Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months

Beijing Zhifei Lvzhu Biopharmaceutical

Status and phase

Unknown

Phase 1

Conditions

Pneumonia, Pneumococcal

Treatments

Biological: 15-Valent Pneumococcal Conjugate Vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04108845

201807001

Details and patient eligibility

About

The purpose of this study is to evaluate safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.

Enrollment

80 estimated patients

Sex

All

Ages

6+ weeks old

Volunteers

Accepts Healthy Volunteers

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.