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Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in Cuba

Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in Cuba

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19673867
Enrollment
400
Registered
2007-08-15
Start date
2006-09-15
Completion date
Unknown
Last updated
2021-10-11

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

Conditions

Poliomyelitis vaccination Infections and Infestations Poliomyelitis

Interventions

Patients will be randomised between: 1. A fractional dose of IPV (0.1 ml or 1/5 of a dose) administered intradermally by needle-free device - potency of IPV is 40-8-32-D antigen units

Sponsors

World Health Organization (WHO) (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy newborns (greater than 2.5 kg, apgar score greater than 9 at five minutes) 2. Living within the catchment area of the participating polyclinics 3. Newborns delivered by caesarian section

Exclusion criteria

Exclusion criteria: 1. Newborns requiring hospitalisation (except if in hospital because of maternal admission) 2. Birth weight below 2.5 kg 3. Apgar score less than 9 4. Residence outside the catchment area, or families expecting to move away during the study period 5. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will also render the newborn ineligible for the study

Design outcomes

Primary

MeasureTime frame
Seroconversion by neutralisation assay between birth and 18 weeks.

Secondary

MeasureTime frame
Seroconversion by neutralisation assay after each dose of study vaccines.

Countries

Cuba, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026