Hematopoietic Cell Transplantation Recipient, Influenza, Malignant Neoplasm
Conditions
Brief summary
This phase II randomized trial studies how well high dose flu vaccine works in treating children who have undergone done stem cell transplant. Higher dose flu vaccine may build a better immune response and may provide better protection against the flu than the standard vaccine.
Detailed description
PRIMARY OBJECTIVES: I. To determine whether high-dose trivalent inactivated influenza vaccine (HD-TIV) compared with standard dose quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a \>= 4-fold rise in hemagglutination-inhibition (HAI) titers, \>= 1:40 HAI titer, or higher geometric mean titer (GMT) to influenza A antigens in pediatric hematopoietic stem cell transplant (HSCT) recipients. SECONDARY OBJECTIVES: I. To determine whether HD-TIV compared with standard dose QIV will increase the probability of achieving a \>= 4-fold rise in HAI titers, \>= 1:40 HAI titer, or higher GMT titers to influenza B antigens in pediatric HSCT recipients. II. To determine the frequency and severity of solicited local injection site adverse events (e.g. pain/ tenderness, redness, and swelling at injection site) with HD-TIV compared to standard QIV in pediatric HSCT recipients. III. To determine the frequency and severity of solicited systemic adverse events (e.g. fevers, headache, fatigue/malaise, nausea, body ache/myalgia, general activity level, and vomiting) with HD-TIV compared to standard dose QIV in pediatric HSCT recipients. IV. To define the relationship between HAI titers, in vivo T and B cell phenotype, and in vitro influenza-specific T and B cell response in pediatric HSCT recipients receiving either HD-TIV or standard dose QIV. V. To correlate HAI responses to microneutralization responses. VI. To compare the persistent HAI and microneutralization (MN) titers for all four antigen seven months after the last vaccine dose to assess for persistence of antibody titers. VII. To compare influenza detection by PCR during influenza season in pediatric HSCT recipients receiving either HD-TIV or standard dose QIV. VIII. To assess HAI and MN response in children vaccinated during year 1 and revaccinated during year 2 using the same antigen dose. OUTLINE: Patients are randomized to 1 of 2 treatment groups. GROUP I (Experimental): Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28. GROUP II (Standard): Patients receive standard dose QIV IM on day 0 and day 28. After completion of study treatment, patients are followed up at 28-42 days, and at 7 months.
Interventions
BIOLOGICALTrivalent Influenza Vaccine
High dose Trivalent Influenza Vaccine given intramuscular
BIOLOGICALQuadrivalent Influenza Vaccine
Standard dose Quadrivalent Influenza Vaccine given intramuscular
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Inclusion criteria 1. Allogeneic HSCT recipients who are 3-35 months post-transplant; 2. 3-17 years of age, inclusive; 3. Available for duration of study; 4. Patients with stable GVHD for at least 4 weeks will be eligible (stable is defined as having no major increases in systemic immunosuppressive therapy for GVHD; adjustments of established medications to obtain a stable target level are acceptable and do not impact eligibility). Parent/legal guardian willing and capable of signing written informed consent; 5. Parent/legal guardian expected to be available for entire study; 6. Parent/legal guardian can be reached by telephone and/or electronic communication. 7. Subjects must have a platelet count of ≥30,000 to receive the immunizations. Patients requiring platelet transfusions are eligible to enroll and must have a platelet count ≥30,000 within 72 hours prior to their immunization, or platelet count ≥75,000 without transfusion documented within 30 days for subjects \<12 months post-transplant and within 90 days for subjects 12-35 months post-transplant. 2.
