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

A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months

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

Study Overview

• Status: Unknown
• Conditions: Pneumonia, Pneumococcal
• Intervention / Treatment: Biological: 15-Valent Pneumococcal Conjugate Vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Laishui, Hebei, China, 074199
      • Recruiting
      • Laishui Center for Disease Control and Prevention
      • Contact: Zhang Po; Phone Number: 86 18903365570; Email: m18903365570@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Received Vaccine: 15-valent pneumococcal Conjugate Vaccine, 0.5 ml/dose	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events in 30 minutes	Occurrence of adverse events in 30 minutes after each vaccination	30 minutes after each vaccination
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
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
SAE	Occurrence of serious adverse events (SAE) from enrolling to 6 months after all vaccinations	from enrolling to 6 months after all vaccinations
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Collaborators: National Institutes for Food and Drug Control, China; Simoon Record Pharma Information Consulting Co., Ltd.; Hebei Center for Disease Control and Prevention; Laishui Center for Disease Control and Prevention
• Investigators: Study Chair: Du lin, master, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 201807001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No