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
  Purpose

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.


Condition Intervention Phase
Influenza Disease
Biological: Adjuvanted trivalent inactivated subunit influenza vaccine
Biological: Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
Biological: Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 4902
Study Start Date: November 2007
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Adjuvanted trivalent inactivated subunit influenza vaccine
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
Active Comparator: 2
Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
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
Sham Comparator: 3
Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
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

  Eligibility

Ages Eligible for Study:   6 Months to 71 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644059

Locations
Germany
Johannes Gutenberg-University
Mainz, Germany, 55101
Sponsors and Collaborators
Novartis
Novartis Vaccines
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina 1,53100 Siena, Italy, Novartis
ClinicalTrials.gov Identifier: NCT00644059     History of Changes
Obsolete Identifiers: NCT01015885
Other Study ID Numbers: V70P5, Eudract number 2007-003786-41
Study First Received: March 20, 2008
Last Updated: September 21, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Influenza
vaccine
children

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014