Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine

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• Poliomyelitis 227

Poliomyelitis

227 studies on the registry are indexed under Poliomyelitis; 12 are open to participants now.

This study's enrollment of 750 is above the median of 456 across 203 interventional studies indexed under Poliomyelitis.

Lead sponsor

PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Study arms

• Experimental
  BBIBP bOPV Lot 1

  Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 1, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.

  Biological: BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1

• Experimental
  BBIBP bOPV Lot 2

  Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 2, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.

  Biological: BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2

• Active comparator
  BioFarma bOPV

  Infants received 2 drops of WHO prequalified liquid bivalent oral polio vaccine manufactured by BioFarma, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.

  Biological: BioFarma Bivalent Oral Poliomyelitis Vaccine

Interventions

• BiologicalBBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1

  Each dose of bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10\^6 cell culture infectious dose 50% (CCID50)/dose and 10\^5.8 CCID50/dose, respectively.

  Also known as: Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), Oral

• BiologicalBBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2

  Each dose of bOPV (2 drops, 0.1 ml) contains types 1 and 3 attenuated polioviruses (Sabin), with at least 10\^6 CCID50/dose and 10\^5.8 CCID50/dose, respectively.

  Also known as: Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), Oral

• BiologicalBioFarma Bivalent Oral Poliomyelitis Vaccine

  Each dose of the WHO prequalified Bio Farma bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10\^6 and 10\^5.8 infective units per dose, respectively.

Primary outcomes

1. Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity

   Solicited systemic reactogenicity events evaluated during the week after each vaccination included fever, vomiting, diarrhea, decreased appetite/ poor feeding, irritability, and decreased activity. Reactions were recorded by participant's parents via memory aid. Each event was graded as: Mild (Grade 1): No or minimal interference with usual activities; no medical intervention/therapy required, Moderate (Grade 2): Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required, Severe (Grade 3): Marked limitation in ability to perform usual activities; medical intervention/therapy required, or Potentially life-threatening (Grade 4): Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. The overall number of participants who experienced any systemic reaction is reported. Grades are based on maximum severity per participant.

   Time frame: 7 days after each vaccination (Weeks 0, 6, 10, and 14)

2. Number of Participants Experiencing Adverse Events

   Adverse events were graded as mild (Grade 1 = No or minimal interference with usual activities; no medical intervention/therapy required), moderate (Grade 2 = Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required), severe (Grade 3 = Marked limitation in ability to perform usual activities; medical intervention/therapy required), or potentially life-threatening (Grade 4 = Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). The overall number of participants who experienced any adverse event is reported. Grades are based on maximum severity per participant.

   Time frame: From the time of the first vaccination through 28 days after each vaccination (up to Day 126).

3. Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1

   The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days.

   Time frame: Screening and 4 weeks post vaccination 4 (Week 18)

4. Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3

   The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days.

   Time frame: Screening and 4 weeks post vaccination 4 (Week 18)

5. Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose

   The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Seroconversion was defined as a titer ≥ 1:8 if seronegative at screening, otherwise a ≥ 4-fold increase in adjusted titers (i.e., adjusted for the decay in maternal antibodies, based on a half life of 28 days).

   Time frame: 4 weeks post vaccination 4 (Week 18)

Secondary outcomes

1. Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers

   Anti-HBsAg titers were measured to assess the impact of concomitant administration of BBIBP liquid bOPV on immune responses to other Expanded Programme on Immunization (EPI) vaccines in comparison to that of the WHO pre-qualified bOPV, 4 weeks after the fourth vaccination. The enzyme-linked immunosorbent assay (ELISA) assays for serum antibodies to HBsAg were performed at the Children's Hospital Medical Center (CCHMC). The HBsAb assay was a qualified assay using a kit from BioRad.

   Time frame: 4 weeks post vaccination 4 (Week 18)

2. Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection

   Seroprotection was defined as a HBsAg titer ≥ 1:10 The ELISA assays for serum antibodies to HBsAg were performed at the Children's Hospital Medical Center (CCHMC). The HBsAb assay was a qualified assay using a kit from BioRad.

   Time frame: 28 days after vaccination 4

3. Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers

   Anti-rotavirus immunoglobulin A titers were measured to assess the impact of concomitant administration of BBIBP liquid bOPV on immune responses to other Expanded Programme on Immunization (EPI) vaccines in comparison to that of the WHO pre-qualified bOPV, 4 weeks after the fourth vaccination. The ELISA assay for antibodies to rotavirus was performed at the Children's Hospital Medical Center (CCHMC) using a validated in-house assay.

   Time frame: 4 weeks post vaccination 4 (Week 18)

Baseline characteristics