Comparison of Immunogenicity of Inactivated Poliovirus Vaccine (IPV) Administered Intramuscularly or Intradermally
Condition: Polio
Study type: Interventional
Phase: Phase 2

Summary: 
      Polio is an acute transmissible disease caused by any of the three polio virus serotypes
      (types 1, 2 or 3). In Mozambique, polio vaccination is part of the immunization schedule of
      the expanded vaccination program. The oral vaccine (OPV) is administered at months 0,2,3, and
      4 and a single dose of the inactivated poliovirus vaccine (IPV) is given intramuscularly at
      month 4. In 2016 shortage of IPV supply caused stock-outs and put strain on IPV use for
      routine immunizations as well as for poliovirus outbreak response. Therefore, assessment of
      new vaccine regimens using smaller doses of IPV are needed. Administration of fractionated
      IPV (fIPV), i.e., 1/5 (0.1mL) of the standard dose, intradermally has shown to be safe and to
      provide an immune response similar to the standard dose of IPV that is currently given
      intramuscularly. However, intradermal administration of fIPV is technically difficult and
      many countries are hesitant to adopt fIPV in their routine immunization schedules. Therefore,
      the investigators need data confirming that the use of the fIPV vaccine intramuscularly is
      safe and the immune response is not inferior to the use of fIPV intradermally. Study
      Objective: to compare the immunogenicity of fIPV administered intramuscularly or
      intradermally in infants at 2 and 4 months of age. Study Hypotheses: the seroconversion rate
      after administration of one or two doses of fIPV intramuscularly is not inferior to the fIPV
      intradermally. The priming effect after fIPV administered intramuscularly is not inferior to
      the fIPV intradermally. Study Methods: This will be a phase II non-inferiority clinical
      trial. 360 children will be enrolled in two study groups, with prior consent of the parents /
      guardians. In group I, 180 children will receive 0.1 ml of IPV intramuscularly and in group
      II 180 children will receive the same dose intradermally. There will not be a group control.
      The children will be selected at birth at pre-defined health units in Maputo city. The
      fractional IPV vaccine will be given to children at 2 and 4 months of age during routine
      vaccinations. In total there will be four study visits, of which the first two are
      vaccination visits. All visits will be performed at the health units. 1 ml of blood will be
      collected at each study visit to assess the immune response before and after vaccination.
      Data will be collected by trained and qualified personnel and in accordance with Good
      Clinical Practice standards. Adverse events following administration of the vaccine will be
      monitored and all serious adverse events will be reported to ethics and regulatory
      committees, and to World Health Organization (WHO). Evaluation of the immune response:
      Seroconversion rates and priming effect will be evaluated. Serum will be tested for the
      presence of neutralizing antibodies against poliovirus using standard neutralization assays
      and immunogenicity will be assessed by titration of anti-polio 2 immunoglobulin G.
    


Intervention name(s): Inactivated poliovirus vaccine in reduced doses
Intervention type(s): Biological
Intervention description(s): contains the following excipients: 2-phenoxyethanol (2.5 mg), water for injection and diluent solution and phosphate buffer having the following composition: sodium phosphate, sodium chloride, potassium chloride, magnesium sulfate, phenol red and calcium chloride.
dosage:0,1ml duration: first dose: month 2 of age; second dose: month 4 of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Polio Virus