Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intradermal Route) - Immunogenicity and Safety of a Vaccine Against Influenza (2010-2011 NH season, intradermal route)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-017688-40-BE
• Date of registration: 10/03/2010
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur SA
• Public title: Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intradermal Route) - Immunogenicity and Safety of a Vaccine Against Influenza (2010-2011 NH season, intradermal route)
• Scientific title: Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intradermal Route) - Immunogenicity and Safety of a Vaccine Against Influenza (2010-2011 NH season, intradermal route)
• Date of first enrolment: 16/04/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017688-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
An individual must fulfill all of the following criteria in order to be eligible for trial
enrollment:
1) Aged 18 years or over on the day of inclusion
2) Informed consent form has been signed and dated
3) Able to attend all scheduled visits and to comply with all trial procedures
4) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
An individual fulfilling any of the following criteria is to be excluded from trial
enrollment:
1) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection
(according to investigator judgment) on the day of vaccination
2) 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
3) Known pregnancy, or a positive urine pregnancy test
4) Currently breastfeeding a child
5) History of pandemic H1N1 influenza vaccination
6) History of clinically or laboratory confirmed pandemic H1N1 influenza infection
7) History of influenza vaccination within the previous 6 months (other than pandemic H1N1 influenza vaccine)
8) Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous
12 months
9) 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)
10) History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B,
or Hepatitis C
11) Receipt of blood or blood-derived products in the past 3 months, which might
interfere with assessment of the immune response
12) Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with trial conduct or completion
13) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
14) Planned receipt of any vaccine in the 3 weeks following the trial vaccination
15) Participation in another clinical trial investigating a vaccine, drug, medical device,
or medical procedure in the 4 weeks preceding the trial vaccination
16) Planned participation in another clinical trial during the present trial period
17) Deprived of freedom by an administrative or court order, or in an emergency
setting, or hospitalized involuntarily
18) Current alcohol abuse or drug addiction that might interfere with the ability to
comply with trial procedures
19) Identified as employees 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 (i.e., immediate, husband,
wife and their children, adopted or natural) of the employees or the Investigator


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Vaccination of adults up to 59 years of age and elderly of 60 years of age and over with inactivated split-virion influenza vaccine administered by the intraderma route

Intervention(s)

Trade Name: INTANZA
Product Name: Intradermal Influenza Vaccine 9µg
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus (split virion, inactivated) A/California/7/2009 (H1N1)-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 90-
Other descriptive name: Influenza virus (split virion, inactivated) A/Perth/16/2009 (H3N2)-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 90-
Other descriptive name: Influenza virus (Split virion, inactivated) B/Brisbane/60/2009-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 90-

Trade Name: INTANZA
Product Name: Intradermal Influenza Vaccine 15µg
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus (split virion, inactivated) A/California/7/2009 (H1N1)-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-
Other descriptive name: Influenza virus (split virion, inactivated) A/Perth/16/2009 (H3N2)-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-
Other descriptive name: Influenza virus (Split virion, inactivated) B/Brisbane/60/2009-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-

Primary Outcome(s)

Main Objective: In each group:
1) To evaluate compliance, in terms of immunogenicity, of the corresponding
strength of the ID influenza vaccine NH 2010-2011 formulation with the
requirements of the Committee for Proprietary Medicinal Products (CPMP) Note
for Guidance (NfG) CPMP/BWP/214/96
2) To describe the safety of the corresponding strength of the ID influenza vaccine,
NH 2010-2011 formulation

Primary end point(s): Immunogenicity :

Immunogenicity will be evaluated before and 21 days after injection of the ID
influenza vaccine using the Hemagglutination Inhibition (HAI) technique. For each
vaccine strain, anti-hemagglutinin (HA) antibody titers will be expressed as HAI titers
obtained in two independent assays on day (D) 0 and D21 samples, summarized at the
subject level by individual geometric mean of the two titers on D0 and D21.
The derived endpoints will be:
- Individual titer ratio D21/D0,
- Seroprotection status: titer =40 (1/dilution [1/dil]) on D0 and D21,
- Seroconversion for subjects with a titer <10 (1/dil) on D0: post-injection titer
=40 (1/dil) on D21 or significant increase for subjects with a titer =10 (1/dil) on
D0: =4-fold increase of post-injection titer on D21

Safety :

Safety will be evaluated within 21 days following injection of the ID influenza
vaccine, NH 2010-2011 formulation.
- The occurrence of the following reactions during the first 3 days following
vaccination will be more specifically reported (as defined by the CPMP NfG
CPMP/BWP/214/96):
- Injection site induration =5 cm for more than 3 days
- Injection site ecchymosis
- Temperature >38°C for 24 hours or more
- Malaise
- Shivering
- Occurrence of unsolicited adverse events (AEs) reported in the 30 minutes after
injection
- Occurrence of solicited (prelisted in the subject diary and electronic Case Report
Form [CRF]) injection site reactions and systemic reactions within 7 days
following injection
- Occurrence of unsolicited (spontaneously reported) AEs within 21 days following
injection
- Occurrence of serious adverse events (SAEs) between V01 up to the end of the
trial
Others endpoints recorded or derived will be described at the time of statistical
analysis plan. Depending on the item, these could include: nature (Medical Dictionary
for Regulatory Activities [MedDRA] preferred term), time of onset, duration, number
of days of occurrence, Grade of severity, relationship to vaccine, action taken, whether the AE led to early termination from the study, seriousness, or outcome.

Secondary Objective: Not applicable

Secondary ID(s)

GID34