Back to resultsA Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
Primary Purpose
Influenza
Status
Enrolling by invitation
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Quadrivalent influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Safety, Immunogenicity, Quadrivalent influenza vaccine
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
Sites / Locations
- Pizhou City Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quadrivalent influenza vaccine
Arm Description
Subjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain.
Outcomes
Primary Outcome Measures
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 < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Number of participants with Adverse Reactions (ARs)
Frequency and severity of ARs for 28 days after each vaccination
Secondary Outcome Measures
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.
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
Number of participants with Adverse Events (AEs)
Frequency and severity of AEs for 28 days after each vaccination
Number of participants with Serious Adverse Events (SAE)
Frequency of SAEs for 6 months after the last vaccination
Full Information
NCT ID
NCT05144464
First Posted
November 23, 2021
Last Updated
March 29, 2022
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Jiangsu Jindike Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05144464
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 19, 2021 (Actual)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Jiangsu Jindike Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Safety, Immunogenicity, Quadrivalent influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quadrivalent influenza vaccine
Arm Type
Experimental
Arm Description
Subjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain.
Intervention Type
Biological
Intervention Name(s)
Quadrivalent influenza vaccine
Intervention Description
Subjects receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection
Primary Outcome Measure Information:
Title
the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI) antibodies against each virus strain after 2nd vaccination ≥40%
Description
The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Time Frame
day 28 after dose 2
Title
Number of participants with Adverse Reactions (ARs)
Description
Frequency and severity of ARs for 28 days after each vaccination
Time Frame
28 days after each vaccination
Secondary Outcome Measure Information:
Title
the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%
Description
A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
Time Frame
day 28 after dose 2
Title
Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5
Description
Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain
Time Frame
day 28 after dose 2
Title
Number of participants with Adverse Events (AEs)
Description
Frequency and severity of AEs for 28 days after each vaccination
Time Frame
28 days after each vaccination
Title
Number of participants with Serious Adverse Events (SAE)
Description
Frequency of SAEs for 6 months after the last vaccination
Time Frame
6 months after the last vaccination
Other Pre-specified Outcome Measures:
Title
Comparision between Seroconversion Rate (SCR) of HAI antibodies against each virus strain post dose 1 and dose 2
Description
The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Time Frame
day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2.
Title
Comparision between Geometric Mean Titre (GMT) of HAI antibodies against each virus strain post dose 1 and dose 2
Time Frame
day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2.
Title
Comparision between seroprotection rates of HAI antibodies against each virus strain post dose 1 and dose 2
Description
A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
Time Frame
day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2.
Title
Comparision between Geometric Mean Fold Increase (GMFI) of HAI antibodies against each virus strain post dose 1 and dose 2
Description
Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain
Time Frame
day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fangyue Meng, Master
Organizational Affiliation
Jiangsu Province Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pizhou City Center for Disease Control and Prevention
City
Xuzhou
State/Province
Jiangsu
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
We'll reach out to this number within 24 hrs