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

Phase 3

Completed

• Conditions: Streptococcus Pneumoniae Infections
• Interventions: 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)

• Registration Number: NCT06817187
• Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-16
• Primary Completion: 2024-03-13
• Study Completion: 2024-03-13
• Status Verified: 2025-01
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
P+DTP group	15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)	370 infants aged 3 months were enrolled in this group.
P-DTP group	Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)	370 infants aged 3 months were enrolled in this group.
DTP group	15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)	370 infants aged 3 months were enrolled in this group.

Primary Outcome Measures

Name	Time	Method
Antibody positive conversion rate	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.

Secondary Outcome Measures

Name	Time	Method
Solicited AEs within 0-7 days after vaccination	0-7 days after vaccination	The occurrence of all solicited adverse events within 0-7 days after each dose of vaccination
AEs within 0-30 minutes after vaccination	0-30 minutes after vaccination	The occurrence of all adverse events within 0-30 minutes after each dose of vaccination
Unsolicited AEs within 0-30 days after vaccination	0-30 days after vaccination	The occurrence of all unsolicited adverse events within 0-30 days after each dose of vaccination.
SAE within 0-6 months after primary immunization	0-6 months after primary immunization	The occurrence of all serious adverse events within 0-6 months after primary immunization.
Positive rate of IgG antibodies	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)
GMC of IgG antibody	30 days after full vaccination	GMC of IgG antibody against 15 serotype specific pneumococcal.

Trial Locations

Locations (1)

Hebei Provincial Center for Disease Control and Prevention; 🇨🇳 Shijiazhuang, Hebei, China