Inactivated Poliovirus Vaccine (IPV) With or Without E.Co... | NCT04232943

NCT04232943

ID	Type	Description	Link
2019-002415-25	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inactivated Poliomyelitis Vaccine (IPV)	Active Comparator	Participants will receive a single intramuscular injection of 0.5 mL inactivated poliomyelitis vaccine (IPV) on Day 1 followed by a single dose (2 drops) of bivalent oral polio vaccine (bOPV) 28 days later.	Biological: Inactivated Poliomyelitis Vaccine (IPV) Biological: Bivalent Oral Polio Vaccine (bOPV)
Inactivated Poliomyelitis Vaccine + dmLT	Experimental	Participants will receive a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	Biological: Inactivated Poliomyelitis Vaccine (IPV) Biological: E.coli Double Mutant Heat-Labile Toxin (dmLT) (adjuvant) Biological: Bivalent Oral Polio Vaccine (bOPV)
Bivalent Oral Polio Vaccine	Active Comparator	Participants will receive one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.	Biological: Bivalent Oral Polio Vaccine (bOPV)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inactivated Poliomyelitis Vaccine (IPV)	Biological	IMOVAX® Polio is a highly purified, inactivated poliovirus vaccine. Each 0.5 mL dose contains: Type 1 (Mahoney) 40 D-antigen units Type 2 (MEF1) 8 D-antigen units Type 3 (Saukett) 32 D-antigen units

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Serious Adverse Events Over the Course of the Study	A serious adverse event (SAE) was any event that resulted in any of the following outcomes: Death; Was life-threatening; Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; Congenital abnormality or birth defect; Important medical event that did not result in one of the above outcomes but jeopardized the health of the study participant or required medical or surgical intervention to prevent one of the outcomes listed in the above definition of SAE.	Up to 6 months
Number of Participants With Severe Adverse Events During the 28 Days Following Study Vaccination	Severe adverse events are events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.	Up to 28 days after study vaccination (prior to bOPV challenge)
Number of Participants With Solicited Local Adverse Events	Solicited adverse events (AEs) are pre-specified local and systemic adverse events that are common or known to be associated with vaccination and that are actively monitored as indicators of vaccine reactogenicity. Local/injection site reactions included pain, erythema/redness, swelling, induration, and hyperpigmentation, applicable to participants in the IPV and IPV + dmLT arms who received study injections. Severity was graded according to the following: Mild: Transient or mild discomfort; does not interfere with activities, erythema or swelling 2.5 - 5 cm, hyperpigmentation 1- 4 cm. Moderate: Mild to moderate limitation in activity; no or minimal medical intervention/therapy required, erythema or swelling 5.1 - 10 cm, hyperpigmentation 4.1 - 8 cm, or repeated use of nonnarcotic pain reliever > 24 hours. Severe: All normal activity is prevented for 24 hours or more, erythema or swelling > 10 cm, hyperpigmentation > 8 cm, or any use of narcotic pain reliever.	7 days following study vaccination

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a Positive Poliovirus Fecal Neutralization Response 28 Days After Vaccination and 14 Days After bOPV Challenge	Positive response is defined as a minimum 4-fold increase from the pre-vaccination (Baseline) value in fecal anti-poliovirus neutralization antibodies. Serotype-specific poliovirus neutralizing antibody quantitation was conducted using standardized assays at the Wright Laboratory at Dartmouth University.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult male or female, ages 18-45, inclusive
Healthy as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history and clinical assessment
History of prior receipt of at least 3 doses of IPV
Willing and able to provide written informed consent and willing to comply with study requirements
Intention to remain in the area during the study period
If female and of childbearing potential, not breastfeeding and not pregnant (based on a negative serum pregnancy test at screening and negative urine pregnancy tests prior to vaccine administration and bOPV challenge), planning to avoid pregnancy until at least three months after bOPV challenge, and willing to use an adequate method of contraception consistently. Effective methods include intrauterine device or hormonal contraceptives (oral, injectable, patch, implant, vaginal ring). Women with credible history of abstinence or in monogamous relationship with a vasectomized partner are also eligible.

