Clinical trial NCT04108845: Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months
Official title: A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pneumonia, Pneumococcal
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Hebei Center for Disease Control and Prevention
name: Laishui Center for Disease Control and Prevention
name: National Institutes for Food and Drug Control, China
name: Simoon Record Pharma Information Consulting Co., Ltd.
First posted: 2019-09-30
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events in 30 minutes
timeFrame: 30 minutes after each vaccination
measure: Solicited adverse events during 7 days
timeFrame: 7 days after each vaccination
measure: Unsolicited adverse events during 30 days
timeFrame: 30 days after each vaccination
measure: SAE
timeFrame: from enrolling to 6 months after all vaccinations
measure: Blood routine of subjects over 18 years old at the fourth day
timeFrame: 4 days after vaccination
measure: Blood biochemistry of subjects over 18 years old at the fourth day
timeFrame: 4 days after vaccination
measure: Urine routine of subjects over 18 years old at the fourth day
timeFrame: 4 days after vaccination
Secondary outcomes:
measure: 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
timeFrame: 30 days after immunization
measure: GMC of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects
timeFrame: 30 days after immunization
Other outcomes:
Locations:
city: Laishui
country: China
facility: Laishui 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: