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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 10, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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 16 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.

Condition or disease Intervention/treatment Phase
Influenza Influenza Immunisation Biological: Influenza Virus Monovalent A/H3N2/Bris 10 M2SR Live Vaccine Other: Placebo Biological: Quadrivalent MDCK Inactivated Influenza Vaccine Phase 1

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 16 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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
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.

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.

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
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.




Primary Outcome Measures :
  1. Frequency of Adverse Event of Special Interest (AESIs) following vaccination [ Time Frame: Day 1 through Day 92 ]
  2. Frequency of New Onset Chronic Medical Conditions (NOCMC) following vaccination [ Time Frame: Day 1 through Day 92 ]
  3. Frequency of SAEs [ Time Frame: Day 1 through Day 366 ]
  4. Frequency of solicited systemic reactogenicity [ Time Frame: Day 1 through Day 8 ]
  5. Frequency of solicited upper respiratory reactogenicity [ Time Frame: Day 1 through Day 8 ]
  6. Frequency of unsolicited non-serious adverse events [ Time Frame: Day 1 through Day 22 ]

Secondary Outcome Measures :
  1. Conserved internal viral protein-specific IFN-gamma ELISPOT responses [ Time Frame: Day 1 ]
  2. Conserved internal viral protein-specific IFN-gamma ELISPOT responses [ Time Frame: Day 22 ]
  3. Conserved internal viral protein-specific IFN-gamma ELISPOT responses [ Time Frame: Day 57 ]
  4. Conserved internal viral protein-specific IFN-gamma ELISPOT responses [ Time Frame: Day 8 ]
  5. Conserved internal viral protein-specific IFN-gamma ELISPOT responses following QIV vaccination [ Time Frame: Day 113 ]
  6. Conserved internal viral protein-specific IFN-gamma ELISPOT responses immediately before QIV vaccination [ Time Frame: Day 92 ]
  7. Frequency of influenza H3 HA-specific H3 M2SR-like viruses [ Time Frame: Day 1 ]
  8. Frequency of influenza H3 HA-specific H3 M2SR-like viruses [ Time Frame: Day 22 ]
  9. Frequency of influenza H3 HA-specific H3 M2SR-like viruses [ Time Frame: Day 57 ]
  10. Frequency of influenza H3 HA-specific H3 M2SR-like viruses [ Time Frame: Day 8 ]
  11. Frequency of influenza H3 HA-specific H3 M2SR-like viruses following QIV vaccination [ Time Frame: Day 113 ]
  12. Frequency of influenza H3 HA-specific H3 M2SR-like viruses immediately before QIV vaccination [ Time Frame: Day 92 ]
  13. Frequency of influenza H3 HA-specific QIV-like viruses [ Time Frame: Day 1 ]
  14. Frequency of influenza H3 HA-specific QIV-like viruses [ Time Frame: Day 22 ]
  15. Frequency of influenza H3 HA-specific QIV-like viruses [ Time Frame: Day 57 ]
  16. Frequency of influenza H3 HA-specific QIV-like viruses [ Time Frame: Day 8 ]
  17. Frequency of influenza H3 HA-specific QIV-like viruses following QIV vaccination [ Time Frame: Day 113 ]
  18. Frequency of influenza H3 HA-specific QIV-like viruses immediately before QIV vaccination [ Time Frame: Day 92 ]
  19. GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  20. GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 22 ]
  21. GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 57 ]
  22. GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 8 ]
  23. 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 ]
  24. 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 ]
  25. GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  26. GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 22 ]
  27. GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 57 ]
  28. GMFR of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 8 ]
  29. 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 ]
  30. 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 ]
  31. GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  32. GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 22 ]
  33. GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 57 ]
  34. GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 8 ]
  35. 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 ]
  36. 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 ]
  37. GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  38. GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 22 ]
  39. GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 57 ]
  40. GMFR of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 8 ]
  41. 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 ]
  42. 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 ]
  43. GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  44. GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 22 ]
  45. GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 57 ]
  46. GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 8 ]
  47. 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 ]
  48. 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 ]
  49. GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  50. GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 22 ]
  51. GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 57 ]
  52. GMTs of nasal sIgA responses directed against the H3N2 M2SR virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 8 ]
  53. 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 ]
  54. 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 ]
  55. GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 1 ]
  56. GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 22 ]
  57. GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 57 ]
  58. GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) with normalization to total sIgA [ Time Frame: Day 8 ]
  59. 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 ]
  60. 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 ]
  61. GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 1 ]
  62. GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 22 ]
  63. GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 57 ]
  64. GMTs of nasal sIgA responses directed against the H3N2 QIV virus measured by EPT (ELISA) without normalization to total sIgA [ Time Frame: Day 8 ]
  65. 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 ]
  66. 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 ]
  67. HAI antibody geometric mean fold rise (GMFR) to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  68. HAI antibody geometric mean titers (GMTs) to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  69. HAI antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  70. HAI antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  71. HAI antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  72. HAI antibody GMFR to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 113 ]
  73. HAI antibody GMFR to the H3N2 M2SR-like virus immediately before QIV vaccination before [ Time Frame: Day 92 ]
  74. HAI antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  75. HAI antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  76. HAI antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  77. HAI antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  78. HAI antibody GMFR to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 113 ]
  79. HAI antibody GMFR to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  80. HAI antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  81. HAI antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  82. HAI antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  83. HAI antibody GMTs to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 113 ]
  84. HAI antibody GMTs to the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  85. HAI antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  86. HAI antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  87. HAI antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  88. HAI antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  89. HAI antibody GMTs to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 113 ]
  90. HAI antibody GMTs to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  91. Neut antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  92. Neut antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  93. Neut antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  94. Neut antibody GMFR to the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  95. Neut antibody GMFR to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 113 ]
  96. Neut antibody GMFR to the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  97. Neut antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  98. Neut antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  99. Neut antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  100. Neut antibody GMFR to the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  101. Neut antibody GMFR to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 113 ]
  102. Neut antibody GMFR to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  103. Neut antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  104. Neut antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  105. Neut antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  106. Neut antibody GMTs to the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  107. Neut antibody GMTs to the H3N2 M2SR-like virus following QIV vaccination [ Time Frame: Day 113 ]
  108. Neut antibody GMTs to the H3N2 M2SR-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  109. Neut antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  110. Neut antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  111. Neut antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  112. Neut antibody GMTs to the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  113. Neut antibody GMTs to the H3N2 QIV-like virus following QIV vaccination [ Time Frame: Day 113 ]
  114. Neut antibody GMTs to the H3N2 QIV-like virus immediately before QIV vaccination [ Time Frame: Day 92 ]
  115. Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  116. Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  117. Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  118. Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  119. 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 ]
  120. 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 ]
  121. Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  122. Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  123. Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  124. Percentage of subjects achieving a serum HAI antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  125. 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 ]
  126. 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 ]
  127. Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 1 ]
  128. Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 22 ]
  129. Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 57 ]
  130. Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 M2SR-like virus [ Time Frame: Day 8 ]
  131. 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 ]
  132. 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 ]
  133. Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 1 ]
  134. Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 22 ]
  135. Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 57 ]
  136. Percentage of subjects achieving a serum Neut antibody titer of > / = 1:40 against the H3N2 QIV-like virus [ Time Frame: Day 8 ]
  137. 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 ]
  138. 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 ]
  139. 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 ]
  140. 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 ]
  141. 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 ]
  142. 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 ]
  143. 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 ]
  144. 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 ]
  145. 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 ]
  146. 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 ]
  147. 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 ]
  148. 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 ]
  149. 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 ]
  150. 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 ]
  151. 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 ]
  152. 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 ]
  153. 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 ]
  154. 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 ]
  155. 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 ]
  156. 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 ]
  157. 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 ]
  158. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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: 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. 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 known hypersensitivity or allergy to eggs, egg or chicken protein, or other components* of the study vaccine.

