Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers

April 20, 2020 updated by: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1950

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Daming, Hebei, China, 056900
        • Daming Center for Disease Control and Prevention
        • Contact:
      • Laishui, Hebei, China, 074199
        • Laishui Center for Disease Control and Prevention
        • Contact:
      • Zhengding, Hebei, China, 050800
        • Zhengding Center for Disease Control and Prevention
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Received Vaccine: 15-valent pneumococcal Conjugate Vaccine(experimental vaccine), 0.5 ml/dose
Biological: 15-Valent Pneumococcal Conjugate Vaccine
4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
Active Comparator: Positive control group
Received Vaccine: 13-valent pneumococcal Conjugate Vaccine(positive control vaccine), 0.5 ml/dose
Biological: 13-Valent Pneumococcal Conjugate Vaccine
4/1 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
Immunogenicity study endpoint
Time Frame: 30 day after each vaccination
Percentage of participants with seroresponse to each vaccination
30 day after each vaccination
Safety study endpoint
Time Frame: 30 day after each vaccination
Occurrence of adverse events during a 30 day follow-up period after each vaccination
30 day after each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Investigators

  • Study Chair: Du lin, master, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

March 1, 2026

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201904002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia, Pneumococcal

Clinical Trials on 15-Valent Pneumococcal Conjugate Vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe