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Withdrawn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
About this trial
This is an interventional prevention trial for Poliomyelitis
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.
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
NCT ID
NCT03016949
First Posted
January 5, 2017
Last Updated
June 26, 2017
Sponsor
Fidec Corporation
Collaborators
Bill and Melinda Gates Foundation
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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