Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00464672
First received: April 23, 2007
Last updated: April 9, 2010
Last verified: April 2010
  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Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   3 Years to 64 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Novartis

Additional 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
Study First Received: April 23, 2007
Results First Received: January 25, 2010
Last Updated: April 9, 2010
Health Authority: United States: Food and Drug Administration
Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Medica (ANMAT)

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
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014