    *Phosphate buffered saline containing sodium chloride, potassium chloride, potassium dihydride phosphate, disodium phosphate with sucrose and glutamic acid.

  7. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
  8. History of anatomic disorder of the nares or nasopharynx (Deviated septum is allowed).
  9. History of chronic sinus infections.
  10. Have a history of Guillain-Barre Syndrome.
  11. Have a history of alcohol or drug abuse prior to study vaccination.
  12. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
  13. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others prior to study vaccination.
  14. Have taken oral, topical, and/or nasal corticosteroids of any dose within 30 days prior to study vaccination.
  15. 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/health-pro/guidances/current/asthma-guidelines/quic-reference-html#estimated-comparative-daily-doses.

  16. Use of aspirin or salicylate-containing products 30 days prior to the first vaccination.
  17. 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).

  18. Received any licensed live or inactivated vaccine within 30 days prior to the first study vaccination.
  19. Received any influenza vaccine (inactivated or live) within 6 months prior to the first study vaccination.
  20. Received immunoglobulin or other blood products within 6 months prior to study vaccination.
  21. 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.

  22. 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.

  23. 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.
  24. 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.
  25. Blood donation within 30 days prior to the study vaccination through 30 days after the last blood drawn for this study.
  26. 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.

  27. Have received any antiviral drug within 3 days of study vaccination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553940


Contacts
Contact: Daniel F Hoft 13145778648 hoftdf@slu.edu

Locations
United States, Missouri
Saint Louis University - Center for Vaccine Development Recruiting
Saint Louis, Missouri, United States, 63104-1015
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03553940     History of Changes
Other Study ID Numbers: 17-0012
HHSN272200800003C
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: July 9, 2018

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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
H3N2 M2SR Prime
Immunogenicity
Influenza
Pediatric
QIV
Safety
Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs