Comparison trial of three needle-free devices for application of intradermal inactivated polio vaccine in young infants in Cuba

Comparison of immune response of fractional inactivated poliovirus vaccine (IPV) administered intradermally using different administration techniques in young infants in Camaguey, Cuba

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000482864

Enrollment

1000

Registered

2012-05-02

Start date

2012-09-01

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

This trial will inform on polio eradication prerequisite regarding implementation of IPV requirements in countries that retain poliovirus in laboratories or in production as well as on the performance and usability of three different needle-free devices to deliver fractional dose IPV (affordable IPV) in routine immunization programs as well as during vaccination campaigns.

Interventions

Intradermal administration of single fractional dose of inactivated polio vaccine via BCG needle or one of three different needle-free devices. There are 4 interventional arms (in each arm one IPV dose is administered): 1 - fIPV intradermally through BCG syringe (fractional dose - 0.1ml) 2 - fIPV Device A (Biojector 2000, dose 0.1 ml) 3 - fIPV Device B (Bioject ID Pen, dose 0.1 ml) 4 - fIPV Device C (Pharmajet, dose 0.1 ml)

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

9 Months to 16 Months

Healthy volunteers

Yes

Inclusion criteria

Healthy infants born between July 1 and December 31, 2011 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers with documented history of receiving two doses of OPV through NIDs in 2012.

Exclusion criteria

Infants <3 percentile for height and weight, residence outside the catchment’s 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