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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Pneumococcal
• Intervention / Treatment: Biological: 23-Valent Pneumococcal Polysaccharide Vaccine

• Study Type: Interventional
• Enrollment (Actual): 1940
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Yizhou, Guangxi, China, 530028
      • Yizhou Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine(experimental vaccine), 0.5 ml/dose	Biological: 23-Valent Pneumococcal Polysaccharide Vaccine; 1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.
Active Comparator: Positive control group; Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine (positive control vaccine), 0.5 ml/dose	Biological: 23-Valent Pneumococcal Polysaccharide Vaccine; 1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Investigators: Study Chair: Du lin, master, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): June 7, 2018
• Study Completion (Actual): June 7, 2018

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 201719906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No