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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001046099

Enrollment

320

Registered

2010-11-30

Start date

2009-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

4 Months to 5 Months

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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.

Outcome results