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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT02111135 |
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Date of registration:
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08/04/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life
IPV005 |
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Scientific title:
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Phase II, Observer-blind, Randomized Study on the Safety, Reactogenicity, Immunogenicity and Impact on Intestinal Shedding of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) or a Single Dose of Standard Trivalent Inactivated Poliovirus Vaccine (t-IPV) When Given Concomitantly With the Third Dose of Bivalent Oral Poliovirus Vaccine (b-OPV) to Infants Early in Life |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02111135 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Panama
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Contacts
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Name:
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Xavier Sáez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Del Niño |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age: 6 weeks (-7 to +14 days).
2. Healthy without obvious medical conditions that preclude the subject to be in the
study as established by the medical history and physical examination.
3. Written informed consent obtained from 1 or 2 parents or legal guardian as per Panama
regulations.
Exclusion Criteria:
1. Previous vaccination against poliovirus.
2. Low birth weight (BW <2,500 gm).
3. Any confirmed or suspected immunosuppressive or immunodeficient condition including
human immunodeficiency virus (HIV) infection.
4. Family history of congenital or hereditary immunodeficiency.
5. Major congenital defects or serious uncontrolled chronic illness (neurologic,
pulmonary, gastrointestinal, hepatic, renal, or endocrine).
6. Known allergy to any component of the study vaccines.
7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular
injections.
8. Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period.
9. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a
contraindication for vaccination (the child can be included at a later time if within
age window and all in/exclusion criteria are met.).
10. Member of the subject's household (living in the same house or apartment unit) has
received OPV in the last 3 months.
11. Subject who, in the opinion of the Investigator, is unlikely to comply with the
protocol or is inappropriate to be included in the study for the safety or the
benefit-risk ratio of the subject.
Age minimum:
6 Weeks
Age maximum:
6 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Polio
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Intervention(s)
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Biological: m-OPV2
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Biological: b-OPV
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Biological: m-IPV HD
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Biological: t-IPV
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Primary Outcome(s)
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Efficacy
[Time Frame: 4 weeks]
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Safety
[Time Frame: 6 weeks]
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Secondary ID(s)
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IPV005ABMG
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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