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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

Primary Purpose

Seasonal Influenza

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TIV
TIVf
Comparator TIV
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seasonal Influenza focused on measuring seasonal influenza, vaccine

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centro de Atención e Investigación Medica - CAIMED
  • Clinical research institute ,S.C(CRI), Blvd Manuel Avila Camacho 1994 Consultorio 1103 Col. San Lucas Tepetlacalco, C.P.54055 Tlalnepantla
  • Centro de Salud Magally Ruiz, Street Bolivar
  • Clinica Hospital San Fernando, Floor 4 Office 419 via España las Sabanas
  • Consultorios America Floor 2 Office 201-1, Via España Vista Hermosa
  • Consultorios Medicos San Judas Tadeo Principal Street, Floor 5 Office 507, Villa Lucre
  • Philippine General Hospital
  • Research Institute for Tropical Medicine, Department of Health Compound
  • Research Institute for Tropical Medicine, Department of Health Compound, FILINVEST Corporate City
  • University of the East Ramon Magsaysay Medical Center, 64 Aurora Boulevard
  • De La Salle Health Sciences Institute
  • Mary Chiles General Hospital, 667 Gastambide St. Sampaloc
  • Philippine Children's Medical Center, Quezon Avenue corner Agham Road

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

TIV (3-8 years)

Control TIV (3-8 years)

TIV ( 9-17 years)

Control TIV ( (9-17 years)

Arm Description

Non-Naive subjects received one dose and naive subjects received two doses, administered 4 weeks apart, of investigational trivalent influenza vaccine (TIV)

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.

All subjects received one dose of investigational TIV. The subjects in this cohort were included only for safety analysis.

All subjects received one dose of the control vaccine. The subjects from this cohort were included only for safety analysis.

Outcomes

Primary Outcome Measures

Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion
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)
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.

Secondary Outcome Measures

Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.
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
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.
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
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
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
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.

Full Information

First Posted
September 24, 2010
Last Updated
February 7, 2014
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01209780
Brief Title
Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza
Keywords
seasonal influenza, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIV (3-8 years)
Arm Type
Experimental
Arm Description
Non-Naive subjects received one dose and naive subjects received two doses, administered 4 weeks apart, of investigational trivalent influenza vaccine (TIV)
Arm Title
Control TIV (3-8 years)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TIV ( 9-17 years)
Arm Type
Experimental
Arm Description
All subjects received one dose of investigational TIV. The subjects in this cohort were included only for safety analysis.
Arm Title
Control TIV ( (9-17 years)
Arm Type
Active Comparator
Arm Description
All subjects received one dose of the control vaccine. The subjects from this cohort were included only for safety analysis.
Intervention Type
Biological
Intervention Name(s)
TIV
Intervention Description
Investigational egg-derived trivalent subunit influenza vaccine.
Intervention Type
Biological
Intervention Name(s)
TIVf
Intervention Description
US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.
Intervention Type
Biological
Intervention Name(s)
Comparator TIV
Intervention Description
US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children <4 years.
Primary Outcome Measure Information:
Title
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion
Description
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
Time Frame
Day 22 for non-naive/Day 50 for naive subjects
Title
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)
Description
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.
Time Frame
Day 22 for non-naive/Day 50 for naive subjects
Secondary Outcome Measure Information:
Title
Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.
Description
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%.
Time Frame
Day 22 for non-naive/Day 50 for naive subjects
Title
Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine
Description
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.
Time Frame
Day 22 for non-naive/Day 50 for naive
Title
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.
Description
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.
Time Frame
Day 1, Day 29, and Day 50
Title
Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine
Description
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.
Time Frame
Day 29 and Day 50
Title
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine
Description
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.
Time Frame
Day 1 to 7 after vaccination
Title
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine
Description
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.
Time Frame
Day 1 to 180 (non-naive )/Day 1 to 209 (naive)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: cancer history of serious chronic, rheumatologic, neurologic and hematologic diseases history of underlying medical condition such as inborn errors of metabolism Known or suspected impairment/alteration of immune function, including: chronic use of oral steroids within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed) receipt of immunostimulants within 60 days prior to Visit 1 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 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
Facility Information:
Facility Name
Centro de Atención e Investigación Medica - CAIMED
City
Carrera 42A # 17-50, Bogotá
Country
Colombia
Facility Name
Clinical research institute ,S.C(CRI), Blvd Manuel Avila Camacho 1994 Consultorio 1103 Col. San Lucas Tepetlacalco, C.P.54055 Tlalnepantla
City
Estado de México
Country
Mexico
Facility Name
Centro de Salud Magally Ruiz, Street Bolivar
City
Panama - La Chorrera
Country
Panama
Facility Name
Clinica Hospital San Fernando, Floor 4 Office 419 via España las Sabanas
City
Panamá
Country
Panama
Facility Name
Consultorios America Floor 2 Office 201-1, Via España Vista Hermosa
City
Panamá
Country
Panama
Facility Name
Consultorios Medicos San Judas Tadeo Principal Street, Floor 5 Office 507, Villa Lucre
City
Panamá
Country
Panama
Facility Name
Philippine General Hospital
City
Taft Avenue, Manila
State/Province
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Research Institute for Tropical Medicine, Department of Health Compound
City
FILINVEST Corporate City, Alabang
State/Province
Muntinlupa City
ZIP/Postal Code
1781
Country
Philippines
Facility Name
Research Institute for Tropical Medicine, Department of Health Compound, FILINVEST Corporate City
City
Alabang, Muntinlupa City
ZIP/Postal Code
1781
Country
Philippines
Facility Name
University of the East Ramon Magsaysay Medical Center, 64 Aurora Boulevard
City
Barangay Dona Imelda Quezon City
ZIP/Postal Code
1113
Country
Philippines
Facility Name
De La Salle Health Sciences Institute
City
Dasmarinas Cavite
ZIP/Postal Code
4115
Country
Philippines
Facility Name
Mary Chiles General Hospital, 667 Gastambide St. Sampaloc
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Philippine Children's Medical Center, Quezon Avenue corner Agham Road
City
Quezon City
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

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

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