NCT00943358

Brief Summary

The purpose of this study is to evaluate the antibody response to one and two doses of influenza A/H1N1v vaccine in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1

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
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

2 months

First QC Date

July 20, 2009

Last Update Submit

August 7, 2012

Conditions

Influenza

Keywords

influenzaimmunogenicityvaccine

Outcome Measures

Primary Outcomes (1)

  • GMT antibody rises

    42 days

Secondary Outcomes (1)

  • frequency of adverse reactions

    42 days

Study Arms (2)

Vaccine

ACTIVE COMPARATOR

adjuvanted influenza vaccine

Biological: MF59 H1N1 vaccine

Vaccine 2

ACTIVE COMPARATOR

non-adjuvanted vaccine

Biological: Plain H1N1 vaccine

Interventions

MF59 H1N1 vaccineBIOLOGICAL

3.75-7.5ug dose

Vaccine
Plain H1N1 vaccineBIOLOGICAL

7.5-15ug

Vaccine 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
  • Male or female subjects 18-50 years who are either healthy or have a stable medical condition.
  • Able to understand and comply with all study procedures and to complete study diaries
  • Individuals who can be contacted throughout the study and are available for all study visits
  • Females should either be using secure contraceptive precautions including:
  • the oral contraceptive pill
  • condom/barrier contraception
  • partner has had a vasectomy
  • be surgically sterilised, or
  • post-menopausal (defined as at least two years since the last menstrual period)

You may not qualify if:

  • Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, autoimmune illnesses (including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder.
  • Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, neomycin or polymixin, or products containing mercury.
  • Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy.
  • Subjects who are at high risk of developing illnesses of the immune system.
  • Individuals who are taking immunostimulant therapy or interferon
  • Individuals who have received blood products or immunoglobulins parenterally during the preceding three months.
  • Women should not be pregnant or lactating.
  • Women who refuse to use a reliable contraceptive method throughout the study
  • Known or suspected drug abuse.
  • Individuals who have received another vaccine or investigational medicinal product in the preceding 2 weeks.
  • Unable to lead an independent life either physically or mentally
  • Regularly drink more than 40 units of alcohol weekly
  • Individuals who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days (chronic antibiotic therapy for prevention of urinary tract infections is acceptable).
  • Individuals who had a temperature \>38oC in the preceding 3 days.
  • Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leicester

Leicester, LE1 5WW, United Kingdom

Location

Related Publications (1)

  • Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.

    PMID: 19745215DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Iain Stephenson, FRCP

    University Hospitals, Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 22, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

GB(1)