Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23
Phase 3
Active, not recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3)Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2)Biological: 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1)
- Registration Number
- NCT06314867
- Lead Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 990
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) 23 Valent Pneumococcal Polysaccharide Vaccine (lot 3) Batch number: Y202112013 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) 23 Valent Pneumococcal Polysaccharide Vaccine (lot 2) Batch number: Y202112012 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) 23 Valent Pneumococcal Polysaccharide Vaccine (lot 1) Batch number: Y202112011
- Primary Outcome Measures
Name Time Method Geometric mean concentration (GMC) levels 30 days after immunization Geometric mean concentration (GMC) levels of 23 serotype specific IgG antibodies
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sichuan Center for Disease Control and Prevention
🇨🇳Chengdu, Sichuan, China