Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine

NCT ID: NCT05460377

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-26
• Study Completion Date: 2024-12-01

Brief Summary

This is an open label and off label, phase IV, randomized clinical trial that will compare the immune response among infants that receive either two full doses of Sabin IPV intramuscularly or two fractional (1/5) dose of Sabin IPV intradermally at 14 weeks and 9 months of age from two different manufacturers.

Detailed Description

After OPV cessation, which is expected within a year of polio eradication certification, IPV will be the only polio vaccine used in essential immunization programs. SAGE has recommended a two-dose intramuscular IPV or intradermal fractional IPV (fIPV) schedule after OPV cessation. While it is expected that there shall be sufficient IPV available - in large part because of several manufacturers establishing production of IPV using Sabin strains (sIPV) - it is dependent on these manufacturers being able to meet promised product development and manufacturing timeline and meet WHO prequalification. It is likely that countries that have introduced intradermal fIPV pre-eradication will continue to use intradermal fIPV post-eradication. Therefore, it is important to generate evidence on immunogenicity of intradermal fractional sIPV in addition to intramuscular sIPV for the schedule recommended by SAGE.

This clinical trial assesses and compares the immunogenicity of full and fractional (1/5) dose Sabin IPV given at 14 weeks and 9 months of age from two different manufacturers. Healthy infants 6 weeks of age will be enrolled in Dhaka, Bangladesh, and randomized to one of four arms:

A. IMBCAMS full dose sIPV at 14 weeks and 9 months B. IMBCAMS fractional dose sIPV at 14 weeks and 9 months C. BIBP full dose sIPV at 14 weeks and 9 months D. BIBP fractional dose sIPV at 14 weeks and 9 months

Participants will be followed until 10 months of age through clinic visits. Blood samples will be collected for measuring immune response.

Conditions

Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IMBCAMS Sabin IPV full dose at 14 weeks and 9 months

Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS).

Group Type: ACTIVE_COMPARATOR

Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS

Intervention Type: BIOLOGICAL

The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intramuscularly by needle and syringe.

IMBCAMS Sabin IPV fractional dose at 14 weeks and 9 months

Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS).

Group Type: ACTIVE_COMPARATOR

Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS

Intervention Type: BIOLOGICAL

The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intradermally by needle and syringe.

BIBP Sabin IPV full dose at 14 weeks and 9 months

Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP).

Group Type: ACTIVE_COMPARATOR

Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP

Intervention Type: BIOLOGICAL

The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intramuscularly by needle and syringe

BIBP Sabin IPV fractional dose at 14 weeks and 9 months

Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP).

Group Type: ACTIVE_COMPARATOR

Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBP

Intervention Type: BIOLOGICAL

The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intradermally by needle and syringe

Interventions

Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS

The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intramuscularly by needle and syringe.

Intervention Type: BIOLOGICAL

Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS

The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intradermally by needle and syringe.

Intervention Type: BIOLOGICAL

Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP

The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intramuscularly by needle and syringe

Intervention Type: BIOLOGICAL

Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBP

The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intradermally by needle and syringe

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy infants 6 weeks of age (range: 42-48 days).
• Parents that consent for participation in the full length of the study (i.e., 34 weeks).
• Parents that are able to understand and comply with planned study procedures.

Exclusion Criteria

• A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
• A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of sIPV or collection of blood by venepuncture.
• Acute diarrhoea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital.
• Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
• Evidence of a chronic medical condition identified by a study medical officer during physical exam.
• Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation or parental recall.
• Known allergy/sensitivity or reaction to polio vaccine, or its contents.
• Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
• Infants from premature births (<37 weeks of gestation).

• Minimum Eligible Age: 42 Days
• Maximum Eligible Age: 48 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

World Health Organization

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention, China

OTHER_GOV

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khalequ Zaman, PhD

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

Icddr,B Study Clinics

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

PR-21092

Identifier Type: -

Identifier Source: org_study_id