ActivePhase 2ACTRN12610001046099

Immune response to two-dose fractional inactivated poliovirus vaccine administered at 4- and 8- month of age

Immune response and seroconversion in two-dose fractional inactivated poliovirus vaccine administered at 4 and 8 months of age


Sponsor

World Health Organization

Enrollment

320 participants

Start Date

Jul 1, 2009

Study Type

Interventional

Conditions

Summary

The purpose of this study is to test the efficacy of a two dose schedule using either fractional or full dose IPV with the ultimate purpose to find a way for developing countries to adopt more affordable IPV use strategies in the future. It is hypothesized the fractional dose arm will be non-inferior to the full dose arm.


Eligibility

Sex: Both males and femalesMin Age: 4 MonthssMax Age: 5 Monthss

Inclusion Criteria2

  • Healthy infants (greater than 3rd percentile for height and weight) at enrollment living within the catchment area of
  • the participating polyclinics.

Exclusion Criteria5

  • Infants less than 3 percentile for height and weight, residence outside the catchment area, or families expecting
  • to move away during the study period, will be excluded. A diagnosis, suspicion or treatment of
  • immunodeficiency disorder (either in the participant or in a member of the immediate family) will render
  • the newborn ineligible for the study. Infants of mother age below legal age (<18 years) or with mentally
  • incapacity will not be eligible to participate.

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Interventions

Two fractional 0.1 ml IPV doses administered intradermally at 4 and 8 month old infants

Two fractional 0.1 ml IPV doses administered intradermally at 4 and 8 month old infants


Locations(1)

camaguey, Cuba

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