Evaluation of Immunogenicity and Safety of Combined Immunization of COVAX (Produced in Wuhan) and PPV23 / IIV4

This is an interventional prevention trial for Influenza, Human Read More

Inclusion Criteria:

• ≥18 years old when enrolled;
• Participants signing the informed consent;
• Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview;
• Having not been administered any pneumonia vaccine or COVID-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment;
• ≥14 days from the most recent vaccination;
• Before enrollment, the body temperature is ≤37.0C as confirmed by medical history and clinical examination.

Exclusion Criteria:

• Having a history of COVID-19 or a positive nucleic acid test for COVID-19;
• Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness;
• Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine;
• Having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or HIV, or having a family member with close contact who suffers from congenital immune disorder;
• Having injection of non-specific immunoglobulin within 1 month prior to enrollment;
• Having acute febrile illness or communicable disease;
• Having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection;
• Having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes;
• Having various infectious, pyogenic, or allergic skin diseases;
• Women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination;
• Having any condition that may affect trial assessment as determined by researchers.

Exclusion criteria for the second dose:

• Having any serious adverse event related to the first dose vaccination;
• After vaccination, having systemic adverse reaction or allergic reaction with a severity of grade 3 or higher as determined by researchers;
• Having a newly emerging condition that meets the exclusion criteria for the first dose;
• Having any condition that may affect trial assessment as determined by researchers.