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Trial record 1 of 1 for:    NCT03553940
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Safety and Immunogenicity Study of an Influenza Vaccination Strategy Including an H3N2 M2SR Prime Followed by a Seasonal Quadrivalent Inactivated Vaccine Boost in a Pediatric Population 9-17 Years Old

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ClinicalTrials.gov Identifier: NCT03553940
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE May 31, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date August 12, 2019
Actual Study Start Date  ICMJE August 15, 2018
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Frequency of Adverse Event of Special Interest (AESIs) following vaccination [ Time Frame: Day 1 through Day 92 ]
  • Frequency of New Onset Chronic Medical Conditions (NOCMC) following vaccination [ Time Frame: Day 1 through Day 92 ]
  • Frequency of SAEs [ Time Frame: Day 1 through Day 366 ]
  • Frequency of solicited systemic reactogenicity [ Time Frame: Day 1 through Day 8 ]
  • Frequency of solicited upper respiratory reactogenicity [ Time Frame: Day 1 through Day 8 ]
  • Frequency of unsolicited non-serious adverse events [ Time Frame: Day 1 through Day 22 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
  • Frequency of Adverse Event of Special Interest (AESIs) following vaccination [ Time Frame: Day 1 through Day 181 ]
  • Frequency of New Onset Chronic Medical Conditions (NOCMC) following vaccination [ Time Frame: Day 1 through Day 181 ]
  • Frequency of SAEs to study vaccination [ Time Frame: Day 1 through Day 366 ]
  • Frequency of solicited systemic reactogenicity [ Time Frame: Day 1 through Day 8 ]
  • Frequency of solicited upper respiratory reactogenicity [ Time Frame: Day 1 through Day 8 ]
  • Frequency of unsolicited non-serious adverse events [ Time Frame: Day 1 through Day 22 ]
Change History Complete list of historical versions of study NCT03553940 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
  • Conserved internal viral protein-specific IFN-gamma ELISPOT responses [ Time Frame: Day 1 ]
  • Conserved internal viral protein-specific IFN-gamma ELISPOT responses [ Time Frame: Day 22 ]
  • Conserved internal viral protein-specific IFN-gamma ELISPOT responses [ Time Frame: Day 57 ]
  • Conserved internal viral protein-specific IFN-gamma ELISPOT responses [ Time Frame: Day 8 ]
  • Conserved internal viral protein-specific IFN-gamma ELISPOT responses following QIV vaccination [ Time Frame: Day 113 ]
  • Conserved internal viral protein-specific IFN-gamma ELISPOT responses immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses [ Time Frame: Day 1 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses [ Time Frame: Day 22 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses [ Time Frame: Day 57 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses [ Time Frame: Day 8 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses following QIV vaccination [ Time Frame: Day 113 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses [ Time Frame: Day 1 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses [ Time Frame: Day 22 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses [ Time Frame: Day 57 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses [ Time Frame: Day 8 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses following QIV vaccination [ Time Frame: Day 113 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses immediately before QIV vaccination [ Time Frame: Day 92 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 22 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 57 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 8 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA following QIV vaccination [ Time Frame: Day 113 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 92 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 22 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 57 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 8 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA following QIV vaccination [ Time Frame: Day 113 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 92 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 22 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 57 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 8 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA following QIV vaccination [ Time Frame: Day 113 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 92 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 22 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 57 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 8 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA following QIV vaccination [ Time Frame: Day 113 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 92 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 22 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 57 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 8 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA following QIV vaccination [ Time Frame: Day 113 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 92 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 22 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 57 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 8 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA following QIV vaccination [ Time Frame: Day 113 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 92 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 22 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 57 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 8 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA following QIV vaccination [ Time Frame: Day 113 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 92 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 22 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 57 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 8 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA following QIV vaccination [ Time Frame: Day 113 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 92 ]
  • HAI antibody geometric mean fold rise (GMFR) to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • HAI antibody geometric mean titers (GMTs) to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • HAI antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  • HAI antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  • HAI antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  • HAI antibody GMFR to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • HAI antibody GMFR to the H3N2 M2SR-like virus immediately before QIV vaccination before [ Time Frame: Day 92 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • HAI antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  • HAI antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  • HAI antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  • HAI antibody GMTs to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • HAI antibody GMTs to the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 113 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses [ Time Frame: Day 22 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses [ Time Frame: Day 57 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses [ Time Frame: Day 8 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses [ Time Frame: Day 22 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses [ Time Frame: Day 57 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses [ Time Frame: Day 8 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses [ Time Frame: Day 22 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses [ Time Frame: Day 57 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses [ Time Frame: Day 8 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses [ Time Frame: Day 22 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses [ Time Frame: Day 57 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses [ Time Frame: Day 8 ]
