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

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

      • Panama, Panama
        • Hospital del Nino

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:

  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.

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
Active Comparator: Group 2
b-OPV, t-IPV and m-OPV2

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
Efficacy
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

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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