NCT00956202

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 vaccines 21 days after each vaccination in all participants.
  • To describe the antibody persistence eight months after the first vaccine administration using HAI method, in a subset of participants 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 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of participants who received two injections.
  • To describe the safety profile of each vaccine in all participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
303

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

15 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
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

1.1 years

First QC Date

August 3, 2009

Last Update Submit

January 10, 2014

Conditions

InfluenzaSwine-origin A/H1N1 Influenza

Keywords

InfluenzaPandemic FluSwine-origin A/H1N1 InfluenzaInactivated split-virion vaccineAdjuvant

Outcome Measures

Primary Outcomes (2)

  • Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines

    21 days post vaccination

  • Safety: To provide information concerning the safety (in terms of solicited injection site and systemic reactions and unsolicited adverse events) of Swine A/H1N1 influenza vaccines.

    0-7 days post-vaccination and entire study duration

Study Arms (3)

A/H1N1 Vaccine Group 1

EXPERIMENTAL

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

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

A/H1N1 Vaccine Group 2

EXPERIMENTAL

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

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

A/H1N1 Vaccine Group 3

EXPERIMENTAL

Participants will receive A/H1N1 Influenza vaccine formulation 3

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

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 a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)

A/H1N1 Vaccine Group 1
Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)BIOLOGICAL

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

A/H1N1 Vaccine Group 2

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All subjects:
  • Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 12 years, and of Informed Consent Form signed by subjects \>12 years.
  • Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
  • Subjects aged 12 to 17 years:
  • For a female of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
  • Subjects aged 3 to 11 years:
  • At Visit 05 (Month 8), for antibody persistence assessment:
  • Having received two injections of the 15 µg HA vaccine (Group 1) or of the 3.8 µg HA + AF03 vaccine (Group 2)
  • Addendum 1 to Informed Consent Form has been signed by the subject's parent(s)/guardian(s) (and by an independent witness if required by local regulations). In addition, provision of addendum 1 to Assent Form signed by subjects aged 6 to 11 years, and of addendum 1 to Informed Consent Form signed by subjects ≥ 12 years.
  • At Visit 06, for participants eligible for the Antibody persistence evaluation who will receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine:
  • Addendum 2 to Informed Consent Form has been signed by the subject and/or subject's parent(s)/guardian(s) (and by an independent witness if required by local regulations). In addition, provision of addendum 2 to Assent Form signed by subjects aged 6 to 11 years, and of addendum 2 to Informed Consent Form signed by subjects ≥ 12 years.

You may not qualify if:

  • All subjects:
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a 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 trial vaccinations
  • 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 the assessment of immune response
  • Known or suspected congenital or acquired immunodeficiency, 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)
  • Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C as reported by parents/legal representative
  • 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
  • Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • 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
  • Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
  • Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Espoo, FIN-02100, Finland

Location

Unknown Facility

Helsinki, FIN-00100, Finland

Location

Unknown Facility

Helsinki, FIN-00930, Finland

Location

Unknown Facility

Jarvenpaa, FIN-04400, Finland

Location

Unknown Facility

Kokkola, 67100, Finland

Location

Unknown Facility

Kotka, FIN-48600, Finland

Location

Unknown Facility

Kuopio, FIN-70100, Finland

Location

Unknown Facility

Lahti, FIN-15140, Finland

Location

Unknown Facility

Oulu, FIN-90220, Finland

Location

Unknown Facility

Pori, FIN-28100, Finland

Location

Unknown Facility

Seinäjoki, 60100, Finland

Location

Unknown Facility

Tampere, FIN-33100, Finland

Location

Unknown Facility

Turku, FIN-20520, Finland

Location

Unknown Facility

Vantaa, FIN-01300, Finland

Location

Unknown Facility

Vantaa, FIN-01600, Finland

Location

Related Links

MeSH Terms

Conditions

Influenza, Human

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

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 11, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

FI(15)