Exclusion Criteria:

History of receiving any OPV at any time
Receipt of IPV in the last five years
History of or planned household contact with an individual receiving OPV in prior 4 weeks, or at any point during the study
Regular contact with children younger than six months (and thus not yet fully vaccinated against polio) and immunocompromised individuals
Presence of fever on the day of vaccination (oral temperature ≥ 38°C)
Received an investigational product within 30 days prior to randomization or planning to participate in another research study involving investigational product during the conduct of this study
Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune diseases) as determined by medical history and/or physical examination that would compromise the participant's health or is likely to result in nonconformance to the protocol or would interfere with the evaluation of responses according to the opinion of the investigator
History of allergic disease or known hypersensitivity to any component of the study vaccine
History of anaphylactic reaction
Receipt of any immunoglobulin therapy and/or blood products in the last 6 months or planned administration during the study period
History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including oral steroids, parenteral steroids, or high-dose inhaled steroids (> 800 μg/day of beclomethasone dipropionate or equivalent), in the last 6 months to either the study subject or their close household contacts (those on nasal or topical steroids may be permitted to participate in the study)
Symptoms of an acute self-limited illness, such as an upper respiratory infection or gastroenteritis, including a temperature ≥ 38.0°C, within the 7 days prior to study vaccines administration
Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody
Clinically significant screening laboratory value
History of receipt of experimental E. coli, enterotoxigenic E. coli (ETEC) labile toxin (LT), or cholera vaccines or live E. coli or Vibrio cholerae challenges.
Receipt of any licensed vaccine within 28 days before enrollment in this study or plans to receive any licensed vaccine between enrollment and 28 days after the bOPV challenge
History of alcohol or drug abuse in the last 5 years
Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the study vaccine

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Antwerpen		Antwerp	Wilrijk		Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36746739	Derived	Erdem R, De Coster I, Withanage K, Mercer LD, Marchant A, Taton M, Cools N, Lion E, Cassels F, Higgins D, Ivinson K, Locke E, Mahmood K, Wright PF, Gast C, White JA, Ackerman ME, Konopka-Anstadt JL, Mainou BA, Van Damme P. Safety, tolerability, and immunogenicity of inactivated poliovirus vaccine with or without E.coli double mutant heat-labile toxin (dmLT) adjuvant in healthy adults; a phase 1 randomized study. Vaccine. 2023 Mar 3;41(10):1657-1667. doi: 10.1016/j.vaccine.2023.01.048. Epub 2023 Feb 4.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL inactivated poliomyelitis vaccine (IPV) on Day 1 followed by a single dose (2 drops) of bivalent oral polio vaccine (bOPV) 28 days later.
FG001	Inactivated Poliomyelitis Vaccine + dmLT

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 3, 2020	Jan 24, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Inactivated Poliomyelitis Vaccine (IPV)
Inactivated Poliomyelitis Vaccine + dmLT

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
BG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
BG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00030 BG00130 BG00220 BG00380

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00018.9± 1.61 BG00118.8± 1.35 BG00220.1± 4.18 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00018 BG00117 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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 With Serious Adverse Events Over the Course of the Study

A serious adverse event (SAE) was any event that resulted in any of the following outcomes:

Death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
Congenital abnormality or birth defect;
Important medical event that did not result in one of the above outcomes but jeopardized the health of the study participant or required medical or surgical intervention to prevent one of the outcomes listed in the above definition of SAE.

The total vaccinated population includes all participants in the enrolled population who were randomized and received a study vaccination.

Posted

Count of Participants

Participants

Up to 6 months

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Units	Counts
Participants	OG00030 OG00130 OG00220

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020

Primary

Number of Participants With Severe Adverse Events During the 28 Days Following Study Vaccination

Severe adverse events are events that interrupted a participant's usual daily activity and may have required systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating.

