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IPV in Moderate to Severe Chronic Malnourished 9-12 Month Old Children in Karachi.

NCT01695798 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2014-01-16

No results posted yet for this study

Summary

Chronic malnutrition is associated with lack of effective gut immunity which is a possible explanation for why we see polio cases among a proportion of children who have received 7 or more doses of OPV.Our proposed idea is to evaluate if IPV antigen given later in life may act together to boost humoral and mucosal immunity in children belonging to low-income background in Karachi who have moderate to severe chronic malnutrition (height for age Z score less than -2SD). We also intend to compare eIPV + OPV with OPV only in non-malnourished infants at 9 -12 month of age. Thus, the proposed study is a combination of two trials, with study population stratified by nutritional status, each with a reference arm (bOPV) and an experimental arm (bOPV plus IPV).

Conditions

  • Immunity to Polio Vaccines in Malnourished Infants
  • Immunity to Polio Vaccines in Non-malnourished Infants

Interventions

BIOLOGICAL

Injectable polio vaccine and Bivalent oral polio vaccine

One dose of IPV given IM (arm, thigh) to infant aged 9-12 month after randomization. There will be two groups Chronic Malnourished group and Non-Malnourished group. Each group has two arms, which were randomized on IPV+bOPV and bOPOV alone

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Anita K.M Zaidi, MBBS, SM · Aga Khan University

  • Ali F Saleem, MBBS, MCR, FCPS · Aga Khan University

  • Farheen Quadri, MBBS, MSCR · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • Pakistan

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01695798 on ClinicalTrials.gov