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

Pneumonia, Pneumococcal Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04108845
• Other study ID #: 201807001
• Status: Recruiting
• Phase: Phase 1
• Start date: June 5, 2019
• Est. completion date: August 2020

Study information

• Verified date: September 2019
• Source: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Pneumococcal

Intervention

Biological:
• 15-Valent Pneumococcal Conjugate Vaccine
3/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.

Locations

Country	Name	City	State
China	Laishui Center for Disease Control and Prevention	Laishui	Hebei

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events in 30 minutes	Occurrence of adverse events in 30 minutes after each vaccination	30 minutes after each vaccination
Primary	Solicited adverse events during 7 days	Occurrence of solicited adverse events during a 7-day follow-up period after each vaccination	7 days after each vaccination
Primary	Unsolicited adverse events during 30 days	Occurrence of unsolicited adverse events during a 30-day follow-up period after each vaccination	30 days after each vaccination
Primary	SAE	Occurrence of serious adverse events (SAE) from enrolling to 6 months after all vaccinations	from enrolling to 6 months after all vaccinations
Primary	Blood routine of subjects over 18 years old at the fourth day	Blood routine test results of subjects over 18 years old at the fourth day after vaccination	4 days after vaccination
Primary	Blood biochemistry of subjects over 18 years old at the fourth day	Blood biochemistry test results of subjects over 18 years old at the fourth day after vaccination	4 days after vaccination
Primary	Urine routine of subjects over 18 years old at the fourth day	Urine routine test results of subjects over 18 years old at the fourth day after vaccination	4 days after vaccination
Secondary	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	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	30 days after immunization
Secondary	GMC of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects	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	30 days after immunization