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.

Novartis

Status and phase: Completed; Phase 1

Conditions: Prophylaxis of A/H3N2v Influenza

Treatments: Biological: Swine Influenza

Study type: Interventional

Funder types: Industry

Identifiers

NCT01855945

V129_01

Details and patient eligibility

About

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.

Enrollment: 627 patients

Sex: All

Ages: 3 to 92 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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627 participants in 3 patient groups

Group A

Experimental group

Description:

3.75 µg H3N2c HA + 0.125 mL MF59

Treatment:

Biological: Swine Influenza

Group B

Experimental group

Description:

7.5 µg H3N2c HÁ + 0.250 mL MF59

Treatment:

Biological: Swine Influenza

Group C

Experimental group

Description:

15 µg H3N2c unadjuvanted

Treatment:

Biological: Swine Influenza