  • Percentage of subjects with seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses after QIV vaccination [ Time Frame: Day 113 ]
  • Percentage of subjects with seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses prior to QIV vaccination [ Time Frame: Day 92 ]
  • Percentage of subjects with seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses after QIV vaccination [ Time Frame: Day 113 ]
  • Percentage of subjects with seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses prior to QIV vaccination [ Time Frame: Day 92 ]
  • Percentage of subjects with seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses after QIV vaccination [ Time Frame: Day 113 ]
  • Percentage of subjects with seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses after QIV vaccination [ Time Frame: Day 113 ]
  • Percentage of subjects with seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses prior to QIV vaccination [ Time Frame: Day 92 ]
  • Percentage of subjects with seroconversion (Neut pre-vaccination titer <1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses prior to QIV vaccination [ Time Frame: Day 92 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
  • Conserved internal viral protein-specific IFN-y ELISPOT responses [ Time Frame: Day 1 ]
  • Conserved internal viral protein-specific IFN-y ELISPOT responses following QIV vaccination [ Time Frame: Day 204 ]
  • Conserved internal viral protein-specific IFN-y ELISPOT responses for Arm 1 [ Time Frame: Day 22 ]
  • Conserved internal viral protein-specific IFN-y ELISPOT responses for Arm 1 [ Time Frame: Day 57 ]
  • Conserved internal viral protein-specific IFN-y ELISPOT responses for Arm 1 [ Time Frame: Day 8 ]
  • Conserved internal viral protein-specific IFN-y ELISPOT responses immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses [ Time Frame: Day 1 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses following QIV vaccination [ Time Frame: Day 204 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses for Arm 1 [ Time Frame: Day 22 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses for Arm 1 [ Time Frame: Day 57 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses for Arm 1 [ Time Frame: Day 8 ]
  • Frequency of influenza H3 HA-specific H3 M2SR-like viruses immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses [ Time Frame: Day 1 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses following QIV vaccination [ Time Frame: Day 204 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses for Arm 1 [ Time Frame: Day 22 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses for Arm 1 [ Time Frame: Day 57 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses for Arm 1 [ Time Frame: Day 8 ]
  • Frequency of influenza H3 HA-specific QIV-like viruses immediately before QIV vaccination [ Time Frame: Day 183 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA following QIV vaccination [ Time Frame: Day 204 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 22 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 57 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 8 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 183 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA following QIV vaccination [ Time Frame: Day 204 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 22 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 57 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 8 ]
  • GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 183 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA following QIV vaccination [ Time Frame: Day 204 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 22 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 57 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 8 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 183 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA following QIV vaccination [ Time Frame: Day 204 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 22 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 57 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 8 ]
  • GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 183 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA following QIV vaccination [ Time Frame: Day 204 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 22 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 57 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 8 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 183 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA following QIV vaccination [ Time Frame: Day 204 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 22 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 57 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 8 ]
  • GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 183 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA following QIV vaccination [ Time Frame: Day 204 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 22 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 57 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA for Arm 1 [ Time Frame: Day 8 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 183 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA following QIV vaccination [ Time Frame: Day 204 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 22 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 57 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA for Arm 1 [ Time Frame: Day 8 ]
  • GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA immediately before QIV vaccination [ Time Frame: Day 183 ]
  • HAI antibody geometric mean fold rise (GMFR) to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • HAI antibody geometric mean titers (GMTs) to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • HAI antibody GMFR to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • HAI antibody GMFR to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 22 ]
  • HAI antibody GMFR to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 57 ]
  • HAI antibody GMFR to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 8 ]
  • HAI antibody GMFR to the H3N2 M2SR-like virus immediately before QIV vaccination before [ Time Frame: Day 183 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 22 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 57 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 8 ]
  • HAI antibody GMFR to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • HAI antibody GMTs to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • HAI antibody GMTs to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 22 ]
  • HAI antibody GMTs to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 57 ]
  • HAI antibody GMTs to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 8 ]
  • HAI antibody GMTs to the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 22 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 57 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 8 ]
  • HAI antibody GMTs to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 22 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 57 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 8 ]
  • Neut antibody GMFR to the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 22 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 57 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 8 ]
