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

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.

Study Overview

• Status: Completed
• 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 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

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Lianyungang, Jiangsu, China, 222300
      • Donghai County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 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 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

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 quadrivalentinfluenza vaccine, 4 weeks apart. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain.	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.

What is the study measuring?

Primary Outcome Measures

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

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
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
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

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 < 1:10and 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
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 1and dose 2		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

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2021
• Primary Completion (Actual): December 25, 2021
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 13, 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: SJLGYM-2021-Ⅳ-01

Drug and device information, study documents

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