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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06314867
• Other study ID #: 20220231
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 30, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: February 2024
• Source: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 990
• Est. completion date: June 30, 2028
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Sichuan Center for Disease Control and Prevention	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean concentration (GMC) levels	Geometric mean concentration (GMC) levels of 23 serotype specific IgG antibodies	30 days after immunization