Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine

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

Summary
A phase II clinical trial of a 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 study's objective is to evaluate the safety and immunogenicity of PCV24. The trial is a single-center, randomized, blinded, parallel-controlled, non-inferiority design II clinical trial.
Short title
Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine
Official title
A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older

Control arm
Active comparator
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 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. Positive conversion rate of specific IgG antibodies by serotype

    Timeframe: 0~30 days after vaccination

    The positive conversion rate of IgG antibody of each serotype covered by pneumococcal vaccine detected by Enzyme linked immunosorbent assay (ELISA) 30 days after immunization in each group.

  1. The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus

    Timeframe: 0~30 days after vaccination

    The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus in subjects 30 days after immunization in each group

Sources for outcomes

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

  1. Volunteers aged 18 and above 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 vaccination with pneumococcal conjugate vaccine, prior vaccination with pneumococcal polysaccharide vaccine for less than 3 years, or previous history of invasive disease caused by Streptococcus pneumoniae;
  2. Have any history of severe allergies in the past, 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 prior to vaccination);
  4. Suffering from more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg when measured on site);
  5. Those who have acute febrile illness or acute infectious disease or have cold symptoms, advanced influenza and take medication;
  6. History of nervous system damage, severe congenital malformations, severe developmental disorders, 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 the disease is in the advanced stage and cannot be controlled smoothly;
  11. Have received blood or blood-related products or immunoglobulins within 3 months;
  12. Received live attenuated vaccine within 14 days;
  13. Other vaccinations 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. 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

  • Pizhou Center for Disease Control and PreventionPizhou, China
  • Xuzhou Center for Disease Control and PreventionXuzhou, China
Sources for sites

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (14)