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Safety and Immunogenicity of One Dose of Inactivated Trivalent Flu Vaccine Administered to Non-elderly Adult and Elderly Subjects

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ClinicalTrials.gov Identifier: NCT01151059
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : March 28, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The present study will evaluate the safety and immunogenicity in healthy people (non-elderly adult and elderly subjects) after one intramuscular (IM) dose of trivalent subunit inactivated flu vaccine.

Condition or disease Intervention/treatment Phase
Seasonal Influenza Biological: Trivalent subunit inactivated flu vaccine, Formulation 2010-2011 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL® S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2010-2011, When Administered to Non-elderly Adult and Elderly Subjects
Study Start Date : June 2010
Primary Completion Date : June 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Group 1
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
Biological: Trivalent subunit inactivated flu vaccine, Formulation 2010-2011
This phase II is performed as a multicenter study site in non-elderly adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22).

Outcome Measures

Primary Outcome Measures :
  1. To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in non-elderly adult and elderly subjects [ Time Frame: 22 days, including the follow-up period ]

Secondary Outcome Measures :
  1. To evaluate the safety of a single IM injection of trivalent subunit inactivated FLU vaccine in non-elderly adult and elderly subjects [ Time Frame: 22 days, including the follow-up period ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Males and females volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry
  • Individuals able to complain with all the study requirements
  • Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

  • Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study
  • Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to: cancer, advanced congestive heart failure, chronic obstructive pulmonary disease (COPD), autoimmune diseases, acute or progressive hepatic and renal disease, severe neurological or psychiatric disorder and severe asthma
  • Individuals with 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/eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate)
  • Individuals with known or suspected impairment/alteration of immune function resulting, for example, from: receipt of immunosuppressive therapy within the past 60 days and for the full length of the study, receipt of immunostimulants, receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study and suspected or known human immunodeficiency virus (HIV) infection or HIV-related disease
  • Individuals with known or suspected history of drug or alcohol abuse
  • Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures for the whole duration of the study
  • Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
  • Individuals within the past 6 months, they have had any seasonal or pandemic laboratory confirmed influenza disease and received any seasonal or pandemic influenza vaccine
  • Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days
  • Individuals that have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days of intended study vaccination
  • Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study
  • Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines
  • Individuals who have ever received blood/blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks and for the full length of the study
  • Individuals who are part of study personnel or close family members conducting this study
  • Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
  • BMI > 35 kg/m2
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151059

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
Chieti, Italy, 66100
Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b
Ferrara, Italy, 44100
Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1
Genova, Italy, 16132
Centro Satellite. ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37
Lanciano, Italy, 66034
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona, 20
Milano, Italy, 20127
Sponsors and Collaborators
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01151059     History of Changes
Other Study ID Numbers: V71_19S
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012

Keywords provided by Novartis ( Novartis Vaccines ):
seasonal influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs