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A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age (T2-ABMG)

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Fidec

Status and phase

Completed
Phase 4

Conditions

Poliomyelitis

Treatments

Biological: Oral Polio Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT02580201
T2-ABMG

Details and patient eligibility

About

The purpose of this study is to assess the safety (serious adverse events [SAEs]), and severe adverse events [AEs] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5 year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in vaccine-naïve infants.

Full description

This will be a single center, open study in children (aged 1 to 5 years) and vaccine-naïve infants, as follows: 50 OPV-vaccinated children aged 1 to 5 years to receive 1 dose of tOPV (Group 1); 104 vaccine-naïve infants to receive 3 doses of tOPV administered 28 days apart (Group 2)

Enrollment

154 patients

Sex

All

Ages

5 weeks to 5 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Age:

    Group 1- Children aged 1-5 years, previously vaccinated with ≥ 3 doses of OPV. Group 2- Infants aged 6 weeks (-7 to +14 days) with no previous polio vaccinations.

  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 guardians as per Dominican Republic regulations.

Exclusion criteria

  1. Previous Vaccinations:

    Group 1: Previous vaccination against poliovirus outside of the national immunization schedule and any vaccine in the previous 4 weeks.

    Group 2: Any vaccination against poliovirus

  2. Group 2: Infants with birth weight (BW) < 2,500 gm.

  3. Any confirmed or suspected immunosuppressive or known 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 or to any antibiotics.

  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, or is scheduled to receive OPV during the study period.

  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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

154 participants in 1 patient group

Oral Polio Vaccine
Experimental group
Description:
Opvero™ (oral) is a trivalent, live attenuated poliomyelitis virus vaccine containing at least 6.0 log 50% cell culture infective dose (CCID50) of LS c2ab strain of live attenuated polio virus type 1, 5.0 log CCID50 of P712, Ch, 2ab strain of live attenuated polio virus type 2, 5.8 log CCID50 Leon I2aIb strain of polio virus type 3. Excipients: human albumin, HEPES buffer solution, magnesium chloride solution (containing polysorbate 80 and phenol red), hydrochloric acid or sodium hydroxide for pH adjustment. The vaccine is presented as a suspension for oral administration. One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the dropper supplied with the multidose container.
Treatment:
Biological: Oral Polio Vaccine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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