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A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine

Primary Purpose

Poliomyelitis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IPV
f-IPV
Sponsored by
Fidec Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

5 Weeks - 7 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Infants of 6 weeks of age (-7 to + 7 days) on date of first vaccination
  • Healthy, as assessed from medical history and physical examination by a study physician
  • Written informed consent obtained from parents or legal representatives that they have been properly informed about the study and are able to comply with planned study procedures

Exclusion Criteria:

  • Vaccinated with any poliovirus vaccine prior to inclusion
  • A household contact with OPV vaccination history in the past 4 weeks
  • HIV infection or pharmacologic immunosuppression.
  • Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde)
  • Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections.
  • Acute severe febrile illness on day of vaccination deemed by the Investigator to be a contraindication for vaccination.
  • Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Group C

    Group D

    Group E

    Group F

    Arm Description

    3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 18, 36 & 40 weeks.

    3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 18, 36 & 40 weeks.

    2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.

    2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.

    3 doses IPV IM at 6, 14 & 36 weeks of age incl. blood sampling at 6, 18, 36 & 40 weeks.

    3 doses f-IPV ID at 6, 14 & 36 weeks of age incl. blood sampling at 6, 18, 36 & 40 weeks.

    Outcomes

    Primary Outcome Measures

    Seroconversion
    Seroconversion will be defined as a change from seronegative to seropositive (antibody titers of ≥1:8) and in infants seropositive at baseline (assumed to be from maternally-derived antibody titers), as a ≥4-fold rise in antibody titers post-vaccination, computed by assuming an exponential decay model with a half-life of 24 days.

    Secondary Outcome Measures

    Seroconversion
    Median titers
    SAEs (Serious Adverse Events)
    IMEs (Important Medical Events)
    These are medically significant events that do not meet any of the SAE criteria, but require medical or surgical consultation or intervention to prevent this event from becoming a SAE.
    Severe local reactions
    Severe local reactions can include severe pain, inflammation, induration and edema in the injection area.

    Full Information

    First Posted
    January 5, 2017
    Last Updated
    June 26, 2017
    Sponsor
    Fidec Corporation
    Collaborators
    Bill and Melinda Gates Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03016949
    Brief Title
    A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine
    Official Title
    A Phase 3, Open-label, Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Infants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Regulatory timelines for approval expired
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    October 2018 (Anticipated)
    Study Completion Date
    November 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fidec Corporation
    Collaborators
    Bill and Melinda Gates Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study will evaluate the humoral immunogenicity in various schedule combinations of full dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).
    Detailed Description
    The study will be conducted in a setting where only IPV is being used for polio prevention in infant immunization schedules. The study population will include infants from Uruguay, a pioneer country in immunization programs in Latin America, where tOPV(trivalent oral polio vaccine) was used until 2012, after which the program changed to an all-IPV schedule without transition. The primary IPV immunization schedule in the country is as stand-alone vaccine at 2, 4 and 6 months of age, with a booster dose at 15 months. This setting allows the evaluation of IPV immunogenicity in a scenario where the circulation of any poliovirus is highly unlikely. Infants will receive two or three doses of full dose IPV IM or fractional dose f-IPV ID, in various schedule combinations (6 and 14 weeks; 10 and 14 weeks; 14 and 36 weeks; 6, 14 and 36 weeks; 10, 14 and 36 weeks). Immunological and safety assessments will be made after one dose, two doses and three doses. The study will be conducted in Montevideo, Uruguay and a total of 1493 infants will be randomized into 6 groups. Other vaccines comprise DTPw-HB-Hib (pentavalent combined diphtheria-tetanus-whole cell pertussis-hepatitis B-Hib vaccine), Pneumococcal conjugate vaccine, Rotavirus and will be administered concomitantly. Optimum immunogenicity expected from the dose/s of IPV in the post-eradication era will have to be balanced with the cost and supply constraints of IPV. This study will be critical to determine how many doses of IPV and which schedule will be recommended for the post-eradication era after the cessation of OPV (oral polio vaccine) usage globally.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Poliomyelitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 18, 36 & 40 weeks.
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 18, 36 & 40 weeks.
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.
    Arm Title
    Group D
    Arm Type
    Experimental
    Arm Description
    2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.
    Arm Title
    Group E
    Arm Type
    Experimental
    Arm Description
    3 doses IPV IM at 6, 14 & 36 weeks of age incl. blood sampling at 6, 18, 36 & 40 weeks.
    Arm Title
    Group F
    Arm Type
    Experimental
    Arm Description
    3 doses f-IPV ID at 6, 14 & 36 weeks of age incl. blood sampling at 6, 18, 36 & 40 weeks.
    Intervention Type
    Biological
    Intervention Name(s)
    IPV
    Intervention Description
    Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
    Intervention Type
    Biological
    Intervention Name(s)
    f-IPV
    Intervention Description
    Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
    Primary Outcome Measure Information:
    Title
    Seroconversion
    Description
    Seroconversion will be defined as a change from seronegative to seropositive (antibody titers of ≥1:8) and in infants seropositive at baseline (assumed to be from maternally-derived antibody titers), as a ≥4-fold rise in antibody titers post-vaccination, computed by assuming an exponential decay model with a half-life of 24 days.
    Time Frame
    To be assessed four weeks after the second vaccination for all groups receiving 2 doses of IPV and four weeks after the second vaccination for all groups receiving 2 doses of f-IPV.
    Secondary Outcome Measure Information:
    Title
    Seroconversion
    Time Frame
    To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV.
    Title
    Median titers
    Time Frame
    To be assessed four weeks after the second or third vaccination, respectively, for the groups receiving IPV and four weeks after the second or third vaccination, respectively, for the groups receiving f-IPV.
    Title
    SAEs (Serious Adverse Events)
    Time Frame
    To be assessed throughout the complete study period, approx. 18 months.
    Title
    IMEs (Important Medical Events)
    Description
    These are medically significant events that do not meet any of the SAE criteria, but require medical or surgical consultation or intervention to prevent this event from becoming a SAE.
    Time Frame
    To be assessed throughout the complete study period, approx. 18 months.
    Title
    Severe local reactions
    Description
    Severe local reactions can include severe pain, inflammation, induration and edema in the injection area.
    Time Frame
    To be assessed throughout the complete study period, approx. 18 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Weeks
    Maximum Age & Unit of Time
    7 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Infants of 6 weeks of age (-7 to + 7 days) on date of first vaccination Healthy, as assessed from medical history and physical examination by a study physician Written informed consent obtained from parents or legal representatives that they have been properly informed about the study and are able to comply with planned study procedures Exclusion Criteria: Vaccinated with any poliovirus vaccine prior to inclusion A household contact with OPV vaccination history in the past 4 weeks HIV infection or pharmacologic immunosuppression. Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde) Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections. Acute severe febrile illness on day of vaccination deemed by the Investigator to be a contraindication for vaccination. Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stella Gutierrez, MD
    Organizational Affiliation
    CASMU Polyclinic 8 de Octubre 3310 Montevideo, Uruguay
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine

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