Influenza
Conditions
Keywords
influenza, rheumatoid arthritis, TNF-alpha-inhibitor, Fluzone®, Fluzone® High Dose
Brief summary
A randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy aged 18 to 64 years of age and healthy gender-and age-matched control subjects . This study will investigate the immunogenicity, safety, and reactogenicity of two different doses of inactivated trivalent influenza virus vaccine (Sanofi Pasteur Fluzone \[15 mcg x 3 strains\] and Sanofi Pasteur Fluzone High Dose \[60 mcg x 3 strains\]) administered intramuscularly in individuals with rheumatoid arthritis receiving anti-TNF-alpha (TNFi) therapy and healthy age- and gender- matched controls.
Detailed description
This is a randomized, double-blinded, Phase II study in adults with Rheumatoid Arthritis receiving TNF-alpha inhibitor therapy, aged 18 years to 64 years of age. This study is designed to investigate the immunogenicity, safety, and reactogenicity of two different doses of inactivated trivalent influenza virus vaccine given at two dose levels (15 mcg and 60 mcg) administered IM in individuals with rheumatoid arthritis receiving anti-TNF-alpha therapy or age and gender matched control subjects. The study is conducted over two seasons, 2011-2012 and 2012-2013. Subjects enrolling between October 2011 and February 2012 will receive the 2011-2012 vaccine, while those enrolling after July 2012 will receive the 2012-2013 vaccine. Immunogenicity testing will determine the proportion of subjects in each group with titer a 4-fold rise in HAI titers (defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer \>/=1:40 or a pre-vaccination HAI titer \>/=1:10 and a minimum four-fold rise in post-vaccination HAI titer) against each of the specific influenza strains included in vaccine the subject received at day 21 following vaccination. The proportion of subjects in each group achieving a serum HAI titer of \>/= 1:40 or a 4-fold rise in HAI titer or greater in HAI titer against each strain in the vaccine compared to the controls subjects. Safety testing will assess the occurrence of vaccine-associated Serious adverse events (SAEs) throughout the course of the study, and the occurrence of solicited local and systemic adverse events (AEs) within 8 days post vaccination. Solicited AEs (including rheumatoid arthritis clinical status) will be assessed during the course of the study. Subjects will have four face to face visits and one telephone contact. Day 0 will include the consent process, a medical history and physical exam for the RA subjects to assess the activity of their RA at the time of enrollment, vital signs, phlebotomy for prevaccine serology. Subjects will be randomized to receive IM seasonal TIV or High-Dose TIV at this visit and will receive the assigned vaccine. They will be observed for 20 minutes and will be taught to fill out a 7 day memory aid that will assess daily temperature, local and systemic reactogenicity. A telephone call will be made to assess reactogenicity and to review the memory aid on day 3. Subjects will return on day 7 for review of the memory aid, AEs/SAEs, vital signs and phlebotomy for serology. A physical exam will be performed if indicated. They will return on day 21 and at 6 months for review of AEs/SAEs, vital signs and phlebotomy for serology. A physical exam will be performed if indicated.
Interventions
BIOLOGICALTrivalent inactivated influenza vaccine
Inactivated trivalent influenza virus vaccine (Sanofi Pasteur Fluzone® High Dose \[60 mcg x 3 strains\]), as a single intramuscular dose. 80 and up to 100 subjects. Subjects enrolling between October 2011 and February 2012 will receive the 2011-2012 vaccine and subjects enrolling after July 2012 will receive the 2012-2013 vaccine.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | Day 0 prior to and Day 21 following immunization | Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. |
| Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | Day 0 prior to and Day 21 following immunization | Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study. | Day 0 to Day 180 | Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnosis. |
| Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | Days 0, 7, 21 and 180 | Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2011-2012 seasonal inactivated TIV. Within each 2011-2012 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately. |
| Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | Days 0, 7, 21 and 180 | Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2012-2013 seasonal inactivated TIV. Within each 2012-2013 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately. |
| Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Day 0 to Day 7 | Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, shivering, and asthenia for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. |
| Number of Participants Reporting Fever | Day 0 to Day 7 | Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days. |
| Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Day 0 to Day 7 | Participants maintained a memory aid to record daily the occurrence of local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. |
| Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Day 0 to Day 7 | Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. |
| Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | Day 0 prior to and Days 7 and 180 following immunization | Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. |
| Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | Day 0 prior to and Days 7 and 180 following immunization | Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. |
| Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 0 to Days 7, 21 and 180 | The RAPID 3 score is an index of the three patient-reported measures from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) R808 and serves as an assessment of patient status for those with rheumatoid arthritis. The score consists of the cumulative total of the Function (FN), Pain (PN), and Patient Global (PTGL) values. The severity of the RAPID 3 score is categorized as: \>12=High Severity; 6.1-12=Moderate Severity; 3.1-6=Low Severity; and ≤3=Remission. The NP2 questionnaire was completed by RA participants at all clinic visits. Scores at Days 7, 21 and 180 were compared to Day 0 to determine worsening, defined as moving from the baseline category to a more severe category. |
| Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | Day 0 prior to and Days 7, 21 and 180 following immunization | Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. |
| Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | Day 0 prior to and Days 7, 21 and 180 following immunization | Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. |
Countries
United States
Participant flow
Recruitment details
Adults with rheumatoid arthritis (RA) receiving tumor necrosis factor (TNF)-alpha-inhibitor therapy and healthy controls were recruited from existing volunteer populations and the community around the clinical site. Participants were enrolled between 20OCT2011 - 3JAN2012 (2011-2012 vaccine); and 12SEP2012 -14JAN2013 (2012-2013 vaccine).
