Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above

ConditionInfluenza
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorShanghai Institute Of Biological Products

About this trial

To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL/dose) to individuals aged 60 and above.

Eligibility criteria

Qualifiers

Age over 60 years old, gender not limited, and able to provide legal identification;

Volunteers voluntarily participate in the study and sign an informed consent form;

Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in all planned follow-up visits.

Disqualifiers

On the day of enrollment, the axillary temperature was ≥ 37.3 ℃;

Those who have had influenza in the past 6 months or meet the definition of influenza like cases;

Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period;

Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to any vaccine/drug, or history of asthma;

Trial design

Treatments tested in this trial

  • Influenza virus split vaccine (0.7mL/vial)
  • Influenza virus split vaccine

Treatment groups

1,200 Participants
are divided into 2 treatment groups