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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00956449
Other study ID # V78_07S
Secondary ID 2009-011004-33
Status Completed
Phase Phase 2
First received August 8, 2009
Last updated March 24, 2017
Start date June 2009
Est. completion date July 2009

Study information

Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HI) at 21 days post immunization in non−elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects eligible for enrollment into this study are male and female adults who are:

- = 18 years of age, mentally competent, willing and able to give informed consent prior to study entry;

- able to comply with all study requirements;

- in good health as determined by:

1. medical history,

2. physical examination,

3. clinical judgment of the investigator.

Exclusion Criteria:

- Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:

- They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:

1. Cancer, except for localized skin cancer

2. Advanced congestive heart failure

3. Chronic obstructive pulmonary disease (COPD)

4. Autoimmune disease (including rheumatoid arthritis)

5. Acute or progressive hepatic disease

6. Acute or progressive renal disease

7. Severe neurological or psychiatric disorder

8. Severe Asthma

- History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to eggs, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin).

- Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from:

1. receipt of immunosuppressive therapy (any parental or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;

2. Receipt of immunostimulants,

3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,

4. Suspected or known HIV infection or HIV-related disease.

- Known or suspected history of drug or alcohol abuse.

- They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;

- Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days). Females who are pregnant or nursing (breastfeeding) mothers or females of childbearing age who do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (oral, injection, transdermal patch, implant, cervical ring), barrier (condom or diaphragm), intrauterine device (IUD) or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry.

- Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months

- Within the past 4 weeks they have received: another vaccine or any investigational agent.

- Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.

- They have experienced fever (i.e., axillary temperature = 38°C) within the last 3 days

- Simultaneous participation in another clinical study.

- Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.

- Severely obese with Body Mass Index (BMI) > 35

- Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Seasonal Influenza Vaccine
1 dose of Influenza Vaccine Surface Antigen, Inactivated

Locations

Country Name City State
United Kingdom The Health Centre Suffolk

Sponsors (2)

Lead Sponsor Collaborator
Novartis Novartis Vaccines

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immunogenicity and tolerability of the Flu vaccines is being measured 2 - 21 days
Secondary To evaluate safety of a single IM (intramuscular) dose of the subunit vaccine of Influenza Vaccine Surface Antigen, Inactivated of Influenza Vaccine 21 days
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