NCT02412514

Brief Summary

This is a phase IV open-label randomized clinical trial that will compare intestinal and humoral immunity in infants receiving inactivated poliovirus vaccine (IPV) and two or three doses of bivalent oral poliovirus vaccine (bOPV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
456

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 20, 2016

Status Verified

April 1, 2016

Enrollment Period

8 months

First QC Date

April 1, 2015

Last Update Submit

July 19, 2016

Conditions

Poliomyelitis

Keywords

polioinactivated poliovirus vaccineoral poliovirus vaccineIPVOPV

Outcome Measures

Primary Outcomes (2)

  • Change in type 1 and 3 excretion of vaccine poliovirus particles in stool one week after administration of the bOPV challenge dose.

    One week

  • Change in type 1, 2 and 3 poliovirus antibody responses prior to administration of poliovirus vaccinations compared to after completion of poliovirus vaccinations.

    12 weeks

Secondary Outcomes (1)

  • Change in type 1 and 3 excretion of vaccine poliovirus in stool two weeks after administration of the bOPV challenge dose at 18 weeks of age.

    Two weeks

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Infants assigned to Arm A will receive bOPV at 6, 10, and 14 weeks of age and IPV at 6 weeks of age.

Biological: bOPV (three dose)Biological: IPV

Arm B

ACTIVE COMPARATOR

Infants assigned to Arm B will receive bOPV at 10 and 14 weeks of age and IPV at 6 weeks of age.

Biological: bOPV (two dose)Biological: IPV

Interventions

bOPV (three dose)BIOLOGICAL

bOPV administered at 6, 10, and 14 weeks of age.

Arm A
bOPV (two dose)BIOLOGICAL

bOPV administered at 10 and 14 weeks of age.

Arm B
IPVBIOLOGICAL

IPV administered at 6 weeks of age

Arm AArm B

Eligibility Criteria

Age6 Weeks - 6 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants 6 weeks of age (range: 42-48 days).
  • 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 diarrhea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV per country guidelines.
  • Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
  • Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation or parental recall.
  • Known allergy/sensitivity or reaction to polio vaccine or contents of polio vaccine.
  • Infants from multiple births. Infants from multiple births will be excluded to reduce the potential for contact transmission of vaccine poliovirus to siblings. The infant(s) from a multiple birth who is/are not enrolled would be likely to receive routine immunization and transmit vaccine poliovirus to the enrolled infant.
  • Infants from premature births (\<37 weeks of gestation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mirpur Clinic (International Centre for Diarrhoeal Disease Research, Bangladesh)

Dhaka, Bangladesh

Location

Related Publications (1)

  • Snider CJ, Zaman K, Estivariz CF, Aziz AB, Yunus M, Haque W, Hendley WS, Weldon WC, Oberste MS, Pallansch MA, Wassilak SGF, Anand A. Assessing the mucosal intestinal and systemic humoral immunity of sequential schedules of inactivated poliovirus vaccine and bivalent oral poliovirus vaccine for essential immunization in Bangladesh: An open-label, randomized controlled trial. Vaccine. 2024 Sep 17;42(22):126216. doi: 10.1016/j.vaccine.2024.126216. Epub 2024 Aug 14.

    PMID: 39146859DERIVED

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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 9, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 20, 2016

Record last verified: 2016-04

Locations

BA(1)