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

NCT06817187 | Completed Phase 3

• 1 other identifier: 201904003
• Study Type: interventional
• Target: 1,110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Streptococcus Pneumoniae Infections

Keywords

15-valent pneumococcal conjugate vaccine; Diphtheria, Tetanus, Pertussis Vaccine

Outcome Measures

Primary Outcomes (1)

• Antibody positive conversion rate

  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 Outcomes (6)

• AEs within 0-30 minutes after vaccination

  0-30 minutes after vaccination

• Solicited AEs within 0-7 days after vaccination

  0-7 days after vaccination

• Unsolicited AEs within 0-30 days after vaccination

  0-30 days after vaccination

• SAE within 0-6 months after primary immunization

  0-6 months after primary immunization

• Positive rate of IgG antibodies

  30 days after full vaccination

Study Arms (3)

P+DTP group

EXPERIMENTAL

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)

P-DTP group

EXPERIMENTAL

370 infants aged 3 months were enrolled in this group.

Biological: Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)

DTP group

ACTIVE COMPARATOR

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)

Interventions

15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) BIOLOGICAL

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).

DTP group

Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) BIOLOGICAL

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).

P-DTP group

Eligibility Criteria

• Age: 3 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 ℃.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, 050021, China

Location

MeSH Terms

Conditions

Pneumococcal Infections; Diphtheria; Tetanus

Interventions

Tetanus Toxoid; Elements; Vaccines, Combined

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Clostridium Infections

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Inorganic Chemicals

Study Officials

• Lin Du, Doctor

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 10, 2025
• Study Start: September 16, 2021
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-01

Locations

CN (1)