A Phase 4 interventional study of IPV and bOPV in Poliomyelitis, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged Up to 1 Day. Per ClinicalTrials.gov, last updated 2016-05-03.
Sponsored by Aga Khan University · Phase 4, Interventional, and Prevention
Poliomyelitis eradication has entered its last phase with only three remaining endemic countries, of which Pakistan is one. There hasn't been a case of wild type poliovirus 2 since 1999, and no case of wild type poliovirus 3 since November 2012. However, paralytic polio resulting from circulating strains of Sabin poliovirus type 2 have become a challenge, and reported from several areas with low population immunity to polio, including in Pakistan. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.
The "Polio Endgame Strategy" consists of set of tasks and activities that will be implemented in the next five years. It includes gradual withdrawal of the widely used oral poliomyelitis vaccine (OPV) containing live poliovirus, and will eventually lead to complete eradication and containment of all wild, vaccine-related (VDPV) and Sabin polioviruses. The withdrawal of the type 2 components of trivalent OPV (tOPV) is the key component in the elimination of cVDPVs. This entails strengthening of the immunization system by introducing at least one dose of affordable IPV into the routine immunization schedule globally and then replacing the trivalent OPV with bivalent OPV in all OPV-using countries - setting the stage for eventually ending bOPV use in 2019-2020. Most of the developing countries have an OPV schedule however many developed and European countries follow the IPV only schedule. The current recommendations for polio eradication and endgame is IPV vaccine to be administered together with third OPV dose, which in most countries occurs at 14 weeks of age.
This study will assess the protection to type 2 poliovirus achieved after completion of the recommended schedule with bOPV and IPV; it will compare immunogenicity of bOPV + IPV schedule with tOPV only schedule; and will quantify the cross-reactivity of bOPV on inducing type 2 immunological reaction. In addition, it will also provide first data on the proposed outbreak response to type 2 (either with mOPV 2 or with a combination of mOPV 2 and IPV 2).
This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.
222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.
This study's enrollment of 900 is above the median of 456 across 199 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IPV at birth, 6 weeks, 10 weeks, 14 weeks, followed by tOPV at 18 and 22 weeks
Biological: IPV
bOPV at birth, 6, 10, and 14 weeks. followed by tOPV at 18 and 22 weeks of age
Biological: bOPV
bOPV at birth, 6, 10 weeks, and IPV+bOPV at 14 weeks, and tOPV at 18 and 22 weeks of age
Biological: bOPV and IPV
bOPV at birth, 6, 10 weeks and bOPV+IPV at 14 weeks and tOPV+IPV2 at 18 weeks and tOPV alone at 22 weeks of age
Biological: bOPV and IPV and IPV2
tOPV at birth, 6, 10, 14, 18 and 22 weeks of age
Biological: tOPV
IPV at birth, 6, 10, 14 weeks of age and tOPV at 18 and 22 weeks of age
bOPV at birth, 6, 10, 14 weeks and tOPV at 18 and 22 weeks of age
bOPV till week 10, bOPV+IPV at 14 and tOPV at 18 and 22 weeks of age
bOPV till week 10, bOPV+IPV at 14, tOPV+IPV2 at 18 and tOPV at 22 weeks of age
tOPV till 22 weeks of age
Difference in seroprevalence of neutralizing antibodies for type 2 in 19 weeks of age between arms
Time frame: 19 weeks of age
Seroprevalence of neutralizing antibodies at 18 weeks of age
Time frame: 18 weeks of age
Difference in shedding of poliovirus type 2 in stool in 19 weeks of age between arms
Time frame: 19 weeks of age
Difference in seroprevalence of neutralizing antibodies at 22 weeks of age between arms
Time frame: 22 weeks of age
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Aga Khan University