Comparison of boosting of mucosal immunity after full and fractional dose of inactivated poliovirus vaccine, clinical trial in children in Sri Lanka, 2016

Comparison of boosting of mucosal immunity after full and fractional dose of inactivated poliovirus vaccine, a randomized clinical trial in 300 children aged 10-12 years of age living in Kalutara district of Sri Lanka, 2016

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000124437

Enrollment

300

Registered

2016-02-03

Start date

2016-02-15

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 study will evaluate the effect of fIPV on boosting mucosal immunity against polioviruses in Sri Lanka, a country with high routine immunization coverage with OPV and IPV introduced in its routine immunization schedule. It will enable decision makers in Sri Lanka as well as in other countries in similar situation, to evaluate risks and benefits of fIPV use for OBR in case of cVDPV2 outbreak following the tOPV to bOPV switch. After April 2016, no country will be allowed to use tOPV therefore this is a last chance to conduct this type of a study and all study procedures must be completed by the end of April 2016.

Interventions

Full one dose (0.5 ml) of inactivated poliovirus vaccine administered intramuscularly or Fractional one dose (0.1 ml) of inactivated poliovirus vaccine administered intradermally

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

10 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

Any child 10-12 years of age residing in the determined area of Kalutara Parent/Guardian provides consent for child’s participation, including vaccination with IPV/OPV and blood and stool sample collections

Exclusion criteria

Contraindication for venepuncture Sick child requiring hospitalization for acute or chronic condition Diagnosis or suspicion of congenital immunodeficiency disorder in the subject or an immediate family member

Outcome results