Prophylaxis of A/H3N2v Influenza Clinical Trial
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.
| Verified date | January 2016 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 627 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 3 Years to 92 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | 42, Research Acros | Dallas | Texas |
| United States | 46, Johnson County Clinical Trials | Lenexa | Kansas |
| United States | 43, Central Kentucky Research Associates | Lexington | Kentucky |
| United States | 41, Benchmark Research | Metairie | Louisiana |
| United States | 50, PMG Research of Raleigh | Raleight | North Carolina |
| United States | 51, Northern California Clinical Research Center | Redding | California |
| United States | 44, Rochester Clinical Research Inc. | Rochester | New York |
| United States | 47, Benchmark Research | Sacramento | California |
| United States | 48, "J. Lewis Research, Inc. | Salt lake City | Utah |
| United States | 45, Omega Medical Research | Warwick | Rhode Island |
| United States | 49, Heartland Research Associates, LLC | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Vaccines |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. | Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to <9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination. | Day 1 through Day 7 after each vaccination | No |
| Primary | Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to <18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination. | Day 1 through Day 7 after each vaccination | No |
| Primary | Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to < 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination. | Day 1 through Day 7 after each vaccination | No |
| Primary | Number of Subjects (= 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (= 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination. | Day 1 through Day 7 after each vaccination | No |
| Primary | Number of Subjects (3 to = 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine. | The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported. The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported. |
Day 1 through Day 366 | No |
| Primary | 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. | The percentages of subjects (3 to = 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported. Seroconversion is defined as HI titer =1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer =1:10) on Day 22 and Day 43. |
Day 22, Day 43 post vaccination | No |
| Primary | Percentages of Subjects (3 to = 65 Years of Age) Achieving HI Titers =1:40 Following Vaccination With H3N2 Monovalent Vaccine. | The percentages of subjects (3 to = 65 years of age) achieving HI titers =1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported. | Day 1, Day 22, Day 43 post vaccination | No |
| Secondary | Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to = 65 Years of Age). | The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to = 65 years. | Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination | No |
| Secondary | Geometric Mean Ratio of Subjects (3 to = 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to = 65 years. | Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1 | No |
| Secondary | Percentages of Subjects (3 to = 65 Years of Age) Achieving HI Titers =1:40 Following Vaccination With H3N2 Monovalent Vaccine. | The percentages of subjects (3 to = 65 years of age) demonstrating HI titers =1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination. | Day 183 and Day 366 post vaccination | No |
| Secondary | 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. | The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to =61 years. Seroconversion is defined as HI titer =1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer =1:10) on Day 22 and Day 43. |
Day 22, Day 43 post vaccination | No |
| Secondary | Percentages of Subjects (3 to = 61 Years of Age) Achieving HI Titers =1:40 Following Vaccination With H3N2 Monovalent Vaccine. | The percentages of subjects achieving HI titers =1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to = 61 years. | Day 1, Day 22, Day 43 post vaccination | No |
| Secondary | GMR in Subjects (3 to = 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine. | GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to = 61 years. | Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1 | No |