Poliomyelitis Clinical Trial
Official title:
A Phase 3, Open-label, Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Infants
The study will evaluate the humoral immunogenicity in various schedule combinations of full dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).
The study will be conducted in a setting where only IPV is being used for polio prevention
in infant immunization schedules.
The study population will include infants from Uruguay, a pioneer country in immunization
programs in Latin America, where tOPV(trivalent oral polio vaccine) was used until 2012,
after which the program changed to an all-IPV schedule without transition.
The primary IPV immunization schedule in the country is as stand-alone vaccine at 2, 4 and 6
months of age, with a booster dose at 15 months. This setting allows the evaluation of IPV
immunogenicity in a scenario where the circulation of any poliovirus is highly unlikely.
Infants will receive two or three doses of full dose IPV IM or fractional dose f-IPV ID, in
various schedule combinations (6 and 14 weeks; 10 and 14 weeks; 14 and 36 weeks; 6, 14 and
36 weeks; 10, 14 and 36 weeks). Immunological and safety assessments will be made after one
dose, two doses and three doses.
The study will be conducted in Montevideo, Uruguay and a total of 1493 infants will be
randomized into 6 groups. Other vaccines comprise DTPw-HB-Hib (pentavalent combined
diphtheria-tetanus-whole cell pertussis-hepatitis B-Hib vaccine), Pneumococcal conjugate
vaccine, Rotavirus and will be administered concomitantly.
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 will be recommended for the
post-eradication era after the cessation of OPV (oral polio vaccine) usage globally.
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