Participants by arm
| Arm | Count |
|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® | 6 |
| Healthy Controls, 2011-2012 Fluzone Standard Dose Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® | 6 |
| RA Participants, 2011-2012 Fluzone High Dose Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose | 10 |
| Healthy Controls, 2011-2012 Fluzone High Dose Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose | 10 |
| RA Participants, 2012-2013 Fluzone Standard Dose Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® | 19 |
| Healthy Controls, 2012-2013 Fluzone Standard Dose Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® | 19 |
| RA Participants, 2012-2013 Fluzone High Dose Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose | 16 |
| Healthy Controls, 2012-2013 Fluzone High Dose Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose | 16 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Healthy Controls, 2012-2013 Fluzone High Dose | RA Participants, 2012-2013 Fluzone High Dose | Healthy Controls, 2012-2013 Fluzone Standard Dose | RA Participants, 2012-2013 Fluzone Standard Dose | RA Participants, 2011-2012 Fluzone Standard Dose | Healthy Controls, 2011-2012 Fluzone High Dose | RA Participants, 2011-2012 Fluzone High Dose | Healthy Controls, 2011-2012 Fluzone Standard Dose |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 10 | 52.1 years STANDARD_DEVIATION 9.4 | 52.8 years STANDARD_DEVIATION 9.5 | 50.1 years STANDARD_DEVIATION 10.8 | 49.8 years STANDARD_DEVIATION 11 | 46.2 years STANDARD_DEVIATION 9.3 | 48.3 years STANDARD_DEVIATION 10.1 | 47.6 years STANDARD_DEVIATION 9.5 | 46.4 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 16 Participants | 15 Participants | 19 Participants | 18 Participants | 5 Participants | 10 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 95 Participants | 15 Participants | 15 Participants | 18 Participants | 19 Participants | 6 Participants | 7 Participants | 10 Participants | 5 Participants |
| Region of Enrollment United States | 102 participants | 16 participants | 16 participants | 19 participants | 19 participants | 6 participants | 10 participants | 10 participants | 6 participants |
| Sex: Female, Male Female | 64 Participants | 9 Participants | 9 Participants | 11 Participants | 11 Participants | 5 Participants | 7 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 38 Participants | 7 Participants | 7 Participants | 8 Participants | 8 Participants | 1 Participants | 3 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 6 | 5 / 6 | 10 / 10 | 9 / 10 | 18 / 19 | 14 / 19 | 16 / 16 | 12 / 16 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 10 | 0 / 10 | 1 / 19 | 0 / 19 | 0 / 16 | 1 / 16 |
Outcome results
Primary
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time frame: Day 0 prior to and Day 21 following immunization
Population: The analysis population includes all RA participants enrolled and vaccinated with the 2011-2012 vaccines.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) | 4 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) | 7 participants |
Comparison: This is the comparison for the B/Brisbane/60/2008 strain.p-value: 0.145Fisher Exact
Comparison: This is the comparison for the A/Perth/16/2009 (A/H3N2) strainp-value: 0.145Fisher Exact
Comparison: This is the comparison for the A/California/7/2009 (A/H1N1) strain.p-value: 0.999Fisher Exact
Primary
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time frame: Day 0 prior to and Day 21 following immunization
Population: The analysis population includes all RA participants enrolled and vaccinated with the 2012-2013 vaccines.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 | 6 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) | 9 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) | 8 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 | 9 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) | 10 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) | 12 participants |
Comparison: This is the comparison for the B/Wisconsin/1/2010 strainp-value: 0.182Fisher Exact
Comparison: This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain.p-value: 0.5Fisher Exact
Comparison: This is the comparison for the A/California/7/2009 (A/H1N1) strain.p-value: 0.087Fisher Exact
Secondary
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season
Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2011-2012 seasonal inactivated TIV. Within each 2011-2012 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.
Time frame: Days 0, 7, 21 and 180
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 7 | 44.9 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 180 | 15.9 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 180 | 71.3 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 0 | 22.4 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 0 | 10.0 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 21 | 40.0 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 180 | 28.3 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 7 | 31.7 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 21 | 50.4 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 0 | 56.6 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 7 | 89.8 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 21 | 89.8 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 7 | 56.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 21 | 71.3 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 180 | 35.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 0 | 20.0 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 7 | 142.5 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 180 | 35.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 0 | 20.0 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 7 | 89.8 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 0 | 22.4 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 21 | 56.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 180 | 142.5 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 21 | 285.1 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 180 | 65.0 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 0 | 24.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 7 | 74.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 21 | 121.3 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 180 | 56.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 0 | 37.3 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 7 | 197.0 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 21 | 211.1 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 0 | 32.5 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 7 | 160.0 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 21 | 288.4 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 180 | 91.9 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 7 | 139.3 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 0 | 41.4 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 0 | 23.0 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 7 | 242.5 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 180 | 56.6 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 21 | 130.0 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 180 | 85.7 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 21 | 242.5 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 180 | 74.6 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/Perth/16/2009 (A/H3N2) - Day 21 | 171.5 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | B/Brisbane/60/2008 - Day 7 | 80.0 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season | A/California/7/2009 (A/H1N1) - Day 0 | 42.1 titers |
Secondary
Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season
Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2012-2013 seasonal inactivated TIV. Within each 2012-2013 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.
Time frame: Days 0, 7, 21 and 180
Population: The analysis population includes all participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 7 | 90.9 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 180 | 49.4 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 180 | 78.5 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 0 | 10.0 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 0 | 31.8 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 21 | 26.8 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 180 | 15.3 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 7 | 21.9 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 21 | 120.6 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 0 | 38.6 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 7 | 109.1 titers |
| RA Participants, 2011-2012 Fluzone Standard Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 21 | 143.4 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 7 | 11.8 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 21 | 113.1 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 180 | 10.8 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 0 | 92.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 7 | 148.7 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 180 | 59.8 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 0 | 9.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 7 | 97.8 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 0 | 38.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 21 | 14.4 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 180 | 117.3 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 21 | 160.0 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 180 | 115.6 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 0 | 9.8 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 7 | 35.1 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 21 | 51.9 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 180 | 16.1 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 0 | 39.1 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 7 | 167.1 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 21 | 257.7 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 0 | 35.1 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 7 | 207.5 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 21 | 442.9 titers |
| RA Participants, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 180 | 123.4 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 7 | 226.3 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 0 | 45.6 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 0 | 7.1 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 7 | 203.0 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 180 | 9.1 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 21 | 20.0 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 180 | 96.2 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 21 | 226.3 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 180 | 100.8 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/Victoria/361/2011 (A/H3N2) - Day 21 | 252.2 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | B/Wisconsin/1/2010 - Day 7 | 19.6 titers |
| Healthy Controls, 2011-2012 Fluzone High Dose | Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season | A/California/7/2009 (A/H1N1) - Day 0 | 49.7 titers |
Secondary
Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time frame: Day 0 prior to and Days 7, 21 and 180 following immunization
Population: The analysis population includes all subjects enrolled and vaccinated with the 2011-2012 vaccines.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 21 | 4 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 7 | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 180 | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 21 | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 7 | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 21 | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 180 | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 3 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 7 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 21 | 3 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 3 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 7 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 21 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 21 | 4 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 180 | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 4 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 180 | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 21 | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 180 | 3 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 21 | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 7 | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 180 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 21 | 7 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 7 | 4 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 7 | 5 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 21 | 6 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 21 | 6 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 21 | 5 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 5 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 2 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 180 | 2 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 180 | 3 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 7 | 4 participants |
Comparison: This is the comparison for the B/Brisbane/60/2008 strain at Day 21.p-value: 0.317McNemar
Comparison: This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.p-value: 0.564McNemar
Comparison: This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.p-value: 0.999McNemar
Comparison: This is the comparison for the B/Brisbane/60/2008 strain at Day 21.p-value: 0.564McNemar
Comparison: This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.p-value: 0.999McNemar
Comparison: This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.p-value: 0.655McNemar
Secondary
Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time frame: Day 0 prior to and Days 7, 21 and 180 following immunization
Population: The analysis population includes all subjects enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 180 | 5 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 21 | 8 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 21 | 6 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 21 | 9 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 180 | 2 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 7 | 6 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 7 | 5 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 21 | 3 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 7 | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 21 | 3 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 180 | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 7 | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 21 | 8 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 180 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 21 | 12 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 21 | 9 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 21 | 10 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 7 | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 9 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 180 | 7 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 180 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 7 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 7 | 7 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 1 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 21 | 5 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 180 | 0 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 7 | 5 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 7 | 9 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 21 | 11 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 180 | 4 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 7 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 21 | 7 participants |
