A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age

NCT02580201 | Completed Phase 4 Results DMC

• 1 other identifier: T2-ABMG
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (2)

• SAEs and AEs G3

  Number of subjects experiencing SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine 28 days after three doses of SABIN tOPV in vaccine-naïve infants in Dominican Republic.

  6 months

• Seroprotection Rate

  Seroprotection rate of type-specific polio neutralizing antibodies at Day 84, 28 days after the third dose of SABIN tOPV in infants (Group 2).

  3 months

Secondary Outcomes (4)

• Neutralizing Antibodies 1

  3 months

• Seroconversion Rate

  3 months

• Neutralizing Antibodies 2

  3 months

• Seroprotection Rates

  4 weeks

Study Arms (1)

Oral Polio Vaccine

EXPERIMENTAL

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

Interventions

Oral Polio Vaccine BIOLOGICAL

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.

Oral Polio Vaccine

Eligibility Criteria

• Age: 5 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
• Written informed consent obtained from 1 or 2 parents or legal guardians as per Dominican Republic regulations.

You may not qualify if:

• 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
• Group 2: Infants with birth weight (BW) \< 2,500 gm.
• Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.
• Family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
• Known allergy to any component of the study vaccines or to any antibiotics.
• Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• 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.
• 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.

Sponsors & Collaborators

• Fidec Corporation: lead
• Bill and Melinda Gates Foundation: collaborator

MeSH Terms

Conditions

Poliomyelitis

Interventions

Poliovirus Vaccine, Oral

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Poliovirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Ricardo Rüttimann
• Organization: FIDEC Corporation

rruttimann@fidec-online.org

+17863546335

Study Officials

• Luis Rivera, MD

  Hospital Maternidad Nuestra Señora de la Altagracia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: October 20, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 11, 2016
• Last Updated: April 18, 2023
• Results First Posted: September 1, 2020

Record last verified: 2023-03