Clinical trial NCT04357522: Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers
Official title: A Single-center, Randomised, Blind, Similar Vaccine Control, Non-inferior Designed Phase III Clinical Trial to Evaluate Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pneumonia, Pneumococcal
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-04-22
Enrollment: 1950
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate Immunogenicity and safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months.


Eligibility criteria: Inclusion Criteria:

* Aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight ≥2.5 kg.
* The guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent.
* The guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required.
* There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day.
* Subaxillary body temperature \<=37.0 C.
* Determine health based on medical history, physical examination, and researcher's judgment.

Exclusion Criteria:

* Have been vaccinated a listed or experimental pneumococcal vaccine.
* History of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past.
* In the past, there was any history of vaccination or serious allergy to drugs. In the past, fever of over 39.5 C related to vaccination occurred in biological products for vaccination and prophylaxis.
* History of convulsion, epilepsy, encephalopathy and psychiatry or family history.
* Had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage.
* History of pathological jaundice confirmed by diagnosis.
* A history of thrombocytopenia or other coagulation disorders with definite diagnosis.
* Human serum gamma globulin injection after birth.
* There are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc.
* Congenital malformations, severe malnutrition, developmental disorders, genetic defects (e.g. broad bean disease).
* Severe chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, malignant tumor.
* Severe asthma.
* Systemic rash, dermatophytes, skin pus or blister.
* Participation in other drug clinical trials.
* Anything that the researcher considers likely to affect the evaluation of the study.

Primary outcomes:
measure: Immunogenicity study endpoint
timeFrame: 30 day after each vaccination
measure: Safety study endpoint
timeFrame: 30 day after each vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Daming
country: China
facility: Daming Center for Disease Control and Prevention
state: Hebei
city: Laishui
country: China
facility: Laishui Center for Disease Control and Prevention
state: Hebei
city: Zhengding
country: China
facility: Zhengding Center for Disease Control and Prevention
state: Hebei
Study officials:
affiliation: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
name: Du Lin, Master
role: STUDY_CHAIR
References: