NCT04063150

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
958

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

August 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 6, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

August 19, 2019

Last Update Submit

May 11, 2022

Conditions

Poliomyelitis

Keywords

inactivated poliovirus vaccinefractional inactivated poliovirus vaccineintradermalintramuscular

Outcome Measures

Primary Outcomes (1)

  • Vaccine response

    Dichotomous (yes/no) variable defined as participants who are either seronegative (\<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 6 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.

    Measured four weeks after administration of study vaccine(s).

Secondary Outcomes (1)

  • Reciprocal antibody titers

    Measured four weeks after administration of study vaccine(s).

Study Arms (7)

IPV at 14 weeks + 9 months

ACTIVE COMPARATOR

Participants in this arm will receive full doses (0.5 mL) of IPV at 14 weeks and 9 months of age.

Biological: IPV

IPV at 6 weeks + 9 months

ACTIVE COMPARATOR

Participants in this arm will receive full doses (0.5 mL) of IPV at 6 weeks and 9 months of age.

Biological: IPV

fIPV ID at 6 weeks + 14 weeks + 9 months

ACTIVE COMPARATOR

Participants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age.

Biological: fIPV (0.1 mL) ID

fIPV ID at 14 weeks + 9 months

ACTIVE COMPARATOR

Participants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age.

Biological: fIPV (0.1 mL) ID

fIPV IM at 6 weeks + 14 weeks + 9 months

ACTIVE COMPARATOR

Participants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age.

Biological: fIPV (0.1mL) IM

fIPV 0.1mL IM at 14 weeks + 9 months

ACTIVE COMPARATOR

Participants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age.

Biological: fIPV (0.1mL) IM

fIPV 0.2mL IM at 14 weeks + 9 months

ACTIVE COMPARATOR

Participants in this arm will receive intramuscular fractional doses (0.2 mL) of IPV at 14 weeks and 9 months of age.

Biological: fIPV (0.2mL) IM

Interventions

fIPV (0.1 mL) IDBIOLOGICAL

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.

fIPV ID at 14 weeks + 9 monthsfIPV ID at 6 weeks + 14 weeks + 9 months
fIPV (0.1mL) IMBIOLOGICAL

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.

fIPV 0.1mL IM at 14 weeks + 9 monthsfIPV IM at 6 weeks + 14 weeks + 9 months
fIPV (0.2mL) IMBIOLOGICAL

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.

fIPV 0.2mL IM at 14 weeks + 9 months
IPVBIOLOGICAL

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.

IPV at 14 weeks + 9 monthsIPV at 6 weeks + 9 months

Eligibility Criteria

Age42 Days - 48 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants 6 weeks of age
  • Parents that consent for participation in the full length of the study.
  • Parents that are able to understand and comply with planned study procedures.

You may not qualify if:

  • Parents and infants who are unable to participate in the full length of the study.
  • A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
  • A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of IPV or collection of blood by venipuncture.
  • Acute diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
  • Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age).
  • Evidence of a chronic medical condition identified by a study medical officer during physical exam.
  • Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
  • Known allergy/sensitivity or reaction to polio vaccine, or its contents.
  • Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant. Even if all births from a multiple birth could be enrolled in the study, we will exclude multiple births as discontinuation of one may lead to discontinuation of multiple participants.
  • Infants from premature births (\<37 weeks of gestation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

icddr,b study clinics (Mirpur and CTU Dhaka)

Dhaka, Bangladesh

Location

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 21, 2019

Study Start

October 6, 2019

Primary Completion

March 25, 2020

Study Completion

March 25, 2020

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)