OPV Transmissibility in Communities After Cessation of Routine OPV Immunization

NCT02376374 | Completed

• 1 other identifier: 31546
• Study Type: interventional
• Target: 1,828
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators propose to study both inter- and intra-household Oral Polio Vaccine (OPV) transmission in a primarily inactivated-polio vaccine (IPV)-vaccinated community in Mexico. The investigators will enroll 3 distinct clusters of households in a municipality in Orizaba, Veracruz, Mexico prior to the February 2015 National Immunization Week (NIW.) These clusters will be physically separate from one another and differ only in the proportion of OPV-eligible children who will receive OPV during the February 2015 NIW (10%, 30% and 70% vaccinated.) The investigators will look at inter-household and intra-household transmission. The investigators will then determine if epidemiologic (i.e.: degree of contact), anthropometric (i.e.: nutritional status) or clinical covariates (i.e.: IPV/OPV immunization history) are associated with intra-household transmission.

Conditions

Polio

Keywords

transmission; vaccine

Outcome Measures

Primary Outcomes (2)

• Inter-household transmission of poliovirus

  Feb 2015-May 2015; 4 months

• Intra-household transmission of poliovirus

  Feb 2015-May 2015; 4 months

Study Arms (3)

10% OPV

EXPERIMENTAL

In this arm, 10% of the households in this community will receive OPV.

Other: Controlling vaccination rates in communities

30% OPV

EXPERIMENTAL

In this arm, 30% of the households in this community will receive OPV.

Other: Controlling vaccination rates in communities

70% OPV

EXPERIMENTAL

In this arm, 70% of the households in this community will receive OPV.

Other: Controlling vaccination rates in communities

Interventions

Controlling vaccination rates in communities OTHER

Three communities will be in three arms, one per arm. From 150 randomly-selected households, 10% will receive OPV in one community, 30% in the second community, and 70% in the third community.

10% OPV; 30% OPV; 70% OPV

Eligibility Criteria

• Age: Up to 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Households with children under the age of 5 who have up-to-date IPV vaccination history and willing to give informed consent and/or assent.

You may not qualify if:

• Unwilling/unable to bring children's IPV vaccination records up-to-date.

Sponsors & Collaborators

• Stanford University: lead
• Bill and Melinda Gates Foundation: collaborator
• Instituto Nacional de Salud Publica, Mexico: collaborator

MeSH Terms

Conditions

Poliomyelitis

Interventions

Residence Characteristics

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OPV transmissibility in communities after cessation of routine OPV immunization

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 3, 2015
• Study Start: February 1, 2015
• Primary Completion: February 28, 2017
• Study Completion: March 31, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05