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Completed

NCT Number: NCT04363359

Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

To evaluate the immunogenicity and safety of 2 doses of quadrivalent influenza virus split vaccine in healthy population aged 6-35 month., so as to provide a data support for phase III clinical trials.

Completed

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Key information

Age range

6 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henan Provincial Center for Disease Control and Prevention

Shangqiu, Henan, 450016, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy infants aged 6-35 months.
  • Volunteer legal guardian or client informed consent, voluntarily participate in and sign informed consent.
  • The volunteer legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.

Exclusion criteria

  • The underarm body temperature on the day of enrollment was > 37.0℃.
  • Have been suffering from influenza within the previous 3 months (confirmed by either clinical, serological or microbiological methods).
  • Any previous influenza vaccination (registered or experimental) within 6 months or any planned influenza vaccination during the study period.
  • Allergic to any component of the vaccine, a history of allergic reactions to eggs or gentamicin sulfate.
  • A history of severe allergy to any vaccine or drug.
  • Preterm birth (delivered before 37 weeks of gestation), low birth weight baby (birth weight < 2300g for girls, <2500g for boys).
  • Dystocia, asphyxia rescue, nervous system damage history;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;
  • A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;
  • Patients who received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);
  • Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
  • History of asthma, past two years of instability requiring emergency treatment, hospitalization, intubation, oral or intravenous administration of corticosteroids;
  • Have received blood or blood-related products;
  • A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or a family history;
  • A history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
  • Planning to relocate before the end of the study or to leave for an extended -period during the scheduled study visit;
  • Participating in or planning to participate in other clinical trials in the near future;
  • The investigators determined that any conditions were inappropriate to participate in the clinical trial.

Treatment and study plan

0.5ml Quadrivalent influenza vaccine

Biological

The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains

0.25ml Quadrivalent influenza vaccine

Biological

The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains

0.25ml Trivalent influenza vaccine(B/V)

Biological

The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains

0.25ml Trivalent influenza vaccine(B/Y)

Biological

The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains

Primary outcomes

  1. seroconversion rate of HI antibodies

    Time frame: 56 days

    28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroconversion rate of HI antibodies against any subtype of influenza virus in each group.

  2. seroprotection rate of HI antibodies

    Time frame: 56 days

    28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroprotection rate of HI antibodies against any subtype of influenza virus in each group.

  3. GMT and GMI of HI antibodies

    Time frame: 56 days

    28 days after receiving two doses of vaccine in subjects aged 6-35 months, GMT and GMI of HI antibodies against any subtype of influenza virus in each group.

Secondary outcomes

  1. Reactogenicity Events

    Time frame: 30 days and 6 months

    • The proportion of all adverse reactions/events in each group through 30 days after the second dose.
    • The proportion of serious adverse events (SAE) within 6 months after inoculation in each group.

Sponsors and collaborators

Lead sponsor

Shanghai Institute Of Biological Products

Industry

Registry information

Official study title

Immunogenicity and Safety of Quadrivalent Influenza Vaccine In 6 to 35 Months Population: a Randomized, Double-blind, Parallel-group Ⅱ Phase of Clinical Trials

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2020
Registry last updated
Dec 26, 2023

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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