Phase I Clinical Trial of PCV24 in People Aged 18 Years and Older

Phase
Recruitment status
Participants
Lead sponsor
Reinovax Biologics Co., LTD
Start date
Number of sites

Summary
Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older . The objective of the study is to evaluate the safety and tolerability of PCV24. The trial is a single-center, randomized, blind,parallel-controlled design I clinical trial.
Short title
Phase I Clinical Trial of PCV24 in People Aged 18 Years and Older
Official title
Phase I Clinical Trial to Evaluate the Safety and Tolerability of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Randomisation ratio
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Reinovax Biologics Co., LTD
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design

  1. Incidence of adverse reactions

    Timeframe: 0-7days after vaccination

    Incidence of adverse reactions within 7 days after vaccination

  1. incidence of adverse events

    Timeframe: 0~30 days after vaccination.

    The incidence of adverse events within 30 days after vaccination.

  2. Incidence of serious adverse events (SAE)

    Timeframe: 0-6 months after vaccination

    Incidence of SAE during the period of safety monitoring

  3. Incidence of clinically significant abnormality in laboratory examination tests

    Timeframe: 0-3days after vaccination

    Incidence of clinically significant abnormality in blood routine, blood biochemistry,coagulation function and urine routine test results within 3 days after vaccination

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  1. Volunteers over the age of 18 on the day of screening, and can provide legal identification;
  2. Informed consent must be obtained from the volunteer and signed informed consent form;
  3. Volunteers are able and willing to comply with the requirements of the clinical trial protocol and can attend all visits;
  4. Armpit body temperature ≤ 37.0 °C on the day of enrollment.

  1. Previous pneumococcal vaccination, or history of invasive disease caused by pneumococcal in the past;
  2. Have any previous history of severe allergies to vaccines or drugs, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Athus reaction), etc.;
  3. Have been diagnosed with congenital or acquired immunodeficiency, or have recently received immunosuppressant therapy, such as systemic glucocorticoid therapy such as prednisone or similar drugs > 5 mg/day for more than 2 consecutive weeks in 1 month before vaccination (Note: the use of topical and inhaled/nebulized steroids can participate);
  4. Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (when measured on site: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥100 mmHg), etc.;
  5. Suffering from acute febrile illness or infectious diseases, such as tuberculosis, viral hepatitis, etc.;
  6. History of nervous system damage, severe congenital malformations, severe developmental disabilities, severe genetic defects, severe malnutrition, etc.;
  7. Have a history or family history of epilepsy, encephalopathy, or psychiatric disorders;
  8. Those who have been diagnosed with thrombocytopenia, any abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities, etc.) or contraindications to intramuscular injection such as anticoagulant therapy;
  9. asplenia, functional asplenia, and asplenia or splenectomy due to any cause;
  10. Suffering from severe chronic diseases or conditions that cannot be controlled smoothly in the advanced stage, such as diabetes, thyroid disease, etc.;
  11. Have received blood or blood-related products or immunoglobulins within 3 months;
  12. Received live attenuated vaccine within 14 days;
  13. Received other vaccines within 7 days;
  14. Received other investigational drugs or vaccines within 1 month;
  15. Is participating in or plans to participate in clinical studies of other drugs or vaccines during the study period;
  16. Any other condition that, in the opinion of the investigator, may interfere with the study evaluation;
  17. Those who have abnormal laboratory tests such as blood routine, blood biochemistry, and urine routine that are clinically significant and cannot be enrolled according to the comprehensive judgment of the investigator;
  18. Exclusion Criteria for Partial Populations:

Females of childbearing potential (18~49 years old): positive urine pregnancy test on the day of enrollment, lactation, or pregnancy plans within 6 months.

Sources for eligibility

  • Zhenjiang Center for Disease Control and PreventionZhenjiang, China
Sources for sites

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)