CompletedNCT00902278Updated Nov 20, 2017Results posted

Immune Responses Induced by Different Licensed Influenza Vaccines

An interventional study of Flulaval and Fluvirin in Immune Response, sponsored by University of Massachusetts, Worcester. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-20.

Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 193
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines.

Read the detailed description

There are currently five licensed inactivated influenza vaccines approved for use in the United States by the Food and Drug Administration.Current influenza virus vaccines consist of 3 components: the HA protein from an H1N1 virus, an H3N2 and an influenza B virus.Influenza vaccines are evaluated and approved by the FDA on the basis of HA and NA content. However, different manufacturing processes are involved in the preparation of these commercial vaccines and evidence suggests that each of these vaccines contain similar patterns of HA protein but different patterns of influenza influenza internal proteins such as NP and M1. The presence of these additional internal proteins of influenza virus which are targets of T cell responses suggest not only the potential for additional protection derived from influenza vaccines other than antibody mediated protection but also differential levels of T cell mediated protection between different manufacturers of commercial influenza vaccines.Each subject will have four blood samples taken- prevaccination and at Days 7, 14,30 and 3-5 months post vaccination. These samples will be tested for T and B cell responses and the results compared between different manufacturers.

Conditions studied

Immune Response

Browse trials for

Influenza, Human 2,214

Keywords

influenzavirus A
influenzavirus B
human influenza
T lymphocytes
influenza vaccines

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 193 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Adults (18-50 years of age)
Willing to donate a blood sample multiple times
Willing to sign informed consent and HIPAA

Exclusion criteria

Exclusion Criteria:

Known systemic hypersensitivity reactions to egg proteins (eggs or egg products), to chicken proteins
Known hypersensitivity to neomycin, thimerosol (mercury derivative), neomycin, or polymyxin
Previous life threatening reaction to influenza vaccine
Individuals with altered immunocompetence state from medical condition ( HIV, cancer) or through immunosuppressive therapy(irradiation,corticosteroids, antimetabolites, alkylating agents, cytotoxic agents)
Occurrence of neurological syndrome within six weeks of previous influenza immunization
Active neurological disorder characterized by changing neurological disorder
Pregnancy
Acute febrile illness
History of anemia or bleeding disorders

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 193 participants (actual)

Study arms

Active comparator
Flulaval
Biological: Flulaval
Active comparator
Fluvirin
Biological: Fluvirin
Active comparator
Fluzone
Biological: Fluzone
Active comparator
Fluarix
Biological: Fluarix
Active comparator
Affluria
Biological: Afluria

Interventions

BiologicalFlulaval
one 0.5-mL dose via intramuscular injection
BiologicalFluvirin
one 0.5-mL dose via intramuscular injection
BiologicalFluzone
one 0.5-mL dose via intramuscular injection
BiologicalFluarix
one 0.5-mL dose via intramuscular injection
BiologicalAfluria
one 0.5-mL dose via intramuscular injection

What researchers measure

Primary outcomes

T Cell Responses Following Immunization
Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups
Time frame: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination

Secondary outcomes

Antibody Responses Following Immunization
Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group
Time frame: Prevaccination and approximately 1 month post vaccination

Results

Posted Nov 20, 2017

Participant flow

We recruited healthy adults subjects during the 2008-2009, 2009-2010, 2010-2011, and 2011-2012 influenza seasons in a clinical research setting.

