three batches of experimental vaccines, respectively. All subjects were vaccinated with 1 dose of 0.5ml, intramuscularly injected into the lateral deltoid muscle of the upper arm.

• Study Type: Interventional
• Enrollment (Actual): 990
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Sichuan Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy volunteers aged 18-59;
• Voluntarily participate and sign an informed consent form;
• Subjects are able to comply with the requirements of the clinical study protocol and complete the prescribed follow-up;
• Has not received pneumococcal vaccine or any other preventive products recently (has not received attenuated live vaccine within 14 days, has not received inactivated vaccine within 7 days);
• Underarm temperature ≤ 37.0 ℃;
• Female participants of childbearing age agree to take effective contraceptive measures within 3 months from the start of the study until the full vaccination period.

Exclusion Criteria:

• Subjects with a history or family history of progressive neurological disorders such as epilepsy, encephalopathy, and mental illness;
• Has a history of severe allergies to any drugs or vaccines in the past;
• Has a allergy history to any component of the experimental vaccine (the main components of the vaccine include type 23 pneumococcal polysaccharides, sodium chloride, sodium dihydrogen phosphate, and sodium dihydrogen phosphate);
• Suffering from severe cardiovascular diseases (heart disease, pulmonary heart disease, pulmonary edema, drug-resistant hypertension (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg)); drug-resistant diabetes;
• Subjects with a history of thrombocytopenia or other coagulation disorders that may cause contraindications for subcutaneous injection;
• Subjects with known immunological dysfunction or low levels, or HIV infection;
• Any situation leading to splenomegaly, splenectomy, or functional splenomegaly;
• Malignant tumors, active or treated tumors that have not been clearly cured, or are likely to recur during the study period;
• Anti tuberculosis prevention or treatment is under way;
• Subjects who are participating in or planning to participate in clinical trials of other drugs or vaccine clinical trials throughout the entire observation period;
• Women of childbearing age are in pregnancy (positive urine pregnancy test) or lactation period;
• Any situation that the researcher believes may affect the evaluation of the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1); Batch number: Y202112011	Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1); All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112011), intramuscularly injected into the lateral deltoid muscle of the upper arm.
Experimental: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2); Batch number: Y202112012	Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2); All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112012), intramuscularly injected into the lateral deltoid muscle of the upper arm.
Experimental: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3); Batch number: Y202112013	Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3); All subjects were vaccinated with 1 dose of 23 Valent Pneumococcal Polysaccharide Vaccine (batch number: Y202112013), intramuscularly injected into the lateral deltoid muscle of the upper arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean concentration (GMC) levels	Geometric mean concentration (GMC) levels of 23 serotype specific IgG antibodies	30 days after immunization

Collaborators and Investigators

• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Investigators: Study Chair: Lin Du, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: 23 Valent Pneumococcal Polysaccharide Vaccine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 20220231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No