Comparison: This is the comparison for the B/Wisconsin/1/2010 strain at Day 21.p-value: 0.18McNemar
Comparison: This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.p-value: 0.763McNemar
Comparison: This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.p-value: 0.096McNemar
Comparison: This is the comparison for the B/Wisconsin/1/2010 strain at Day 21p-value: 0.157McNemar
Comparison: This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.p-value: 0.705McNemar
Comparison: This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.p-value: 0.132McNemar
Secondary
Number of Participants Reporting Fever
Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.
Time frame: Day 0 to Day 7
Population: The analysis population includes all participants enrolled and vaccinated in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Fever | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Fever | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Fever | 0 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Fever | 0 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Fever | 0 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Fever | 0 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Fever | 0 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Fever | 0 participants |
Secondary
Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale
Participants maintained a memory aid to record daily the occurrence of local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time frame: Day 0 to Day 7
Population: The analysis population includes all participants enrolled and vaccinated in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Swelling | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Tenderness | 5 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Redness | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Pain | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Swelling | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Pain | 3 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Tenderness | 5 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Redness | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Tenderness | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Pain | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Swelling | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Redness | 0 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Redness | 1 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Swelling | 0 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Tenderness | 9 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Pain | 4 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Redness | 1 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Swelling | 3 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Tenderness | 6 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Pain | 4 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Swelling | 6 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Tenderness | 12 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Redness | 3 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Pain | 6 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Tenderness | 12 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Pain | 8 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Redness | 5 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Swelling | 5 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Tenderness | 10 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Pain | 5 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Swelling | 6 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale | Redness | 2 participants |
Secondary
Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions
Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Time frame: Day 0 to Day 7
Population: The analysis population includes all participants enrolled and vaccinated in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Redness | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Swelling | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Redness | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Swelling | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Redness | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Swelling | 1 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Redness | 1 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Swelling | 0 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Redness | 1 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Swelling | 3 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Redness | 3 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Swelling | 6 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Swelling | 5 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Redness | 5 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Redness | 2 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions | Swelling | 6 participants |
Secondary
Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale
Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, shivering, and asthenia for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
Time frame: Day 0 to Day 7
Population: The analysis population includes all participants enrolled and vaccinated in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Malaise | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Arthralgia | 6 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Chills | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Feverishness | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Nausea | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Asthenia | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Shivering | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Headache | 4 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Myalgia | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Malaise | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Arthralgia | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Myalgia | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Headache | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Asthenia | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Nausea | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Chills | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Feverishness | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Shivering | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Myalgia | 4 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Malaise | 5 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Feverishness | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Chills | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Nausea | 3 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Arthralgia | 7 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Asthenia | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Shivering | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Headache | 3 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Chills | 0 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Headache | 5 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Myalgia | 1 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Asthenia | 1 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Feverishness | 1 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Shivering | 0 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Malaise | 1 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Nausea | 0 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Arthralgia | 0 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Feverishness | 1 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Headache | 8 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Arthralgia | 18 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Chills | 4 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Nausea | 6 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Shivering | 2 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Malaise | 13 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Myalgia | 14 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Asthenia | 12 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Malaise | 3 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Feverishness | 1 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Myalgia | 2 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Headache | 5 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Nausea | 1 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Chills | 0 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Arthralgia | 1 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Shivering | 1 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Asthenia | 0 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Arthralgia | 14 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Chills | 0 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Nausea | 5 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Shivering | 0 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Headache | 8 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Feverishness | 1 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Myalgia | 13 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Malaise | 13 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Asthenia | 9 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Asthenia | 0 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Myalgia | 2 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Nausea | 0 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Feverishness | 0 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Malaise | 1 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Arthralgia | 2 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Shivering | 0 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Headache | 2 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale | Chills | 0 participants |
Secondary
Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study.
