NCT00260312

Brief Summary

The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2001

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

August 1, 2001

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
Last Updated

December 1, 2005

Status Verified

January 1, 2004

First QC Date

November 29, 2005

Last Update Submit

November 29, 2005

Conditions

Level of Immunity Against Poliovirus Infection

Keywords

inactivedpoliovaccinecubatrialrandomizederadication

Outcome Measures

Primary Outcomes (1)

  • Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity

Interventions

Inactivated Polio Vaccine given at an accelerated scheduleBIOLOGICAL

Eligibility Criteria

Age6 Weeks - 2 Months
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants born 18 - 20 weeks prior to the first round of the 2002 National Immunization Days in cuba (in March 2002).
  • Born healthy at one of the 4 designated maternity hospitals in Cuba

You may not qualify if:

  • Serious congenital defect/disease at birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cuba IPV Study Collaborative Group. Randomized, placebo-controlled trial of inactivated poliovirus vaccine in Cuba. N Engl J Med. 2007 Apr 12;356(15):1536-44. doi: 10.1056/NEJMoa054960.

    PMID: 17429085DERIVED

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 Officials

  • Miguel Galindo, MD

    Ministry of Public Health, Cuba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

August 1, 2001

Study Completion

January 1, 2003

Last Updated

December 1, 2005

Record last verified: 2004-01