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Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01209780
First received: September 24, 2010
Last updated: February 7, 2014
Last verified: February 2014

September 24, 2010
February 7, 2014
September 2010
March 2011   (final data collection date for primary outcome measure)
  • Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion [ Time Frame: Day 22 for non-naive/Day 50 for naive subjects ] [ Designated as safety issue: No ]

    The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination.

    Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer <1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer

  • Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs) [ Time Frame: Day 22 for non-naive/Day 50 for naive subjects ] [ Designated as safety issue: No ]
    The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.
Immunogenicity [ Time Frame: Day 22 (+5) for non-naive subjects; Day 50 (+5) for naive subjects ] [ Designated as safety issue: No ]
To demonstrate the non-inferiority of the antibody responses of trivalent subunit inactivated flu test vaccine when compared to US licensed trivalent inactivated flu control vaccines 21 days after last vaccination in children ages 3 to 8 years
Complete list of historical versions of study NCT01209780 on ClinicalTrials.gov Archive Site
  • Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine. [ Time Frame: Day 22 for non-naive/Day 50 for naive subjects ] [ Designated as safety issue: No ]

    The percentages of 3 to 8 year old subjects achieving HI titers ≥40 after receiving either one or two doses of investigational TIV or control vaccine, 21 days after last vaccination, are reported.

    This criterion according to the US (CBER)guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40, is ≥70%.

  • Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine [ Time Frame: Day 22 for non-naive/Day 50 for naive ] [ Designated as safety issue: No ]

    The percentages of 3 to 8 years-old subjects achieving seroconversion in HI antibody titers after receiving either one or two doses of investigational TIV or control vaccine, at 21 days after last vaccination, are reported.

    This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 22 and day 50 (21 days after last vaccination) is ≥40.

  • Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine. [ Time Frame: Day 1, Day 29, and Day 50 ] [ Designated as safety issue: No ]

    The percentage of 3 to 8 years-old vaccine-naive subjects achieving HI titers ≥40, after receiving two doses of investigational TIV or control vaccine. The time frame of evaluation was 28 days after first (Day 29) and 21 days after second vaccine dose (Day 50).

    This criterion according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%, for each vaccine strain.

  • Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine [ Time Frame: Day 29 and Day 50 ] [ Designated as safety issue: No ]

    The percentages of 3 to 8 years-old vaccine naive children achieving seroconversion or significant increase in HI antibody titers after receiving two doses of investigational TIV or control vaccine, are reported. The time frame of evaluation was 28 days after first (Day 29) and 21 days after the second dose (Day 50).

    This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 29 and day 50 is ≥40, for each vaccine strain.

  • Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine [ Time Frame: Day 1 to 7 after vaccination ] [ Designated as safety issue: Yes ]
    The number of 3-17 year old children with solicited local and systemic adverse events and other adverse events, after receiving either one or two doses of investigational TIV as compared to control vaccine are reported.
  • Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine [ Time Frame: Day 1 to 180 (non-naive )/Day 1 to 209 (naive) ] [ Designated as safety issue: Yes ]
    The number of 3-17 year old children reporting any unsolicited adverse event and any serious adverse event (SAE) after receiving either one or two doses of investigational TIV and control vaccine are reported.
Safety [ Time Frame: Day 180 (-7/+14) for non-naive subjects; Day 209 (-7/+14) for naive subjects ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of trivalent subunit inactivated flu test vaccine and comparator in children and adolescents 3 to 17 years
Not Provided
Not Provided
 
Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
A Multi-center, Phase III, Randomized, Observer Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of a Trivalent Subunit Inactivated Flu Vaccine in Healthy Children and Adolescents 3 to 17 Years of Age

This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Seasonal Influenza
  • Biological: TIV
    Investigational egg-derived trivalent subunit influenza vaccine.
  • Biological: TIVf
    US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.
  • Biological: Comparator TIV
    US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children <4 years.
  • Experimental: TIV (3-8 years)
    Non-Naive subjects received one dose and naive subjects received two doses, administered 4 weeks apart, of investigational trivalent influenza vaccine (TIV)
    Intervention: Biological: TIV
  • Active Comparator: Control TIV (3-8 years)
    Non-Naive subjects received one dose and Naive subjects received two doses, administered 4 weeks apart, of control vaccine. Subjects aged 3 to <4 years and subjects aged 4 to 8 years received different control TIV.
    Interventions:
    • Biological: TIVf
    • Biological: Comparator TIV
  • Experimental: TIV ( 9-17 years)
    All subjects received one dose of investigational TIV. The subjects in this cohort were included only for safety analysis.
    Intervention: Biological: TIV
  • Active Comparator: Control TIV ( (9-17 years)
    All subjects received one dose of the control vaccine. The subjects from this cohort were included only for safety analysis.
    Intervention: Biological: TIVf
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3116
September 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females aged 3 to 17 years, in good health as determined by medical history, physical examination and clinical judgment of the investigator
  • Documented consent provided by parents or legal guardians
  • For individuals 8 years of age and older, informed assent to participate in the study after the nature of the study had been explained to them in terms they could understand
  • Individuals and parents/guardians who were able to comply with all study procedures and were available for all clinic visits scheduled in the study

Exclusion Criteria:

  • Parents or legal guardians and individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study
  • Parents or legal guardians and individuals providing assent who do not consent to the retention of the subject's serum samples after study completion
  • Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may have interfered with the subject's ability to participate in the study
  • Individuals with history or any illness that, in the opinion of the investigator, might have interfered with the results of the study or posed additional risk to the subjects due to participation in the study
  • History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, latex, to any excipients, and to eggs (including ovalbumin), chicken protein, influenza viral protein, kanamycin, neomycin sulphate, cetyltrimethylammonium bromide (CTAB), polysorbate 80, neomycin, polymixin, formaldehyde, thimerosal, beta propiolactone, or nonoxynol-9
  • History of any serious disease, such as:

    1. cancer
    2. history of serious chronic, rheumatologic, neurologic and hematologic diseases
    3. history of underlying medical condition such as inborn errors of metabolism
  • Known or suspected impairment/alteration of immune function, including:

    1. chronic use of oral steroids within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed)
    2. receipt of immunostimulants within 60 days prior to Visit 1
    3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study
    4. HIV infection or HIV-related disease
  • Pregnant or breast-feeding female and any positive or indeterminate pregnancy test
  • Received an influenza vaccine within 6 months prior to Visit 1
  • Laboratory-confirmed or suspected influenza disease within 6 months prior to Visit 1
  • Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
  • Experienced a fever and/or any acute illness within 3 days prior to each study vaccination
Both
3 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Colombia,   Mexico,   Panama,   Philippines
 
NCT01209780
V71_18
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Not Provided
Novartis
February 2014

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