Influenza
Conditions
Brief summary
A random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months. A total of 2,772 subjects in the 6-35 month age group were randomly divided into experimental vaccine 1, experimental vaccine 2 and control vaccine groups at a ratio of 1:1:1, and received the corresponding vaccine respectively. 2 doses in the whole course, 28 days apart. Safety observation: All subjects received 30 minutes of immediate response observation after each dose of vaccine and 0-7 days of systematic active safety observation; After 7 days of vaccination, the incidence of adverse events was observed by combining regular weekly follow-up with subject's voluntary report. Safety observation was conducted for 0-28/30 days after each dose of vaccine. Serious adverse events (SAE) were collected within 6 months after the first dose was administered. Immunogenicity observation: Blood samples were collected before the first dose and 28 days after the full dose for influenza virus HI antibody detection. Observation of immune persistence: Blood samples of 3 and 6 months after immunity were collected for influenza virus HI antibody detection.
Interventions
BIOLOGICALQuadrivalent influenza virus subunit vaccine
This vaccine（0.5ml） is produced by Ab&b Biotechnology Co., Ltd.JS。Subjects will receive two doses of quadrivalent influenza virus subunit vaccine administered 28 days apart by intramuscular injection
BIOLOGICALQuadrivalent split influenza virus vaccine
This vaccine（0.25ml） is produced by HUALAN BIO。Subjects will receive two doses of quadrivalent split influenza virus vaccine administered 28 days apart by intramuscular injection
Sponsors
Henan Center for Disease Control and Prevention
Ab&B Bio-tech Co., Ltd.JS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* 6-35 months healthy infants; * The legal guardian voluntarily consented to the subject's participation in the study, and the legal guardian/trustee signed the Informed Consent Form and complied with the requirements of the protocol.
Exclusion criteria
1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events/reactions within 0-7 days after each dose of inoculation | Within 0-7 days after each dose | Occurrence of adverse events/reactions within 0-7 days after each dose of inoculation |
| Occurrence of serious adverse events within 6 months from the first dose to the full course of vaccination | Within 6 months from the first dose to the full course of vaccination | Occurrence of serious adverse events within 6 months from the first dose to the full course of vaccination |
| The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 28 days after full immunization | At 28 days after full immunization | The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 28 days after full immunization |
| Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation | Within 30 minutes after each dose | Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation |
| Occurrence of adverse events/reactions within 8-28/30 days after each dose of inoculation | Within 8-28/30 days after each dose | Occurrence of adverse events/reactions within 8-28/30 days after each dose of inoculation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The seroconversion rates ,the proportion of antibody titer≥1:40, and the GMT 6 months after full immunization | At 6 months after full immunization | The seroconversion rates ,the proportion of antibody titer≥1:40, and the GMT 6 months after full immunization |
| The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 3 months after full immunization | At 3 months after full immunization | The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 3 months after full immunization |
Countries
China
Outcome results
None listed