Total vaccinated population

Posted

Count of Participants

Participants

Up to 28 days after study vaccination (prior to bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Primary

Number of Participants With Solicited Local Adverse Events

Solicited adverse events (AEs) are pre-specified local and systemic adverse events that are common or known to be associated with vaccination and that are actively monitored as indicators of vaccine reactogenicity.

Local/injection site reactions included pain, erythema/redness, swelling, induration, and hyperpigmentation, applicable to participants in the IPV and IPV + dmLT arms who received study injections.

Severity was graded according to the following:

Mild: Transient or mild discomfort; does not interfere with activities, erythema or swelling 2.5 - 5 cm, hyperpigmentation 1- 4 cm.

Moderate: Mild to moderate limitation in activity; no or minimal medical intervention/therapy required, erythema or swelling 5.1 - 10 cm, hyperpigmentation 4.1 - 8 cm, or repeated use of nonnarcotic pain reliever > 24 hours.

Severe: All normal activity is prevented for 24 hours or more, erythema or swelling > 10 cm, hyperpigmentation > 8 cm, or any use of narcotic pain reliever.

Total vaccinated population - participants who received intramuscular injection

Posted

Count of Participants

Participants

7 days following study vaccination

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.

Primary

Number of Participants With Solicited Systemic Adverse Events

Systemic reactions included fever (oral temperature ≥ 38.0°C), chills, fatigue, headache, muscle aches/myalgia, joint ache/arthralgia, rash, nausea, vomiting, and diarrhea.

Severity was graded according to the following:

Mild: Transient or mild discomfort; does not interfere with activities, 2-3 vomiting episodes in 24 hours, 3-5 loose stools/day or diarrhea volume <1000 mL/day, or temperature 38.0 - 38.9˚C.

Moderate: Mild to moderate limitation in activity; no or minimal medical intervention/therapy required, 4-5 vomiting episodes in 24 hours, 6-9 loose stools/day or 1000-1999 mL output per 24 hours, or temperature 39.0 - 39.9˚C.

Severe: All normal activity is prevented for 24 hours or more, > 6 vomiting episodes in 24 hours, > 10 loose stools/day or orthostatic hypotension, or temperature > 40.0˚C.

Total vaccinated population

Posted

Count of Participants

Participants

7 days following study vaccination

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.

Primary

Number of Participants With Unsolicited Adverse Events During the 28 Days Following Study Vaccination

An adverse event is any untoward medical occurrence in a participant after administration of the investigational vaccine and that does not necessarily have a causal relationship with the investigational vaccine.

AEs were graded for severity on the following scale:

Grade 1 - Mild: Transient or mild discomfort; does not interfere with activities;

Grade 2 - Moderate: Mild to moderate limitation in activity; no or minimal medical intervention/therapy required;

Grade 3 - Severe: All normal activity is prevented for 24 hours or more.

Total vaccinated population

Posted

Count of Participants

Participants

28 days following study vaccination

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine

Primary

Percentage of Participants Positive for bOPV Viral Shedding 7 Days Following bOPV Challenge

The presence of the bOPV virus (Sabin strains Type 1 and Type 3) in stool samples was determined using polymerase chain reaction (PCR).

Participants in the per protocol population who received the bOPV challenge and had available shedding data.

The per protocol (PP) population includes all enrolled participants who were randomized, received a study vaccination, and who had no protocol violations determined to potentially interfere with the immunogenicity assessment up to each time point.

Posted

Number

95% Confidence Interval

percentage of participants

Day 36 (7 days after bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Secondary

Percentage of Participants With a Positive Poliovirus Fecal Neutralization Response 28 Days After Vaccination and 14 Days After bOPV Challenge

Positive response is defined as a minimum 4-fold increase from the pre-vaccination (Baseline) value in fecal anti-poliovirus neutralization antibodies. Serotype-specific poliovirus neutralizing antibody quantitation was conducted using standardized assays at the Wright Laboratory at Dartmouth University.