  • Neut antibody GMFR to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 22 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 57 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 8 ]
  • Neut antibody GMTs to the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 22 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 57 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 8 ]
  • Neut antibody GMTs to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 22 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 57 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 8 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 22 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 57 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 8 ]
  • Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 22 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 57 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus for Arm 1 [ Time Frame: Day 8 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 204 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 22 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 57 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus for Arm 1 [ Time Frame: Day 8 ]
  • Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 183 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses for Arm 1 [ Time Frame: Day 22 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses for Arm 1 [ Time Frame: Day 57 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses for Arm 1 [ Time Frame: Day 8 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses for Arm 1 [ Time Frame: Day 22 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses for Arm 1 [ Time Frame: Day 57 ]
  • Percentage of subjects achieving seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses for Arm 1 [ Time Frame: Day 8 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses for Arm 1 [ Time Frame: Day 22 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses for Arm 1 [ Time Frame: Day 57 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses for Arm 1 [ Time Frame: Day 8 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses for Arm 1 [ Time Frame: Day 22 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses for Arm 1 [ Time Frame: Day 57 ]
  • Percentage of subjects achieving seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses for Arm 1 [ Time Frame: Day 8 ]
  • Percentage of subjects with seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses after QIV vaccination [ Time Frame: Day 204 ]
  • Percentage of subjects with seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses prior to QIV vaccination [ Time Frame: Day 183 ]
  • Percentage of subjects with seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses after QIV vaccination [ Time Frame: Day 204 ]
  • Percentage of subjects with seroconversion (HAI pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses prior to QIV vaccination [ Time Frame: Day 183 ]
  • Percentage of subjects with seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses after QIV vaccination [ Time Frame: Day 204 ]
  • Percentage of subjects with seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses after QIV vaccination [ Time Frame: Day 204 ]
  • Percentage of subjects with seroconversion (Neut pre-vaccination titer < 1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 QIV-like viruses prior to QIV vaccination [ Time Frame: Day 183 ]
  • Percentage of subjects with seroconversion (Neut pre-vaccination titer <1:10 and post-vaccination titer > / = 1:40, or pre-vaccination titer > / = 1:10 and min 4-fold rise in post-vaccination titer) against H3N2 M2SR-like viruses prior to QIV vaccination [ Time Frame: Day 183 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of an Influenza Vaccination Strategy Including an H3N2 M2SR Prime Followed by a Seasonal Quadrivalent Inactivated Vaccine Boost in a Pediatric Population 9-17 Years Old
Official Title  ICMJE A Phase I Trial to Evaluate the Safety and Immunogenicity of an Influenza Vaccination Strategy Including a H3N2 M2SR Prime Followed by a Seasonal Quadrivalent Inactivated Vaccine Boost in a Pediatric Population 9-17 Years Old
Brief Summary This is a Phase I double-blind, randomized, placebo-controlled study in 50 healthy adolescents and children, 9-17 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity of a prime-boost regimen of H3N2 M2SR intranasal influenza vaccine (manufactured by FluGen) followed by licensed inactivated Quadrivalent Influenza Vaccine (QIV) boost administered intramuscularly Subjects will be enrolled in one of two groups in a 1:1 ratio. Arm 1 will receive one dose of M2SR intranasally on Day 1 and one dose of QIV on Day 92. Arm 2 will receive one dose of placebo (saline) intranasally on Day 1, and one dose of QIV on Day 92. Study duration will be approximately 28 months with patient participation duration approximately 13 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live attenuated influenza H3N2 M2SR vaccine.
Detailed Description This is a Phase I double-blind, randomized, placebo-controlled study in 50 healthy adolescents and children, 9-17 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity of a prime-boost regimen of H3N2 M2SR intranasal influenza vaccine (manufactured by FluGen) followed by licensed inactivated Quadrivalent Influenza Vaccine (QIV) boost administered intramuscularly. Subjects will be enrolled in one of two groups in a 1:1 ratio. Arm 1 will receive one dose of M2SR intranasally on Day 1 and one dose of QIV on Day 92. Arm 2 will receive one dose of placebo (saline) intranasally on Day 1, and one dose of QIV on Day 92. Study duration will be approximately 28 months with patient participation duration approximately 13 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live attenuated influenza H3N2 M2SR vaccine. The secondary study objectives are to identify circulating and mucosal antibody responses induced by H3N2 M2SR vaccination and to identify cellular immune responses induced by H3N2 M2SR vaccination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Influenza
  • Influenza Immunisation
Intervention  ICMJE
  • Biological: Influenza Virus Monovalent A/H3N2/Bris 10 M2SR Live Vaccine
    Live monovalent influenza A/H3N2-based M2SR (M2 defective Single Replication vaccine), comprised of 5 out of 8 gene segments on the donor virus influenza A/Puerto Rica/8/34. HA and NA derive from an A/Brisbane/10/2007-like virus. Administered intranasally as s single dose.
  • Other: Placebo
    H3N2 M2SR vaccine placebo (normal saline). Administered intranasally as a single dose.
  • Biological: Quadrivalent MDCK Inactivated Influenza Vaccine
    A quadrivalent cell culture inactivated vaccine (ccIV4) is an inactivated subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells indicated for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Administered intramuscularly as a single dose.
Study Arms  ICMJE
  • Experimental: Arm 1
    A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92. N=25
    Interventions:
    • Biological: Influenza Virus Monovalent A/H3N2/Bris 10 M2SR Live Vaccine
    • Biological: Quadrivalent MDCK Inactivated Influenza Vaccine
  • Placebo Comparator: Arm 2
    A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92. N=25
    Interventions:
    • Other: Placebo
    • Biological: Quadrivalent MDCK Inactivated Influenza Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Parent(s)/legal guardian(s) must provide written informed consent prior to initiation of any study procedures, and subject must provide assent.
  2. Are able to understand and comply with planned study procedures and be available for all study visits.
  3. Are males or non-pregnant females, 9-17 years old, inclusive at the time of enrollment.
  4. Are in good health*.

