A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania

NCT02582255 | Completed Phase 4 Results DMC

• 1 other identifier: M3-ABMG
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (2)

• SAEs and Severe AEs

  Incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in children 1 to 5 years.

  3 months

• Seroprotection Rate of Type 2 Polio Neutralizing Antibodies.

  Seroprotection rate at type 2 polio neutralizing antibodies measured at D28 after the first dose of mOPV2.

  1 month

Secondary Outcomes (2)

• Seroprotection Rate for Type 2 Polio Neutralizing Antibodies.

  3 months

• Incidence of Any Serious Adverse Events (SAEs), Any Solicited AEs, Any Unsolicited AEs, and Any Important Medical Events (IMEs).

  3 months

Study Arms (2)

Sabin mOPV2 1 dose

EXPERIMENTAL

IPV-vaccinated children to receive 1 dose of SABIN mOPV2 (Group 1)

Biological: Sabin mOPV2

SABIN mOPV2 2 doses

EXPERIMENTAL

IPV-vaccinated children to receive 2 doses of SABIN mOPV2 (Group 2)

Biological: Sabin mOPV2

Interventions

Sabin mOPV2 BIOLOGICAL

Polio Sabin™ Mono Two (oral) is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2. Magnesium chloride is used as a stabilizer. Polio Sabin™ Mono Two (Oral) contains trace amounts of neomycin sulphate and polymyxin B sulphate. One dose of vaccine (0.1 mL) is contained in two drops which are delivered from the polyethylene dropper supplied with vaccine.

Also known as: mOPV2

SABIN mOPV2 2 doses; Sabin mOPV2 1 dose

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 5 years of age, previously vaccinated with three or four doses of IPV.
• Healthy without obvious medical conditions that preclude entry of the subject into the study as established by the medical history and physical examination.
• Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.

You may not qualify if:

• Previous vaccination against poliovirus outside the national immunization schedule.
• 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.
• 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.
• 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

Related Publications (1)

• Bandyopadhyay AS, Gast C, Brickley EB, Ruttimann R, Clemens R, Oberste MS, Weldon WC, Ackerman ME, Connor RI, Wieland-Alter WF, Wright P, Usonis V. A Randomized Phase 4 Study of Immunogenicity and Safety After Monovalent Oral Type 2 Sabin Poliovirus Vaccine Challenge in Children Vaccinated with Inactivated Poliovirus Vaccine in Lithuania. J Infect Dis. 2021 Jan 4;223(1):119-127. doi: 10.1093/infdis/jiaa390.

  PMID: 32621741 DERIVED

MeSH Terms

Conditions

Poliomyelitis

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

Results Point of Contact

• Title: Ricardo Rüttimann
• Organization: FIDEC

rruttimann@fidec-online.org

+13058540075

Study Officials

• Vytautas Usonis, Prof

  Vilnius University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: October 21, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: December 22, 2016
• Last Updated: January 14, 2020
• Results First Posted: December 16, 2019

Record last verified: 2020-01