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| Name | Class |
|---|---|
| Beijing Bio-Institute Biological Products Co., Ltd., formerly Beijing TiantanBio | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBIBP bOPV Lot 1 | Experimental | 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. |
|
| BBIBP bOPV Lot 2 | Experimental | 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. |
|
| BioFarma bOPV | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days after each vaccination (Weeks 0, 6, 10, and 14) |
| 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. | From the time of the first vaccination through 28 days after each vaccination (up to Day 126). |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Cowden, MD, MSPH | US Army Medical Research Unit-Kenya | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Medical Research Institute/Walter Reed Project | Kisumu | Nyanza | PO Box 54-40100 | Kenya | ||
| Kenya Medical Research Institute (KEMRI)/Walter Reed Project |
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:
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 to Week 18 |
|
| ||||||||||||||||||||||||
| Week 18 to Week |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | BBIBP bOPV Lot 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety population included all enrolled participants who had safety data available, assigned according to the actual treatment received at Day 0. | Posted | Count of Participants | Participants | 7 days after each vaccination (Weeks 0, 6, 10, and 14) |
From the time of the first vaccination through completion of the study at 3 months after the last vaccination (Day 182) for serious adverse events and through 28 days after each vaccination (up to Day 126) for non-serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Flores | PATH | (202) 822-0033 | jeflores@path.org |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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|
| BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2 | Biological | 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. |
|
|
| BioFarma Bivalent Oral Poliomyelitis Vaccine | Biological | 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. |
|
| Screening and 4 weeks post vaccination 4 (Week 18) |
| 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. | Screening and 4 weeks post vaccination 4 (Week 18) |
| 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). | 4 weeks post vaccination 4 (Week 18) |
| 4 weeks post vaccination 4 (Week 18) |
| 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. | 28 days after vaccination 4 |
| 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. | 4 weeks post vaccination 4 (Week 18) |
| Kericho |
| Kenya |
| Received Non-study Polio Vaccine |
|
| Relocated Out of Study Area |
|
| Death |
|
| NOT COMPLETED |
|
|
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Length at Enrollment | Median | Full Range | centimeters |
|
| Weight at Enrollment | Median | Full Range | kilograms |
|
| Body Mass Index (BMI) at Enrollment | Median | Full Range | kg/m^2 |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | 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. |
|
|
| 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. | Safety population | Posted | Count of Participants | Participants | From the time of the first vaccination through 28 days after each vaccination (up to Day 126). |
|
|
|
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | Screening and 4 weeks post vaccination 4 (Week 18) |
|
|
|
|
| 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. | Per Protocol Immunogenicity (PP-IMM) population | Posted | Geometric Mean | 95% Confidence Interval | titer | Screening and 4 weeks post vaccination 4 (Week 18) |
|
|
|
|
| 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). | Per Protocol Immunogenicity (PP-IMM) population | Posted | Count of Participants | Participants | 4 weeks post vaccination 4 (Week 18) |
|
|
|
|
| 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. | Participants who received all 4 bOPV vaccinations and ≥ 3 hepatitis B virus vaccinations at least 21 days prior to blood draw. | Posted | Geometric Mean | 95% Confidence Interval | titer | 4 weeks post vaccination 4 (Week 18) |
|
|
|
|
| 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. | Participants who received all 4 bOPV vaccinations and ≥ 3 hepatitis B virus vaccinations at least 21 days prior to blood draw. | Posted | Count of Participants | Participants | 28 days after vaccination 4 |
|
|
|
|
| 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. | Participants who received all 4 bOPV vaccinations and ≥ 2 Rotavirus vaccinations at least 21 days prior to blood draw | Posted | Geometric Mean | 95% Confidence Interval | titer | 4 weeks post vaccination 4 (Week 18) |
|
|
|
|
| 1 |
| 249 |
| 13 |
| 249 |
| 143 |
| 249 |
| EG001 | 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. | 0 | 250 | 16 | 250 | 142 | 250 |
| EG002 | 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. | 0 | 250 | 17 | 250 | 151 | 250 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Breast abcess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pyomyositis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Sepsis neonatal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Convulsion neonatal | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Herbal toxicity | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Ankyloglossia congenital | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
|
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
|
| Talipes | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Anal ulcer | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyschezia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gingival discolouration | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gingival disorder | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gingival pruritus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Infantile colic | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Mucous stools | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abscess sterile | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Developmental delay | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Granuloma | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Irritability postvaccinal | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Mass | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vaccination site pain (for other EPI vaccines) | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vaccination site swelling (for other EPI vaccines) | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Dysentery | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Eczema infected | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Eye infection bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Myiasis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Omphalitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Ophthalmia neonatorum | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Sepsis neonatal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Septic rash | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Skin bacterial infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Tinea capitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Tinea faciei | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Umbilical sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Adverse event following immunisation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Poor feeding infant | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Umbilical cord abnormality | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Umbilical cord haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Umbilical granuloma | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dandruff | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Milia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Umbilical haematoma | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
Not provided
Not provided
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| Title | Measurements |
|---|---|
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Death |
|
| 4 Weeks after vaccination 4 |
|
| Ratio of Geometric Mean Titers | 1.08 | 2-Sided | 95 | 0.87 | 1.34 | Lot 1 + Lot 2 / BioFarma bOPV | Non-Inferiority | Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was > 0.5. |
| 4 Weeks after vaccination 4 |
|
| Ratio of Geometric Mean Titers | 1.47 | 2-Sided | 95 | 1.21 | 1.79 | BBIBP bOPV Lot 1 + Lot 2 / BioFarma bOPV | Non-Inferiority | Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was > 0.5. |
| Serotype 3 |
|
| For Serotype 3 | Difference in seroconversion rate | 2.2 | 2-Sided | 95 | -0.1 | 5.6 | BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV | Non-Inferiority | Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent. |
| For Serotype 1 | Difference in seroconversion rate | -0.4 | 2-Sided | 95 | -3.0 | 2.1 | Lot 1 - Lot 2 | Other | Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes. |
| For Serotype 3 | Difference in seroconversion rate | 0.1 | 2-Sided | 95 | -2.6 | 2.8 | Lot 1 - Lot 2 | Non-Inferiority | Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes. |