Clinical trial NCT06817187: Clinical Study on the Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Streptococcus Pneumoniae Infections
Keywords: 15-valent pneumococcal conjugate vaccine
Diphtheria, Tetanus, Pertussis Vaccine
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 1110
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Antibody positive conversion rate
timeFrame: 30 days after full vaccination
Secondary outcomes:
measure: AEs within 0-30 minutes after vaccination
timeFrame: 0-30 minutes after vaccination
measure: Solicited AEs within 0-7 days after vaccination
timeFrame: 0-7 days after vaccination
measure: Unsolicited AEs within 0-30 days after vaccination
timeFrame: 0-30 days after vaccination
measure: SAE within 0-6 months after primary immunization
timeFrame: 0-6 months after primary immunization
measure: Positive rate of IgG antibodies
timeFrame: 30 days after full vaccination
measure: GMC of IgG antibody
timeFrame: 30 days after full vaccination
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Provincial Center for Disease Control and Prevention
state: Hebei
Study officials:
affiliation: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
name: Lin Du, Doctor
role: STUDY_CHAIR
References: