Clinical Study on the Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Dip… (NCT06817187) | Clinical Trial Compass
CompletedPhase 3
Clinical Study on the Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine
China1,110 participantsStarted 2021-09-16
Plain-language 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
Who can participate
Age range3 Months – 3 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, c…