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

Beijing Zhifei Lvzhu Biopharmaceutical

Status and phase: Completed; Phase 3

Conditions: Streptococcus Pneumoniae Infections

Treatments: Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed); Biological: Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06817187

201904003

Details and patient eligibility

About

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

Enrollment: 1,110 patients

Sex: All

Ages: 3 to 3 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,110 participants in 3 patient groups

P+DTP group

Experimental group

Description:

370 infants aged 3 months were enrolled in this group.

Treatment:

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

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

P-DTP group

Experimental group

Description:

370 infants aged 3 months were enrolled in this group.

Treatment:

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

DTP group

Active Comparator group

Description:

370 infants aged 3 months were enrolled in this group.

Treatment:

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

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