The per protocol (PP) population includes all enrolled participants who were randomized and received a study vaccination and who had no protocol violations determined to potentially interfere with the immunogenicity assessment up to each time point.

Posted

Number

95% Confidence Interval

percentage of participants

Day 29 (28 days after study vaccination) and Day 43 (14 days after bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL inactivated poliomyelitis vaccine (IPV) on Day 1 followed by a single dose (2 drops) of bivalent oral polio vaccine (bOPV) 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002

Secondary

Level of Fecal Poliovirus Immunoglobulin A (IgA) Antibodies at Baseline, 28 Days After Vaccination and 14 Days After bOPV Challenge

Fecal IgA were quantified using a Luminex assay in which monovalent IPVs are covalently conjugated to fluorescently coated beads in order to quantify total and polio-type specific concentrations of IgA in stool specimens.

Per protocol population with available data at each time point

Posted

Median

95% Confidence Interval

relative fluorescence units

Baseline (before vaccination), Day 29 (28 days after study vaccination, prior to bOPV challenge) and Day 43 (14 days after bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Secondary

Change From Baseline in Fecal Poliovirus IgA Antibodies 28 Days After Study Vaccination and 14 Days After bOPV Challenge

Per protocol population with available data at each time point

Posted

Median

95% Confidence Interval

relative fluorescence units

Baseline, Day 29 (28 days after study vaccination, prior to bOPV challenge) and Day 43 (14 days after bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Units	Counts

Secondary

Serum Neutralizing Antibody Seroconversion Rate 28 Days After Study Vaccination

Serum neutralizing antibody seroconversion rate is defined as the percentage of participants demonstrating a minimum four-fold increase in type-specific poliovirus serum neutralizing antibody titers between baseline and 28 days post vaccination, or post-vaccination titer > 1:8 if seronegative at baseline.

Per protocol population

Posted

Number

95% Confidence Interval

percentage of participants

Day 29 (28 days after study vaccination, prior to bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Secondary

Geometric Mean Titer of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days After Study Vaccination

Per protocol population with available data at each time point

Posted

Geometric Mean

95% Confidence Interval

titer

Baseline (pre-vaccination) and Day 29 (28 days after study vaccination, prior to bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Units	Counts
Participants

Secondary

Seroprotection Rate of Serum Poliovirus Neutralizing Antibodies at Baseline and 28 Days Following Vaccination

Seroprotection rate of serum poliovirus neutralizing antibodies is defined as a type-specific poliovirus serum neutralizing antibody titer ≥ 1:8.

Per protocol population with available data at each time point

Posted

Number

95% Confidence Interval

percentage of participants

Baseline (before vaccination) and Day 29 (28 days after vaccination, prior to bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Secondary

Geometric Mean Fold-Rise in Serum Poliovirus Neutralizing Antibodies

Per protocol population

Posted

Geometric Mean

95% Confidence Interval

fold-rise

Baseline (before vaccination) and Day 29 (28 days after vaccination, prior to bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Units	Counts
Participants

Secondary

Percentage of Participants With a Circulating Poliovirus IgA Antibody-Secreting Cell Response

Poliovirus antibody secreting cell (ASC) response is defined as ≥ 8 ASC/10⁶ peripheral blood mononuclear cells (PBMC) at any time point following both study vaccination and bOPV challenge.

Per protocol population with available data at each time point

Posted

Number

95% Confidence Interval

percentage of participants

Baseline (pre-vaccination), Day 8 (7 days after study vaccination), Day 29 (28 days after study vaccination prior to bOPV challenge), and Day 36 (7 days after bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Secondary

Number of Circulating Poliovirus IgA Antibody Secreting Cells at Baseline and After Study Vaccination

Per protocol population with available data at each time point

Posted

Median

95% Confidence Interval

cells/10⁶ PBMC

Baseline (pre-vaccination), Day 8 (7 days after study vaccination), Day 29 (28 days after study vaccination prior to bOPV challenge), and Day 36 (7 days after bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Units	Counts

Secondary

Percentage of Participants With a Circulating Poliovirus Immunoglobulin G (IgG) Antibody-Secreting Cell Response

Poliovirus antibody secreting cell (ASC) response is defined as ≥ 8 ASC/10⁶ peripheral blood mononuclear cells (PBMC) at any time point following both study vaccination and bOPV challenge.

Per protocol population with available data at each time point

Posted

Number

95% Confidence Interval

percentage of participants

Baseline (pre-vaccination), Day 8 (7 days after study vaccination), Day 29 (28 days after study vaccination prior to bOPV challenge), and Day 36 (7 days after bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Secondary

Number of Circulating Poliovirus IgG Antibody Secreting Cells at Baseline and After Study Vaccination

Per protocol population with available data at each time point

Posted

Median

95% Confidence Interval

cells/10⁶ PBMC

Baseline (pre-vaccination), Day 8 (7 days after study vaccination), Day 29 (28 days after study vaccination prior to bOPV challenge), and Day 36 (7 days after bOPV challenge)

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Units	Counts

Secondary

Area Under the Curve (AUC) of Viral Shedding in Stool for 28 Days After bOPV Challenge

AUC was calculated using the linear trapezoidal rule with all samples collected from Day 33 to 57.

Per protocol population

Posted

Median

Standard Deviation

log₁₀(CCID₅₀/g) * days

Days 33, 36, 43, 50, and 57 (i.e., 4, 7, 14, 21, and 28 days, respectively, following bOPV challenge).

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Units

Secondary

Time to Cessation of Viral Shedding in Stool After bOPV Challenge

Time to cessation of viral shedding in stool is defined as the study day of the first instance of 3 consecutive samples PCR-negative for virus, with samples taken on separate days.

Per-protocol population participants who received the bOPV challenge and had post-challenge viral shedding results.

Posted

Median

95% Confidence Interval

days

Days 33, 36, 39, 43, 46, 50, and 57

ID	Title	Description
OG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.
OG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Inactivated Poliomyelitis Vaccine	Participants received a single intramuscular injection of 0.5 mL IPV on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	30	30	29	30
EG001	Inactivated Poliomyelitis Vaccine + dmLT	Participants received a single intramuscular injection of 0.5 mL IPV co-administered with 0.5 μg of dmLT on Day 1 followed by a single dose (2 drops) of bOPV 28 days later.	30	30	28	30
EG002	Bivalent Oral Polio Vaccine	Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.	20	20	15	20

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site pain	General disorders	MedDRA 20.1	Systematic Assessment	EG00024 events22 affected30 at risk EG00124 events24 affected30 at risk EG0020 events0 affected20 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG00011 events11 affected30 at risk EG00116 events13 affected30 at risk EG0029 events9 affected20 at risk
Chills	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0021 events1 affected20 at risk
Injection site induration	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected30 at risk EG0020 events0 affected20 at risk
Influenza like illness	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Injection site discolouration	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Injection site erythema	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Injection site haemorrhage	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Injection site swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Injection site warmth	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Thirst	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Vessel puncture site erythema	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG00016 events15 affected30 at risk EG00126 events17 affected30 at risk EG00214 events14 affected20 at risk
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Presyncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected30 at risk EG0015 events4 affected30 at risk EG00210 events7 affected20 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0007 events7 affected30 at risk EG0016 events5 affected30 at risk EG0024 events4 affected20 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0012 events1 affected30 at risk EG0023 events3 affected20 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Toothache	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected30 at risk EG00110 events9 affected30 at risk EG0020 events0 affected20 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0021 events1 affected20 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected30 at risk EG0012 events2 affected30 at risk EG0020 events0 affected20 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0022 events2 affected20 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Cystitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Gingivitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Pulpitis dental	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Skin infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Tonsillitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0012 events2 affected30 at risk EG0022 events2 affected20 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0012 events2 affected30 at risk EG0020 events0 affected20 at risk
Alanine aminotransferase increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
C-reactive protein increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Haemoglobin decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Excessive cerumen production	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Motion sickness	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Blepharitis	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk
Eye irritation	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0011 events1 affected30 at risk EG0020 events0 affected20 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected30 at risk EG0010 events0 affected30 at risk EG0021 events1 affected20 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected30 at risk EG0010 events0 affected30 at risk EG0020 events0 affected20 at risk

ID	Term
D011051	Poliomyelitis

Ancestor Terms

ID	Term
D009187	Myelitis
D002494	Central Nervous System Infections
D007239	Infections
D004769	Enterovirus Infections
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

ID	Term
D011054	Poliovirus Vaccine, Inactivated
D000277	Adjuvants, Pharmaceutic

Ancestor Terms

ID	Term
D015164	Vaccines, Inactivated
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D023321	Poliovirus Vaccines
D014765	Viral Vaccines
D010592	Pharmaceutic Aids
D004364	Pharmaceutical Preparations
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses

Units	Counts
Participants	OG00030 OG00130 OG00220

Participants received one dose (2 drops) of bOPV on Day 1 followed by a second dose of bOPV 28 days later.

Units	Counts
Participants	OG00029 OG00125 OG00220

Units	Counts
Participants	OG00030 OG00127 OG00220

OG00029
OG00125
OG00220

OG0011.40(0.000 to 4.900)

OG0020.45(0.000 to 6.400)

OG0017.60(1.100 to 17.600)

OG0023.60(0.700 to 13.000)

OG00115.10(9.100 to 22.100)

OG00214.10(6.600 to 32.100)

OG0018.35(2.100 to 13.600)

OG0025.10(0.050 to 13.600)

OG0012.80(0.000 to 11.800)

OG0023.55(0.000 to 8.200)

OG00110.90(5.900 to 16.400)

OG0027.90(0.200 to 20.650)

OG0013.40(0.000 to 7.900)

OG0029.85(1.900 to 17.900)

OG0019.10(2.300 to 13.300)

OG0028.85(2.900 to 13.350)

OG001-8.60(-14.400 to 0.200)

OG002-1.65(-9.900 to 0.100)

OG001-3.75(-14.650 to 1.850)

OG002-11.75(-23.050 to -0.550)

OG001-9.35(-15.300 to 0.000)

OG002-14.10(-28.100 to -2.950)

OG001-4.00(-11.000 to -0.950)

OG002-0.20(-11.500 to 5.900)

OG001-3.25(-6.900 to 5.400)

OG002-0.20(-15.600 to 8.100)

OG00125048(13152 to 47705)

OG00215657(7770.3 to 31549)

OG001205.0(100.47 to 418.37)

OG002221.2(96.30 to 508.11)

OG00143251(23053 to 81147)

OG002241.3(119.95 to 485.51)

OG0011266.4(666.45 to 2406.4)

OG0022041.3(956.82 to 4354.9)

OG00152165(30175 to 90179)

OG0027874.5(4331.6 to 14315)

OG001100(86.28 to 100)

OG002100(83.16 to 100)

OG00196.3(81.03 to 99.91)

OG00290.0(68.30 to 98.77)

OG001100(86.28 to 100)

OG00295.0(75.13 to 99.87)

OG001100(87.23 to 100)

OG00290.0(68.30 to 98.77)

OG001100(86.28 to 100)

OG002100(83.16 to 100)

OG0017.4(0.91 to 24.29)

OG00225.0(8.66 to 49.10)

OG0010.0(0.00 to 13.23)

OG0020.0(0.00 to 16.84)

OG00115.4(4.36 to 34.87)

OG0020.0(0.00 to 16.84)

OG0010.0(0.00 to 12.77)

OG0020.0(0.00 to 16.84)

OG0013.7(0.09 to 18.97)

OG00210.0(1.23 to 31.70)

OG0010.0(0.00 to 13.23)

OG0020.0(0.00 to 16.84)

OG0017.7(0.95 to 25.13)

OG0020.0(0.00 to 16.84)

OG0010.0(0.00 to 12.77)

OG0020.0(0.00 to 16.84)

OG0013.7(0.09 to 18.97)

OG00215.0(3.21 to 37.89)

OG0010.0(0.00 to 13.23)

OG0020.0(0.00 to 16.84)

OG0017.7(0.95 to 25.13)

OG0020.0(0.00 to 16.84)

OG0010.50(0.000 to 1.250)

OG0020.63(0.000 to 4.917)

OG0010.00(0.000 to 0.000)

OG0020.00(0.000 to 0.250)

OG0010.38(0.000 to 2.500)

OG0020.17(0.000 to 0.708)

OG0010.00(0.000 to 0.083)

OG0020.00(0.000 to 0.333)

OG0010.00(0.000 to 0.750)

OG0020.00(0.000 to 0.167)

OG0010.00(0.000 to 0.250)

OG0020.00(0.000 to 0.250)

OG0010.08(0.000 to 0.250)

OG0020.00(0.000 to 0.500)

OG0010.00(0.000 to 0.000)

OG0020.21(0.000 to 0.250)

OG0010.00(0.000 to 0.250)

OG0020.00(0.000 to 0.375)

OG0010.00(0.000 to 0.000)

OG0020.00(0.000 to 0.125)

OG0010.00(0.000 to 0.500)

OG0020.00(0.000 to 0.375)

OG00174.1(53.72 to 88.89)

OG00250.0(27.20 to 72.80)

OG0010.0(0.00 to 13.23)

OG0020.0(0.00 to 16.84)

OG00123.1(8.97 to 43.65)

OG00210.0(1.23 to 31.70)

OG0010.0(0.00 to 12.77)

OG0020.0(0.00 to 16.84)

OG00151.9(31.95 to 71.33)

OG00210.0(1.23 to 31.70)

OG0010.0(0.00 to 13.23)

OG0020.0(0.00 to 16.84)

OG0013.8(0.10 to 19.64)

OG0020.0(0.00 to 16.84)

OG0010.0(0.00 to 12.77)

OG0020.0(0.00 to 16.84)

OG00140.7(22.39 to 61.20)

OG00220.0(5.73 to 43.66)

OG0010.0(0.00 to 13.23)

OG0020.0(0.00 to 16.84)

OG0013.8(0.10 to 19.64)

OG0025.0(0.13 to 24.87)

OG00118.00(9.750 to 49.500)

OG0027.00(1.000 to 19.375)

OG0010.00(0.000 to 0.250)

OG0020.00(0.000 to 0.000)

OG0012.00(0.000 to 5.125)

OG0020.38(0.000 to 1.000)

OG0010.25(0.000 to 0.250)

OG0020.00(0.000 to 0.000)

OG0019.50(2.250 to 19.000)

OG0020.13(0.000 to 0.250)

OG0010.00(0.000 to 0.375)

OG0020.00(0.000 to 0.250)

OG0010.25(0.000 to 1.375)

OG0020.00(0.000 to 0.375)

OG0010.00(0.000 to 0.250)

OG0020.00(0.000 to 0.250)

OG0015.25(1.500 to 14.750)

OG0020.25(0.000 to 4.875)

OG0010.00(0.000 to 0.250)

OG0020.00(0.000 to 0.000)

OG0010.50(0.000 to 1.750)

OG0020.00(0.000 to 0.250)