Status:
COMPLETED
A Clinical Trial of an Quadrivalent Inactivated Influenza Vaccine in Healthy Children Aged 6 to 35 Months
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
Changchun Institute of Biological Products Co., Ltd.
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE1
Brief Summary
In this single-center, randomized, blinded, positive-controlled design, the investigators will assess the safety and immunogenicity of 2 doses of an inactivated quadrivalent influenza vaccine in child...
Eligibility Criteria
Inclusion
- Healthy infants and young children aged 6-35 months, provide vaccination certificate and birth medical certificate.
- The subject or legal guardian can provide with informed consent and sign the informed consent form.
- The subjects or legal guardians are able to and willing to use a thermometer, a scale and fill in a diary card/contact card as required, and be able to comply with the requirements of the clinical trial protocol to complete clinical research.
Exclusion
- st dose:
- Axillary temperature\>37.0℃
- Participants aged 24-35 months, with abnormal blood routine, blood biochemical and urine routine indexes and judged by the researchers as having clinical significance.
- Influenza within the past 3 months (confirmed clinically, serologically or microbiological).
- Have previously received any influenza vaccine (registered or experimental) or planned to receive any influenza vaccine during the study.
- Allergy to any component of the study vaccine, history of allergic reaction to eating eggs or using gentamicin sulfate.
- History of severe allergies to any vaccines or drugs.
- Preterm (delivered before 37 weeks of gestation), low birth weight (birth weight \<2500g) infants (only for volunteers aged 6 months to 12 months).
- Dystocia, suffocation rescue, nervous system damage history.
- Congenital malformations or developmental disorders affecting organ function, genetic defects, severe malnutrition, etc..
- Acute illness, severe chronic illness, or acute exacerbation of chronic illness on the day of vaccination.
- History of vaccination with the live attenuated vaccine within 14 days prior to vaccination and other vaccination within 7 days.
- Those receiving immune enhancement or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
- Have congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
- History of asthma, unstable in the past two years requiring urgent treatment, hospitalization, intubation, oral or intravenous corticosteroids.
- Receive blood or blood-related products within 3 months.
- Have a medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
- History of coagulation abnormalities (eg, coagulation factor deficiency, coagulation disorder)
- Plan to relocate before the end of the study or to be away from home for an extended period of time during scheduled study visits
- Participating in or planning to participate in other clinical trials in the near future
- Abnormal laboratory test indicators, except for minor abnormalities that have no clinical significance as judged by the doctor.
- The investigator judges any situation that is inappropriate to participate in this clinical trial
- nd dose:
- Severe allergic reaction after the first dose of the vaccine.
- Serious adverse reactions causally related to the first dose of the vaccine.
- After the first vaccination, newly discovered or newly occurred do not meet the first-dose inclusion criteria or meet the first-dose exclusion criteria will be determined by the investigator whether to continue participating in the study.
- Other reasons for exclusion in the opinion of the investigator.
Key Trial Info
Start Date :
October 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05212623
Start Date
October 26 2021
End Date
June 16 2022
Last Update
October 28 2022
Active Locations (1)
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1
Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009