- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03016949
A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
3 doses IPV IM at 10, 14 & 36 weeks of age incl.
blood sampling at 10, 18, 36 & 40 weeks.
|
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Experimental: Group B
3 doses f-IPV ID at 10, 14 & 36 weeks of age incl.
blood sampling at 10, 18, 36 & 40 weeks.
|
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Experimental: Group C
2 doses IPV IM at 14 & 36 weeks of age incl.
blood sampling at 14, 18, 36 & 40 weeks.
|
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Experimental: Group D
2 doses f-IPV ID at 14 & 36 weeks of age incl.
blood sampling at 14, 18, 36 & 40 weeks.
|
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Experimental: Group E
3 doses IPV IM at 6, 14 & 36 weeks of age incl.
blood sampling at 6, 18, 36 & 40 weeks.
|
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
Experimental: Group F
3 doses f-IPV ID at 6, 14 & 36 weeks of age incl.
blood sampling at 6, 18, 36 & 40 weeks.
|
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroconversion
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.
|
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
|
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.
|
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.
|
|
SAEs (Serious Adverse Events)
Time Frame: To be assessed throughout the complete study period, approx. 18 months.
|
To be assessed throughout the complete study period, approx. 18 months.
|
|
IMEs (Important Medical Events)
Time Frame: To be assessed throughout the complete study period, approx. 18 months.
|
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.
|
To be assessed throughout the complete study period, approx. 18 months.
|
Severe local reactions
Time Frame: To be assessed throughout the complete study period, approx. 18 months.
|
Severe local reactions can include severe pain, inflammation, induration and edema in the injection area.
|
To be assessed throughout the complete study period, approx. 18 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stella Gutierrez, MD, CASMU Polyclinic 8 de Octubre 3310 Montevideo, Uruguay
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPV-003-ABMG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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