    *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, ER, or urgent care for condition and no adverse symptoms that need medical intervention). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Low dose topical steroids, herbals, vitamins, and supplements are permitted.

  5. Oral temperature is less than 100.0 degrees Fahrenheit.
  6. For female adolescent of child-bearing potential* must agree to correctly use an acceptable method of contraception** from 30 days prior to vaccination until 30 days after the last study vaccination.

    *Defined by the onset of menses, and not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating.

    **Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, and correct use of male condoms with the use of applied spermicide, intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables, contraceptive patches or oral contraceptives ("the pill"). Method of contraception will be captured on the appropriate data collection form.

  7. Female adolescent of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccination.
  8. Males who are sexually active with a female of childbearing potential must agree not to father a child for 30 days after receipt of the first study vaccination.
  9. Agrees not to participate in another clinical trial during the study period.
  10. Agrees not to donate blood or blood products to a blood bank for 12 months after receiving the investigational vaccine.
  11. Weight = / > 34 kg or 75 pounds.
  12. Hemoglobin = / > 11.5 g/dL.
  13. Hematocrit > 35%.
  14. Ferritin level > 15 ng/mL.
  15. Parent/legal guardian must provide consent to future use of stored samples.

Exclusion Criteria:

  1. Have an acute illness*, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to each study vaccination.

    *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.

  2. Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation*.

    *Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study.

  3. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
  4. Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma skin cancers that are not active are permitted.
  5. Have known HIV, hepatitis B, or hepatitis C infection.
  6. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
  7. History of anatomic disorder of the nares or nasopharynx (Deviated septum is allowed).
  8. History of chronic sinus infections.
  9. Have a history of Guillain-Barre Syndrome.
  10. Have a history of alcohol or drug abuse prior to study vaccination.
  11. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
  12. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others prior to study vaccination.
  13. Have taken oral and/or nasal corticosteroids of any dose within 30 days prior to each study vaccination or plan to take in the 30 days following the first study vaccination.
  14. Have taken high-dose*,** inhaled corticosteroids within 30 days (prior to study vaccination).

    *High-dose defined as per age as using inhaled high dose per reference chart.

    **https://www.nhlbi.nih.gov/files/docs/guidelines/asthma_org.pdf.

  15. Use of aspirin or salicylate-containing products 30 days prior to the first vaccination.
  16. Recurring or active wheezing or diagnosis of asthma, or history of significant wheezing*.

    *Medically significant wheezing: defined as wheezing on physical exam plus sign of respiratory distress (tachypnea, retractions, or dyspnea), hypoxemia (O2 saturation < 95%), or new bronchodilator prescription, or use of daily bronchodilator therapy (not on an "as needed" basis).

  17. Received any licensed live or inactivated vaccine within 30 days prior to or plan to receive any licensed live or inactivated vaccine within 30 days after each study vaccination.
  18. Received any influenza vaccine (inactivated or live) within 6 months prior to the first study vaccination and until the end of the study.
  19. Received immunoglobulin or other blood products within 6 months prior to study vaccination.
  20. Received an experimental agent* within 30 days prior to the first study vaccination, or expects to receive an experimental agent** during the 12-month trial-reporting period.

    *Including vaccine, drug, biologic, device, blood product, or medication.

    **Other than from participation in this study.

  21. Are participating or plan to participate in another clinical trial with an interventional agent* that will be received during the 12-month trial-reporting period.

    *Including agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) during the 12-month study period.

  22. Prior history of H3N2 actual or potential exposure or infection prior to the first study vaccination, or receipt of experimental vaccines within the past year prior to the first study vaccine.
  23. Female adolescent subject who is breastfeeding or plans to breastfeed at any given time from the first study vaccination until 30 days after the last study vaccination.
  24. Blood donation within 30 days prior to the study vaccination through 30 days after the last blood drawn for this study.
  25. Have signs or symptoms that could confound or confuse assessment of study vaccine reactogenicity*.

    *The study vaccination should be postponed/deferred until signs or symptoms have resolved and if within the acceptable protocol-specified window for that visit.

  26. Have received any antiviral drug within 3 days of study vaccination.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Daniel F. Hoft 13149775500 daniel.hoft@health.slu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03553940
Other Study ID Numbers  ICMJE 17-0012
HHSN272200800003C
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP