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).

A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine

Poliomyelitis

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.

f-IPV

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

Seroconversion will be defined as a change from seronegative to seropositive (antibody titers of ≥1:8) and in infants seropositive at baseline (assumed to be from maternally-derived antibody titers), as a ≥4-fold rise in antibody titers post-vaccination, computed by assuming an exponential decay model with a half-life of 24 days.

These are medically significant events that do not meet any of the SAE criteria, but require medical or surgical consultation or intervention to prevent this event from becoming a SAE.

Severe local reactions can include severe pain, inflammation, induration and edema in the injection area.

3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 18, 36 & 40 weeks.

3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 18, 36 & 40 weeks.

2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.

2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.

3 doses IPV IM at 6, 14 & 36 weeks of age incl. blood sampling at 6, 18, 36 & 40 weeks.

3 doses f-IPV ID at 6, 14 & 36 weeks of age incl. blood sampling at 6, 18, 36 & 40 weeks.

A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?