Exclusion criteria
1. History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein; 2. History of Guillain-Barre syndrome; 3. Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerism is permitted); 4. History of receiving current year seasonal influenza vaccine post-transplant; 5. Pregnant female; 6. History of proven influenza disease after September 1, 2018 prior to enrollment 7. Non-allogeneic (e.g. autologous) or syngeneic hematopoietic SCT recipients; 8. History of known active infection with HIV, Hepatitis B or Hepatitis C; 9. History of known severe latex hypersensitivity; 10. Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days prior to enrollment, including day of enrollment; 11. Receipt of IVIG/SCIG \<27 days prior to calendar day of vaccination; 12. Subjects who have participated in year 1 and/or 2 of the study, and received study vaccine Criteria for temporarily delaying vaccine administration: The following conditions are temporary or self-limiting, and a subject may be included in the study once the condition has resolved, provided that the subject is otherwise eligible: 1). Fever ≥100.4ºF/38.0ºC (oral measurement), or an acute illness within 48 hours of enrollment 2). Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks prior to potential study vaccination. Note: if patients were eligible for vaccine 1, they will be eligible to receive vaccine 2 regardless of any changes on their GVHD status, unless it is deemed not medically safe to receive influenza vaccine. For subjects who were enrolled and vaccinated in 2016-17, 2017-18, or 2018-19, the goal is to enroll individuals who participated in the previous influenza season year and administer the same vaccination as the previous year. These subjects are referred to as repeaters. For example, subjects enrolled in 2016-17 could re-enroll in 2017-18, subjects enrolled in 2017-18 could re-enroll in 2018-19, and subjects in 2018-19 are deemed eligible to re-enroll in 2019-20 as repeaters. Subjects may only enroll as a repeater one time and must enroll the year after their original enrollment. Subjects must receive at least one vaccine to be eligible as a repeater in the subsequent year. Enrollment Criteria for Subjects who Participated in the previous influenza season * Repeaters will retain their original study ID and their randomization number * Previous screen failures will not be enrolled. * If visit 4 from the previous influenza season and visit 1 from the current influenza season year occur on the same day, lab results from visit 4 (prior to consent) can be part of visit 1. 1. Inclusion criteria 1. Available for duration of study; 2. Patients with stable GVHD for at least 4 weeks will be eligible (stable is defined as no major change in systemic immunosuppressive therapy for worsening GVHD; adjustment of actual dose to obtain a stable target level is acceptable). 3. Subjects must have a platelet count of ≥30,000 to receive the immunizations. Patients requiring platelet transfusions are eligible to enroll and must have a platelet count ≥30,000 within 72 hours prior to their immunization, or platelet count ≥75,000 without transfusion documented within 30 days for subjects \<12 months post-transplant and within 90 days for subjects 12-35 months post-transplant. 4. Parent/legal guardian willing and capable of signing written informed consent; 5. Parent/legal guardian expected to be available for entire study; 6. Parent/legal guardian can be reached by telephone and/or electronic communication. 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | Visit 1 (baseline) was day 0; visit 2 was 28-42 days after visit 1; visit 3 was 28-42 days after visit 2; and visit 4 was 138-222 days after visit 2. | Point estimates and 95% confidence intervals for proportion of subjects achieving seroconversion (4-fold or greater rise in HAI titers from visit 1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Solicited Local and Systemic Adverse Events | Up to 7 days following each vaccination: up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2 | The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol. Solicited injection site AEs included: pain, tenderness, erythema/redness, and swelling/induration. The diameter of any erythema/redness and swelling/induration was measured to evaluate redness size and swelling size. Solicited systemic AEs included: fevers, fatigue/malaise, headache, nausea, body ache/myalgia, generally activity, and vomiting. |
| T and B Cell Phenotype Assessed by Mass Cytometry | Visit 1 (baseline) was day 0; visit 2 was 28-42 days after visit 1; visit 3 was 28-42 days after visit 2; and visit 4 was 138-222 days after visit 2. | T and B cell response was assessed at visit 1,visit 2, visit 3, and visit 4. Results are incomplete due to pending grant funding for laboratory testing. This outcome will be updated once the funding has been obtained and results are available. |
| T and B Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays | Visit 1 (baseline) was day 0; optional visit 1 was 5-10 days after visit 1; visit 2 was 28-42 days after visit 1; optional visit 2 was 5-10 days after visit 2; visit 3 was 28-42 days after visit 2; and visit 4 was 138-222 days after visit 2. | T and B cell response was assessed at visit 1, an optional visit 5-10 days after visit 1, visit 2, an optional visit 5-10 days after visit 2, visit 3, and visit 4. Results are pending due to pending grant funding for laboratory testing. This outcome will be updated once the funding has been obtained and results are available. |
| Percentage of Individuals in Each Group Who Test Positive for Influenza | During the influenza season, up to 6 months | The percentage of breakthrough flu in vaccinated participants, separated by treatment group. |
Countries
United States
Participant flow
Recruitment details
A total of 200 children were targeted with the expectation of a 20% drop out rate, as described in Section C17 in the protocol. We were able to enroll 170 subjects with an 8% dropout rate between Visit 1 and Visit 4.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 - High Dose TIV Patients receive HD-TIV intramuscularly (IM) on day 0 and day 28.
