Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

Beijing Zhifei Lvzhu Biopharmaceutical

Status and phase

Completed

Phase 3

Conditions

Pneumonia, Pneumococcal

Treatments

Biological: 23-Valent Pneumococcal Polysaccharide Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT04278248

201719906

Details and patient eligibility

About

The purpose of this study is to evaluate Immunogenicity and safety of 23-Valent Pneumococcal Polysaccharide Vaccine in healthy volunteers aged 2 Years and above.

Enrollment

1,940 patients

Sex

All

Ages

2+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

2 years old and above healthy people.
Subject or legal representative who consent and has signed written informed consent.
Subject or legal representative who is able to comply with all study procedures.
Subject who didn't vaccinate pneumococcal vaccines and did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
Axillary temperature ≤37.0 ℃.

Exclusion criteria

History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
Allergic history after vaccination.
Known allergy to any component of the test vaccine（the test vaccine mainly contains 23 types of pneumococcal polysaccharide and PBS buffer）
Subjects who diagnosis of thrombocytopenia or other history of coagulopathy.
Known immunological impairment or dysfunction.
Subjects who have received whole blood, plasma, and immunoglobulin therapy within one month.
Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome.
Known or suspected to suffer from: respiratory system disease，acute infection or chronic disease active period，severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease,children's mother has HIV infection and other serious and infectious diseases.
In pregnancy or lactation or pregnant women.
Subjects aged 18 years and above whose systolic blood pressure≥160mmHg and diastolic blood pressure≥100mmHg.
Any contraindications that investigators consider related to vaccination.