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Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 3
Locations
Dominican Republic
Study Type
Interventional
Intervention
nOPV2
Sponsored by
Fidec Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Infants aged 6 to 8 weeks with birth weight > 2,500 g.
  2. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination.
  3. Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.

Exclusion Criteria:

  1. Infants who have received previous vaccination against poliomyelitis.
  2. Infants with anyone under 5 years of age in their household (living in the same house or apartment unit) who does not have the complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic National Immunization Program (NIP).
  3. Infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration.
  4. Infants having a member of their household (living in the same house or apartment unit) who has received oral poliomyelitis vaccine (OPV) in the previous 3 months before study vaccine administration.
  5. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
  6. Family history of congenital or hereditary immunodeficiency.
  7. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
  8. Known allergy to any component of the study vaccine or to any antibiotics that share molecular composition with the nOPV2 vaccine.
  9. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  10. Acute severe febrile illness on the 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 inclusion criteria are met.).
  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.
  12. Infants from multiple births or born prematurely (< 37 weeks of gestation)

Sites / Locations

  • Clinica Cruz Jiminián
  • Hospital Universitario Maternidad Nuestra Señora de la Altagracia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

2 doses, 1 week apart

2 doses, 2 week apart

2 doses, 4 week apart

Arm Description

Administration of 2 doses of nOPV2, 1 week apart

Administration of 2 doses of nOPV2, 2 weeks apart

Administration of 2 doses of nOPV2, 4 weeks apart

Outcomes

Primary Outcome Measures

Seroconversion rate at 1 week interval
Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 1-week interval to infants 6 to 8 weeks of age
Seroconversion rate at 2 weeks interval
Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 2-weeks intervals to infants 6 to 8 weeks of age
Seroconversion rate at 4 weeks interval
Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 4-weeks intervals to infants 6 to 8 weeks of age

Secondary Outcome Measures

Neutralizing antibodies at 1 week interval
Geometric mean and median titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 1 week apart.
Neutralizing antibodies at 2 weeks interval
Geometric mean and median titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 2 weeks apart.
Neutralizing antibodies at 4 weeks interval
Geometric mean and median titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 4 weeks apart.
Serious Adverse Events (SAEs) and Important Medical Events (IMEs)
Incidence of SAEs and IMEs from the date of informed consent throughout the study period in all groups by severity and by causal association.
Solicited Adverse Events (AEs)
Incidence of mild, moderate and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea and irritability) for 7 days after each dose of study vaccine in all groups.
Unsolicited Adverse Events (AEs)
Incidence of mild, moderate and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea and irritability) for 28 days after each dose of study vaccine in all groups.

Full Information

First Posted
August 19, 2021
Last Updated
December 9, 2022
Sponsor
Fidec Corporation
Collaborators
Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05033561
Brief Title
Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants
Official Title
A Phase III Open-label Randomized Controlled Study to Evaluate the Safety and Immunogenicity of nOPV2 at Different Intervals of Administration in Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidec Corporation
Collaborators
Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study to determine immunogenicity and safety following administration of 2 doses of novel oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or the standard 4-week interval in infants
Detailed Description
This will be a multicenter, randomized, controlled, open-label, parallel-group Phase III study in healthy infants aged 6 to 8 weeks who have never been vaccinated against poliomyelitis. Approximately 900 infants will be included in the study and randomized with a 1:1:1 ratio to the following treatment groups: Group A: approximately 300 subjects to receive 2 doses of nOPV2 administered 1 week apart, at Day 0 and Day 7; Group B: approximately 300 subjects to receive 2 doses of nOPV2 administered 2 weeks apart, at Day 0 and Day 14; Group C (control group): approximately 300 subjects to receive 2 doses of nOPV2 administered 4 weeks apart, at Day 0 and Day 28. A total of 4 on-site visits are planned. Approximately 7 days after each administration of study vaccine, a phone call or on-site visit will be performed to monitor subjects' safety and review with the subject's parent(s)/guardian(s) any solicited AEs reported in the electronic diary card. All subjects will have a safety follow-up phone call 6 months after the last dose of study vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
905 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 doses, 1 week apart
Arm Type
Experimental
Arm Description
Administration of 2 doses of nOPV2, 1 week apart
Arm Title
2 doses, 2 week apart
Arm Type
Experimental
Arm Description
Administration of 2 doses of nOPV2, 2 weeks apart
Arm Title
2 doses, 4 week apart
Arm Type
Active Comparator
Arm Description
Administration of 2 doses of nOPV2, 4 weeks apart
Intervention Type
Biological
Intervention Name(s)
nOPV2
Intervention Description
Novel Oral Poliomyelitis Type 2 Vaccine
Primary Outcome Measure Information:
Title
Seroconversion rate at 1 week interval
Description
Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 1-week interval to infants 6 to 8 weeks of age
Time Frame
4 weeks
Title
Seroconversion rate at 2 weeks interval
Description
Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 2-weeks intervals to infants 6 to 8 weeks of age
Time Frame
4 weeks
Title
Seroconversion rate at 4 weeks interval
Description
Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 4-weeks intervals to infants 6 to 8 weeks of age
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Neutralizing antibodies at 1 week interval
Description
Geometric mean and median titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 1 week apart.
Time Frame
4 weeks
Title
Neutralizing antibodies at 2 weeks interval
Description
Geometric mean and median titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 2 weeks apart.
Time Frame
4 weeks
Title
Neutralizing antibodies at 4 weeks interval
Description
Geometric mean and median titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 4 weeks apart.
Time Frame
4 weeks
Title
Serious Adverse Events (SAEs) and Important Medical Events (IMEs)
Description
Incidence of SAEs and IMEs from the date of informed consent throughout the study period in all groups by severity and by causal association.
Time Frame
6 months
Title
Solicited Adverse Events (AEs)
Description
Incidence of mild, moderate and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea and irritability) for 7 days after each dose of study vaccine in all groups.
Time Frame
1 week
Title
Unsolicited Adverse Events (AEs)
Description
Incidence of mild, moderate and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea and irritability) for 28 days after each dose of study vaccine in all groups.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infants aged 6 to 8 weeks with birth weight > 2,500 g. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in 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. Exclusion Criteria: Infants who have received previous vaccination against poliomyelitis. Infants with anyone under 5 years of age in their household (living in the same house or apartment unit) who does not have the complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic National Immunization Program (NIP). Infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration. Infants having a member of their household (living in the same house or apartment unit) who has received oral poliomyelitis vaccine (OPV) in the previous 3 months before study vaccine administration. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household. 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 vaccine or to any antibiotics that share molecular composition with the nOPV2 vaccine. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Acute severe febrile illness on the 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 inclusion criteria are met.). 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. Infants from multiple births or born prematurely (< 37 weeks of gestation)
Facility Information:
Facility Name
Clinica Cruz Jiminián
City
Santo Domingo
Country
Dominican Republic
Facility Name
Hospital Universitario Maternidad Nuestra Señora de la Altagracia
City
Santo Domingo
Country
Dominican Republic

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants

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