Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subject (Aged 6 to 72 Months) Versus Control Vaccines

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00644059
First received: March 20, 2008
Last updated: September 21, 2010
Last verified: September 2010

March 20, 2008
September 21, 2010
November 2007
April 2010   (final data collection date for primary outcome measure)
  • To evaluate safety and tolerability of one and two 0.25mL IM injections of the adjuvanted and non-adjuvanted influenza vaccines [ Time Frame: 7 days postvaccination ] [ Designated as safety issue: Yes ]
    Solicited local and systemic reactions were assessed and compared between adjuvanted and non-adjuvanted influenza vaccines in 6 to 36 month old subjects
  • To evaluate efficacy of two 0.25mL IM injections of the adjuvanted influenza vaccine and non-influenza vaccines [ Time Frame: Each subject was assessed for one influenza season ] [ Designated as safety issue: No ]
    Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine and non-influenza vaccines in 6 to 36 month old subjects. This primary endpoint is only for homologous strains.
To evaluate safety and tolerability of one or two 0,25mL or 0,50mL IM injections of the study vaccine, compared to active control vaccine [ Time Frame: 181 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00644059 on ClinicalTrials.gov Archive Site
  • To evaluate the efficacy of two 0.25mL injections and one 0.5mL IM injection of adjuvanted influenza vaccine [ Time Frame: Each subject was assessed for one influenza season ] [ Designated as safety issue: No ]
    This is similar to the primary efficacy outcome measure however it is performed on a different age group (e.g., 6 to 72 months) etc
  • To evaluate immunogenicity of one or two 0.25mL injections and one 0.5mL injection with the study vaccines [ Time Frame: blood draws up to 180 days after subject's first injection ] [ Designated as safety issue: No ]
    This is performed on a different age group (e.g., 6 to 72 months) etc.
  • To evaluate the safety and tolerability of one or two 0.25mL injections and one 0.5mL IM injection of study vaccines [ Time Frame: up to 1 year for each subject ] [ Designated as safety issue: Yes ]
    This is similar to the primary safety outcome measure however it is performed on different a age group (e.g., 6 to 72 months) etc
To evaluate the efficacy ot the study vaccine .compared to that of the control vaccine. To evaluate the immunogenicity of the study vaccine, compared to that of the active control vaccine and control vaccine. [ Time Frame: 181 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subject (Aged 6 to 72 Months) Versus Control Vaccines
A Phase III, Randomized, Observer-blind, Controlled, Multi-center Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of One and Two Intramuscular Doses of Influenza Vaccine Versus Control Vaccines in Healthy Subject Aged 6 to 72 Months

This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25mL or 0.5mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza and non-adjuvanted influenza control vaccines in subjects 6 to 72 months of age.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Influenza Disease
  • Biological: Adjuvanted trivalent inactivated subunit influenza vaccine
    Either two intramuscular (IM) injections of half (0.25 mL) dose or one IM injection of full dose (0.5 mL), depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.
    Other Name: Fluad
  • Biological: Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
    For both vaccines, either two intramuscular (IM) injections of half (0.25 mL) dose or one IM injection of full dose (0.5 mL), depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.
    Other Names:
    • 1) Agrippal
    • 2) Influsplit SSW
  • Biological: Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
    1. Meningococcal vaccine: two 0.5mL IM injections
    2. Tick-borne encephalitis vaccine: two 0.25mL IM injections
    Other Names:
    • 1. Menjugate
    • 2. Encepur Children
  • Experimental: 1
    Adjuvanted trivalent inactivated subunit influenza vaccine
    Intervention: Biological: Adjuvanted trivalent inactivated subunit influenza vaccine
  • Active Comparator: 2
    Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
    Intervention: Biological: Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
  • Sham Comparator: 3
    Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
    Intervention: Biological: Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
Vesikari T, Knuf M, Wutzler P, Karvonen A, Kieninger-Baum D, Schmitt HJ, Baehner F, Borkowski A, Tsai TF, Clemens R. Oil-in-water emulsion adjuvant with influenza vaccine in young children. N Engl J Med. 2011 Oct 13;365(15):1406-16. doi: 10.1056/NEJMoa1010331.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4902
August 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children whose parents/legal guardians have given written informed consent prior to study entry: a) aged 6 to <72 months b) aged 6 to <36 months
  • In good health as determined by: a) medical history, b) physical examination, c) clinical judgment of the investigator

Exclusion criteria:

  • Administration of licensed vaccines (including licensed H1N1sw vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study. Routine vaccines, according to local recommendations, or any other vaccines not foreseen in the protocol could be given after the active trial phase (i.e., 21 days after last vaccination) has been concluded.
  • Receipt of another investigational vaccine or any investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and participation in another clinical trial during the present study.
  • Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start (untreated common cold is acceptable). The severity of the infectious disease occurred will be based on the investigator's judgment.
  • Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 2 days prior to study start.
  • Experience an axillary temperature equal to or greater than 37.8°C (rectal temperature equal to or greater than 38.3°C) within the 2 days before enrollment.
  • Any serious disease in the opinion of the investigator including, for example: a) cancer, b) autoimmune disease (including rheumatoid arthritis under immunosuppressive therapy), c) insulin dependent diabetes mellitus, d) chronic pulmonary disease, asthma under inhalative therapy only is acceptable, e) acute or progressive hepatic disease, f) acute or progressive renal disease.
  • Known or suspected impairment/alteration of immune function, for example, resulting from: a) receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy), b) receipt of immunostimulants, c) receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and for the full length of the study, d) high risk for developing an immunocompromising disease (suspected or known HIV infection or HIV-related disease).
  • Bleeding diathesis.
  • History of hypersensitivity to any component of the study medication or chemically related substances.
  • History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component.
  • Laboratory confirmed influenza disease.
  • History of neurological disorder or seizures (febrile seizures allowed).
  • Received any influenza vaccine.
  • Major surgery planned during the study period.
  • Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, e.g., planned travel or relocation of residence that would interfere with completion of study.
Both
6 Months to 71 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00644059
V70P5, Eudract number 2007-003786-41
Yes
Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina 1,53100 Siena, Italy, Novartis
Novartis
Novartis Vaccines
Not Provided
Novartis
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP