The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule combinations in the Expanded Program on Immunization (EPI) primary series.
This study prioritizes comparisons involving two-dose regimens recently recommended by the World Health Organization (WHO) Strategic Advisory Group of Experts on immunization (SAGE) and Pan American Health Organization (PAHO) in response to global IPV supply shortages 21. Furthermore, the study will provide data on the comparative humoral immunogenicity of various schedules to inform polio immunization policy for the post-eradication era. The study population will include infants in Dominican Republic and Panama. Absence of wild and circulating vaccine derived polioviruses along with the lack of regular Supplementary Immunization Activities (SIAs) in the Latin America region provide an ideal epidemiologic setting to study polio vaccine immunogenicity. Infants will receive two or three doses of full-dose IPV IM or f-IPV ID, in two schedules (10, 14 and 36 weeks and 14 and 36 weeks). Immunological and safety assessments will be made after one dose, two doses and three doses. A total of 773 infants will be enrolled and distributed into 4 groups, according to a randomization scheme. During the study period, infants will be administered other concomitant vaccines according to the national schedules of the participating countries, but the effect, if any, of the concomitant administration on IPV immunogenicity will not be assessed. Optimum immunogenicity expected from the dose(s) of IPV in the post-eradication era will have to be balanced with the cost and supply constraints of IPV. This study will be critical to determine how many doses of IPV and which schedule are optimal for the post-eradication era after the global cessation of Oral Polio Vaccine (OPV) use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
773
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
Hospital Universitario Nuestra Señora de la Alta Gracia
Santo Domingo, Dominican Republic
Cevaxin Vaccination Center
David, Panama
Cevaxin Vaccination Center
La Chorrera, Panama
Cevaxin Vaccination Center
Panama City, Panama
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM
To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
Time frame: To be assessed 4 weeks after the last dose
Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM
To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Time frame: To be assessed 4 weeks after the last dose
Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Time frame: To be assessed 4 weeks after the last dose
Seroconversion Superiority of 2 Doses IPV IM at Different Schedules
To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.
Time frame: To be assessed 4 weeks after the second dose
Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose f-IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.
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Time frame: To be assessed 4 weeks after the second dose
Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM
To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Time frame: To be assessed 4 weeks after the last dose
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM
To determine if the seroconversion rate of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen also administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
Time frame: To be assessed 4 weeks after the last dose
Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM
To determine if the seroconversion rate to a 3-dose regimen of f-IPV administered at 10, 14, and 36 weeks of age is non-inferior to that of a 2-dose IPV regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
Time frame: To be assessed 4 weeks after the last dose
Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions
To assess the safety of each vaccine (IPV and f-IPV) as measured by the number of subjects experiencing serious adverse events (SAEs), important medical events (IMEs) and/or severe local reactions. This assessments is done in the Total Vaccinated Population (744 subjects).
Time frame: 9 months