Trial Outcomes & Findings for High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant (NCT NCT02860039)

Last Updated: 2024-10-22

Results Overview

Point estimates and 95% confidence intervals for proportion of subjects achieving seroconversion (4-fold or greater rise in HAI titers from visit 1).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

170 participants

Primary outcome timeframe

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.

Results posted on

2024-10-22

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	85	85
Overall Study Visit 1	85	85
Overall Study Visit 2	84	83
Overall Study Visit 3	78	83
Overall Study Visit 4	74	81
Overall Study Visit 1 Repeat	32	34
Overall Study Visit 2 Repeat	31	34
Overall Study Visit 3 Repeat	30	34
Overall Study Visit 4 Repeat	26	22
Overall Study COMPLETED	74	81
Overall Study NOT COMPLETED	11	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Death	4	0
Overall Study Lost to Follow-up	2	2
Overall Study Protocol Violation	3	1
Overall Study Withdrawal by Subject	1	0
Overall Study Not otherwise eligible	1	1

Baseline Characteristics

High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 - High Dose TIV n=85 Participants 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	Group 2 - Standard Dose QIV n=85 Participants 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	Total n=170 Participants Total of all reporting groups
Age, Categorical <=18 years	85 Participants n=39 Participants	85 Participants n=41 Participants	170 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	11.7811 years n=39 Participants	10.6476 years n=41 Participants	10.8694 years n=35 Participants
Sex: Female, Male Female	40 Participants n=39 Participants	36 Participants n=41 Participants	76 Participants n=35 Participants
Sex: Female, Male Male	45 Participants n=39 Participants	49 Participants n=41 Participants	94 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=39 Participants	17 Participants n=41 Participants	36 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=39 Participants	68 Participants n=41 Participants	134 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Asian	4 Participants n=39 Participants	2 Participants n=41 Participants	6 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	19 Participants n=39 Participants	12 Participants n=41 Participants	31 Participants n=35 Participants
Race (NIH/OMB) White	55 Participants n=39 Participants	62 Participants n=41 Participants	117 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=39 Participants	8 Participants n=41 Participants	15 Participants n=35 Participants
Region of Enrollment United States	85 participants n=39 Participants	85 participants n=41 Participants	170 participants n=35 Participants

PRIMARY outcome

Timeframe: 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.

Point estimates and 95% confidence intervals for proportion of subjects achieving seroconversion (4-fold or greater rise in HAI titers from visit 1).

Outcome measures

Outcome measures
Measure	Group 1 - High Dose TIV n=85 Participants 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	Group 2 - Standard Dose QIV n=85 Participants 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
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 Interval 0.25 to 0.47	0.35 proportion of participants Interval 0.25 to 0.46
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 Interval 0.06 to 0.2	0.25 proportion of participants Interval 0.17 to 0.35
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 Interval 0.13 to 0.3	0.20 proportion of participants Interval 0.13 to 0.3
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 Interval 0.31 to 0.53	0.31 proportion of participants Interval 0.22 to 0.42
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 Interval 0.21 to 0.43	0.29 proportion of participants Interval 0.2 to 0.4
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 Interval 0.14 to 0.31	0.14 proportion of participants Interval 0.08 to 0.23
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 Interval 0.3 to 0.52	0.31 proportion of participants Interval 0.22 to 0.42
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 Interval 0.16 to 0.34	0.23 proportion of participants Interval 0.15 to 0.33
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 Interval 0.35 to 0.57	0.46 proportion of participants Interval 0.35 to 0.57
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 Interval 0.24 to 0.46	0.38 proportion of participants Interval 0.28 to 0.49
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 Interval 0.12 to 0.3	0.41 proportion of participants Interval 0.31 to 0.52
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 Interval 0.11 to 0.29	0.42 proportion of participants Interval 0.31 to 0.53

