Clinical trial NCT05144464: A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
Official title: A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Influenza
Keywords: Safety, Immunogenicity, Quadrivalent influenza vaccine
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Jiangsu Jindike Biotechnology Co., Ltd.
First posted: 2021-12-03
Enrollment: 240
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects received 2 doses of an inactivated quadrivalent influenza vaccine, 4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2.
Primary purpose: PREVENTION

Brief summary: Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For those aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. For those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine, they require 2 dose of influenza vaccine. but the evidence on how to select vaccine doses for quadrivalent influenza vaccine is limited in China. The study is a prospective, open-label comparison of the immunogenicity and reactogenicity of 1 versus 2 doses of an inactivated quadrivalent influenza vaccine in subjects of 3-8 years old with different history of influenza vaccination.

Detailed description: Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.

Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2, A/H1N1, and B antigens included in the vaccine were measured at each time point

Eligibility criteria: 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 the informed consent
* Subjects themselves or their guardians can and will comply with the requirements of the protocol
* Subjects have received ≥2 doses of trivalent or quadrivalent infuenza vaccine before enrollment (Doses need not have been received during same or consecutive seasons); Subjects have not received infuenza vaccine before enrollment
* Subjects with temperature \<=37.0°C on axillary setting

Exclusion Criteria:

* Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
* Subject who is allergic to any ingredient of the vaccine
* Subject with damaged or low immune function which has already been known
* Subject with acute febrile illness or infectious disease
* Major congenital defects or serious chronic illness, including perinatal brain damage
* Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
* Subject who has serious allergic history
* Subject who developed guillain-Barre syndrome post influenza vaccination
* Any prior administration of immunodepressant or corticosteroids in last 6 months
* Any prior administration of influenza vaccine in last 6 month
* Any prior administration of blood products in last 3 months
* Any prior administration of other research medicine/vaccine in last 30 days
* Any prior administration of any attenuated live vaccine in last 14 days
* Any prior administration of subunit or inactivated vaccines in last 7 days, such as pneumococcal vaccine
* Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent for subject's guardian

Primary outcomes:
measure: the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI) antibodies against each virus strain after 2nd vaccination ≥40%
timeFrame: day 28 after dose 2
measure: Number of participants with Adverse Reactions (ARs)
timeFrame: 28 days after each vaccination
Secondary outcomes:
measure: the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%
timeFrame: day 28 after dose 2
measure: Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5
timeFrame: day 28 after dose 2
measure: Number of participants with Adverse Events (AEs)
timeFrame: 28 days after each vaccination
measure: Number of participants with Serious Adverse Events (SAE)
timeFrame: 6 months after the last vaccination
Other outcomes:
measure: Comparision between Seroconversion Rate (SCR) of HAI antibodies against each virus strain post dose 1 and dose 2
timeFrame: day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2.
measure: Comparision between Geometric Mean Titre (GMT) of HAI antibodies against each virus strain post dose 1 and dose 2
timeFrame: day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2.
measure: Comparision between seroprotection rates of HAI antibodies against each virus strain post dose 1 and dose 2
timeFrame: day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2.
measure: Comparision between Geometric Mean Fold Increase (GMFI) of HAI antibodies against each virus strain post dose 1 and dose 2
timeFrame: day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2.
Locations:
city: Xuzhou
country: China
facility: Pizhou City Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Province Centers for Disease Control and Prevention
name: Fangyue Meng, Master
role: PRINCIPAL_INVESTIGATOR
References: