A Phase 4 interventional study of Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS and Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS in Poliomyelitis, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in Bangladesh. Open to participants aged 42 Days to 48 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Centers for Disease Control and Prevention · Phase 4, Interventional, and Prevention
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.
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.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
This study's enrollment of 1,224 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
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Exclusion Criteria:
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).
Biological: Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS
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).
Biological: Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS
Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP).
Biological: Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP
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).
Biological: Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBP
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.
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.
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
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
Vaccine response
Dichotomous (yes/no) variable defined as participants who are either seronegative (\<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.
Time frame: Measured 4 weeks after administration of study vaccine
Reciprocal antibody titers
Variable of the observed reciprocal antibody titer results.
Time frame: Measured 4 weeks after administration of study Vaccine
Priming
Dichotomous (yes/no) variable defined as participants who are either seronegative (\<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.
Time frame: Measured 7 days after challenge dose (e.g. 9 months + 7 days)
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2022 to primary completion in Jul 2023, 11 months.
Of 30 phase 4 interventional studies under Poliomyelitis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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