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.

NCT ID: NCT01855945

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 627 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-09-30

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.

Conditions

Prophylaxis of A/H3N2v Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

3.75 µg H3N2c HA + 0.125 mL MF59

Group Type: EXPERIMENTAL

Swine Influenza

Intervention Type: BIOLOGICAL

Comparison of different dosages of vaccines

Group B

7.5 µg H3N2c HÁ + 0.250 mL MF59

Group Type: EXPERIMENTAL

Swine Influenza

Intervention Type: BIOLOGICAL

Comparison of different dosages of vaccines

Group C

15 µg H3N2c unadjuvanted

Group Type: EXPERIMENTAL

Swine Influenza

Intervention Type: BIOLOGICAL

Comparison of different dosages of vaccines

Interventions

Swine Influenza

Comparison of different dosages of vaccines

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 92 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines and Diagnostics

Role: STUDY_CHAIR

Novartis Vaccines

Locations

51, Northern California Clinical Research Center

Redding, California, United States

47, Benchmark Research

Sacramento, California, United States

46, Johnson County Clinical Trials

Lenexa, Kansas, United States

49, Heartland Research Associates, LLC

Wichita, Kansas, United States

43, Central Kentucky Research Associates

Lexington, Kentucky, United States

41, Benchmark Research

Metairie, Louisiana, United States

44, Rochester Clinical Research Inc.

Rochester, New York, United States

50, PMG Research of Raleigh

Raleight, North Carolina, United States

45, Omega Medical Research

Warwick, Rhode Island, United States

42, Research Acros

Dallas, Texas, United States

48, "J. Lewis Research, Inc.

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25538277 (View on PubMed)

Other Identifiers

V129_01

Identifier Type: -

Identifier Source: org_study_id