Trial Outcomes & Findings for Flu Vaccine Response in Patients on Biologic Therapies (NCT NCT03277703)

NCT ID: NCT03277703

Last Updated: 2026-08-06

Results Overview

immunological vaccine response

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

4-6 weeks post final influenza vaccination dose (if participants received a booster, this was after the booster dose) in Year 1 and Year 2

Results posted on

2026-08-06

Participant Flow

Patients were recruited at the beginning of the 2017-2018 flu season and 2018-2019 flu season. Recruitment ended end of the flu season. First patient was enrolled 11/3/2027and last patient completed last visit 12/30/2019. Patients were screened during routine outpatient clinic visits at Pediatric Rheumatology or Pediatric Gastroenterology.

One patient consented to study and was enrolled and was randomized to Group but withdrew prior to vaccination.

Participant milestones

Participant milestones
Measure	Group 1 Booster Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 2 Standard Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 but will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population
Year 1 STARTED	13	16
Year 1 COMPLETED	13	16
Year 1 NOT COMPLETED	0	0
Year 2 STARTED	13	16
Year 2 COMPLETED	13	16
Year 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flu Vaccine Response in Patients on Biologic Therapies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 - Booster n=13 Participants Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 2 - Standard n=16 Participants Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 but will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=20 Participants	13 Participants n=20 Participants	21 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=20 Participants	3 Participants n=20 Participants	8 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Continuous	17 years n=20 Participants	15 years n=20 Participants	16 years n=40 Participants
Sex: Female, Male Female	7 Participants n=20 Participants	9 Participants n=20 Participants	16 Participants n=40 Participants
Sex: Female, Male Male	6 Participants n=20 Participants	7 Participants n=20 Participants	13 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	1 Participants n=20 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants
Race (NIH/OMB) White	12 Participants n=20 Participants	12 Participants n=20 Participants	24 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Region of Enrollment United States	13 participants n=20 Participants	16 participants n=20 Participants	29 participants n=40 Participants

PRIMARY outcome

Timeframe: 4-6 weeks post final influenza vaccination dose (if participants received a booster, this was after the booster dose) in Year 1 and Year 2

immunological vaccine response

Outcome measures

Outcome measures
Measure	Group 1 - Booster n=13 Participants Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 2 - Standard n=16 Participants Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 but will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 1 - Year 1 Flu A (H3N2) Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 2 - Year 1 Flu A (H3N2) Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 but will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 1 - Year 1 Flu B Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 2 - Year 1 Flu B Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 but will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 1 - Year 2 Flu A (H1N1) Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 2 - Year 2 Flu A (H1N1) Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 but will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 1 - Year 2 Flu A (H3N2) Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 2 - Year 2 Flu A (H3N2) Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 but will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 1 - Year 2 Flu B Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1 and year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population	Group 2 - Year 2 Flu B Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1 but will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2. Influenza vaccine: The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies. Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population
Influenza Hemagglutination Inhibition (HAI) Titer Year 1 Flu A (H1N1)	220.3 geometric mean titer Interval 167.1 to 290.5	160.0 geometric mean titer Interval 85.0 to 301.1	—	—	—	—	—	—	—	—	—	—
Influenza Hemagglutination Inhibition (HAI) Titer Year 1 Flu A (H3N2)	258.5 geometric mean titer Interval 173.9 to 384.5	216.7 geometric mean titer Interval 118.6 to 395.9	—	—	—	—	—	—	—	—	—	—
Influenza Hemagglutination Inhibition (HAI) Titer Year 1 Flu B	40.0 geometric mean titer Interval 22.7 to 70.5	20.0 geometric mean titer Interval 20.0 to 20.0	—	—	—	—	—	—	—	—	—	—
Influenza Hemagglutination Inhibition (HAI) Titer Year 2 Flu A (H1N1)	264.9 geometric mean titer Interval 173.8 to 403.6	170.4 geometric mean titer Interval 96.5 to 300.9	—	—	—	—	—	—	—	—	—	—
Influenza Hemagglutination Inhibition (HAI) Titer Year 2 Flu A (H3N2)	127.0 geometric mean titer Interval 97.3 to 165.8	96.6 geometric mean titer Interval 48.3 to 193.4	—	—	—	—	—	—	—	—	—	—
Influenza Hemagglutination Inhibition (HAI) Titer Year 2 Flu B	29.4 geometric mean titer Interval 22.2 to 38.9	22.7 geometric mean titer Interval 13.7 to 37.5	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: through study completion, an average of 2 years

decreased influenza rates - seroprotection