NCT00954798

Brief Summary

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives:

  • To describe the immune response to study vaccine 21 days after each vaccination.
  • To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections.
  • To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain.
  • To describe the safety profiles of study vaccines in all participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

6 active sites

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

August 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

August 3, 2009

Last Update Submit

January 10, 2014

Conditions

InfluenzaSwine-origin A/H1N1 Influenza

Keywords

InfluenzaPandemic FluSwine-origin InfluenzaInactivated split-virion vaccineAdjuvantAdult

Outcome Measures

Primary Outcomes (2)

  • To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine

    21 days post-vaccination

  • To provide information concerning the safety in terms of solicited injection site and systemic reactions following vaccination with Swine A/H1N1 influenza vaccine

    0 to7 days post-vaccination and entire study duration

Study Arms (3)

A/H1N1 Vaccine Group 1

EXPERIMENTAL

All participants will receive A/H1N1 vaccine formulation 1 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13.

Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)

A/H1N1 Vaccine Group 2

EXPERIMENTAL

All participants will receive A/H1N1 vaccine formulation 2 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13.

Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)

A/H1N1 Vaccine Group 3

EXPERIMENTAL

Participants will receive A/H1N1 vaccine formulation 3

Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)

Interventions

Swine A/H1N1 influenza vaccine (split virion, inactivated)BIOLOGICAL

0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)

A/H1N1 Vaccine Group 1

Eligibility Criteria

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

You may qualify if:

  • Informed Consent Form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination
  • Entitled to national social security
  • At Visit 05, for antibody persistence assessment:
  • Addendum 1 to Informed Consent Form has been signed and dated
  • Having received two vaccinations with the vaccine formulation 1 or 2.
  • At Month 13, for trivalent influenza vaccine (TIV) administration in subjects who received the A/H1N1 influenza vaccine:
  • \- Addendum 2 to Informed Consent Form has been signed and dated

You may not qualify if:

  • Known pregnancy, or a positive urine pregnancy test
  • Currently breastfeeding a child
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
  • Planned receipt of any vaccine prior to the Day 42 blood sample
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
  • Employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Angers, 49000, France

Location

Unknown Facility

Château-Gontier, 53200, France

Location

Unknown Facility

Cherbourg, 50100, France

Location

Unknown Facility

Équeurdreville-Hainneville, 50120, France

Location

Unknown Facility

Laval, 53000, France

Location

Unknown Facility

Tiercé, 49125, France

Location

Related Links

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Medical Monitor

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 7, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

FR(6)