Trivalent Influenza Vaccine: High dose Trivalent Influenza Vaccine given intramuscular
Laboratory Biomarker Analysis: Correlative studies | 85 |
| Group 2 - Standard Dose QIV Patients receive standard dose QIV IM on day 0 and day 28.
Quadrivalent Influenza Vaccine: Standard dose Quadrivalent Influenza Vaccine given intramuscular
Laboratory Biomarker Analysis: Correlative studies | 85 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Not otherwise eligible | 1 | 1 |
| Overall Study | Protocol Violation | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1 - High Dose TIV | Group 2 - Standard Dose QIV | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 85 Participants | 85 Participants | 170 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.7811 years | 10.6476 years | 10.8694 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 17 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 68 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 12 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 8 Participants | 15 Participants |
| Race (NIH/OMB) White | 55 Participants | 62 Participants | 117 Participants |
| Region of Enrollment United States | 85 participants | 85 participants | 170 participants |
| Sex: Female, Male Female | 40 Participants | 36 Participants | 76 Participants |
| Sex: Female, Male Male | 45 Participants | 49 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 85 | 0 / 85 |
| other Total, other adverse events | 1 / 85 | 2 / 85 |
| serious Total, serious adverse events | 17 / 85 | 9 / 85 |
Outcome results
Primary
Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers
Point estimates and 95% confidence intervals for proportion of subjects achieving seroconversion (4-fold or greater rise in HAI titers from visit 1).
Time frame: Visit 1 (baseline) was day 0; visit 2 was 28-42 days after visit 1; visit 3 was 28-42 days after visit 2; and visit 4 was 138-222 days after visit 2.
Population: The number analyzed for each row represents the number of participants that completed the indicated visit and had a recorded HAI titer for the indicated antigen and visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H1N1 Visit 2 | 0.20 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H1N1 Visit 3 | 0.42 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H1N1 Visit 4 | 0.31 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H3N2 Visit 2 | 0.22 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H3N2 Visit 3 | 0.41 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H3N2 Visit 4 | 0.36 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Victoria Visit 2 | 0.24 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Victoria Visit 3 | 0.46 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Victoria Visit 4 | 0.34 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Yamagata Visit 2 | 0.12 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Yamagata Visit 3 | 0.20 proportion of participants |
| Group 1 - High Dose TIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Yamagata Visit 4 | 0.19 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Yamagata Visit 3 | 0.41 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H1N1 Visit 2 | 0.20 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Victoria Visit 2 | 0.23 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H1N1 Visit 3 | 0.31 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Yamagata Visit 2 | 0.25 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H1N1 Visit 4 | 0.29 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Victoria Visit 3 | 0.46 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H3N2 Visit 2 | 0.14 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Yamagata Visit 4 | 0.42 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H3N2 Visit 3 | 0.31 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | B/Victoria Visit 4 | 0.38 proportion of participants |
| Group 2 - Standard Dose QIV | Immunogenicity as Measured by the Number of Subjects Who Achieve a 4-fold (or Greater) Rise in Post-vaccination HAI Titers | A/H3N2 Visit 4 | 0.35 proportion of participants |
Secondary
Percentage of Individuals in Each Group Who Test Positive for Influenza
The percentage of breakthrough flu in vaccinated participants, separated by treatment group.
