NCT03239496

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
773

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_3

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 18, 2020

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

July 28, 2017

Results QC Date

August 1, 2020

Last Update Submit

July 10, 2023

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (3)

  • Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM

    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

    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

    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 Outcomes (6)

  • Seroconversion Superiority of 2 Doses IPV IM at Different Schedules

    To be assessed 4 weeks after the second dose

  • Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules

    To be assessed 4 weeks after the second dose

  • Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM

    To be assessed 4 weeks after the last dose

  • Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM

    To be assessed 4 weeks after the last dose

  • Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM

    To be assessed 4 weeks after the last dose

  • +1 more secondary outcomes

Study Arms (4)

Group A

EXPERIMENTAL

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

Biological: IPV

Group B

EXPERIMENTAL

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

Biological: IPV

Group C

EXPERIMENTAL

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

Biological: f-IPV

Group D

EXPERIMENTAL

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

Biological: f-IPV

Interventions

IPVBIOLOGICAL

Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)

Group AGroup B
f-IPVBIOLOGICAL

Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)

Group CGroup D

Eligibility Criteria

Age5 Weeks - 7 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants of 6 weeks of age (-7 to + 7 days) on date of enrollment.
  • Healthy, as assessed from medical history and physical examination by a study physician,
  • 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.

You may not qualify if:

  • 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(s) to be a contraindication for vaccination,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitario Nuestra Señora de la Alta Gracia

Santo Domingo, Dominican Republic

Location

Cevaxin Vaccination Center

David, Panama

Location

Cevaxin Vaccination Center

La Chorrera, Panama

Location

Cevaxin Vaccination Center

Panama City, Panama

Location

Related Publications (1)

  • Bandyopadhyay AS, Gast C, Rivera L, Saez-Llorens X, Oberste MS, Weldon WC, Modlin J, Clemens R, Costa Clemens SA, Jimeno J, Ruttimann R. Safety and immunogenicity of inactivated poliovirus vaccine schedules for the post-eradication era: a randomised open-label, multicentre, phase 3, non-inferiority trial. Lancet Infect Dis. 2021 Apr;21(4):559-568. doi: 10.1016/S1473-3099(20)30555-7. Epub 2020 Oct 23.

    PMID: 33284114DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Results Point of Contact

Title
Ricardo Rüttimann
Organization
FIDEC Corporation
rruttimann@fidec-online.org
+17863546335

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 4, 2017

Study Start

October 23, 2017

Primary Completion

November 13, 2018

Study Completion

November 13, 2018

Last Updated

July 21, 2023

Results First Posted

August 18, 2020

Record last verified: 2023-07

Locations

DO(1)PA(3)