A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China.
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      In April 2017, WHO recommended that a two-dose, Inactivated Poliovirus Vaccine, IPV-only
      schedule at 4 months and 8 months of age can be used after polio eradication, with a schedule
      seroconversion target of at least 90%. However, there is no such data for China domestic
      Sabin strain IPVs to support a 2-dose schedule among Chinese infants.

      This research is to determine the seroconversion rates among two arms:

      Group 1: two-dose schedule, infants will be received two doses of Sabin IPV, the first dose
      at 4 month of age, and the second dose at 8-11 month of age.

      Group 2: three-dose schedule, infants will be received three doses of Sabin IPV at 2, 3 and 4
      month of age respectively. This schedule is currently recommended by manufacture's package
      insert for routine use.

      The hypothesis is the seroconversion will be above 90% in both groups.
    

Detailed description: 
      As a part of global polio eradication endgame immunization strategy, WHO requested all
      OPV-using countries to introduce at least one dose of IPV into the routine immunization
      schedule. Ideally IPV should be administered after 14 weeks of age, however an IPV-OPV
      sequential schedule is acceptable if VAPP is a concern. China stopped trivalent OPV in
      routine immunization in May 2016, introduced one dose of IPV at 2 months followed by three
      doses of type I / III bivalent OPV (bOPV) at 3 and 4 months and 4 years. A Sabin strain IPV
      was licensed in January 2015, and a second Sabin IPV was approved by China FDA in September
      2017. The production capacity will increase in the next few years and will meet the demands
      of an IPV-only schedule in China. Other Sabin IPVs are in clinical trial stages, which will
      lead to sufficient IPV production for China to export IPV.

      In April 2017, WHO/SAGE recommended that a two-dose, IPV-only schedule can be used after
      polio eradication, with a schedule seroconversion target of at least 90%. The recommendation
      was based in part on a study conducted in Cuba using Salk-IPV at 4 months and 8 months of
      age. Considering that risk of polio virus transmission is decreasing over time, and that IPV
      - either domestic Sabin-IPV or imported Salk-IPV - is expensive (6 USD/dose) for a program
      serving a birth cohort of 18 million, an efficient two-dose, IPV-only schedule will be very
      competitive with a more traditional 4-dose IPV-only schedule. However, for domestic Sabin
      IPVs, there are no such data to support a 2-dose schedule among Chinese infants.

      The overall objective of this research is to determine the seroconversion rates of two
      reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.

      Group 1: two-dose schedule, infants will be received two doses of Sabin IPV, the first dose
      at 4 month of age, and the second dose at 8-11 month of age.

      Group 2: three-dose schedule, infants will be received three doses of Sabin IPV at 2, 3 and 4
      month of age respectively. This schedule is currently recommended by manufacture's package
      insert for routine use.

      The hypothesis is the seroconversion will be above 90% in both groups.
    

Intervention name(s): Sabin IPV
Intervention type(s): Biological
Intervention description(s): We select one Sabin IPV product, produced by Kunming Bio institute, which is available for China's National Immunization Program in the selected study sites.
Other intervention name(s): Sabin strain Inactivated Poliovirus Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a multi-center, randomized, open-label, seroconversion/immunogenicity study.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Inactivated Poliovirus Vaccine; Sabin strain