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

NCT05313893 | Completed Phase 4

• 1 other identifier: SJLGYM-2021-Ⅳ-01
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Safety; Immunogenicity; Quadrivalent influenza vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70%

  day 28 after dose 2

• Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5

  day 28 after dose 2

• Number of participants with Adverse Events (AEs)

  28 days after each vaccination

• Number of participants with Serious Adverse Events (SAE)

  6 months after the last vaccination

Other Outcomes (4)

• Comparision between Seroconversion Rate (SCR) 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 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

  day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2

Study Arms (1)

Quadrivalent influenza vaccine

EXPERIMENTAL

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

Interventions

Quadrivalent influenza vaccine BIOLOGICAL

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

Quadrivalent influenza vaccine

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Donghai County Center for Disease Control and Prevention

Lianyungang, Jiangsu, 222300, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: September 11, 2021
• Primary Completion: December 25, 2021
• Study Completion: May 30, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-03

Locations

CN (1)