NCT02133781

Brief Summary

This is an exploratory study using a strategy that has not been previously employed to investigate the effects of age and vaccine type on specific kinds of immune responses to licensed, seasonal 2009-2010 influenza vaccines in children and adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

March 10, 2017

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

May 6, 2014

Results QC Date

January 13, 2017

Last Update Submit

May 7, 2018

Conditions

Influenza

Keywords

Inactivated influenza vaccineLive, attenuated influenza vaccineChild identical twinsYoung and elderly adults

Outcome Measures

Primary Outcomes (1)

  • Number of Participants From Each Arm Who Received Influenza Vaccine

    Day 0 to 28

Secondary Outcomes (1)

  • Number of Participants With Related Adverse Events

    Day 0 to 28 post-immunization

Other Outcomes (1)

  • To Investigate the Effects of Age and Vaccine Type on B-cell Responses to Influenza Vaccine

    Day 0 to 28

Study Arms (3)

Age 8-17 years (identical twins )

EXPERIMENTAL

Participants will be randomized to receive either Fluzone® 2009-2010 Formula or FluMist® 2009-2010 Formula

Biological: Fluzone® 2009-2010 FormulaBiological: FluMist® 2009-2010 Formula

Age 18-30 years (non-twins)

EXPERIMENTAL

Participants will be receive Fluzone® 2009-2010 Formula

Biological: Fluzone® 2009-2010 Formula

Age >70 years (non-twins)

EXPERIMENTAL

Participants will receive Fluzone® 2009-2010 Formula

Biological: Fluzone® 2009-2010 Formula

Interventions

Fluzone® 2009-2010 FormulaBIOLOGICAL

This vaccine is given intramuscularly

Also known as: Trivalent inactivated influenza vaccine (TIV), FDA-licensed seasonal influenza vaccine
Age 18-30 years (non-twins)Age 8-17 years (identical twins )Age >70 years (non-twins)
FluMist® 2009-2010 FormulaBIOLOGICAL

This vaccine is given intranasally

Also known as: Live, attenuated influenza vaccine (LAIV), FDA-licensed seasonal influenza vaccine
Age 8-17 years (identical twins )

Eligibility Criteria

Age8 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Otherwise healthy, ambulatory children 8-17 year-old twins, adults 18-30 years old (non-twin) or 70-100 year-old elderly non-twin adults.
  • Willing to complete the informed consent process.
  • Availability for follow-up for the planned duration of the study at least 28 days after immunization.
  • Acceptable medical history by medical history and vital signs.

You may not qualify if:

  • Prior off-study vaccination with the current seasonal TIV or LAIV in Fall 2009
  • Allergy to egg or egg products, or to vaccine components, including gentamicin, gelatin, arginine or MSG (for LAIV only), or thimerosal (TIV multidose vials only).
  • Life-threatening reactions to previous influenza vaccinations
  • Asthma or history of wheezing (for volunteers randomized to LAIV)
  • Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  • History of immunodeficiency (including HIV infection)
  • 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.
  • Blood pressure \>150 systolic or \>95 diastolic at first study visit
  • Hospitalization in the past year for congestive heart failure or emphysema.
  • Chronic Hepatitis B or C.
  • 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 only). Use of oral steroids (\<20 mg prednisone-equivalent/day) may be acceptable for volunteers 70-100 yrs of age after review by the investigator.
  • Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV
  • 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).
  • 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.
  • History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford LPCH Vaccine Program

Stanford, California, 94305, United States

Location

Related Publications (6)

  • He XS, Sasaki S, Narvaez CF, Zhang C, Liu H, Woo JC, Kemble GW, Dekker CL, Davis MM, Greenberg HB. Plasmablast-derived polyclonal antibody response after influenza vaccination. J Immunol Methods. 2011 Feb 28;365(1-2):67-75. doi: 10.1016/j.jim.2010.12.008. Epub 2010 Dec 21.

    PMID: 21182843BACKGROUND

  • Sasaki S, Sullivan M, Narvaez CF, Holmes TH, Furman D, Zheng NY, Nishtala M, Wrammert J, Smith K, James JA, Dekker CL, Davis MM, Wilson PC, Greenberg HB, He XS. Limited efficacy of inactivated influenza vaccine in elderly individuals is associated with decreased production of vaccine-specific antibodies. J Clin Invest. 2011 Aug;121(8):3109-19. doi: 10.1172/JCI57834. Epub 2011 Jul 25.

    PMID: 21785218BACKGROUND

  • He XS, Sasaki S, Baer J, Khurana S, Golding H, Treanor JJ, Topham DJ, Sangster MY, Jin H, Dekker CL, Subbarao K, Greenberg HB. Heterovariant cross-reactive B-cell responses induced by the 2009 pandemic influenza virus A subtype H1N1 vaccine. J Infect Dis. 2013 Jan 15;207(2):288-96. doi: 10.1093/infdis/jis664. Epub 2012 Oct 29.

    PMID: 23107783BACKGROUND

  • Jiang N, He J, Weinstein JA, Penland L, Sasaki S, He XS, Dekker CL, Zheng NY, Huang M, Sullivan M, Wilson PC, Greenberg HB, Davis MM, Fisher DS, Quake SR. Lineage structure of the human antibody repertoire in response to influenza vaccination. Sci Transl Med. 2013 Feb 6;5(171):171ra19. doi: 10.1126/scitranslmed.3004794.

    PMID: 23390249BACKGROUND

  • Brodin P, Jojic V, Gao T, Bhattacharya S, Angel CJ, Furman D, Shen-Orr S, Dekker CL, Swan GE, Butte AJ, Maecker HT, Davis MM. Variation in the human immune system is largely driven by non-heritable influences. Cell. 2015 Jan 15;160(1-2):37-47. doi: 10.1016/j.cell.2014.12.020.

    PMID: 25594173BACKGROUND

  • de Bourcy CFA, Dekker CL, Davis MM, Nicolls MR, Quake SR. Dynamics of the human antibody repertoire after B cell depletion in systemic sclerosis. Sci Immunol. 2017 Sep 29;2(15):eaan8289. doi: 10.1126/sciimmunol.aan8289.

    PMID: 28963118DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Dr. Cornelia Dekker
Organization
Stanford University School of Medicine, Dept. of Pediatrics
cdekker@stanford.edu
650-724-4437

Study Officials

  • Cornelia L Dekker, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Harry B Greenberg, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Xiaosong He, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Pediatrics

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 8, 2014

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 6, 2018

Results First Posted

March 10, 2017

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)