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

Pneumonia, Pneumococcal Clinical Trial

Official title:

A Randomized, Blinded, Parallel Controlled, Phase Ⅲ Clinical Trial to Evaluate Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278248
• Other study ID #: 201719906
• Status: Completed
• Phase: Phase 3
• Start date: January 12, 2018
• Est. completion date: June 7, 2018

Study information

• Verified date: February 2020
• Source: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1940
• Est. completion date: June 7, 2018
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Pneumococcal

Intervention

Biological:
• 23-Valent Pneumococcal Polysaccharide Vaccine
1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.

Locations

Country	Name	City	State
China	Yizhou Center for Disease Control and Prevention	Yizhou	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity study endpoint	Percentage of participants with seroresponse to each vaccination	30 day after each vaccination
Primary	Safety study endpoint	Occurrence of adverse events during a 30 day follow-up period after each vaccination	30 day after each vaccination