TIV and High Dose TIV in Subjects With Rheumatoid Arthritis

Inclusion Criteria

Inclusion Criteria for RA Subjects

• Male or non-pregnant female between the ages of 18 and 64 years, inclusive, who has stable RA and has received TNFi therapy during the previous 3 months.
• Female subjects: for the 30 days prior to enrollment through 30 days following receipt of TIV or HTIV vaccine must fulfill one of the following: (i) she is not able to bear children because she has been surgically sterilized (tubal ligation or hysterectomy) for at least one year or is at least 1 year post-menopausal or (ii) she agrees to practice effective methods of contraception including, but not limited to, abstinence, barrier methods (such as a condom or diaphragm) used with a spermicide, birth control pills, patches or hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices). Adherence to contraceptive method will be captured on the appropriate case report form (CRF).
• In good health, as determined by vital signs (see toxicity table in section 9.2.1.1), medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and physical examination.
• Intend to be available through 6 months following receipt of vaccine.
• Able to understand and comply with planned study procedures.
• Provide written informed consent prior to initiation of any study procedures.

Inclusion Criteria for Healthy Subjects

• Male or non-pregnant female between the ages of 18 and 64 years, inclusive.
• Female subjects: for the 30 days prior to enrollment through 30 days following receipt of TIV or HTIV vaccine must fulfill one of the following: (i) she is not able to bear children because she has been surgically sterilized (tubal ligation or hysterectomy) for at least one year or is at least 1 year post-menopausal or (ii) she agrees to practice effective methods of contraception including, but not limited to, abstinence, barrier methods (such as a condom or diaphragm) used with a spermicide, birth control pills, patches or hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices). Adherence to contraceptive method will be captured on the appropriate case report form (CRF).
• In good health, as determined by vital signs (see toxicity table in section 9.2.1.1), medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and physical examination.
• Intend to be available through 6 months following receipt of vaccine.
• Able to understand and comply with planned study procedures.
• Provide written informed consent prior to initiation of any study procedures.

Exclusion Criteria

Exclusion Criteria for all Subjects

• For subjects enrolled after July 2012: Enrolled in this study during the 2011-2012 flu season.
• Has received the seasonal influenza vaccine for the current season. For subjects enrolling between October 2011 and February 2012, this is the 2011-2012 seasonal influenza vaccine. For subjects enrolling after July 2012, this is the 2012-2013 seasonal influenza vaccine.
• Has a known allergy to eggs, egg proteins or other components in the vaccines (i.e. formaldehyde, gelatin sodium phosphate, sodium chloride, octylphenol ethoxylate).
• Has a known or suspected latex allergy or sensitivity.
• Has a positive urine or serum pregnancy test within 24 hours prior to vaccination (if female of childbearing potential as defined in Inclusion criterion 2), or women who are breastfeeding.
• Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
• Has an active neoplastic disease or a history of any hematologic malignancy (cancers of blood or bone marrow) or current bleeding or blood clotting disorder.
• For "healthy volunteer" (without RA) subjects: Long term (at least 14 days of prednisone 2 mg/kg or equivalent other glucocorticoid) use of oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or eq