Back to results

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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Quadrivalent influenza vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Safety, Immunogenicity, Quadrivalent influenza vaccine

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Donghai County 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 quadrivalentinfluenza vaccine, 4 weeks apart. Each 0.5-ml dosecontained 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 < 1:10and 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

NCT05313893

First Posted

March 29, 2022

Last Updated

August 13, 2022

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT05313893

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 anInactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8Years

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

September 11, 2021 (Actual)

Primary Completion Date

December 25, 2021 (Actual)

Study Completion Date

May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Province Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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 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.

Detailed 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

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, and4 weeks after dose 2.

Masking

None (Open Label)

Allocation

N/A

Enrollment

252 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Quadrivalent influenza vaccine

Arm Type

Experimental

Arm Description

Subjects received 2 doses of 0.5 mL of quadrivalentinfluenza vaccine, 4 weeks apart. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain.

Intervention Type

Biological

Intervention Name(s)

Quadrivalent influenza vaccine

Intervention Description

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

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

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

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 1and dose 2

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

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 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

Facility Information:

Facility Name

Donghai County Center for Disease Control and Prevention

City

Lianyungang

State/Province

Jiangsu

ZIP/Postal Code

222300

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