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

NCT04278248 | Completed Phase 3

• 1 other identifier: 201719906
• Study Type: interventional
• Target: 1,940
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Pneumococcal

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine(experimental vaccine), 0.5 ml/dose

Biological: 23-Valent Pneumococcal Polysaccharide Vaccine

Positive control group

ACTIVE COMPARATOR

Received Vaccine: 23-valent Pneumococcal Polysaccharide Vaccine (positive control vaccine), 0.5 ml/dose

Biological: 23-Valent Pneumococcal Polysaccharide Vaccine

Interventions

23-Valent Pneumococcal Polysaccharide Vaccine BIOLOGICAL

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

Positive control group; experimental group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ℃.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Yizhou Center for Disease Control and Prevention

Yizhou, Guangxi, 530028, China

Location

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Du Lin, Master

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: January 12, 2018
• Primary Completion: June 7, 2018
• Study Completion: June 7, 2018
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)