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Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV When Administered at 9-13 Months of Age in Bangladesh

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ClinicalTrials.gov Identifier: NCT03890497
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Tracking Information
First Submitted Date  ICMJE March 19, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date April 10, 2020
Actual Study Start Date  ICMJE September 27, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2019)
Seroconversion to PV2 two months after the first fIPV or IPV dose [ Time Frame: 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV When Administered at 9-13 Months of Age in Bangladesh
Official Title  ICMJE Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV
Brief Summary

Following a recommendation on October 2017 meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization; low- risk bOPV-using countries may adopt 2 dose fIPV schedule prior to global OPV cessation as it provides better seroconversion than 1 full dose IPV and in the post-cessation era, the 2 fIPV doses will provide sufficient (above 90%) seroconversion. Countries, which delayed the introduction of IPV or had a vaccine stock-out, should provide 1 full dose or 2 fIPV doses to all children who were missed as soon as supply becomes available. The IPV supply situation is expected to improve in 2018; all countries are expected to have access to IPV for their routine immunization programmes from the end of the first quarter of 2018.

While immunogenicity after one and two doses of IPV and fIPV has been estimated when administered to younger children ; the immunogenicity of IPV (or fIPV) when administered at 9 months of age or later is not known. We propose to conduct a study to assess the immunogenicity of one and two doses of fIPV and IPV when administered between 9-13 months of age.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
• To assess the seroconversion to PV2 after one and two doses of fIPV and IPV when first dose is administered to children aged between 9 and 13 months with second dose administered 2 months later.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Poliomyelitis
Intervention  ICMJE Biological: IPV
The inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally
Other Name: fIPV
Study Arms  ICMJE
  • Active Comparator: Full dose of IPV
    IPV first dose between 9 -13 months with second dose administered 2 months later.
    Intervention: Biological: IPV
  • Active Comparator: Fractional Dose of IPV
    fIPV first dose between 9 -13 months with second dose administered 2 months later
    Intervention: Biological: IPV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Apparently healthy children with no obvious clinical symptom of illness
  2. Parents/legal guardians of participants willing to give written informed consent and willing to comply with study protocol.
  3. Free of obvious health problems (congenital abnormalities, severe malnutrition, acute or chronic diarrhea, bleeding disorder etc) as established by medical history and screening evaluation including clinical examination.
  4. Resident of study area.

Exclusion Criteria:

  1. Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination or planned participation in another clinical trial during the present trial period.
  2. A diagnosis or suspicion of congenital or acquired immunodeficiency disorder, malignancy,
  3. A diagnosis or suspicion of bleeding disorder
  4. Acute or persistent diarrhoea
  5. History of allergy or systemic hypersensitivity to any of the vaccine components
  6. Chronic illness at a stage that could interfere with trial conduct or completion.
  7. Presence of significant malnutrition
  8. History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.

09. Febrile illness or acute illness on the day of inclusion

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 13 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Asma Aziz, MBBS, MPH +8801719326323 ext 3812 asma.aziz@icddrb.org
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03890497
Other Study ID Numbers  ICMJE PR- 18016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Centre for Diarrhoeal Disease Research, Bangladesh
Study Sponsor  ICMJE International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators  ICMJE World Health Organization
Investigators  ICMJE Not Provided
PRS Account International Centre for Diarrhoeal Disease Research, Bangladesh
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP