Clinical trial NCT02580201: A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age
Official title: A Phase 4 Study to Evaluate the Safety and Immunogenicity of Trivalent Oral Polio Vaccine in Healthy Polio Vaccinated Children 1 to 5 Years of Age and in Healthy Unvaccinated Infants at 6 Weeks of Age in the Dominican Republic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Poliomyelitis
Lead sponsor: Fidec Corporation
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2015-10-20
Enrollment: 154
Sex: ALL
Minimum age (years): 5
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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)

Eligibility criteria: 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.

Primary outcomes:
measure: SAEs and AEs G3
timeFrame: 6 months
measure: Seroprotection Rate
timeFrame: 3 months
Secondary outcomes:
measure: Neutralizing Antibodies 1
timeFrame: 3 months
measure: Seroconversion Rate
timeFrame: 3 months
measure: Neutralizing Antibodies 2
timeFrame: 3 months
measure: Seroprotection Rates
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Maternidad Nuestra Señora de la Altagracia
name: Luis Rivera, MD
role: PRINCIPAL_INVESTIGATOR
References: