B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this exploratory study, investigators will be looking at immune response differences between age groups and between the two different influenza vaccines given to identical twins, vaccine-naive young adults and elderly participants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

B-cell Immunity to Influenza (SLVP017)- Year 1, 2009

NCT02133781

Influenza

COMPLETED PHASE4

B-cell Immunity to Influenza (SLVP017)- Year 5, 2013

NCT03020537

Influenza

COMPLETED PHASE4

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 2, 2010

NCT03022396

Influenza

COMPLETED PHASE4

T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009

NCT01987349

Influenza

COMPLETED PHASE4

Influenza Immunity Against Pandemic Respiratory Virus

NCT00138281

Influenza

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an exploratory study of healthy children and adults who are given either standard trivalent, inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV). There are no exclusions for gender, ethnicity or race. Following confirmation of written informed consent, baseline blood samples will be drawn from all study participants prior to immunization. The volunteers enrolled in any the three groups (A,B,C) cannot have been immunized with previous year's seasonal influenza vaccine. The identical twins in Groups A will be randomized to each receive a different vaccine (TIV or LAIV) than their twin. The non-twin children in Group B will also be randomly assigned to receive either TIV or LAIV. Non-twin elderly adults in Group C will be given standard TIV. All participants will receive a single dose of their assigned influenza vaccine, either by intramuscular (IM) injection (TIV) or intranasal application (LAIV).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A: 8-17 yo identical twins

Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair

Group Type OTHER

Fluzone

Intervention Type BIOLOGICAL

Influenza Virus Vaccine Suspension for Intramuscular Injection

FluMist

Intervention Type BIOLOGICAL

Influenza Virus Vaccine Live, Intranasal Intranasal Spray

Group B: 8-30 yo non-twin

Group B: 8-30 years old non-twin individuals randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))

Group Type OTHER

Fluzone

Intervention Type BIOLOGICAL

Influenza Virus Vaccine Suspension for Intramuscular Injection

FluMist

Intervention Type BIOLOGICAL

Influenza Virus Vaccine Live, Intranasal Intranasal Spray

Group C: 70-100 yo non-twin

Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))

Group Type OTHER

Fluzone

Intervention Type BIOLOGICAL

Influenza Virus Vaccine Suspension for Intramuscular Injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluzone

Influenza Virus Vaccine Suspension for Intramuscular Injection

Intervention Type BIOLOGICAL

FluMist

Influenza Virus Vaccine Live, Intranasal Intranasal Spray

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Healthy, ambulatory 8-17 year old identical twins, 8-30 year old non-twins, or 70-100 year old elderly non-twin adults.
2. Willing to complete the informed consent process.
3. Availability for follow-up for the planned duration of the study at least 28 days after immunization.
4. Acceptable medical history by medical history and vital signs.

Exclusion Criteria

1. Prior vaccination with seasonal TIV or LAIV or H1N1.
2. Prior off-study vaccination with the current seasonal TIV or LAIV
3. Allergy to egg or egg products, or to vaccine components
4. Life-threatening reactions to previous influenza vaccinations
5. Asthma or history of wheezing
6. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
7. History of immunodeficiency (including HIV infection)
8. Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
9. Blood pressure \>150 systolic or \>95 diastolic at first study visit
10. Hospitalization in the past year for congestive heart failure or emphysema.
11. Chronic Hepatitis B or C.
12. Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in all groups; inhaled steroid use is not permissible except for non-LAIV Group C only). Use of oral steroids (\<20mg prednisone-equivalent/day) may be acceptable for volunteers 70-100 yrs of age after review by the investigator.
13. Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV (Groups A and B only)
14. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
15. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
16. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
17. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
18. Receipt of blood or blood products within the past 6 months
19. Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
20. Inactivated vaccine 14 days prior to vaccination
21. Live, attenuated vaccine within 60 days of vaccination
22. History of Guillain-Barré Syndrome
23. Pregnant or lactating woman
24. Use of investigational agents within 30 days prior to enrollment
25. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment
26. Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.

Minimum Eligible Age

8 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes