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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05144464
Recruitment Status : Enrolling by invitation
First Posted : December 3, 2021
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Jiangsu Jindike Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Quadrivalent influenza vaccine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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, and 4 weeks after dose 2.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 19, 2021
Actual Primary Completion Date : November 23, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

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




Primary Outcome Measures :
  1. the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI) antibodies against each virus strain after 2nd vaccination ≥40% [ Time Frame: day 28 after 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.

  2. Number of participants with Adverse Reactions (ARs) [ Time Frame: 28 days after each vaccination ]
    Frequency and severity of ARs for 28 days after each vaccination


Secondary Outcome Measures :
  1. the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70% [ Time Frame: day 28 after dose 2 ]
    A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.

  2. Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5 [ Time Frame: day 28 after dose 2 ]
    Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain

  3. Number of participants with Adverse Events (AEs) [ Time Frame: 28 days after each vaccination ]
    Frequency and severity of AEs for 28 days after each vaccination

  4. Number of participants with Serious Adverse Events (SAE) [ Time Frame: 6 months after the last vaccination ]
    Frequency of SAEs for 6 months after the last vaccination


Other Outcome Measures:
  1. Comparision between Seroconversion Rate (SCR) 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. ]
    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.

  2. 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. ]
  3. Comparision between seroprotection rates 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. ]
    A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.

  4. Comparision between Geometric Mean Fold Increase (GMFI) 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. ]
    Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI) against each virus strain



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05144464


Locations
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China, Jiangsu
Pizhou City Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Jiangsu Jindike Biotechnology Co., Ltd.
Investigators
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Principal Investigator: Fangyue Meng, Master Jiangsu Province Centers for Disease Control and Prevention
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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT05144464    
Other Study ID Numbers: JSVCT122
First Posted: December 3, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Safety, Immunogenicity, Quadrivalent influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases