Poliomyelitis
Conditions
Brief summary
The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV) manufactured by Beijing Bio-Institute Biological Products Co., Ltd (BBIBP) has a similar immunogenicity profile to a WHO prequalified bOPV.
Detailed description
BBIBP has been one of the two suppliers of trivalent oral polio vaccine (tOPV) in China since 1985, with control of polio in China evidence of the effectiveness of its vaccine. The company plans to introduce a liquid formulation of bOPV (types 1 and 3) to meet increasing global demand with the phasing-out of tOPV. The proposed study is intended to provide data sufficient to obtain World Heath Organization (WHO) prequalification for the BBIBP bOPV, thus making the vaccine available to help meet global demand. Infants were enrolled and randomized prior to the birth dose of bOPV. The first dose of study vaccine was administered during the first two weeks of life and then co-administered with the primary Expanded Programme on Immunization (EPI) series vaccines in Kenya at 6, 10 and 14 weeks of age. The Kenya EPI schedule includes the following additional vaccines: * Bacille Calmette-Guérin Vaccine (BCG) at birth * Diphtheria and Tetanus Toxoid with Whole Cell Pertussis, Haemophilus influenzae Type V vaccine (Hib), and Hepatitis B Vaccine (DTwPHibHep) at 6, 10, 14 weeks; * Pneumococcal Conjugate vaccine (PCV) at 6, 10, 14 weeks * Rotavirus vaccine (Rotarix) at 6, 10 weeks
Interventions
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.
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.
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.
Sponsors
Beijing Bio-Institute Biological Products Co., Ltd., formerly Beijing TiantanBio
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy, full-term infants, as established by medical history and clinical examination before entering into the study. * Parents willing to provide written informed consent. * Age: infants less than 2 weeks of age at the time of enrollment (from the 1st through the 14th day of life, inclusive)
Exclusion criteria
* Birth weight (as documented at first medical contact) less than 2.5 kg * Presence of diarrhea or vomiting in the previous 24 hours or on the day of enrollment (temporary exclusion) * Presence of fever (\> 37.5°C) on the day of enrollment (temporary exclusion) * Acute disease at the time of enrollment (temporary exclusion) * Significant malnutrition as per Investigator's judgment * Concurrent participation in another clinical study at any time during the study period in which the infant will be exposed to an investigational or a non-investigational product * Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol * Known or suspected impairment of immunological function (including human immunodeficiency virus \[HIV\] exposure) based on medical history and physical examination * Previous receipt of polio virus vaccine * Household contact with a known immunosuppressed individual * Unwillingness or inability of parents for active follow-up by the study staff * History of any neurological disorders or seizures * Any medical condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence or a participant's ability to give informed consent * Maternal HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose | 4 weeks post vaccination 4 (Week 18) | 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). |
| Number of Participants Experiencing Adverse Events | From the time of the first vaccination through 28 days after each vaccination (up to Day 126). | 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. |
| Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 | Screening and 4 weeks post vaccination 4 (Week 18) | 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. |
| Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 | Screening and 4 weeks post vaccination 4 (Week 18) | 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. |
| Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | 7 days after each vaccination (Weeks 0, 6, 10, and 14) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection | 28 days after vaccination 4 | 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. |
| Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers | 4 weeks post vaccination 4 (Week 18) | 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. |
| Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers | 4 weeks post vaccination 4 (Week 18) | 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. |
Countries
Kenya
Participant flow
Recruitment details
Subjects were recruited from the communities in the vicinity of the study clinics (KEMRI/Walter Reed Project Kombewa Clinical Research Center and Obama Children's Hospital in Kisumu and at the Kenya Medical Research Institute/Walter Reed Project in Kericho, Kenya).
