Trial to assess whether it is safe and efficient to vaccinate children with lower dose of Inactivated Poliovirus Vaccine (IPV) , Cuba 2017

Comparison of Immunogenicity of full dose Inactivated Poliovirus Vaccine (IPV) and fractional dose IPV administered to infants intramuscularly or intradermally, Cuba 2017

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001525370

Enrollment

400

Registered

2017-11-03

Start date

2017-08-28

Completion date

2017-09-28

Last updated

2017-11-13

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

Conditions

None listed

Brief summary

Inactivated poliovirus vaccine (IPV) has been introduced globally, however, in 2016 shortages of IPV supply caused stock-outs and put strain on IPV use for routine immunizations as well as for poliovirus outbreak response; this shortage is going to last until 2018 if not longer. Administration of 1/5th IPV dose intradermally (fractional IPV or fIPV) has been proved to be safe and provides similar immune response as full dose IPV administered intramuscular, however, fIPV administered with BCG needle and syringe (BCG NS) intradermally is technically difficult and many countries are hesitant to adopt fIPV in their routine immunization schedules because of the additional needs for training of health staff. fIPV administered intramuscularly has been less examined; the few documented uses of intramuscular fIPV suggest no safety concerns, however, it is unclear whether desired immunogenicity could be achieved. In this study we will compare immunogenicity achieved after two doses of full dose IPV or fIPV administered at the age of 4 and 8 months to poliovirus naive children in Cuba. We will assess two volumes of fIPV doses: 1/5th and 2/5th of full dose (0.1 ml and 0.2 ml).

Interventions

Arm A: intramuscular (i.m.) administration of fractional dose of Inactivated Poliovirus Vaccine (fIPV) - 0.1ml [one dose at 4 months of age and one dose at 8 months of age] Arm B: im fIPV - 0.2ml [one dose at 4 months of age and one dose at 8 months of age] Arm C:: intradermal (i.d.) fIPV - 0.1ml [one dose at 4 months of age and one dose at 8 months of age]

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

4 Months to 4 Months

Healthy volunteers

Yes

Inclusion criteria

Healthy infants born between April 15 and May 31, 2017 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers in Camaguey, Cuba

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 child 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