A Phase 2, Randomized, Observer-Blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess the Safety and Immunogenicity of a Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Panama

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 subjects).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 4
Healthy Volunteers: t
View:

• Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator.

• Parent(s) or guardian(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.

• Resides in study area and parent(s) or guardian(s) understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form \[ICF\] and assessment by the investigator).

• Parent(s) or guardian(s) agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol adjusted schedule.

• Male or female child from ≥1 to \<5 years-of-age at the time of initial study vaccination.

• Based on available documentation or parental/guardian(s) report, previously completed the primary poliomyelitis immunization series for the jurisdiction, with last dose received more than 28 days prior to initial study vaccination.

• Male or female infant expected to be 6 weeks of age (43rd to 49th day of life \[with day of birth being the first day of life\], inclusive + 6 day window), at the time of initial study vaccination.

• Prior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available parental/guardian(s) report or documentation.

• Male or female newborn (1st day of life + 3-day window), at the time of initial study vaccination.

• Prior to study vaccination has received no doses of IPV or OPV vaccine, based on no evidence of such vaccination per available parental/guardian(s) report or documentation.

Locations
Other Locations
Panama
Cevaxin - 24 de Diciembre
RECRUITING
Panama City
Cevaxin - Chorrera
RECRUITING
Panama City
Cevaxin-- Avenida Mexico
RECRUITING
Panama City
Contact Information
Primary
Xavier Saez-Llorens, MD
xavier.saez-llorens@cevaxin.com
+507 203-9760
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2025-11-20
Participants
Target number of participants: 1532
Treatments
Experimental: Group 1: Young Children, nOPV3 10^5.5 CCID50
48 young children aged 1 to \<5 years will receive 2 doses of nOPV3 at a dose level of 10\^5.5 CCID50 on Day 1 and Day 29
Experimental: Group 3: Young Children, nOPV3 10^6.0 CCID50
48 young children aged 1 to \<5 years will receive 2 doses of nOPV3 at a dose level of 10\^6.0 CCID50 on Day 1 and Day 29
Experimental: Group 5: Young Children, nOPV3 10^6.5 CCID50
48 young children aged 1 to \<5 years will receive 2 doses of nOPV3 at a dose level of 10\^6.5 CCID50 on Day 1 and Day 29
Active_comparator: Groups 2, 4 and 6: Young Children, mOPV3
48 young children aged 1 to \<5 years will receive 2 doses of mOPV3 at a dose level of ≥ 10\^5.8 CCID50 on Day 1 and Day 29
Experimental: Group 7: Infants, nOPV3 10^5.5 CCID50
240 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV3 at a dose level of 10\^5.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Experimental: Group 9: Infants, nOPV3 10^5.5 CCID50
240 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV3 at a dose level of 10\^6.0 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Experimental: Group 11: Infants, nOPV3 10^6.5 CCID50
140 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV3 at a dose level of 10\^6.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Active_comparator: Groups 8, 10 and 12: Infants, mOPV3
240 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of mOPV3 at a dose level of ≥ 10\^5.8 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Experimental: Group 13: Neonates, nOPV3 10^5.5 CCID50
120 neonates (day of birth + 3 days) will receive 2 doses of nOPV3 at a dose level of 10\^5.5 CCID50 on Day 1 and Day 29.
Experimental: Group 15: Neonates, nOPV3 10^6.0 CCID50
120 neonates (day of birth + 3 days) will receive 2 doses of nOPV3 at a dose level of 10\^6.0 CCID50 on Day 1 and Day 29.
Experimental: Group 17: Neonates, nOPV3 10^6.5 CCID50
120 neonates (day of birth + 3 days) will receive 2 doses of nOPV3 at a dose level of 10\^6.5 CCID50 on Day 1 and Day 29.
Active_comparator: Groups 14, 16 and 18: Neonates, mOPV
120 neonates (day of birth + 3 days) will receive 2 doses of mOPV3 at a dose level of ≥ 10\^5.8 CCID50 on Day 1 and Day 29
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control and Prevention, Bill and Melinda Gates Foundation, PT Bio Farma, Technical Resources International, Inc. (TRI)
Leads: PATH

This content was sourced from clinicaltrials.gov

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