Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
958 participants
INTERVENTIONAL
2019-10-06
2020-03-25
Brief Summary
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Note: This study was terminated early due to the COVID-19 pandemic. Due to early study closure, the study objectives could not be evaluated as planned. Both of the primary objectives and several secondary objectives could not be evaluated because none of the study participants reached the corresponding endpoint. Due to limited sample size, the analysis approach for four secondary objectives was changed from a non-inferiority assessment to a comparison of proportions between groups.
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Detailed Description
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Healthy infants 6 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of seven study arms. Infants will be followed-up until 10 months of age through clinic visits. Blood specimens will be collected to test for immunological response.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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IPV at 14 weeks + 9 months
Participants in this arm will receive full doses (0.5 mL) of IPV at 14 weeks and 9 months of age.
IPV
Full dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.5 milliliter (mL) dose by intramuscular (IM) injection.
IPV at 6 weeks + 9 months
Participants in this arm will receive full doses (0.5 mL) of IPV at 6 weeks and 9 months of age.
IPV
Full dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.5 milliliter (mL) dose by intramuscular (IM) injection.
fIPV ID at 6 weeks + 14 weeks + 9 months
Participants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age.
fIPV (0.1 mL) ID
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal (ID) injection in lieu of the full 0.5 mL dose.
fIPV ID at 14 weeks + 9 months
Participants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age.
fIPV (0.1 mL) ID
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal (ID) injection in lieu of the full 0.5 mL dose.
fIPV IM at 6 weeks + 14 weeks + 9 months
Participants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age.
fIPV (0.1mL) IM
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.
fIPV 0.1mL IM at 14 weeks + 9 months
Participants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age.
fIPV (0.1mL) IM
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.
fIPV 0.2mL IM at 14 weeks + 9 months
Participants in this arm will receive intramuscular fractional doses (0.2 mL) of IPV at 14 weeks and 9 months of age.
fIPV (0.2mL) IM
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.2 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.
Interventions
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fIPV (0.1 mL) ID
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal (ID) injection in lieu of the full 0.5 mL dose.
fIPV (0.1mL) IM
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.
fIPV (0.2mL) IM
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.2 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.
IPV
Full dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.5 milliliter (mL) dose by intramuscular (IM) injection.
Eligibility Criteria
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Inclusion Criteria
* Parents that consent for participation in the full length of the study.
* Parents that are able to understand and comply with planned study procedures.
Exclusion Criteria
* 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 diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
* Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age).
* Evidence of a chronic medical condition identified by a study medical officer during physical exam.
* Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
* Known allergy/sensitivity or reaction to polio vaccine, or its contents.
* Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant. Even if all births from a multiple birth could be enrolled in the study, we will exclude multiple births as discontinuation of one may lead to discontinuation of multiple participants.
* Infants from premature births (\<37 weeks of gestation).
42 Days
48 Days
ALL
Yes
Sponsors
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International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Centers for Disease Control and Prevention
FED
Responsible Party
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Locations
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icddr,b study clinics (Mirpur and CTU Dhaka)
Dhaka, , Bangladesh
Countries
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Other Identifiers
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19058
Identifier Type: -
Identifier Source: org_study_id
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