Status:
COMPLETED
A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
Influenza
Eligibility:
All Genders
3-8 years
Phase:
PHASE4
Brief Summary
Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses ...
Detailed Description
Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.Blood samples were obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of dose 1 and before ...
Eligibility Criteria
Inclusion
- Aged 3-8 years old
- Healthy subjects judged from medical history and clinical examination
- Subjects themselves or their guardians able to understand and sign theinformed consent
- Subjects themselves or their guardians can and will comply with therequirements of the protocol
- Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment
- Subjects with temperature \<=37.0°C on axillary setting
Exclusion
- Any prior administration of other research medicine/vaccine in last 30 days
- Any prior administration of influenza vaccine in last 6 month
- Any prior administration of immunodepressant or corticosteroids in last 3 months
- Any prior administration of blood products in last 3 months
- Any prior administration of any attenuated live vaccine in last 14 days
- Any prior administration of subunit or inactivated vaccines in last 7 days
- Subject who developed guillain-Barre syndrome post influenza vaccination
- Subject who is allergic to any ingredient of the vaccine
- Subject with acute febrile illness or infectious disease
- Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection
- Subject with damaged or low immune function which has already beenknown
- Subject with congenital heart disease or other birth defects unsuitable for vaccination.
- Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections.
- Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol
Key Trial Info
Start Date :
September 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT05313893
Start Date
September 11 2021
End Date
May 30 2022
Last Update
August 17 2022
Active Locations (1)
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1
Donghai County Center for Disease Control and Prevention
Lianyungang, Jiangsu, China, 222300