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Group 1 - High Dose TIV n=85 Participants 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	Group 2 - Standard Dose QIV n=85 Participants 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
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Fever	0.024 proportion of participants Interval 0.003 to 0.082	0.012 proportion of participants Interval 0.0 to 0.064
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Fatigue	0.188 proportion of participants Interval 0.112 to 0.288	0.235 proportion of participants Interval 0.15 to 0.34
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Headache	0.165 proportion of participants Interval 0.093 to 0.261	0.153 proportion of participants Interval 0.084 to 0.247
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Nausea	0.129 proportion of participants Interval 0.066 to 0.22	0.141 proportion of participants Interval 0.075 to 0.234
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Myalgia	0.188 proportion of participants Interval 0.112 to 0.288	0.153 proportion of participants Interval 0.084 to 0.247
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - General activity	0.129 proportion of participants Interval 0.066 to 0.22	0.188 proportion of participants Interval 0.112 to 0.288
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Vomiting	0.071 proportion of participants Interval 0.026 to 0.147	0.071 proportion of participants Interval 0.026 to 0.147
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Pain	0.341 proportion of participants Interval 0.242 to 0.452	0.341 proportion of participants Interval 0.242 to 0.452
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Tenderness	0.435 proportion of participants Interval 0.328 to 0.547	0.424 proportion of participants Interval 0.317 to 0.536
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Redness size	0.035 proportion of participants Interval 0.007 to 0.1	0.035 proportion of participants Interval 0.007 to 0.1
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Swelling	0.106 proportion of participants Interval 0.05 to 0.192	0.082 proportion of participants Interval 0.034 to 0.162
Proportion of Solicited Local and Systemic Adverse Events Vaccine 1 - Swelling size	0.047 proportion of participants Interval 0.013 to 0.116	0.024 proportion of participants Interval 0.003 to 0.082
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Fever	0.071 proportion of participants Interval 0.027 to 0.149	0.072 proportion of participants Interval 0.027 to 0.151
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Fatigue	0.179 proportion of participants Interval 0.104 to 0.277	0.1181 proportion of participants Interval 0.105 to 0.28
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Headache	0.143 proportion of participants Interval 0.076 to 0.236	0.157 proportion of participants Interval 0.086 to 0.253
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Nausea	0.131 proportion of participants Interval 0.067 to 0.222	0.133 proportion of participants Interval 0.068 to 0.225
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Myalgia	0.060 proportion of participants Interval 0.02 to 0.133	0.157 proportion of participants Interval 0.086 to 0.253
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - General activity	0.107 proportion of participants Interval 0.05 to 0.194	0.169 proportion of participants Interval 0.095 to 0.267
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Vomiting	0.048 proportion of participants Interval 0.013 to 0.117	0.048 proportion of participants Interval 0.013 to 0.119
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Pain	0.345 proportion of participants Interval 0.245 to 0.457	0.253 proportion of participants Interval 0.164 to 0.36
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Tenderness	0.429 proportion of participants Interval 0.321 to 0.541	0.265 proportion of participants Interval 0.174 to 0.373
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Redness size	0.083 proportion of participants Interval 0.034 to 0.164	0.048 proportion of participants Interval 0.013 to 0.119
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Swelling	0.167 proportion of participants Interval 0.094 to 0.264	0.072 proportion of participants Interval 0.027 to 0.151
Proportion of Solicited Local and Systemic Adverse Events Vaccine 2 - Swelling size	0.060 proportion of participants Interval 0.02 to 0.133	0.048 proportion of participants Interval 0.013 to 0.119

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the influenza season, up to 6 months

The percentage of breakthrough flu in vaccinated participants, separated by treatment group.

Outcome measures

Outcome measures
Measure	Group 1 - High Dose TIV n=85 Participants 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	Group 2 - Standard Dose QIV n=85 Participants 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
Percentage of Individuals in Each Group Who Test Positive for Influenza	11 Participants	13 Participants

Adverse Events

Group 1 - High Dose TIV

Serious events: 17 serious events

Other events: 1 other events

Deaths: 4 deaths

Group 2 - Standard Dose QIV

Serious events: 9 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1 - High Dose TIV n=85 participants at risk 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	Group 2 - Standard Dose QIV n=85 participants at risk 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
General disorders Fever	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	2.4% 2/85 • Number of events 2 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Skin and subcutaneous tissue disorders Swelling	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.

Additional Information

Natasha Halasa, MD, MPH

Vanderbilt-Ingram Cancer Center

Phone: 800-811-8480

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1 - High Dose TIV n=85 participants at risk 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	Group 2 - Standard Dose QIV n=85 participants at risk 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
Infections and infestations Viral illness	4.7% 4/85 • Number of events 5 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations Group A Streptococcus	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations Pneumonia	2.4% 2/85 • Number of events 2 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	2.4% 2/85 • Number of events 2 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations Metapneumovirus	3.5% 3/85 • Number of events 3 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations Influenza	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations RSV	2.4% 2/85 • Number of events 2 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations Sepsis	2.4% 2/85 • Number of events 2 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations Coronavirus	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations Influenza B and RSV	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations C. difficile/Salmonella	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations BK Virus	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations Pansinusitis	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Skin and subcutaneous tissue disorders Allergic contact dermatitis	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Cardiac disorders Pericardial effusion	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Cardiac disorders Hypertension	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Gastrointestinal disorders Abdominal pain	1.2% 1/85 • Number of events 2 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Gastrointestinal disorders Nausea	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Gastrointestinal disorders Gastritis	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Gastrointestinal disorders GI GVHD	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
General disorders Fever	2.4% 2/85 • Number of events 2 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
General disorders Opioid withdrawal	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Nervous system disorders Altered mental status	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations Liver abscess	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.
Infections and infestations Adenovirus	1.2% 1/85 • Number of events 1 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.	0.00% 0/85 • AEs and SAEs will be collected through 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Adverse events will be followed until resolution or until considered stable.