NCT01138397

Brief Summary

The aim of this study is to evaluate the new formulation of the influenza vaccine for the 2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the corresponding population and to check its compliance with the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 Objectives:

  • To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine NH 2010-2011 formulation with the requirements of the CPMP NfG CPMP/BWP/214/96.
  • To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2010-2011 formulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

2 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

June 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

June 4, 2010

Last Update Submit

October 5, 2015

Conditions

Influenza

Keywords

InfluenzaInfluenza vaccineInfluenza virusIntradermal

Outcome Measures

Primary Outcomes (2)

  • Information concerning the immunogenicity of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.

    21 days post-vaccination

  • Information concerning the safety (solicited and unsolicited adverse events) of the Influenza virus vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation.

    21 days post-vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

Participants at 18 to 59 years of age

Biological: Influenza virus vaccine (split virion, inactivated)

Group 2

EXPERIMENTAL

Participants at 60 years of age or older

Biological: Influenza virus vaccine (split virion, inactivated)

Interventions

Influenza virus vaccine (split virion, inactivated)BIOLOGICAL

0.1 mL, Intradermal

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 vaccination until at least 4 weeks after vaccination

You may not qualify if:

  • Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
  • Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • Known pregnancy, or a positive urine pregnancy test
  • Currently breastfeeding a child
  • History of pandemic H1N1 influenza vaccination
  • History of clinically or laboratory confirmed pandemic H1N1 influenza infection
  • History of influenza vaccination within the previous 6 months (other than pandemic H1N1 influenza vaccine)
  • Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous 12 months
  • Known or suspected congenital or acquired immunodeficiency, resulting for example from:
  • End-stage renal disease requiring dialysis
  • Active neoplastic disease or active hematologic malignancy
  • Receipt of immunosuppressive therapy or other immune-modifying drugs such as, but not limited to: 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)
  • History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Antwerp, 2610, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Related Links

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

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 6, 2015

Record last verified: 2015-10

Locations

BE(2)