Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers

Launched by BEIJING ZHIFEI LVZHU BIOPHARMACEUTICAL CO., LTD · Apr 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called the 15-Valent Pneumococcal Conjugate Vaccine, which aims to protect against pneumonia and other serious infections caused by a type of bacteria known as Streptococcus pneumoniae. The researchers are looking for healthy babies who are 2 to 3 months old to see how well the vaccine works and to ensure it is safe for use.

To participate, babies must be at least 6 weeks old, have a healthy birth weight, and their guardians must understand the study and agree to participate. Guardians will need to keep track of their child's health and follow up for up to three years after the vaccination. However, there are certain conditions that would exclude a child from participating, such as having received other pneumococcal vaccines or having significant health issues. This study is important because it could help improve vaccination strategies and better protect young children from pneumonia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight ≥2.5 kg.
• • The guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent.
• • The guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required.
• • There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day.
• • Subaxillary body temperature \<=37.0 C.
• • Determine health based on medical history, physical examination, and researcher's judgment.
• Exclusion Criteria:
• • Have been vaccinated a listed or experimental pneumococcal vaccine.
• • History of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past.
• • In the past, there was any history of vaccination or serious allergy to drugs. In the past, fever of over 39.5 C related to vaccination occurred in biological products for vaccination and prophylaxis.
• • History of convulsion, epilepsy, encephalopathy and psychiatry or family history.
• • Had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage.
• • History of pathological jaundice confirmed by diagnosis.
• • A history of thrombocytopenia or other coagulation disorders with definite diagnosis.
• • Human serum gamma globulin injection after birth.
• • There are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc.
• • Congenital malformations, severe malnutrition, developmental disorders, genetic defects (e.g. broad bean disease).
• • Severe chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, malignant tumor.
• • Severe asthma.
• • Systemic rash, dermatophytes, skin pus or blister.
• • Participation in other drug clinical trials.
• • Anything that the researcher considers likely to affect the evaluation of the study.