NCT01633216

Brief Summary

This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The results of this study will guide the Global Polio Eradication Program in the implementation of new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV in outbreak responses in countries with weak routine immunization systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 8, 2013

Status Verified

June 1, 2012

Enrollment Period

7 months

First QC Date

June 30, 2012

Last Update Submit

January 6, 2013

Conditions

Healthy Infants

Keywords

poliovirus,trivalent oral polio vaccine,bivalent oral polio vaccine,monovalent oral polio vaccine

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity

    To assess the immunogenicity of each study vaccine and vaccination schedule, antibody titers against poliovirus types 1, 2 and 3 will be determined in sera extracted from blood collected before (at 6 weeks of age) and after receiving 3 doses of study vaccine.

    7 months

Study Arms (5)

Bivalent OPV 2 week interval

ACTIVE COMPARATOR

Group A will receive 3 doses of bOPV at 6, 8 and 10 weeks of age (2-week interval between doses).

Biological: Bivalent OPV 2 week interval

Bivalent OPV 4 week interval

ACTIVE COMPARATOR

Group B will receive 3 doses of bOPV at 6, 10 and 14 weeks of age (4-week interval between doses).

Biological: Bivalent OPV 4 week interval

Monovalent OPV 2week interval

ACTIVE COMPARATOR

Group C will receive 3 doses of mOPV1 at 6, 8 and 10 weeks of age (2-week interval between doses).

Biological: Monovalent OPV 2 week interval

Monovalent OPV 4 week interval

ACTIVE COMPARATOR

Group D will receive 3 doses of mOPV1 at 6, 10 and 14 weeks of age (4-week interval between doses).

Biological: Monovalent OPV 4 week interval

Trivalent OPV 4 week interval

ACTIVE COMPARATOR

Group E will receive 3 doses of tOPV at 6, 10 and 14 weeks of age (4-week interval between doses and similar to the current routine immunization schedule).

Biological: Trivalent OPV 4 week interval

Interventions

Bivalent OPV 2 week intervalBIOLOGICAL

Group A will receive 3 doses of bOPV at 6, 8 and 10 weeks of age (2-week interval between doses).

Bivalent OPV 2 week interval
Bivalent OPV 4 week intervalBIOLOGICAL

Group B will receive 3 doses of bOPV at 6, 10 and 14 weeks of age (4-week interval between doses).

Bivalent OPV 4 week interval
Monovalent OPV 2 week intervalBIOLOGICAL

Group C will receive 3 doses of mOPV1 at 6, 8 and 10 weeks of age (2-week interval between doses).

Monovalent OPV 2week interval
Monovalent OPV 4 week intervalBIOLOGICAL

Group D will receive 3 doses of mOPV1 at 6, 10 and 14 weeks of age (4-week interval between doses).

Monovalent OPV 4 week interval
Trivalent OPV 4 week intervalBIOLOGICAL

Group E will receive 3 doses of tOPV at 6, 10 and 14 weeks of age (4-week interval between doses and similar to the current routine immunization schedule).

Trivalent OPV 4 week interval

Eligibility Criteria

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

You may qualify if:

  • Healthy infants of 6 weeks of age (±2 days).
  • Study families reside within the Health and Demographic Surveillance System (HDSS) area, service area of the ICDDR,B.
  • Family able to understand and comply with planned study procedures

You may not qualify if:

  • Family residence outside the ICDDR,B HDSS service area, or families expecting to move away during the study period, will be excluded.
  • A diagnosis or suspicion of immunodeficiency disorder (either in the infant or in a member of the immediate family).
  • A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
  • Acute diarrhea, infection or illness at the time of the first visit (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 first visit (6 weeks of age).
  • Receipt of OPV or IPV at any time before enrollment based upon mother's recall or immunization card if available.
  • Because of contact transmission of vaccine poliovirus strains, newborns from multiple births will be excluded from the study to prevent transmission of vaccine strains received during routine immunization from the twin to the study participant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Matlab

Matlab, Chandpur, Bangladesh

Location

Mirpur

Dhaka, Dhaka Division, 1216, Bangladesh

Location

Related Publications (2)

  • Emperador DM, Velasquez DE, Estivariz CF, Lopman B, Jiang B, Parashar U, Anand A, Zaman K. Interference of Monovalent, Bivalent, and Trivalent Oral Poliovirus Vaccines on Monovalent Rotavirus Vaccine Immunogenicity in Rural Bangladesh. Clin Infect Dis. 2016 Jan 15;62(2):150-6. doi: 10.1093/cid/civ807. Epub 2015 Sep 8.

    PMID: 26349548DERIVED

  • Estivariz CF, Anand A, Gary HE Jr, Rahman M, Islam J, Bari TI, Wassilak SG, Chu SY, Weldon WC, Pallansch MA, Heffelfinger JD, Luby SP, Zaman K. Immunogenicity of three doses of bivalent, trivalent, or type 1 monovalent oral poliovirus vaccines with a 2 week interval between doses in Bangladesh: an open-label, non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2015 Aug;15(8):898-904. doi: 10.1016/S1473-3099(15)00094-8. Epub 2015 Jun 17.

    PMID: 26093980DERIVED

Study Design

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

Study Record Dates

First Submitted

June 30, 2012

First Posted

July 4, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 8, 2013

Record last verified: 2012-06

Locations

BA(2)