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

NCT06314867 | Active Not Recruiting Phase 3

• 1 other identifier: 20220231
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

23 Valent Pneumococcal Polysaccharide Vaccine

Outcome Measures

Primary Outcomes (1)

• Geometric mean concentration (GMC) levels

  Geometric mean concentration (GMC) levels of 23 serotype specific IgG antibodies

  30 days after immunization

Study Arms (3)

23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)

EXPERIMENTAL

Batch number: Y202112011

Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)

23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)

EXPERIMENTAL

Batch number: Y202112012

Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)

23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)

EXPERIMENTAL

Batch number: Y202112013

Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)

Interventions

23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) BIOLOGICAL

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.

23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)

23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) BIOLOGICAL

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.

23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)

23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) BIOLOGICAL

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.

23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, 610041, China

Location

Study Officials

• Lin Du

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: March 11, 2024
• First Posted: March 18, 2024
• Study Start: January 30, 2023
• Primary Completion: December 30, 2024
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 4, 2024

Record last verified: 2024-02

Locations

CN (1)