Recruitment

Recruitment Status
Completed
Estimated Enrollment
600

Inclusion Criterias

Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
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
Males and females 3 years of age and older
...
Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
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
Males and females 3 years of age and older
Individuals who can comply with study procedures and are available for follow-up

Exclusion Criterias

Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
Intrauterine device (IUD);
For adults 18 years or older: Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years
...
Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
Intrauterine device (IUD);
For adults 18 years or older: Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years
Individuals who have had a previous confirmed or suspected illness from swine flu (H3N2v)
Individuals who are allergic to any of the vaccine components.
autoimmune disorders;
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)
"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
Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse;
Individuals who have received any prior H3N2v vaccine
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
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
autoimmune disease such as rheumatoid arthritis, HIV infection, hypo- or agammaglobulinemia;
Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered
For children 17 years of age and younger: Individuals who have had ever a malignancy
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
Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry.
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
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
Individuals with a body temperature >38°C (>100.4°F) or any acute illness within 3 days of intended study vaccination
Individuals with a BMI > 35 kg/m2 (adults), > 29 kg/m2 (adolescents), or > 21 kg/m2 (children)
If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination
Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome
Individuals who have a suspected/confirmed diagnosis for any Adverse event of Special interest
Individuals who are research staff involved with the clinical study or family/household members of research staff
Individuals with a history of drug or alcohol abuse within the past 2 years
Systemic therapy with corticosteroids or other immunosuppressive therapy.
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
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

Summary

Conditions
Prophylaxis of A/H3N2v Influenza
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 3 years and 92 years
Gender
Both males and females

Inclusion Criterias

Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
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
Males and females 3 years of age and older
...
Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
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
Males and females 3 years of age and older
Individuals who can comply with study procedures and are available for follow-up

Exclusion Criterias

Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
Intrauterine device (IUD);
For adults 18 years or older: Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years
...
Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
Intrauterine device (IUD);
For adults 18 years or older: Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years
Individuals who have had a previous confirmed or suspected illness from swine flu (H3N2v)
Individuals who are allergic to any of the vaccine components.
autoimmune disorders;
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)
"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
Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse;
Individuals who have received any prior H3N2v vaccine
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
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
autoimmune disease such as rheumatoid arthritis, HIV infection, hypo- or agammaglobulinemia;
Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered
For children 17 years of age and younger: Individuals who have had ever a malignancy
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
Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry.
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
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
Individuals with a body temperature >38°C (>100.4°F) or any acute illness within 3 days of intended study vaccination
Individuals with a BMI > 35 kg/m2 (adults), > 29 kg/m2 (adolescents), or > 21 kg/m2 (children)
If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination
Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome
Individuals who have a suspected/confirmed diagnosis for any Adverse event of Special interest
Individuals who are research staff involved with the clinical study or family/household members of research staff
Individuals with a history of drug or alcohol abuse within the past 2 years
Systemic therapy with corticosteroids or other immunosuppressive therapy.
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
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

Locations

Redding, California, 96001
Rochester, New York, 14609
Dallas, Texas, 75234
Lexington, Kentucky, 40509
Lenexa, Kansas, 66213
...
Redding, California, 96001
Rochester, New York, 14609
Dallas, Texas, 75234
Lexington, Kentucky, 40509
Lenexa, Kansas, 66213
Sacramento, California, 95822
Wichita, Kansas, 67207
Metairie, Louisiana, 70006
Salt lake City, Utah, 84109
Warwick, Rhode Island, 02886
Raleight, North Carolina, 27609

Tracking Information

NCT #
NCT01855945
Collaborators
Not Provided
Investigators
Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines