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Immunogenicity of Intramuscular and Intradermal IPV

NCT04063150 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 958

Last updated 2022-05-18

No results posted yet for this study

Summary

This is an open-label phase IV randomized clinical trial that will compare immune responses among infants who receive different dose schedules of either fractional dose or full dose inactivated poliovirus vaccine (IPV), delivered either intramuscularly or intradermally.

Note: This study was terminated early due to the COVID-19 pandemic. Due to early study closure, the study objectives could not be evaluated as planned. Both of the primary objectives and several secondary objectives could not be evaluated because none of the study participants reached the corresponding endpoint. Due to limited sample size, the analysis approach for four secondary objectives was changed from a non-inferiority assessment to a comparison of proportions between groups.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

fIPV (0.1 mL) ID

Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal (ID) injection in lieu of the full 0.5 mL dose.

BIOLOGICAL

fIPV (0.1mL) IM

Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.

BIOLOGICAL

fIPV (0.2mL) IM

Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.2 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.

BIOLOGICAL

IPV

Full dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.5 milliliter (mL) dose by intramuscular (IM) injection.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
48 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-06
Primary Completion
2020-03-25
Completion
2020-03-25

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063150 on ClinicalTrials.gov