Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
- Summary
- This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to preliminary evaluate the safety and immunogenicity of the study vaccine
- Short title
- Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
- Official title
- An Open-label Combined Randomized Double-blind, Positive Control Clinical Trial in Subjects Aged 2 Months (Minimum 6 Weeks) and Above to Preliminary Evaluate the Safety and Immunogenicity of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-05-28
- First posted
- 2021-10-25
- Registry last updated
- 2026-01-28
- Primary completion date
- 2024-05-26
- Start date
- 2023-01-03
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05092386
- ClinicalTrials.gov ID
- NCT05092386
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Double masking
- Masking description
- Open label design will be adopted for children and adolescents aged 6-17 years and infants aged 3 months, and randomized, blind and positive control design was adopted for other populations
- Masked roles
- Investigators, Outcome assessors
Safety index-incidence of adverse reactions
Timeframe: Day 0-30 after each dose of experimental vaccine
Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine
Safety index-incidence of adverse reactions
Timeframe: Day 0-7 after each dose of experimental vaccine
Incidence of adverse reactions 0 to 7 days after each dose of experimental vaccine
Safety index-incidence of abnormal indicators
Timeframe: Day 3 after vaccination after each dose of experimental vaccine
Incidence of abnormal indicators of Blood routine, blood biochemistry and urine routine 3 days after vaccination in subjects aged 2 years and older
Safety index-Incidence of serious adverse events during the safety observation period
Timeframe: 1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization
Incidence of serious adverse events during the safety observation period, including 1 month after vaccination in subject aged 6 years and older, and 6 months after primary immunization and 1 month after booster immunization in subject aged 2 months (minimum 6 weeks) to 5 years(if any)
Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype
Timeframe: Day 30 after vaccination
Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype at 30 days after vaccination in subjects of all age groups
Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype
Timeframe: Day 30 after vaccination
Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype at 30 days after vaccination in subjects of all age groups
Immunogenicity index-Seropositive rates，GMCs and GMI of serum specific antibody
Timeframe: Day 30 after vaccination
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMCs) and GMI of serum specific antibody at 30 days after primary immunization in subjects of all age groups
Immunogenicity index-Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)
Timeframe: Day 30 after vaccination
Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)in subjects of all age groups at 30 days after primary immunization
Immunogenicity index-Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC)
Timeframe: Day 30 before and after booster immunization
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC) in subjects aged 2 months (Minimum 6 weeks), 3 months and 7 \~ 11 months at 30 days before and after booster immunization
Immunogenicity index-Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT)
Timeframe: Day 30 before and after booster immunization
Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT) in subjects aged 2 months (Minimum 6 weeks), 3 months, and 7\~ 11 months at 30 days before and after booster immunization
- Sex
- All
- Age groups
- Children, Adults
- Minimum age
- 6 Weeks
- Maximum age
- 49 Years
- Healthy volunteers
- Yes
- Healthy infants aged 2 months (minimum 6 weeks), healthy infants aged 3 months, healthy infants aged 7 ~ 11 months, healthy infants aged 12~ 23 months, healthy children aged 2~ 5 years, healthy adolescent and children aged 6~ 17 years, healthy adults aged 18~ 49 years；
- Proven legal identification and vaccination certificate (vaccination certificate is required for those aged 5 and below)；
- The subject and/or guardian can understand and voluntarily sign the informed consent form.
- Have received pneumococcal polysaccharide vaccine or pneumococcal polysaccharide conjugate vaccine;
- Have Bacterial pneumonia or invasive pneumococcal infectious disease (IPD) caused by pneumococcus confirmed by sputum culture;
- History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Autoimmune disease or immunodeficiency / immunosuppression;
- Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- History of thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy due to any circumstance;
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- History of alcohol or drug abuse;
- Receipt of blood products within in the past 3 months;
- Receipt of other investigational drugs in the past 30 days;
- Receipt of attenuated live vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
- Axillary temperature >37.0°C;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
- Henan Center for Diseases Control and PreventionZhengzhou, China
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Pneumococcal infection Primary condition