Clinical Study on the Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine

February 4, 2025 updated by: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

A Single Center, Randomized, Open Label, Controlled Clinical Study to Evaluate the Mutual Influence of Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed)

This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1110

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
      • Shijiazhuang, Hebei, China, 050021
        • Hebei Provincial Center for Disease Control and Prevention

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Infants aged 3 months (90-119 days old), full-term (37-42 weeks pregnant), with a birth weight of ≥ 2.5kg;
  • The legal guardian provides informed consent and signs the informed consent form;
  • The legal guardian agrees to comply with the requirements of the clinical research protocol, is willing to accept a follow-up of 10 months, and has the ability to use thermometers, scales, and fill out diary cards; 4) Have not received pneumococcal vaccine or pertussis vaccine, and have no history of receiving other live vaccines in the past 14 days or non live vaccines in the past 7 days; 5) Underarm temperature ≤ 37.0 ℃.

Exclusion Criteria:

  • A history of invasive diseases caused by Streptococcus pneumoniae that has been confirmed through cultivation;
  • Known to be allergic to any component of the experimental vaccine, especially those allergic to diphtheria toxoid, or those who previously have a fever of 39.5 ℃ or above after receiving vaccine;
  • History or family history of seizures, epilepsy, encephalopathy, and mental illness;
  • Infants born with abnormal labor processes (difficult labor, instrumental delivery) or with a history of asphyxia or neurological organ damage;
  • A history of confirmed thrombocytopenia or other coagulation disorders may result in contraindications for subcutaneous injection;
  • Injecting human normal immunoglobulin after birth;
  • Known or suspected immunological dysfunction, receiving immunosuppressive therapy (radiation therapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), such as continuous treatment with systemic corticosteroids (prednisone or similar drugs) for ≥ 14 days, human immunodeficiency virus (HIV) infection, etc;
  • Having congenital malformations, severe malnutrition, developmental disorders, and genetic defects (such as favism);
  • Currently suffering from serious chronic diseases, infectious diseases, active infections, liver diseases, kidney diseases, cardiovascular diseases, and malignant tumors;
  • Severe asthma;
  • Systemic rash, skin ringworm, skin suppuration or blisters;
  • Currently or planning to participate in clinical trials of other drugs in the near future; Researchers believe that any situation that may 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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: P+DTP group
370 infants aged 3 months were enrolled in this group.
Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
Administer 0.5ml of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) separately at different locations upon enrollment. Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
Vaccination with 15-Valent Pneumococcal Conjugate Vaccine with a 7-day interval (+15 day window period) followed by vaccination with Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed). Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Experimental: P-DTP group
370 infants aged 3 months were enrolled in this group.
Biological: Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
Only administer the Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Active Comparator: DTP group
370 infants aged 3 months were enrolled in this group.
Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
Administer 0.5ml of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) separately at different locations upon enrollment. Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
Vaccination with 15-Valent Pneumococcal Conjugate Vaccine with a 7-day interval (+15 day window period) followed by vaccination with Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed). Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibody positive conversion rate
Time Frame: 30 days after full vaccination
The positive conversion rates of diphtheria antibody (anti-D), tetanus antibody (anti-T), pertussis toxin antibody (anti-PT), and pertussis filamentous hemagglutinin antibody (anti-FHA) in P+DTP, P-DTP, and DTP groups，respectively.
30 days after full vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AEs within 0-30 minutes after vaccination
Time Frame: 0-30 minutes after vaccination
The occurrence of all adverse events within 0-30 minutes after each dose of vaccination
0-30 minutes after vaccination
Solicited AEs within 0-7 days after vaccination
Time Frame: 0-7 days after vaccination
The occurrence of all solicited adverse events within 0-7 days after each dose of vaccination
0-7 days after vaccination
Unsolicited AEs within 0-30 days after vaccination
Time Frame: 0-30 days after vaccination
The occurrence of all unsolicited adverse events within 0-30 days after each dose of vaccination.
0-30 days after vaccination
SAE within 0-6 months after primary immunization
Time Frame: 0-6 months after primary immunization
The occurrence of all serious adverse events within 0-6 months after primary immunization.
0-6 months after primary immunization
Positive rate of IgG antibodies
Time Frame: 30 days after full vaccination
Positive rate of susceptible individuals with 15 serotype specific pneumococcal IgG antibodies (percentage of subjects with antibody concentration ≥ 0.35 μ g/ml)
30 days after full vaccination
GMC of IgG antibody
Time Frame: 30 days after full vaccination
GMC of IgG antibody against 15 serotype specific pneumococcal.
30 days after full 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: Lin Du, Doctor, 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 (Actual)

September 16, 2021

Primary Completion (Actual)

March 13, 2024

Study Completion (Actual)

March 13, 2024

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201904003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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