Clinic Trial to Evaluate the Safety and Immunogenicity by Different Sequential Schedules of bOPV and IPV
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      With the progress of the eradication of polio, bivalent oral attenuated live poliomyelitis
      vaccine against type 1 and 3 (bOPV) and inactivated poliomyelitis vaccine made by Sabin
      strain (sIPV) are required to use in the "Strategy of Polio Eradication & Endgame Strategic
      Plan 2013-2018" worldwide.

      To evaluate the safety and immunogenicity by different sequential schedules of bOPV/tOPV with
      IPV(sIPV/cIPV), a randomized, double blind, single center and parallel phase Ⅲ clinic trial
      was performed in Infants of two-month-old in Guangxi Province, China.
    

Detailed description: 
      According to the requirement of the Strategy of Polio Eradication & Endgame Strategic Plan
      2013-2018, bivalent oral attenuated live poliomyelitis vaccine against type 1 and 3 (bOPV)
      and inactivated poliomyelitis vaccine made by Sabin strain (sIPV) need to be used to
      eradiation both the wild poliovirus and vaccine-derived poliovirus.

      By studying different sequential immunization schedules of bOPV(candy/liquid) with
      IPV(cIPV/sIPV) to evaluate the safety and immunogenicity of bivalent oral poliomyelitis
      vaccine co-administered with IPV in healthy Infants. A randomized, double blind, single
      center and parallel phase Ⅲ clinic trial was performed in Guangxi Province in China. A total
      of 1200 infants at 2 months old were selected, and randomly divided into 12 different groups
      (100 individuals were included in each group) administrated the vaccines at 0, 28, 56 days
      schedule. The bOPV(bivalent oral attenuated live poliomyelitis vaccine against type 1 and
      type 3), tOPV(trivalent OPV against type 1, type 2 and type 3), sIPV (Inactivated
      Poliomyelitis Vaccine Made from Sabin Strains)and conventional IPV (Inactivated Poliomyelitis
      Vaccine Made from Wild Polio Strains) were assign to different group of sequential
      immunization schedules.

      The detail of each group as following:

      1)1-dose cIPV + 2-doses bOPV (Candy); 2)1-dose sIPV + 2-doses bOPV (Candy); 3)2-doses cIPV +
      1-dose bOPV (Candy); 4)2-doses sIPV + 1-dose bOPV (Candy); 5)2-doses cIPV + 1-dose tOPV
      (Candy); 6)2-doses sIPV + 1-dose tOPV (Candy); 7)1-dose cIPV + 2-doses bOPV (Liquid);
      8)1-dose sIPV + 2-doses bOPV (Liquid); 9)2-doses cIPV + 1-dose bOPV (Liquid); 10)2-doses sIPV
      + 1-dose bOPV (Liquid); 11)2-doses cIPV + 1-dose tOPV (Liquid); 12)2-doses sIPV + 1-dose tOPV
      (Liquid).

      Blood Sample was collected before vaccination and 28 days after the third dose of
      vaccination. Neutralization antibody against type I, Type I and Type III poliomyelitis virus
      were detected to evaluate the seroprotection rates and antibody geometric mean
      concentrations. The safety of different sequential schedule immunization for the vaccines
      also been monitored.

      The first 10% of subjects in each research site，fecal samples were collected to test polio
      virus shedding.The 7 times are before the second dose immunization and the 7、14、28 days after
      the second and the third dose immunization.
    

Intervention name(s): 1-dose cIPV + 2-doses bOPV (Candy); 1-dose sIPV + 2-doses bOPV (Candy); 2-doses cIPV + 1-dose bOPV (Candy); 2-doses sIPV + 1-dose bOPV (Candy); 2-doses cIPV + 1-dose tOPV (Candy); 2-doses sIPV + 1-dose tOPV (Candy); 1-dose cIPV + 2-doses bOPV (Liquid); 1-dose sIPV + 2-doses bOPV (Liquid); 2-doses cIPV + 1-dose bOPV (Liquid); 2-doses sIPV + 1-dose bOPV (Liquid); 2-doses cIPV + 1-dose tOPV (Liquid); 2-doses sIPV + 1-dose tOPV (Liquid)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Health subjects received 1-dose cIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Candy) through mouth at 0, 28, 56 days schedule.; Health subjects received 1-dose sIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Candy) through mouth at 0, 28, 56 days schedule.; Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Candy) through mouth at 0, 28, 56 days schedule.; Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Candy) through mouth at 0, 28, 56 days schedule.; Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Candy) through mouth at 0, 28, 56 days schedule.; Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Candy) through mouth at 0, 28, 56 days schedule.; Health subjects received 1-dose cIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Liquid) through mouth at 0, 28, 56 days schedule.; Health subjects received 1-dose sIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Liquid) through mouth at 0, 28, 56 days schedule.; Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Liquid) through mouth at 0, 28, 56 days schedule.; Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Liquid) through mouth at 0, 28, 56 days schedule.; Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Liquid) through mouth at 0, 28, 56 days schedule.; Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Liquid) through mouth at 0, 28, 56 days schedule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: bOPV; IPV; sequential immunization; immunogenecity; safety