Pre-assignment details
Infants were enrolled prior to receipt of the birth dose of bivalent oral poliomyelitis vaccine (bOPV} and were were allocated to 1 of 3 arms: 1. Beijing Bio-Institute Biological Products Co., Ltd. (BBIBP) liquid bOPV Lot 1; 2. BBIBP liquid bOPV Lot 2; and 3. World Health Organization (WHO) prequalified comparator bOPV (BioFarma).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 249 |
| 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. | 250 |
| 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. | 250 |
| Total | 749 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Week 18 to Week | Lost to Follow-up | 2 | 2 | 1 |
| Week 18 to Week | Received Non-study Polio Vaccine | 6 | 6 | 3 |
| Week 18 to Week | Withdrawal by Subject | 0 | 0 | 2 |
| Week 1 to Week 18 | Death | 1 | 0 | 0 |
| Week 1 to Week 18 | Lost to Follow-up | 0 | 0 | 2 |
| Week 1 to Week 18 | Received Non-study Polio Vaccine | 8 | 10 | 9 |
| Week 1 to Week 18 | Relocated Out of Study Area | 0 | 0 | 1 |
| Week 1 to Week 18 | Withdrawal by Subject | 6 | 12 | 5 |
Baseline characteristics
| Characteristic | BBIBP bOPV Lot 1 | Total | BioFarma bOPV | BBIBP bOPV Lot 2 |
|---|---|---|---|---|
| Age, Continuous | 1.0 days | 1.0 days | 1.0 days | 1.0 days |
| Body Mass Index (BMI) at Enrollment | 12.9 kg/m^2 | 12.9 kg/m^2 | 12.8 kg/m^2 | 13.0 kg/m^2 |
| Length at Enrollment | 49.5 centimeters | 49.5 centimeters | 49.0 centimeters | 49.5 centimeters |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 248 Participants | 748 Participants | 250 Participants | 250 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 249 participants | 749 participants | 250 participants | 250 participants |
| Sex: Female, Male Female | 123 Participants | 355 Participants | 121 Participants | 111 Participants |
| Sex: Female, Male Male | 126 Participants | 394 Participants | 129 Participants | 139 Participants |
| Weight at Enrollment | 3.2 kilograms | 3.1 kilograms | 3.1 kilograms | 3.1 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 249 | 0 / 250 | 0 / 250 |
| other Total, other adverse events | 143 / 249 | 142 / 250 | 151 / 250 |
| serious Total, serious adverse events | 13 / 249 | 16 / 250 | 17 / 250 |
Outcome results
Primary
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)
Population: Per Protocol Immunogenicity (PP-IMM) population includes all enrolled participants who were randomized, received all 4 doses of bOPV per the assigned treatment group, had post-vaccination immunogenicity measurement(s),and no major protocol violations that would have potentially interfered with the immunogenicity assessment of the study vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BBIBP bOPV Lot 1 | Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 | Screening | 40.9 titer |
| BBIBP bOPV Lot 1 | Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 | 4 Weeks after vaccination 4 | 55192 titer |
| BBIBP bOPV Lot 2 | Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 | 4 Weeks after vaccination 4 | 65790 titer |
| BBIBP bOPV Lot 2 | Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 | Screening | 41.5 titer |
| BioFarma bOPV | Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 | Screening | 41.2 titer |
| BioFarma bOPV | Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 | 4 Weeks after vaccination 4 | 60151 titer |
| BioFarma bOPV | Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 | Screening | 47.7 titer |
| BioFarma bOPV | Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 | 4 Weeks after vaccination 4 | 55634 titer |
95% CI: [0.65, 1.08]
95% CI: [0.87, 1.34]
Primary
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)
Population: Per Protocol Immunogenicity (PP-IMM) population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| BBIBP bOPV Lot 1 | Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 | Screening | 12.5 titer |
| BBIBP bOPV Lot 1 | Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 | 4 Weeks after vaccination 4 | 11374 titer |
| BBIBP bOPV Lot 2 | Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 | Screening | 15.6 titer |
| BBIBP bOPV Lot 2 | Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 | 4 Weeks after vaccination 4 | 12390 titer |
| BioFarma bOPV | Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 | Screening | 13.9 titer |
| BioFarma bOPV | Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 | 4 Weeks after vaccination 4 | 11861 titer |
| BioFarma bOPV | Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 | 4 Weeks after vaccination 4 | 8063 titer |
| BioFarma bOPV | Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 | Screening | 14.3 titer |
95% CI: [0.73, 1.15]
95% CI: [1.21, 1.79]
Primary
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)
Population: Per Protocol Immunogenicity (PP-IMM) population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BBIBP bOPV Lot 1 | Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose | Serotype 3 | 223 Participants |
| BBIBP bOPV Lot 1 | Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose | Serotype 1 | 223 Participants |
| BBIBP bOPV Lot 2 | Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose | Serotype 1 | 215 Participants |
| BBIBP bOPV Lot 2 | Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose | Serotype 3 | 214 Participants |
| BioFarma bOPV | Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose | Serotype 1 | 438 Participants |
| BioFarma bOPV | Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose | Serotype 3 | 437 Participants |
| BioFarma bOPV | Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose | Serotype 3 | 217 Participants |
| BioFarma bOPV | Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose | Serotype 1 | 219 Participants |
Comparison: For serotype 195% CI: [-0.5, 4.6]
Comparison: For Serotype 395% CI: [-0.1, 5.6]
Comparison: For Serotype 195% CI: [-3, 2.1]
Comparison: For Serotype 395% CI: [-2.6, 2.8]
Primary
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).
