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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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ClinicalTrials.gov Identifier: NCT02580201
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Fidec Corporation

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.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: Oral Polio Vaccine Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : November 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 11, 2016

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Arm Intervention/treatment
Experimental: Oral Polio Vaccine

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.

Biological: Oral Polio Vaccine

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.





Primary Outcome Measures :
  1. To evaluate the Safety 28 days after three doses of SABIN tOPV in vaccine-naïve infants in Dominican Republic. [ Time Frame: 6 months ]

    Incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in children (Group 1) and infants (Group 2). Immunogenicity: seroprotection rate of type-specific polio neutralizing antibodies at Day 84, 28 days after the third dose of SABIN tOPV in infants (Group 2).

    (Seroprotection is defined as type-specific antibody titers ≥1:8 and seroprotection rate as the percentage of seroprotected subjects per group.)




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Ages Eligible for Study:   5 Weeks to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580201


Sponsors and Collaborators
Fidec Corporation
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Luis Rivera, MD Hospital Maternidad Nuestra Señora de la Altagracia

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Responsible Party: Fidec Corporation
ClinicalTrials.gov Identifier: NCT02580201     History of Changes
Other Study ID Numbers: T2-ABMG
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs