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

NCT05144464 | Unknown Phase 4

• 1 other identifier: JSVCT122
• Study Type: interventional
• Target: 240
• 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 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.

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 \< 1:10 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

• 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 quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain.

Biological: Quadrivalent influenza vaccine

Interventions

Quadrivalent influenza vaccine BIOLOGICAL

Subjects receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Jiangsu Jindike Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Pizhou City Center for Disease Control and Prevention

Xuzhou, Jiangsu, China

Location

Related Publications (1)

• Wen F, Liu S, Zhou L, Zhu Y, Wang W, Wei M, Xu X, Liu Y, Shuai Q, Yu J, Jing P, Li J, Zhu F. Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3-8 years with or without previous influenza vaccination histories. Hum Vaccin Immunother. 2025 Dec;21(1):2468074. doi: 10.1080/21645515.2025.2468074. Epub 2025 Feb 24.

  PMID: 39993940 DERIVED

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 Officials

• Fangyue Meng, Master

  Jiangsu Province Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

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, and 4 weeks after dose 2.

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 3, 2021
• Study Start: September 19, 2021
• Primary Completion: November 23, 2021
• Study Completion: April 30, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)