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Completed

NCT Number: NCT03704740

Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months

This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled, and each subject is administered with single or two doses of vaccines depending on previous vaccination history.

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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

6 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SK Bioscience

Gyeonggi-do, Seongnam-si, 13494, South Korea

About this study

This is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the immunogenicity and safety of NBP607-QIV compared to Agrippal which are indicated for active immunization for the the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled. Each subject is administered with single or two doses of vaccines depending on previous vaccination history, and randomly assigned in 2:1 ratio.

Stratified randomization for trial site and age strata is used to achieve the balance of treatment assignment.

Total of three or five visits are scheduled depeding on dosing schedule. For subjects assigned to single-dose vaccination schedule, blood sampling is conducted for immunogenicity assessment before and 4 weeks after single vaccination at Visit 1 and 3 respectively. Safety is monitored 3 days, 4 weeks after vaccination through Visit 2* and 3 (* telephone contact). For subjects assigned to two-dose vaccination schedule, blood sampling is conducted before first vaccination and 4 weeks after second vaccination at Visit 1 and Visit 5 respectively. Safety is monitored 3 days, 4 weeks after each vaccination through Visit 2*, 3, 4*, and 5 (* telephone contact)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 6 to 35 months
  • Those who were normal gestational age at birth (for children aged 6 months to <1 year)
  • Those who have provided written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study

Exclusion criteria

  • Those with any immunodeficiency disease or malignancy
  • Those with hypersensitivity to vaccination
  • Those who are contraindicated for intramuscular injection due to thrombocytopenia or other coagulopathy
  • Those with history of treatment with any of immunosuppressants or immunoregulators within 12 weeks prior to screening
  • Those with history of receiving blood product or treatment with immunoglobulin within 24 weeks prior to screening
  • Those with history of influenza vaccination within 24 weeks prior to screening
  • Those with any severe chronic conditions that interfere with study participation

Treatment and study plan

NBP607-QIV

Biological

Purified inactivated influenza virus surface antigens of four strains (quadrivalent)

Agrippal

Biological

Influenza virus surface antigens of three strains (trivalent)

Primary outcomes

  1. Post-vaccination GMT(Geometric Mean Titer) by HI(Hemagglutination-inhibition) assay for the common strains (A/H1N1, A/H3N2, and B/Victoria)

    Time frame: 4 weeks after last IP(Investigational Product) vaccination

    Post-vaccination GMT will be adjusted for pre-vaccination titer

  2. Seroconversion rate by HI assay for the common strains (A/H1N1, A/H3N2, and B/Victoria)

    Time frame: 4 weeks after last IP(Investigational Product) vaccination

    Seroconversion rate is defined as the proportion of subjects who meet either of the following criteria:

    • Post-vaccination HI titer of ≥1:40 for subjects with pre-vaccination HI titer of <1:10
    • Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥1:10

  3. Seroconversion rate by HI assay for the exclusive strain (B/Yamagata)

    Time frame: 4 weeks after last IP(Investigational Product) vaccination

    Seroconversion rate is defined as the proportion of subjects who meet either of the following criteria:

    • Post-vaccination HI titer of ≥1:40 for subjects with pre-vaccination HI titer of <1:10
    • Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥1:10

  4. GMR(Geometric mean ratio) by HI assay for the exclusive strain (B/Yamagata)

    Time frame: 4 weeks after last IP(Investigational Product) vaccination

    The fold-rise of the geometric mean HI titer from pre- to post-vaccination

Secondary outcomes

  1. Seroprotection rate by HI assay for all strains

    Time frame: 4 weeks after last IP(Investigational Product) vaccination

    Seroprotection rate is defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40

  2. CHMP(Committee for Medicinal Products for Human Use) criteria assessment for the common strains (A/H1N1, A/H3N2, and B/Victoria)

    Time frame: 4 weeks after last IP(Investigational Product) vaccination

    CHMP criteria for seroconversion rate, GMR(Geometric Mean Ratio) will be assessed

  3. Consistency of immunogenicity among countries

    Time frame: 4 weeks after last IP(Investigational Product) vaccination

    Post-vaccination GMT and seroconversion rate for the common strains (A/H1N1, A/H3N2, and B/Victoria), and CHMP criteria for seroconversion rate and GMR for the exclusive strain (B/Yamagata) will be assessed

  4. Percentage of participants with Adverse Events(AEs)

    Time frame: 7 days for Solicited AE and 4 weeks for Unsolicited AE, SAE after last IP(Investigational Product) vaccination

    Incidence rate of Solicited AE, unsolicited AE, SAE(Serious Adverse Event) will be assessed

  5. Vital sign

    Time frame: 4 weeks after last IP(Investigational Product) vaccination

    Body temperature will be assessed

  6. Height

    Time frame: 4 weeks after last IP(Investigational Product) vaccination

    Height in centimeters will be assessed

  7. Weight

    Time frame: 4 weeks after last IP(Investigational Product) vaccination

    Weight in kilograms will be assessed

Sponsors and collaborators

Lead sponsor

SK Bioscience Co., Ltd.

Industry

Registry information

Official study title

A Multinational, Comparative Phase III Clinical Trial to Assess the Efficacy (Immunogenicity) and Safety of NBP607-QIV (0.5 mL) (Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine) in Children Aged 6 to 35 Months

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2018
Registry last updated
May 11, 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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