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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1940 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-12

Study Completion Date

2018-06-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumonia, Pneumococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

23-Valent Pneumococcal Polysaccharide Vaccine

Intervention Type BIOLOGICAL

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

Positive control group

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

Group Type ACTIVE_COMPARATOR

23-Valent Pneumococcal Polysaccharide Vaccine

Intervention Type BIOLOGICAL

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

Interventions

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23-Valent Pneumococcal Polysaccharide Vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes