Immunogenicity of Intramuscular Inactivated Poliovirus Vaccine

NCT02291263 | Completed Phase 3 DMC

• 1 other identifier: ICDDRB-RRC-PR-13097
• Study Type: interventional
• Target: 738
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be an open-label phase III randomized clinical trial comparing different combinations and regimens of polio vaccines. The trial will compare one and two doses of IPV administered at 6 weeks or 14 weeks or 6 and 14 weeks of age. All participants will also receive bOPV at 6, 10 and 14 weeks of age.

Conditions

Poliomyelitis

Keywords

Polio; Inactivated polio vaccine; IPV; oral polio vaccine

Outcome Measures

Primary Outcomes (1)

• Change in antibody titers at 18 and 19 weeks of age compared to 6 weeks of age

  The primary analytical approach will be intention-to-treat analysis. Sum of seroconversion and priming as one outcome. Seroconversion is defined as either seronegative participants (\<1:8 titers) who become seropositive (≥1:8) or participants who demonstrate a 4-fold change in titers between two specimens, e.g. a change from 1:8 to 1:32 from 6 weeks to 18 weeks of age, respectively. Priming is defined as absence of type 2 seroconversion by 18 weeks with type 2 seroconversion at 19 weeks, i.e. seronegative participants at 18 weeks (\<1:8 titers) who become seropositive at 19 weeks (≥1:8) or a 4-fold rise in type 2 antibody titers at 19 weeks compared to 18 weeks

  Change at 18 and 19 weeks of age compared to 6 weeks of age

Study Arms (3)

Arm A

ACTIVE COMPARATOR

Group A will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. Group A participants will also receive inactivated polio vaccine (IPV) at 6 weeks of age. An additional dose of IPV will be administered at 18 weeks of age.

Biological: bOPV/IPV (6 weeks)

Arm B

ACTIVE COMPARATOR

Group B will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. Group B participants will also receive inactivated polio vaccine (IPV) at 14 weeks of age. An additional dose of IPV will be administered at 18 weeks of age.

Biological: bOPV/IPV (14 weeks)

Arm C

ACTIVE COMPARATOR

Group C will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. Group C participants will also receive inactivated polio vaccine (IPV) at 6 and 14 weeks of age. An additional dose of IPV will be administered at 18 weeks of age.

Biological: bOPV/IPV (6 & 14 weeks)

Interventions

bOPV/IPV (6 weeks) BIOLOGICAL

bOPV at 6, 10 and 14 weeks of age IPV at 6 weeks of age

Arm A

bOPV/IPV (14 weeks) BIOLOGICAL

bOPV at 6, 10 and 14 weeks of age IPV at 14 weeks of age

Arm B

bOPV/IPV (6 & 14 weeks) BIOLOGICAL

bOPV at 6, 10 and 14 weeks of age IPV at 6 and14 weeks of age

Arm C

Eligibility Criteria

• Age: 6 Weeks - 7 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants 6-7 weeks of age
• Family that consents for participation in the full length of the study
• Family that is able to understand and comply with planned study procedures

You may not qualify if:

• Family that is unable to participate in the full length of the study
• 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 IPV or collection of blood by venipuncture
• Acute diarrhea, infection or illness at the time of enrollment (6-7 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV per country guidelines
• Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age)
• 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 contents of polio vaccine
• Infants from multiple births. Infants from multiple births will be excluded to reduce the potential for contact transmission of vaccine poliovirus to siblings. The infant(s) from a multiple birth who is/are not enrolled would be likely to receive routine immunization and transmit vaccine poliovirus to the enrolled infant
• Infants from premature births (\<37 weeks of gestation)

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

Mirpur clinic (International Center for Diarrhoeal Disease Research, Bangladesh)

Dhaka, Bangladesh

Location

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

Study Officials

• Md. Khalequzzaman, MBBS, PhD

  International Center for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

• Abhijeet Anand, MBBS, MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 14, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

BA (1)