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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Influenza
• Intervention / Treatment: Biological: Quadrivalent influenza vaccine

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

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Pizhou City Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadrivalent influenza vaccine; 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.	Biological: Quadrivalent influenza vaccine; Subjects receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Reactions (ARs)	Frequency and severity of ARs for 28 days after each vaccination	28 days after each vaccination
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.	day 28 after dose 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of participants with Adverse Events (AEs)	Frequency and severity of AEs for 28 days after each vaccination	28 days after each vaccination
Number of participants with Serious Adverse Events (SAE)	Frequency of SAEs for 6 months after the last vaccination	6 months after the last vaccination
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 < 1:10 and 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.
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.
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.
Comparision between Geometric Mean Fold Increase (GMFI) of HAI antibodies against each virus strain post dose 1 and dose 2	Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain	day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2.

Collaborators and Investigators

• Sponsor: Jiangsu Province Centers for Disease Control and Prevention
• Collaborators: Jiangsu Jindike Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Fangyue Meng, Master, Jiangsu Province Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2021
• Primary Completion (Actual): November 23, 2021
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Safety, Immunogenicity, Quadrivalent influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: JSVCT122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No