NCT01201902

Brief Summary

The purpose of this study is to assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than or equal to 65 years of age.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
592

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
Last Updated

September 20, 2010

Status Verified

September 1, 2010

Enrollment Period

2 months

First QC Date

September 13, 2010

Last Update Submit

September 17, 2010

Conditions

Influenza Infection

Outcome Measures

Primary Outcomes (1)

  • HI antibody responses after 1 and/or 2 vaccinations

    21 days after vaccination

Secondary Outcomes (1)

  • Solicited local & general AE, Unsolicited AE, AE until 6 months after last vaccination

    the date of vaccination until 6 days after vaccination, 42days after first vaccination, 6 months after last vaccination

Study Arms (5)

Group 1 : Low dose with adjuvant

EXPERIMENTAL

Group 1: 18 \~ 64 years old subjects

Biological: Adjuvanted influenza A(H1N1) vaccine

Group 1: High dose with adjuvant

EXPERIMENTAL

Group 1: 18 \~ 64 years old subjects

Biological: Adjuvanted influenza A(H1N1) vaccine

Group1 : Plain vaccine

ACTIVE COMPARATOR

Group 1: 18 \~ 64 years old subjects

Biological: un-adjuvanted influenza A(H1N1) vaccine

Group 2 : Low dose with adjuvant

EXPERIMENTAL

Group 2: greater than or equal to 65 years of age

Biological: Adjuvanted influenza A(H1N1) vaccine

Group 2 : high dose with adjuvant

EXPERIMENTAL

Group 2: greater than or equal to 65 years of age

Biological: Adjuvanted influenza A(H1N1) vaccine

Interventions

Adjuvanted influenza A(H1N1) vaccineBIOLOGICAL

0.25ml, Intramuscular on Day 0 and 21

Also known as: Split-virion vaccine
Group 1 : Low dose with adjuvant
un-adjuvanted influenza A(H1N1) vaccineBIOLOGICAL

0.5ml, Intramuscular on Day 0 and 21

Also known as: Split-virion vaccine
Group1 : Plain vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults age 18 and older.
  • Are able to understand and comply with planned study procedures.
  • Provide written informed consent prior to initiation of any study procedures.

You may not qualify if:

  • Have a known allergy to eggs, chickens or other components of the vaccine(including MF59).
  • Have immunosuppression including immunodeficiency disease.
  • Have a history of Guillain-Barre Syndrome.
  • Have a diagnosis of thrombocytopenia.
  • Have a chronic disease that the investigator believes may interfere with successful completion of the study. (Excluding regulating hypertension)
  • Hemophilia Patients or Are receiving anti-coagulating agents. Low-dose aspirin (100mg/day) purpose of prevention is allowed.
  • Are receiving anti-viral agents.
  • Have an acute fever, a temperature greater than 38℃(100.4 degrees Fahrenheit) within 72 hours of vaccination or Have a symptom of acute febrile illness within 14 days prior to vaccination in this study.
  • Received below agents or expect to receive agents within following periods. A. Have immunosuppression therapy, radiotherapy, use of high-dose glucocorticoids or prednisolone(≥15mg/day) within 6 months prior to vaccination in this study.Inhaled, nasal and topical steroids are allowed) B. Have a history of receiving immunoglobulin or other blood product within 3 months prior to vaccination in this study.
  • C. Received an experimental agent within 1 month prior to vaccination in this study.
  • D. Received any vaccines(live licensed and inactivated licensed) within 1 month prior to vaccination in this study. (Excluding seasonal Influenza vaccine)
  • Those who are not eligible to receive vaccine injection in the arm deltoid muscle.
  • Pregnant females, Nursing mom, Those women who have a chance to become pregnant, but not taking a proper contraception.
  • Not agree to abstain from drinking following 7 days of vaccination.
  • Have any condition (clinically regardful medical or psychological condition) that would, in the opinion of the site investigator, render them unable to meet the requirements of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Woo-ju Kim

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 15, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

July 1, 2010

Last Updated

September 20, 2010

Record last verified: 2010-09