Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Polio

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

b-OPV, m-IPV HD and m-OPV2

Group Type EXPERIMENTAL

b-OPV

Intervention Type BIOLOGICAL

m-OPV2

Intervention Type BIOLOGICAL

m-IPV HD

Intervention Type BIOLOGICAL

Group 2

b-OPV, t-IPV and m-OPV2

Group Type ACTIVE_COMPARATOR

b-OPV

Intervention Type BIOLOGICAL

m-OPV2

Intervention Type BIOLOGICAL

t-IPV

Intervention Type BIOLOGICAL

Interventions

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b-OPV

Intervention Type BIOLOGICAL

m-OPV2

Intervention Type BIOLOGICAL

m-IPV HD

Intervention Type BIOLOGICAL

t-IPV

Intervention Type BIOLOGICAL

Eligibility 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.
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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

6 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes