Pneumonia, Pneumococcal
Conditions
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.
Interventions
1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.
Sponsors
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity study endpoint | 30 day after each vaccination | Percentage of participants with seroresponse to each vaccination |
| Safety study endpoint | 30 day after each vaccination | Occurrence of adverse events during a 30 day follow-up period after each vaccination |
Countries
China
Outcome results
None listed