Time frame: During the influenza season, up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 - High Dose TIV | Percentage of Individuals in Each Group Who Test Positive for Influenza | 11 Participants |
| Group 2 - Standard Dose QIV | Percentage of Individuals in Each Group Who Test Positive for Influenza | 13 Participants |
Secondary
Proportion of Solicited Local and Systemic Adverse Events
The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol. Solicited injection site AEs included: pain, tenderness, erythema/redness, and swelling/induration. The diameter of any erythema/redness and swelling/induration was measured to evaluate redness size and swelling size. Solicited systemic AEs included: fevers, fatigue/malaise, headache, nausea, body ache/myalgia, generally activity, and vomiting.
Time frame: Up to 7 days following each vaccination: up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2
Population: The number of subjects analyzed for Vaccine 1 represents the number of subjects who attended Visit 1 and received the first vaccine. The number of subjects analyzed for Vaccine 2 represents the number of subjects who attended Visit 2 and received the second vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Swelling | 0.167 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Pain | 0.341 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Headache | 0.165 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Tenderness | 0.435 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Pain | 0.345 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Redness size | 0.035 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Nausea | 0.129 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Swelling | 0.106 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Swelling size | 0.047 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Fever | 0.024 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Fever | 0.071 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Myalgia | 0.188 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Fatigue | 0.179 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Swelling size | 0.060 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Headache | 0.143 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - General activity | 0.129 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Nausea | 0.131 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Vomiting | 0.048 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Myalgia | 0.060 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Fatigue | 0.188 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - General activity | 0.107 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Vomiting | 0.071 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Tenderness | 0.429 proportion of participants |
| Group 1 - High Dose TIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Redness size | 0.083 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Nausea | 0.133 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Vomiting | 0.048 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Pain | 0.253 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Tenderness | 0.265 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Redness size | 0.048 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Swelling | 0.072 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Swelling size | 0.048 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Swelling | 0.082 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Fever | 0.012 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Fatigue | 0.235 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Headache | 0.153 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Nausea | 0.141 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Myalgia | 0.153 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - General activity | 0.188 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Vomiting | 0.071 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Pain | 0.341 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Tenderness | 0.424 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Redness size | 0.035 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 1 - Swelling size | 0.024 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Fever | 0.072 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Fatigue | 0.1181 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Headache | 0.157 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - Myalgia | 0.157 proportion of participants |
| Group 2 - Standard Dose QIV | Proportion of Solicited Local and Systemic Adverse Events | Vaccine 2 - General activity | 0.169 proportion of participants |
Secondary
T and B Cell Phenotype Assessed by Mass Cytometry
T and B cell response was assessed at visit 1,visit 2, visit 3, and visit 4. Results are incomplete due to pending grant funding for laboratory testing. This outcome will be updated once the funding has been obtained and results are available.
Time frame: Visit 1 (baseline) was day 0; visit 2 was 28-42 days after visit 1; visit 3 was 28-42 days after visit 2; and visit 4 was 138-222 days after visit 2.
Secondary
T and B Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays
T and B cell response was assessed at visit 1, an optional visit 5-10 days after visit 1, visit 2, an optional visit 5-10 days after visit 2, visit 3, and visit 4. Results are pending due to pending grant funding for laboratory testing. This outcome will be updated once the funding has been obtained and results are available.
Time frame: Visit 1 (baseline) was day 0; optional visit 1 was 5-10 days after visit 1; visit 2 was 28-42 days after visit 1; optional visit 2 was 5-10 days after visit 2; visit 3 was 28-42 days after visit 2; and visit 4 was 138-222 days after visit 2.