Clinical trial NCT01855945: Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.
Official title: Phase I Multi-center, Observer-Blind, Randomized, Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated Novel Swine Origin A/H3N2v Monovalent Subunit Influenza Virus Vaccine (H3N2c) in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to < 65 Years and Elderly ≥ 65 Years and Older.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prophylaxis of A/H3N2v Influenza
Keywords: Influenza
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 627
Sex: ALL
Minimum age (years): 3
Maximum age (years): 92
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to \<9 years, adolescents 9 to \<18 years, adults 18 to \<65 years and elderly 65 years and older.


Eligibility criteria: Inclusion Criteria:

1. Males and females 3 years of age and older
2. Individuals or, (for children and adolescents) parents or legal guardians, who have given written consent after the nature of the study has been explained according to local regulatory requirements. Assent is required depending on age of child/adolescent
3. Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
4. Individuals who can comply with study procedures and are available for follow-up

Exclusion Criteria:

1. Individuals with behavioral or cognitive impairment, including psychiatric illness, as determined by the investigator's clinical judgement may interfere with the subject's ability to participate in study
2. Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome
3. Individuals or (for children and adolescents) parents or legal guardians who are not able to comprehend and to follow all required study procedures for the whole period of the study
4. Individuals with a history of illness/with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study
5. Individuals who have a suspected/confirmed diagnosis for any Adverse event of Special interest
6. Individuals with known or suspected impairment of the immune system including, but not limited to:

   * autoimmune disease such as rheumatoid arthritis, HIV infection, hypo- or agammaglobulinemia;
   * autoimmune disorders;
   * Systemic therapy with corticosteroids or other immunosuppressive therapy.
   * Receipt of immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the study
7. Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered
8. If female, "of childbearing potential", sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry
9. "Of childbearing potential" is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy
10. Acceptable birth control methods are defined as one or more of the following:

    1. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
    2. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse;
    3. Intrauterine device (IUD);
    4. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry.
11. If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination
12. Individuals who are allergic to any of the vaccine components.
13. For children 17 years of age and younger: Individuals who have had ever a malignancy
14. For adults 18 years or older: Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years
15. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study
16. Individuals with a body temperature \>38°C (\>100.4°F) or any acute illness within 3 days of intended study vaccination
17. Individuals who have had a previous confirmed or suspected illness from swine flu (H3N2v)
18. Individuals who have received any prior H3N2v vaccine
19. Individuals who have received any other type of influenza vaccination (e.g., "seasonal") within 14 days prior to enrolment, or who plans to receive influenza vaccine during the treatment phase of this study (seasonal influenza vaccination is allowed after Day 43/Visit 3)
20. Individuals who received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study or who are planning to receive any (non-influenza) vaccine within 4 weeks from the study vaccines
21. Individuals who are research staff involved with the clinical study or family/household members of research staff
22. Individuals with a BMI \> 35 kg/m2 (adults), \> 29 kg/m2 (adolescents), or \> 21 kg/m2 (children)
23. Individuals with a history of drug or alcohol abuse within the past 2 years

Primary outcomes:
measure: Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 1 through Day 7 after each vaccination
measure: Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 1 through Day 7 after each vaccination
measure: Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 1 through Day 7 after each vaccination
measure: Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 1 through Day 7 after each vaccination
measure: Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 1 through Day 366
measure: Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 22, Day 43 post vaccination
measure: Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 1, Day 22, Day 43 post vaccination
Secondary outcomes:
measure: Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).
timeFrame: Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination
measure: Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1
measure: Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 183 and Day 366 post vaccination
measure: Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 22, Day 43 post vaccination
measure: Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 1, Day 22, Day 43 post vaccination
measure: GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
timeFrame: Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1
Other outcomes:
Locations:
city: Redding
country: United States
facility: 51, Northern California Clinical Research Center
state: California
city: Sacramento
country: United States
facility: 47, Benchmark Research
state: California
city: Lenexa
country: United States
facility: 46, Johnson County Clinical Trials
state: Kansas
city: Wichita
country: United States
facility: 49, Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: 43, Central Kentucky Research Associates
state: Kentucky
city: Metairie
country: United States
facility: 41, Benchmark Research
state: Louisiana
city: Rochester
country: United States
facility: 44, Rochester Clinical Research Inc.
state: New York
city: Raleight
country: United States
facility: 50, PMG Research of Raleigh
state: North Carolina
city: Warwick
country: United States
facility: 45, Omega Medical Research
state: Rhode Island
city: Dallas
country: United States
facility: 42, Research Acros
state: Texas
city: Salt lake City
country: United States
facility: 48, "J. Lewis Research, Inc.
state: Utah
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References:
citation: Johnson C, Hohenboken M, Poling T, Jaehnig P, Kanesa-Thasan N. Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer-Blind, Dose-Ranging Study. J Infect Dis. 2015 Jul 1;212(1):72-80. doi: 10.1093/infdis/jiu826. Epub 2014 Dec 23.