- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02111135
Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life (IPV005)
July 16, 2015 updated by: Vaxtrials S.A.
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Panama, Panama
- Hospital del Nino
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 6 weeks (-7 to +14 days).
- Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 or 2 parents or legal guardian as per Panama regulations.
Exclusion Criteria:
- Previous vaccination against poliovirus.
- Low birth weight (BW <2,500 gm).
- Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- Known allergy to any component of the study vaccines.
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- 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.).
- Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
b-OPV, m-IPV HD and m-OPV2
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Active Comparator: Group 2
b-OPV, t-IPV and m-OPV2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 6 weeks
|
To assess and compare descriptively the safety of a single dose of a m-IPV2 HD vaccine in healthy infants to that of a licensed t-IPV vaccine when given concomitantly with the third dose of b-OPV measured by the incidence of serious adverse events (SAEs) and important medical events (IMEs) from the day of vaccine administration until day of last visit at study week 15 (~ week 21 of life).
|
6 weeks
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Efficacy
Time Frame: 4 weeks
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To determine whether 1 dose of a m-IPV2 HD vaccine given to infants is superior to 1 dose of t-IPV given at study week 8 (~14 weeks of age) in inducing a humoral immune response to type 2 poliovirus when measured as seroconversion to type 2 poliovirus (type-specific titers ≥1:8 and >4-fold over expected levels of maternally-derived antibody) and as median titers four weeks later at study week 12 (~ 18 weeks of age).
|
4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Xavier Sáez, MD, Hospital del Nino
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Brickley EB, Strauch CB, Wieland-Alter WF, Connor RI, Lin S, Weiner JA, Ackerman ME, Arita M, Oberste MS, Weldon WC, Saez-Llorens X, Bandyopadhyay AS, Wright PF. Intestinal Immune Responses to Type 2 Oral Polio Vaccine (OPV) Challenge in Infants Previously Immunized With Bivalent OPV and Either High-Dose or Standard Inactivated Polio Vaccine. J Infect Dis. 2018 Jan 17;217(3):371-380. doi: 10.1093/infdis/jix556.
- Saez-Llorens X, Clemens R, Leroux-Roels G, Jimeno J, Clemens SA, Weldon WC, Oberste MS, Molina N, Bandyopadhyay AS. Immunogenicity and safety of a novel monovalent high-dose inactivated poliovirus type 2 vaccine in infants: a comparative, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2016 Mar;16(3):321-30. doi: 10.1016/S1473-3099(15)00488-0. Epub 2015 Dec 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
April 8, 2014
First Submitted That Met QC Criteria
April 8, 2014
First Posted (Estimate)
April 10, 2014
Study Record Updates
Last Update Posted (Estimate)
July 20, 2015
Last Update Submitted That Met QC Criteria
July 16, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- IPV005ABMG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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