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

NCT ID: NCT06314867

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 990 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2028-06-30

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.

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)

Batch number: Y202112011

Group Type: EXPERIMENTAL

23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)

Intervention Type: 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 2)

Batch number: Y202112012

Group Type: EXPERIMENTAL

23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)

Intervention Type: 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 3)

Batch number: Y202112013

Group Type: EXPERIMENTAL

23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Du

Role: STUDY_CHAIR

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Locations

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, China

Countries

China

Other Identifiers

20220231

Identifier Type: -

Identifier Source: org_study_id