A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV

July 10, 2023 updated by: Fidec Corporation

A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full-Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Latin American Infants

The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule combinations in the Expanded Program on Immunization (EPI) primary series.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study prioritizes comparisons involving two-dose regimens recently recommended by the World Health Organization (WHO) Strategic Advisory Group of Experts on immunization (SAGE) and Pan American Health Organization (PAHO) in response to global IPV supply shortages 21. Furthermore, the study will provide data on the comparative humoral immunogenicity of various schedules to inform polio immunization policy for the post-eradication era.

The study population will include infants in Dominican Republic and Panama. Absence of wild and circulating vaccine derived polioviruses along with the lack of regular Supplementary Immunization Activities (SIAs) in the Latin America region provide an ideal epidemiologic setting to study polio vaccine immunogenicity.

Infants will receive two or three doses of full-dose IPV IM or f-IPV ID, in two schedules (10, 14 and 36 weeks and 14 and 36 weeks). Immunological and safety assessments will be made after one dose, two doses and three doses.

A total of 773 infants will be enrolled and distributed into 4 groups, according to a randomization scheme. During the study period, infants will be administered other concomitant vaccines according to the national schedules of the participating countries, but the effect, if any, of the concomitant administration on IPV immunogenicity will not be assessed.

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 are optimal for the post-eradication era after the global cessation of Oral Polio Vaccine (OPV) use.

Study Type

Interventional

Enrollment (Actual)

773

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Santo Domingo, Dominican Republic
        • Hospital Universitario Nuestra Señora de la Alta Gracia
      • David, Panama
        • Cevaxin Vaccination Center
      • La Chorrera, Panama
        • Cevaxin Vaccination Center
      • Panama city, Panama
        • Cevaxin Vaccination Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 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 A
3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 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
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 C
3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 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 Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM
Time Frame: To be assessed 4 weeks after the last dose
To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
To be assessed 4 weeks after the last dose
Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM
Time Frame: To be assessed 4 weeks after the last dose
To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
To be assessed 4 weeks after the last dose
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID
Time Frame: To be assessed 4 weeks after the last dose
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
To be assessed 4 weeks after the last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion Superiority of 2 Doses IPV IM at Different Schedules
Time Frame: To be assessed 4 weeks after the second dose
To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.
To be assessed 4 weeks after the second dose
Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules
Time Frame: To be assessed 4 weeks after the second dose
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose f-IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.
To be assessed 4 weeks after the second dose
Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM
Time Frame: To be assessed 4 weeks after the last dose
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
To be assessed 4 weeks after the last dose
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM
Time Frame: To be assessed 4 weeks after the last dose
To determine if the seroconversion rate of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen also administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
To be assessed 4 weeks after the last dose
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM
Time Frame: To be assessed 4 weeks after the last dose
To determine if the seroconversion rate to a 3-dose regimen of f-IPV administered at 10, 14, and 36 weeks of age is non-inferior to that of a 2-dose IPV regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
To be assessed 4 weeks after the last dose
Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions
Time Frame: 9 months
To assess the safety of each vaccine (IPV and f-IPV) as measured by the number of subjects experiencing serious adverse events (SAEs), important medical events (IMEs) and/or severe local reactions. This assessments is done in the Total Vaccinated Population (744 subjects).
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2017

Primary Completion (Actual)

November 13, 2018

Study Completion (Actual)

November 13, 2018

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (Actual)

August 4, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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