Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

Influenza Clinical Trial

Official title:

Immunogenicity and Safety of Quadrivalent Influenza Vaccine In 6 to 35 Months Population: a Randomized, Double-blind, Parallel-group Ⅱ Phase of Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363359
• Other study ID #: CXSL1900048-?+?
• Status: Completed
• Phase: Phase 2
• Start date: January 15, 2020
• Est. completion date: September 14, 2021

Study information

• Verified date: December 2023
• Source: Shanghai Institute Of Biological Products
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1980
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
China	Henan Provincial Center for Disease Control and Prevention	Shangqiu	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute Of Biological Products

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seroconversion rate of HI antibodies	28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroconversion rate of HI antibodies against any subtype of influenza virus in each group.	56 days
Primary	seroprotection rate of HI antibodies	28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroprotection rate of HI antibodies against any subtype of influenza virus in each group.	56 days
Primary	GMT and GMI of HI antibodies	28 days after receiving two doses of vaccine in subjects aged 6-35 months, GMT and GMI of HI antibodies against any subtype of influenza virus in each group.	56 days
Secondary	Reactogenicity Events	The proportion of all adverse reactions/events in each group through 30 days after the second dose.; The proportion of serious adverse events (SAE) within 6 months after inoculation in each group.	30 days and 6 months