A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years

Influenza Clinical Trial

Official title:

A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of anInactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313893
• Other study ID #: SJLGYM-2021-?-01
• Status: Completed
• Phase: Phase 4
• Start date: September 11, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: March 2022
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent history of influenza vaccination.

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 dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each timepoint

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: May 30, 2022
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Quadrivalent influenza vaccine
Subjects receive two doses of quadrivalent influenzavaccine administered 4 weeks apart by intramuscularinjection. Each 0.5-ml dosecontained 15 µg of hemagglutinin per strain.

Locations

Country	Name	City	State
China	Donghai County Center for Disease Control and Prevention	Lianyungang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparision between Seroconversion Rate (SCR) of HAI antibodies against each virus strain post dose 1 and dose 2	The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10and a post-vaccination titer =1:40 or a pre-vaccination titer =1:10 and = four-fold increase in post-vaccination titer.	day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2
Other	Comparision between Geometric Mean Titre (GMT) of HAI antibodies against each virus strain post dose 1 and dose 2		day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2
Other	Comparision between seroprotection rates of HAI antibodies against each virus strain post dose 1 and dose 2	A seroprotected subject is defined as a vaccinated subject with serum HAI titer= 1:40.	day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2
Other	Comparision between Geometric Mean Fold Increase (GMFI) of HAI antibodies against each virus strain post dose 1and dose 2		day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2
Primary	the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI)antibodies against each virus strain after 2nd vaccination =40%	The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10and a post-vaccination titer =1:40 or a pre-vaccination titer =1:10 and = four-fold increase in post-vaccination titer.	day 28 after dose 2
Primary	Number of participants with Adverse Reactions (ARs)	Frequency and severity of ARs for 28 days after each vaccination	28 days after each vaccination
Secondary	the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination=70%	A seroprotected subject is defined as a vaccinated subject with serum HAI titer= 1:40.	day 28 after dose 2
Secondary	Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5	Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI)against each virus strain	day 28 after dose 2
Secondary	Number of participants with Adverse Events (AEs)	Frequency and severity of AEs for 28 days after each vaccination	28 days after each vaccination
Secondary	Number of participants with Serious Adverse Events (SAE)	Frequency of SAEs for 6 months after the last vaccination	6 months after the last vaccination