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BBIBP bOPV Lot 1 | Number of Participants Experiencing Adverse Events | Any adverse event | 143 Participants |
| BBIBP bOPV Lot 1 | Number of Participants Experiencing Adverse Events | Grade 1 | 111 Participants |
| BBIBP bOPV Lot 1 | Number of Participants Experiencing Adverse Events | Grade 2 | 24 Participants |
| BBIBP bOPV Lot 1 | Number of Participants Experiencing Adverse Events | Grade 3 | 7 Participants |
| BBIBP bOPV Lot 1 | Number of Participants Experiencing Adverse Events | Grade 4 | 0 Participants |
| BBIBP bOPV Lot 1 | Number of Participants Experiencing Adverse Events | Death | 1 Participants |
| BBIBP bOPV Lot 2 | Number of Participants Experiencing Adverse Events | Death | 0 Participants |
| BBIBP bOPV Lot 2 | Number of Participants Experiencing Adverse Events | Grade 2 | 17 Participants |
| BBIBP bOPV Lot 2 | Number of Participants Experiencing Adverse Events | Grade 3 | 10 Participants |
| BBIBP bOPV Lot 2 | Number of Participants Experiencing Adverse Events | Grade 4 | 1 Participants |
| BBIBP bOPV Lot 2 | Number of Participants Experiencing Adverse Events | Any adverse event | 142 Participants |
| BBIBP bOPV Lot 2 | Number of Participants Experiencing Adverse Events | Grade 1 | 114 Participants |
| BioFarma bOPV | Number of Participants Experiencing Adverse Events | Death | 0 Participants |
| BioFarma bOPV | Number of Participants Experiencing Adverse Events | Grade 1 | 117 Participants |
| BioFarma bOPV | Number of Participants Experiencing Adverse Events | Grade 2 | 27 Participants |
| BioFarma bOPV | Number of Participants Experiencing Adverse Events | Grade 3 | 7 Participants |
| BioFarma bOPV | Number of Participants Experiencing Adverse Events | Any adverse event | 151 Participants |
| BioFarma bOPV | Number of Participants Experiencing Adverse Events | Grade 4 | 0 Participants |
Primary
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)
Population: The safety population included all enrolled participants who had safety data available, assigned according to the actual treatment received at Day 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BBIBP bOPV Lot 1 | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Grade 3 | 6 Participants |
| BBIBP bOPV Lot 1 | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Grade 1 | 149 Participants |
| BBIBP bOPV Lot 1 | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Grade 2 | 32 Participants |
| BBIBP bOPV Lot 1 | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Any systemic reaction | 187 Participants |
| BBIBP bOPV Lot 2 | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Grade 1 | 139 Participants |
| BBIBP bOPV Lot 2 | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Any systemic reaction | 179 Participants |
| BBIBP bOPV Lot 2 | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Grade 2 | 32 Participants |
| BBIBP bOPV Lot 2 | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Grade 3 | 8 Participants |
| BioFarma bOPV | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Grade 1 | 153 Participants |
| BioFarma bOPV | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Grade 2 | 18 Participants |
| BioFarma bOPV | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Grade 3 | 4 Participants |
| BioFarma bOPV | Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity | Any systemic reaction | 175 Participants |
Secondary
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)
Population: Participants who received all 4 bOPV vaccinations and ≥ 3 hepatitis B virus vaccinations at least 21 days prior to blood draw.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BBIBP bOPV Lot 1 | Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers | 320 titer |
| BBIBP bOPV Lot 2 | Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers | 322 titer |
| BioFarma bOPV | Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers | 321 titer |
| BioFarma bOPV | Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers | 267 titer |
95% CI: [0.89, 1.63]
Secondary
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)
Population: Participants who received all 4 bOPV vaccinations and ≥ 2 Rotavirus vaccinations at least 21 days prior to blood draw
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| BBIBP bOPV Lot 1 | Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers | 22.7 titer |
| BBIBP bOPV Lot 2 | Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers | 35.8 titer |
| BioFarma bOPV | Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers | 28.3 titer |
| BioFarma bOPV | Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers | 28.6 titer |
95% CI: [0.71, 1.38]
Secondary
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
Population: Participants who received all 4 bOPV vaccinations and ≥ 3 hepatitis B virus vaccinations at least 21 days prior to blood draw.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BBIBP bOPV Lot 1 | Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection | 192 Participants |
| BBIBP bOPV Lot 2 | Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection | 194 Participants |
| BioFarma bOPV | Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection | 386 Participants |
| BioFarma bOPV | Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection | 196 Participants |
p-value: 0.558695% CI: [-3.86, 4.48]Fisher's exact 1-tailed test