A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
ConditionInfluenza
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60+
SponsorShanghai Institute Of Biological Products
About this trial
This is a randomized, blinded, controlled phase I clinical trial with a total of 120 participants aged ≥ 60 years. Experimental group: Influenza virus split vaccine (0.7mL/vial), control group 1: Influenza virus split vaccine, control group 2: placebo group. The three groups were recruited at a ratio of 1:1:1, and 40 individuals were randomly vaccinated in each group. Each person was injected with one dose of the vaccine into the deltoid muscle of the upper arm. Participants in each study group are required to undergo laboratory indicator tests before and on the 4th day after vaccination.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Influenza virus split vaccine (0.7mL/vial)
Biological/VaccineInfluenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each
Influenza virus split vaccine
Biological/VaccineInfluenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each
Phosphate buffer solution (PBS)
Biological/VaccinePBS, with a specification of 0.5mL/bottle.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control group 1Active comparator 1 intervention
Group C: Control group 2Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Unsolicited Adverse Events
Other adverse events that occurred among participants within 0-30 days after vaccination, in addition to the solicited adverse events.
Time frame
30 days after vaccination2
Solicited Adverse Events (AEs)
Adverse events defined by the protocol that occurred to the participant during 0-7 days after vaccination.
Time frame
7 days after vaccination3
Serious Adverse Events (SAE)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Time frame
6 months after vaccinationSecondary outcomes
1
Seroconversion rate
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame
30 days after vaccination2
Ratio of ≥1:40
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame
30 days after vaccination3
Geometric mean titer (GMT)
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMT of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame
30 days after vaccination4
Geometric mean increase (GMI)
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame
30 days after vaccinationSponsors and contacts
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Source ClinicalTrials.gov