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

NCT04108845 | Unknown Phase 1

• 1 other identifier: 201807001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumonia, Pneumococcal

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• 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

  30 days after immunization

• GMC of vaccine serotype specific pneumococcal IgG antibody in 2-month-old and 3-month-old subjects

  30 days after immunization

Study Arms (1)

experimental group

EXPERIMENTAL

Received Vaccine: 15-valent pneumococcal Conjugate Vaccine, 0.5 ml/dose

Biological: 15-Valent Pneumococcal Conjugate Vaccine

Interventions

15-Valent Pneumococcal Conjugate Vaccine BIOLOGICAL

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

experimental group

Eligibility Criteria

• Age: 6 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ℃.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead
• Hebei Center for Disease Control and Prevention: collaborator
• Laishui Center for Disease Control and Prevention: collaborator
• National Institutes for Food and Drug Control, China: collaborator
• Simoon Record Pharma Information Consulting Co., Ltd.: collaborator

Study Sites (1)

Laishui Center for Disease Control and Prevention

Laishui, Hebei, 074199, China

RECRUITING

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Du Lin, Master

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 30, 2019
• Study Start: June 5, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)