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NCT Number: NCT05313893

A Clinical Trial 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 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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Donghai County Center for Disease Control and Prevention

Lianyungang, Jiangsu, 222300, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 < 1:10and 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 outcomes

  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 outcomes

  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 < 1:10and 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 1and dose 2

    Time frame: day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Registry information

Official study title

A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of anInactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8Years

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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