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

Phase 3

Completed

• Conditions: Pneumonia, Pneumococcal
• Interventions: Biological: 23-Valent Pneumococcal Polysaccharide Vaccine

• Registration Number: NCT04278248
• Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-12
• Primary Completion: 2018-06-07
• Study Completion: 2018-06-07
• Status Verified: 2020-02
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1940

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive control group	23-Valent Pneumococcal Polysaccharide Vaccine	Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine (positive control vaccine), 0.5 ml/dose
experimental group	23-Valent Pneumococcal Polysaccharide Vaccine	Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine(experimental vaccine), 0.5 ml/dose

Primary Outcome Measures

Name	Time	Method
Safety study endpoint	30 day after each vaccination	Occurrence of adverse events during a 30 day follow-up period after each vaccination
Immunogenicity study endpoint	30 day after each vaccination	Percentage of participants with seroresponse to each vaccination

Trial Locations

Locations (1)

Yizhou Center for Disease Control and Prevention; 🇨🇳 Yizhou, Guangxi, China