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.
Time frame: Day 0 to Day 180
Population: The analysis population includes all participants enrolled and vaccinated in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study. | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study. | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study. | 0 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study. | 0 participants |
| RA Participants, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study. | 0 participants |
| Healthy Controls, 2012-2013 Fluzone Standard Dose | Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study. | 0 participants |
| RA Participants, 2012-2013 Fluzone High Dose | Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study. | 0 participants |
| Healthy Controls, 2012-2013 Fluzone High Dose | Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study. | 0 participants |
Secondary
Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time frame: Day 0 prior to and Days 7 and 180 following immunization
Population: The analysis population includes all RA subjects enrolled and vaccinated with the 2011-2012 vaccines.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 7 | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 180 | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 7 | 1 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 180 | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 3 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 7 | 4 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 180 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Brisbane/60/2008 - Day 180 | 3 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Perth/16/2009 (A/H3N2) - Day 7 | 6 participants |
Comparison: This is the comparison for the B/Brisbane/60/2008 strain at Day 7.p-value: 0.234Fisher Exact
Comparison: This is the comparison for the B/Brisbane/60/2008 strain at Day 180.p-value: 0.25Fisher Exact
Comparison: This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 7.p-value: 0.145Fisher Exact
Comparison: This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 180.p-value: 0.5Fisher Exact
Comparison: This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.p-value: 0.999Fisher Exact
Comparison: This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.p-value: 0.5Fisher Exact
Secondary
Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received
Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.
Time frame: Day 0 prior to and Days 7 and 180 following immunization
Population: The analysis population includes RA participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose recipient is not included at Day 180 because the participant was out of window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 7 | 5 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 180 | 2 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 7 | 6 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 180 | 5 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 6 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 7 | 9 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 7 | 6 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 180 | 7 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | B/Wisconsin/1/2010 - Day 180 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/California/7/2009 (A/H1N1) - Day 180 | 7 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received | A/Victoria/361/2011 (A/H3N2) - Day 7 | 7 participants |
Comparison: This is the comparison for the B/Wisconsin/1/2010 strain at Day 7.p-value: 0.716Fisher Exact
Comparison: This is the comparison for the B/Wisconsin/1/2010 strain at Day 180.p-value: 0.999Fisher Exact
Comparison: This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 7.p-value: 0.503Fisher Exact
Comparison: This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 180.p-value: 0.475Fisher Exact
Comparison: This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.p-value: 0.182Fisher Exact
Comparison: This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.p-value: 0.014Fisher Exact
Secondary
Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire
The RAPID 3 score is an index of the three patient-reported measures from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) R808 and serves as an assessment of patient status for those with rheumatoid arthritis. The score consists of the cumulative total of the Function (FN), Pain (PN), and Patient Global (PTGL) values. The severity of the RAPID 3 score is categorized as: \>12=High Severity; 6.1-12=Moderate Severity; 3.1-6=Low Severity; and ≤3=Remission. The NP2 questionnaire was completed by RA participants at all clinic visits. Scores at Days 7, 21 and 180 were compared to Day 0 to determine worsening, defined as moving from the baseline category to a more severe category.
Time frame: Day 0 to Days 7, 21 and 180
Population: All RA participants are included in the analysis population for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 7 | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 180 | 0 participants |
| RA Participants, 2011-2012 Fluzone Standard Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 21 | 1 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 7 | 0 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 180 | 3 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 21 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 21 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 7 | 2 participants |
| RA Participants, 2011-2012 Fluzone High Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 180 | 3 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 7 | 2 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 180 | 3 participants |
| Healthy Controls, 2011-2012 Fluzone High Dose | Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire | Day 21 | 2 participants |