Pneumonia, Pneumococcal
Conditions
Brief summary
The purpose of this study is to evaluate safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.
Interventions
BIOLOGICAL15-Valent Pneumococcal Conjugate Vaccine
3/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
Sponsors
Hebei Center for Disease Control and Prevention
Laishui Center for Disease Control and Prevention
National Institutes for Food and Drug Control, China
Simoon Record Pharma Information Consulting Co., Ltd.
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 2 months old (at a minimum of 6 weeks old) and above healthy people. * Subject or legal representative who consent and has signed written informed consent. * Subject and parent/guardian who is able to comply with all study procedures and to use thermometer, scale and fill in diary card and contact card as required. * Subject who didn't vaccinate 13-valent or 7-valent pneumococcal conjugate vaccine. * Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination. * Axillary temperature ≤37.0 ℃.
Exclusion criteria
* Subject with a history of a prior bacterial culture of an aggressive disease caused by S. pneumoniae. * Subject with any previous history of severe vaccination or drug allergy, occurrence of fever ≥ 39.0° related to vaccination of biological products for previous vaccination. * Subject who are allergic to diphtheria toxins. * Children below 1 year old with abnormal labor（dystocia, instrument midwifery), birth weight \<2500g, asphyxia rescue history, nerve organ damage history, and pathological history of yellow plague determined by diagnosis. * History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease. * Subject who diagnosis of thrombocytopenia or other history of coagulopathy. * 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: severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease, serious respiratory system disease, acute infection or chronic disease active period. * Known or suspected to suffer from immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxicity drugs), HIV infection, etc. * Received blood products or immunoglobulin within 3 months before enrolling (hepatitis B immunoglobulin was acceptable), or planned to use it during the clinical trial period (before blood samples were collected after immunization). * Subject who plan to participate in or is in any other clinical trial (vaccines, drugs, medical devices, etc.). * In pregnancy or lactation or pregnant women. * ≥18-year-old subject with blood routine, blood chemistry or urinalysis laboratory collection abnormalities. * Any condition that, in the judgment of investigator, may affect trial assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine routine of subjects over 18 years old at the fourth day | 4 days after vaccination | Urine routine test results of subjects over 18 years old at the fourth day after vaccination |
| Blood routine of subjects over 18 years old at the fourth day | 4 days after vaccination | Blood routine test results of subjects over 18 years old at the fourth day after vaccination |
| Blood biochemistry of subjects over 18 years old at the fourth day | 4 days after vaccination | Blood biochemistry test results of subjects over 18 years old at the fourth day after vaccination |
| Adverse events in 30 minutes | 30 minutes after each vaccination | Occurrence of adverse events in 30 minutes after each vaccination |
| Solicited adverse events during 7 days | 7 days after each vaccination | Occurrence of solicited adverse events during a 7-day follow-up period after each vaccination |
| Unsolicited adverse events during 30 days | 30 days after each vaccination | Occurrence of unsolicited adverse events during a 30-day follow-up period after each vaccination |
| SAE | from enrolling to 6 months after all vaccinations | Occurrence of serious adverse events (SAE) from enrolling to 6 months after all vaccinations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMC of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects | 30 days after immunization | Geometric mean concentration (GMC) of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects on 30 days after immunization with 15-valent pneumococcal polysaccharide conjugate vaccine |
| Subjects ratio of vaccine serotype specific pneumococcal IgG antibody concentration ≥ 0.35 ug/ml or 1.0 ug/ml in 2-month-old and 3-month-old subjects | 30 days after immunization | Subjects ratio of vaccine serotype specific pneumococcal IgG antibody concentration ≥ 0.35 ug/ml or 1.0 ug/ml in 2-month-old and 3-month-old subjects on 30 days after immunization with 15-valent pneumococcal polysaccharide conjugate vaccine |
Countries
China
Outcome results
None listed