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Completed

NCT Number: NCT02467842

Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects

All participants received a single dose of their assigned vaccine on Day 0. They were followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse events were collected for 6 months post-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

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

In a randomized controlled phase III trial undertaken in 10 university hospitals of South Korea, adults and elderly subjects were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine (TIV), NBP607-Y and NBP607-V. Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition (HI) assay. Safety was assessed for 6 months post-vaccination: solicited adverse events for 7 days, unsolicited adverse events (AEs) for 21 days and serious adverse events (SAE) for 6 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults aged 19 years and older
  • Those who are able to comply with the requirements for the study
  • If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration

Exclusion criteria

  • Disorders in immune function
  • Any malignancy or lymphoproliferative disorder
  • History of Guillain-Barré syndrome
  • Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
  • Experience of fever (>38.0 ℃) within 24 hours following vaccination
  • Body temperature >38.0 ℃ at the vaccination day
  • Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products within 3 months
  • Influenza vaccination within 6 months
  • Subjects who have participated in other interventional study within 4 weeks
  • Any vaccination within 1 month
  • Those who are planning to receive any vaccine within 1 month from the study vaccine
  • Individuals with any serious chronic or progressive disease
  • Pregnant or breast-feeding women
  • Any other reason that in the opinion of the investigator might interfere with the study

Treatment and study plan

NBP607-QIV

Biological

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria

NBP607-Y

Biological

Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata

NBP607-V

Biological

Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria

Primary outcomes

  1. Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects

    Time frame: At Day 21 post vaccination.

    GMTs of anti-influenza antibodies were measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. For each A strain, the titers were made with the pooled TIV group (NBP60-Y and NBP607-V).

    For each A strain, the comparion was made with the pooled TIV groups (Y+V/QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is Y/QIV).

  2. Seroconversion Rate (SCR) After Vaccination in All Subjects

    Time frame: At Day 21 post vaccination.

    SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

    For each A strain, the comparion was made with the pooled TIV groups (Y+V minus QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Difference of SCR (Diff.SCR) is Y minus QIV).

  3. Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

    Time frame: At Day 21 post vaccination.

    SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40.

  4. Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

    Time frame: At Day 21 post vaccination.

    SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

  5. Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

    Time frame: At Day 21 post vaccination.

    GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination.

Secondary outcomes

  1. Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects

    Time frame: At Day 21 post vaccination.

    GMTs of anti-influenza antibodies were measured for B strains: B/Victoria, and B/Yamagata.

    For each B strain, the comparison was made with the TIV group which did not contain the correponding B strain (i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is V/QIV).

  2. Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects

    Time frame: At Day 21 post vaccination.

    SCR was measured for each B strain: B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

  3. Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years

    Time frame: At Day 21 post vaccination.

    SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40.

  4. Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years

    Time frame: At Day 21 post vaccination.

    SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

  5. Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years

    Time frame: At Day 21 post vaccination.

    GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine in Adults and Elderly Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 10, 2015
Registry last updated
May 8, 2020

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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