Clinical trial NCT05477693: Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine
Official title: A Randomized, Double-blind, Positive-controlled Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Population Aged 2 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Infections
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 1800
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.

Detailed description: This study is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Merck Sharp \& Dohme.A total of 1800 subjects including 900 subjects aged 2\~17 years,360 subjects aged 18\~59 years and 540 subjects aged 60 years and above will be enrolled.Subjects in each age group will be randomly divided into two groups according to the ratio of 2:1, and received one dose of experimental vaccine or control vaccine.

Eligibility criteria: Inclusion Criteria:

* Children aged 2 years and above in stable health;
* The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form.If the subject aged 16 to 17 years with full capacity for civil conduct and his/her labor income is his/her main source of living, the informed consent can be signed only by the subject himself/herself);
* Proven legal identity.

Exclusion Criteria:

* Have received any pneumococcal vaccine;
* History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture.
* Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
* History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
* Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) 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;
* 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;
* A long history of alcohol or drug abuse;
* Receipt of blood products within in the past 3 months;
* Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine;
* Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days;
* Receipt of inactivated or subunit vaccines in the past 7 days;
* Onset of various acute or chronic diseases within 3 days prior to the study;
* Underarm body temperature before vaccination\>37.0°C;
* The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials within 1 months;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Primary outcomes:
measure: Immunogenicity index-Seroconversion rate (2-fold increase rate)
timeFrame: 30 days after vaccination
Secondary outcomes:
measure: Immunogenicity index-Geometric Mean Concentration (GMC)
timeFrame: 30 days after vaccination
measure: Immunogenicity index-Geometric Mean Increase (GMI)
timeFrame: 30 days after vaccination
measure: Immunogenicity index-Seroconversion rate
timeFrame: 30 days after vaccination
measure: Immunogenicity index-GMC
timeFrame: 30 days after vaccination
measure: Immunogenicity index-GMI
timeFrame: 30 days after vaccination
measure: Safety index-Incidence of adverse reactions
timeFrame: Within 30 days after vaccination
measure: Safety index-incidence of adverse reactions
timeFrame: Within 7 days after vaccination
measure: Safety index-Incidence of serious adverse events
timeFrame: Within 30 days after vaccination
Other outcomes:
Locations:
city: Weinan
country: China
facility: Linwei District Center for Disease Control and Prevention
state: Shanxi
Study officials:
affiliation: Shanxi Provincial Center for Disease Prevention and Control
name: Weijun Hu
role: PRINCIPAL_INVESTIGATOR
References: