A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months (NCT06049927) | Clinical Trial Compass
CompletedPhase 3
A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
China3,300 participantsStarted 2023-09-16
Plain-language summary
A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the Immunogenicity and safety of the vaccine.
Who can participate
Age range6 Months – 35 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:
* Healthy infants aged 6-35 months;
* Proven vaccination certificate and birth certificate;
* The subjects' guardians can understand and voluntarily sign the informed consent form.
Exclusion Criteria:
* Received any circulating seasonal influenza vaccine prior to enrollment or had an influenza vaccine schedule during the study;
* Suffering from seasonal influenza in the past 6 moths;
* Axillary temperature \>37.0°C;
* History of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma;
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
* Severe chronic diseases(Such as down syndrome, diabetes, sickle cell anaemia or neurological disorders);
* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency / immunosuppression (such as HIV, after organ transplantation)
* Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition;
* Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
* Continuous use of corticosteroids or other immunosuppressive agents for ≥ 14 days within the past 6 months (excluding allergic rhinitis corticosteroid spray thera…
What they're measuring
1
Seroconversion rates of HI antibody
Timeframe: 28 days after full schedule immunization
2
Geometric Mean Titers (GMTs) of HI antibody
Timeframe: 28 days after full schedule immunization
3
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Timeframe: 28 days after full schedule immunization