Clinical trial NCT06314867: Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Healthy Volunteers
Keywords: 23 Valent Pneumococcal Polysaccharide Vaccine
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Geometric mean concentration (GMC) levels
timeFrame: 30 days after immunization
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Center for Disease Control and Prevention
state: Sichuan
Study officials:
affiliation: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
name: Lin Du
role: STUDY_CHAIR
References: