Persistence of IPV Immunity
Poliomyelitis
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring IPV, Routine immunization, Single dose, Persistence of immunity
Eligibility Criteria
Inclusion Criteria:
We will be including Nepali infants who fulfil the following criteria:
- Born after 30 April 2016
- Healthy infant or mild illness
- Age groups within one of the following age groups: 7-12 months or >24 months.
- Receipt of one dose of IPV at 3- 6 months of age (if age >24months) or zero doses (if age within 7-12 months). IPV receipt must be validated through immunization card or registry book.
- Parents that consent for participation in the full length of the study.
- Parents those are able to understand and comply with planned study procedures.
Exclusion Criteria:
- Parents and infants who are unable to participate in the full length of the study.
- A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of IPV or collection of blood by venipuncture.
- Acute infection or illness at the time of enrollment that would require infant's admission to a hospital.
- Evidence of a chronic medical condition identified by a study medical officer during physical exam.
- Known allergy/sensitivity or reaction to polio vaccines.
Discontinuation Criteria
- Withdrawal of consent for participation for any reason.
- Request by parents of participant to terminate all study procedures.
- Identification of immunodeficiency disorder, bleeding disorder or another medical condition for which continued participation, in the opinion of the principal investigator, would pose a risk to the participant to continue in the study.
- Receipt of immunosuppressive medications.
- Receipt of any polio (OPV or IPV) vaccine outside of study after enrollment (as per parent's report).
- Allergic reaction to a dose of polio vaccine.
- Unable to collect or obtain blood at enrollment.
- Premature termination of the study.
- Temporary discontinuation of study activities may occur if there is a mOPV2 campaign.
Sites / Locations
- Kanti Children's Hospital
- Patan Hospital
- Tribhuvan University Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Study Arm A
Study arm B
Children {Age > 24 months and who received a single dose Inactivated Polio Vaccine (IPV) at the time of routine immunization} in this arm will receive an IPV (0.5ml) intramuscularly at the time of enrolment in the trial
Children {Age 7-12 months and have not received any IPV till date of enrolment} in this arm will receive an Inactivated Polio Vaccine, IPV (0.5 ml) intramuscularly at the time of enrolment in the trial and a repeat dose of IPV (0.5 ml) after 1 month