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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06314867
Other study ID # 20220231
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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