This phase I-like, open-label, monocenter, descriptive, single-arm clinical safety study will investigate the Shenzhen quadrivalent influenza vaccine (Shz QIV) in 100 participants aged 6 months and older in China. Participants aged 9 years or more will receive a single dose of Shz QIV, and participants aged 6 months to 8 years will receive two doses of Shz QIV administered 28 days apart.
Healthy participants will either receive a single dose (participants 9 years or older) or two doses (participants 6 months to 8 years) of the Shz QIV. Safety in terms of serious adverse events, solicited injection site and systemic reactions, and unsolicited adverse events will be collected before and 28 days after each and any dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
101
Administered intramuscularly in the anterolateral aspect of the thigh in infants (aged 6 to 12 months) or into the deltoid muscle (participants aged more than 12 months), 28 days apart.
Administered intramuscularly into the deltoid muscle, 28 days apart
Administered intramuscularly into the deltoid muscle.
Investigational Site 002
Xishuangbanna Dai Autonomous Prefecture, Yunnan, China
Occurrence of serious adverse reactions or Grade 3 non-serious adverse reactions following vaccination with Shz QIV
Number of participants reporting serious adverse reactions and Grade 3 adverse reactions following a vaccination with Shz QIV
Time frame: Within 28 days after vaccination
Occurrence of unsolicited systemic AEs reported in the 30 minutes following vaccination/each and any vaccination
Time frame: Within 30 minutes after vaccination
Occurrence of solicited (prelisted in the subject diary and the electronic Case Report Form [CRF]) injection site reactions and systemic reactions occurring between D0 and D7 after vaccination/each and any vaccination
Time frame: Up to 7 days after vaccination
Occurrence of unsolicited (spontaneously reported) AEs from D0 to D28 after vaccination/each and any vaccination
Time frame: Up to 7 days after vaccination
Occurrence of SAEs
Time frame: Up to 56 days after the 1st vaccination
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