Phase 4
N=413
Comparison of Three Licensed Influenza Vaccines
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT03068949 ↗Enrolled (actual)
413
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Mean Change of HAI Serum Antibody Titers to A/California/07/09 (H1N1) — 1937; 383; 607 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FluBlok (Biological); Fluzone (Biological); FluCelVax (Biological); Fluzone HD (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change of HAI Serum Antibody Titers to A/California/07/09 (H1N1) |
1937; 383; 607 | — |
| PRIMARY Mean Change of HAI Serum Antibody Titers to A/Michigan/45/2015 (H1N1) |
564; 420; 354; 898 | — |
| PRIMARY Mean Change of HAI Serum Antibody Titers to A/Switzerland/9715293/13 (H3N2) |
1733; 1711; 799 | — |
| PRIMARY Mean Change of MN Serum Antibody Titers to A/California/07/09 (H1N1) |
2786; 373; 881 | — |
| PRIMARY Mean Change of MN Serum Antibody Titers to A/Michigan/45/2015 (H1N1) |
1007; 554; 308; 1477 | — |
| PRIMARY Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From pH1N1 HA |
71.2; 21.4; 29.5; 39.8 | — |
| PRIMARY Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From H3 HA |
93.2; 14.0; 21.5; 58.6 | — |
| PRIMARY Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From Influenza B HA |
178.0; 89.2; 79.0; 42.1 | — |
| PRIMARY Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From NP |
-23.9; -9.7; -16.9; 19.6 | — |
| PRIMARY Mean Change in CD4 T Cells Reactivity to Pools of Total pHA Peptides Derived From M1 |
-18.9; -18.7; 20.9; -36.3 | — |
Summary
This study will evaluate in detail the way that the immune system responds to three different kinds of flu shots that are licensed in the United States.
Eligibility Criteria
Inclusion Criteria
- Aged between 18 and 49 years of age (inclusive).
- Female subjects must fulfill one of the following: (i) not able to bear children because she has been surgically sterilized (tubal ligation or hysterectomy) or (ii) agrees to practice effective methods of contraception that may include, but are not limited to abstinence, barrier methods, monogamous relationship with vasectomized partner, birth control pills, patches, hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices), from 30 days prior to study enrollment through 30 days following receipt of the last dose of vaccine.
- Female subjects of childbearing potential must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination.
- The subject must be in good health, as determined by: vital signs (heart rate >55 to 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
- The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
- The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days.
- The subject has an acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include any acute or chronic medical disease or conditions defined as persisting for 3 months (defines ad 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses of the subject's successful completion of the study.
- Subjects with an active infection or that has an acute illness or an oral temperature greater than 99.9F (37.7C) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated symptoms resolved are eligible to enroll as long as treatment is completed and symptoms resolved > 3 days prior to enrollment.
- The subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period.
- The subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
- The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis, or is receiving psychiatric drugs. Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensation are allowed enrollment into the study.
- The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment.
- The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- The subject has any condition that the principal investigator (PI) believes may interfere with successful completion of the study.
Data sourced from ClinicalTrials.gov (NCT03068949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.