Participant flow — Overall Study
Milestone	Flulaval	Fluvirin	Fluzone	Fluarix	Afluria
Started	54	36	54	12	37
Completed	50	34	49	12	35
Not completed	4	2	5	0	2
Withdrew: Physician decision	1	0	2	0	1
Withdrew: Lost to follow-up	3	2	3	0	1

Outcome measures

PrimaryT Cell Responses Following Immunization

Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups

Time frame:: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination
Reported as:: Mean · fold change

T Cell Responses Following Immunization
fold change	Flulaval	Fluvirin	Fluzone	Fluarix	Afluria
H1N1 virus	—	1.5 ± .55	1.7 ± .84	1.9 ± .56	1.6 ± .71
H3N2 virus	—	2.4 ± 1.28	2.1 ± 1.34	2.7 ± 1.23	1.7 ± .60
B virus	—	1.5 ± .61	1.6 ± .59	1.6 ± .59	1.4 ± .61

SecondaryAntibody Responses Following Immunization

Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group

Time frame:: Prevaccination and approximately 1 month post vaccination
Reported as:: Geometric mean · fold change

Antibody Responses Following Immunization
fold change	Flulaval	Fluvirin	Fluzone	Fluarix	Afluria
H1N1	—	7.32 (-61.28 to 75.92)	7.02 (-54.6 to 68.62)	5.71 (-9.49 to 20.91)	5.26 (-5.88 to 16.4)
H3N2	—	7.6 (-30.1 to 45.3)	7.2 (-74.8 to 89.2)	4.9 (-6.2 to 16)	5.6 (-14.9 to 26.1)
B	—	3.4 (-41.6 to 48.4)	9.3 (-34 to 52.6)	9.6 (-52.99 to 72.21)	4.0 (-6.9 to 14.9)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Flulaval	0/52 (0%)	0/52 (0%)	30/52 (57.7%)
Fluvirin	0/34 (0%)	0/34 (0%)	24/34 (70.6%)
Fluzone	0/53 (0%)	0/53 (0%)	32/53 (60.4%)
Fluarix	0/11 (0%)	0/11 (0%)	6/11 (54.5%)
Afluria	0/36 (0%)	0/36 (0%)	25/36 (69.4%)

Most frequent other events

Showing 10 of 17

Most frequent other events
Event	Flulaval	Fluvirin	Fluzone	Fluarix	Afluria
HeadacheNervous system disorders	8/52	6/34	8/53	4/11	4/36
Injection site soreness/tendernessSkin and subcutaneous tissue disorders	17/52	10/34	11/53	1/11	13/36
Arm sorenessMusculoskeletal and connective tissue disorders	4/52	0/34	9/53	1/11	8/36
Sore throatGastrointestinal disorders	4/52	6/34	4/53	0/11	4/36
FatigueGeneral disorders	3/52	4/34	4/53	0/11	2/36
Joint painMusculoskeletal and connective tissue disorders	3/52	0/34	0/53	1/11	0/36
Muscle stiffness/achiness/painMusculoskeletal and connective tissue disorders	2/52	2/34	4/53	1/11	0/36
feversInfections and infestations	2/52	0/34	1/53	1/11	3/36
nauseaGastrointestinal disorders	1/52	1/34	2/53	1/11	2/36
injection site swellingSkin and subcutaneous tissue disorders	0/52	0/34	1/53	1/11	0/36

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Flulaval	Fluvirin	Fluzone	Fluarix	Afluria	Total
<=18 years	0	0	0	0	0	0
Between 18 and 65 years	54	36	54	12	37	193
>=65 years	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Flulaval	Fluvirin	Fluzone	Fluarix	Afluria	Total
Female	41	32	37	6	25	141
Male	13	4	17	6	12	52

Region of Enrollment
Region of Enrollment(participants)	Flulaval	Fluvirin	Fluzone	Fluarix	Afluria	Total
United States	54	36	54	12	37	193

Study locations

1 site

University of Massachusetts Medical School
Worcester, Massachusetts 01605, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00902278
Lead sponsor: University of Massachusetts, Worcester
Responsible party: Mary Co (Study Principle Investigator, University of Massachusetts, Worcester) — Principal investigator
First posted: May 15, 2009
Start date: Oct 2008
Primary completion: Apr 2016
Completion: Apr 2016
Results posted: Nov 20, 2017
Last update: Nov 20, 2017

Study contacts

Mary Dawn T Co, MD

principal investigator · University of Massachusetts, Worcester

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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