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
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 92
Updated:4/21/2016
Start Date:May 2013
End Date:September 2014

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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.

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.


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
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Metairie, Louisiana 70006
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Dallas, Texas 75234
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Lenexa, Kansas 66213
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Lexington, Kentucky 40509
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Raleight, North Carolina 27609
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Rochester, New York 14609
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Sacramento, California 95822
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Salt lake City, Utah 84109
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Warwick, Rhode Island 02886
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