Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV When Administered at 9-13 Months of Age in Bangladesh

NCT ID: NCT03890497

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2022-09-30

Brief Summary

Following a recommendation on October 2017 meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization; low- risk bOPV-using countries may adopt 2 dose fIPV schedule prior to global OPV cessation as it provides better seroconversion than 1 full dose IPV and in the post-cessation era, the 2 fIPV doses will provide sufficient (above 90%) seroconversion. Countries, which delayed the introduction of IPV or had a vaccine stock-out, should provide 1 full dose or 2 fIPV doses to all children who were missed as soon as supply becomes available. The IPV supply situation is expected to improve in 2018; all countries are expected to have access to IPV for their routine immunization programmes from the end of the first quarter of 2018.

While immunogenicity after one and two doses of IPV and fIPV has been estimated when administered to younger children ; the immunogenicity of IPV (or fIPV) when administered at 9 months of age or later is not known. We propose to conduct a study to assess the immunogenicity of one and two doses of fIPV and IPV when administered between 9-13 months of age.

Conditions

Poliomyelitis

Study Design

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

Study Groups

Full dose of IPV

IPV first dose between 9 -13 months with second dose administered 2 months later.

Group Type: ACTIVE_COMPARATOR

IPV

Intervention Type: BIOLOGICAL

The inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally

Fractional Dose of IPV

fIPV first dose between 9 -13 months with second dose administered 2 months later

Group Type: ACTIVE_COMPARATOR

IPV

Intervention Type: BIOLOGICAL

The inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally

Interventions

IPV

The inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally

Intervention Type: BIOLOGICAL

Other Intervention Names

fIPV

Eligibility Criteria

Inclusion Criteria

1. Apparently healthy children with no obvious clinical symptom of illness

2. Parents/legal guardians of participants willing to give written informed consent and willing to comply with study protocol.

3. Free of obvious health problems (congenital abnormalities, severe malnutrition, acute or chronic diarrhea, bleeding disorder etc) as established by medical history and screening evaluation including clinical examination.

4. Resident of study area.

Exclusion Criteria

1. Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination or planned participation in another clinical trial during the present trial period.

2. A diagnosis or suspicion of congenital or acquired immunodeficiency disorder, malignancy,

3. A diagnosis or suspicion of bleeding disorder

4. Acute or persistent diarrhoea

5. History of allergy or systemic hypersensitivity to any of the vaccine components

6. Chronic illness at a stage that could interfere with trial conduct or completion.

7. Presence of significant malnutrition

8. History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.

09. Febrile illness or acute illness on the day of inclusion

-

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 13 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Matlab Health Research Centre

Chāndpur, , Bangladesh

Site Status: RECRUITING

Mirpur Study clinic

Dhaka, , Bangladesh

Site Status: RECRUITING

Countries

Bangladesh

Central Contacts

Asma Aziz, MBBS, MPH

Role: CONTACT

asma.aziz@icddrb.org

+8801719326323 ext. 3812

Facility Contacts

Asma Aziz, MBBS, MPH

Role: primary

asma.aziz@icddrb.org

+8801719326323 ext. 3812

Asma Aziz, MBBS,MPH

Role: primary

asma.aziz@icddrb.org

+8801719326323 ext. 3812

References

Aziz AB, Verma H, Jeyaseelan V, Yunus M, Nowrin S, Moore DD, Mainou BA, Mach O, Sutter RW, Zaman K. One Full or Two Fractional Doses of Inactivated Poliovirus Vaccine for Catch-up Vaccination in Older Infants: A Randomized Clinical Trial in Bangladesh. J Infect Dis. 2022 Oct 17;226(8):1319-1326. doi: 10.1093/infdis/jiac205.

Reference Type: DERIVED

PMID: 35575051 (View on PubMed)

Other Identifiers

PR-18016

Identifier Type: -

Identifier Source: org_study_id