Clinical trial
Immunogenicity and Safety of Quadrivalent Influenza Vaccine In 6 to 35 Months Population: a Randomized, Double-blind, Parallel-group Ⅱ Phase of Clinical Trials
Name
CXSL1900048-Ⅰ+Ⅱ
Description
To evaluate the immunogenicity and safety of 2 doses of quadrivalent influenza virus split vaccine in healthy population aged 6-35 month., so as to provide a data support for phase III clinical trials.
Trial arms
Trial start
2020-01-15
Estimated PCD
2021-09-14
Trial end
2021-09-14
Status
Completed
Phase
Early phase I
Treatment
0.5ml Quadrivalent influenza vaccine
The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
Arms:
Quadrivalent influenza vaccine HD
0.25ml Quadrivalent influenza vaccine
The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
Arms:
Quadrivalent influenza vaccine LD
0.25ml Trivalent influenza vaccine(B/V)
The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains
Arms:
Trivalent influenza vaccine Victoria
0.25ml Trivalent influenza vaccine(B/Y)
The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains
Arms:
Trivalent influenza vaccine Yamagata
Size
1980
Primary endpoint
seroconversion rate of HI antibodies
56 days
seroprotection rate of HI antibodies
56 days
GMT and GMI of HI antibodies
56 days
Eligibility criteria
Inclusion Criteria:
* Healthy infants aged 6-35 months.
* Volunteer legal guardian or client informed consent, voluntarily participate in and sign informed consent.
* The volunteer legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.
Exclusion Criteria:
* The underarm body temperature on the day of enrollment was \> 37.0℃.
* Have been suffering from influenza within the previous 3 months (confirmed by either clinical, serological or microbiological methods).
* Any previous influenza vaccination (registered or experimental) within 6 months or any planned influenza vaccination during the study period.
* Allergic to any component of the vaccine, a history of allergic reactions to eggs or gentamicin sulfate.
* A history of severe allergy to any vaccine or drug.
* Preterm birth (delivered before 37 weeks of gestation), low birth weight baby (birth weight \< 2300g for girls, \<2500g for boys).
* Dystocia, asphyxia rescue, nervous system damage history;
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
* Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;
* A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;
* Patients who received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);
* Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
* History of asthma, past two years of instability requiring emergency treatment, hospitalization, intubation, oral or intravenous administration of corticosteroids;
* Have received blood or blood-related products;
* A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or a family history;
* A history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
* Planning to relocate before the end of the study or to leave for an extended -period during the scheduled study visit;
* Participating in or planning to participate in other clinical trials in the near future;
* The investigators determined that any conditions were inappropriate to participate in the clinical trial.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1980, 'type': 'ACTUAL'}}
Updated at
2023-12-26
1 organization
3 products
1 indication
Organization
Shanghai Institute of Biological ProductsIndication
InfluenzaProduct
Trivalent influenza vaccine