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Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00464672
First Posted: April 24, 2007
Last Update Posted: October 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
  Purpose
This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.

Condition Intervention Phase
Influenza Biological: Influenza virus vaccine Biological: Comparator influenza vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age [ Time Frame: 21 days after vaccination ]
    To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.

  • Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age [ Time Frame: 21 days after vaccination ]
    Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.


Secondary Outcome Measures:
  • Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age [ Time Frame: 7 days after vaccination ]
    Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.

  • Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age [ Time Frame: 21 days after vaccination ]
    To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.

  • Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age [ Time Frame: 21 days after vaccination ]
    Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.

  • Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age [ Time Frame: 21 days after vaccination ]
    To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.

  • Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age [ Time Frame: 7 days after vaccination ]
    Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.

  • Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age [ Time Frame: 50 days after last vaccination ]
    To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.

  • Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age [ Time Frame: 50 days after last vaccination ]
    Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.

  • Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age [ Time Frame: 50 days after last vaccination ]
    To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.

  • Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. [ Time Frame: 7 days after each vaccination ]
    Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.

  • Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age [ Time Frame: 21 days after vaccination ]
    Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.


Enrollment: 1893
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza virus vaccine Biological: Influenza virus vaccine
Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
Active Comparator: Comparator influenza vaccine Biological: Comparator influenza vaccine
Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects 3 to 64 years of age

Exclusion Criteria:

  • Receipt of other investigational products within 3 months or other vacine within 1 month;
  • Allergy to eggs, egg products, or any other vaccine component;
  • Laboratory confirmed influenza disease within 6 months;
  • Have previously received an influenza vaccination (3 to 8 years only);
  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): NCT00464672


Locations
Argentina
Site 2: C1425AWK
Buenos Aires, Argentina
Site 1: X5000BJH
Cordoba, Argentina
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Director: Novartis Vaccines and Diagnostics Novartis
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines and Diagnostics, Novartis
ClinicalTrials.gov Identifier: NCT00464672     History of Changes
Other Study ID Numbers: V71P5
IND: 13299
First Submitted: April 23, 2007
First Posted: April 24, 2007
Results First Submitted: January 25, 2010
Results First Posted: May 5, 2010
Last Update Posted: October 1, 2015
Last Verified: September 2015

Keywords provided by Novartis:
Influenza, Egg-Derived, Healthy Children, Healthy Adolescents, Healthy Adults, Safety, Immunogenicity, Trivalent, Inactivated, Vaccination

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