Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh
Official Title
A Randomized, Double-blind, Placebo-controlled, Dose-Escalation Study Evaluating the Safety, Tolerability, and Immunogenicity of an Oral Inactivated ETEC Vaccine (ETVAX) Alone and Together With dmLT Adjuvant in Descending Age Groups in Bangladesh
Acronym
ETVAX/dmLT
Organization
PATHOTHER
Status Module
Record Verification Date
Sep 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2015
Primary Completion Date
Jul 29, 2017Actual
Completion Date
Jul 29, 2017Actual
First Submitted Date
Aug 17, 2015
First Submission Date that Met QC Criteria
Aug 20, 2015
First Posted Date
Aug 24, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 3, 2018
Results First Submitted that Met QC Criteria
Sep 10, 2018
Results First Posted Date
Sep 12, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 10, 2018
Last Update Posted Date
Sep 12, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PATHOTHER
Collaborators
Name
Class
Scandinavian Biopharma AB
INDUSTRY
International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.
Detailed Description
This Phase I/II trial will serve to assess whether ETVAX is safe and provides mucosal as well as systemic immune responses against the key protective antigens when tested in different age-groups in Bangladesh. This study provides an opportunity to test the safety profile of a mucosal adjuvant, double-mutant LT (dmLT), in adults and children, as well as provide the opportunity to potentially assess the ability of dmLT to further enhance the mucosal and systemic antibody responses to key antigens in the ETVAX vaccine among age groups in developing country sites, like Bangladesh, that have proved refractory to oral immunization with enteric vaccines. In addition, this study also allows for the evaluation of the potential dose-sparing effect of dmLT when combined with a lower dose of vaccine. Finally, this clinical trial is considered an essential study along the critical path of the overall clinical development plan before determining whether the vaccine can be tested for protective efficacy in children in developing countries.
Conditions Module
Conditions
Escherichia Coli Diarrhea
Keywords
ETEC diarrhea
Escherichia Coli (ETEC)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
475Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Adult: ETVAX (Full)
Experimental
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Other: Bicarbonate Buffer
Adult: ETVAX (Full) + 10 ug dmLT
Experimental
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Biological: dmLT
Other: Bicarbonate Buffer
Adult: Placebo
Placebo Comparator
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Other: Bicarbonate Buffer
24-59 months: ETVAX (1/4)
Experimental
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Other: Bicarbonate Buffer
24-59 months: ETVAX (1/2)
Experimental
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ETVAX
Biological
Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:
Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg
The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity
Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. The solicited AEs of nausea (adults only), abdominal pain/stomach ache (adults and children 24-59 months only), fever, vomiting and diarrhea were evaluated daily for 7 days post vaccination.
7 days after each vaccination (Day 7 and Day 21)
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine
Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. Unsolicited AEs were assessed through Day 42 and serious adverse events (SAEs) were assessed over the entire duration of the study.
6 months ± 14 days after the first dose
Secondary Outcomes
Measure
Description
Time Frame
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Adults
Inclusion Criteria:
Healthy male or female adults 18-45 years old, inclusive
General good health as determined by the screening evaluation no greater than 7days before enrollment and vaccination
Properly informed about the study, able to understand it and sign or thumb print the informed consent form
Available for the entire period of the study and reachable by study staff throughout the entire follow-up period
Females of childbearing potential who are willing to take a urine pregnancy test at screening and before the second vaccination. Pregnancy tests must be negative before each vaccination. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is also acceptable.
Informed Consent (signature or thumb print provided, with witness signature)
Exclusion Criteria:
Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol.
History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrollment
Screening positive with hepatitis B antigen and/or hepatitis C antibodies
Participation in research involving another investigational product (defined as receipt of investigational product) during the 30 days before planned date of first vaccination or concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product
Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician
History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature ≥ 37.5 C (99.5 F) on axillary, oral, or tympanic measurement)
Prior receipt of any cholera (e.g., Dukoral, Shanchol) or ETEC vaccine
Prior receipt of a blood transfusion or blood products, including immunoglobulins
Evidence of current illicit drug use or drug dependence
Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, over-the-counter (OTC) agents) or immunosuppressive drug
Any condition which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives
Receipt of antimicrobial drugs for any reason within 14 days before vaccination
History of diarrhea during the 7 days before vaccination (see protocol definition of diarrhea)
Culture positive for ETEC, Shigella, V. Cholerae or Salmonella within 7 days before vaccination.
Acute disease at the time of enrollment or 3 days prior to enrollment
History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids.
Children, Toddlers and Infants Inclusion Criteria
Healthy male or female infants/toddlers/children ages:
Part B: >24 and ≤59 months old at the time of enrollment
Part C: ≥12 and <24 months old at the time of enrollment
Part D: ≥6 and <12 months at the time of enrollment
General good health as determined by the screening evaluation no greater than 7 days before enrollment and vaccination
Parent properly informed about the study, able to understand it and sign or thumb print the informed consent form
Parent and child available for the entire study period of the study and reachable by study staff throughout the entire follow-up period
Informed Consent (signature or thumb of parent, with signature of witness, provided)
Exclusion Criteria
Presence of any significant known systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would endanger the participant's health or is likely to result in non-conformance to the protocol.
History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder or presence of a significant medical condition that in the opinion of the Investigator precludes participation in the study. Known or suspected impairment of immunological function based on medical history and physical examination. Clinical evidence of active gastrointestinal illness and acute disease at the time of enrollment
Screening positive with hepatitis B antigen and/or hepatitis C antibodies
Participation in research involving another investigational product (defined as receipt of investigational product) during the 30 days before planned date of first vaccination or concurrently participating in another clinical study at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product
Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician
History of febrile illness within 48 hours prior to vaccination and fever at the time of immunization (fever is defined as a temperature ≥ 37.5 C (99.5 F) on axillary, oral, or tympanic measurement)
Prior receipt of any cholera (e.g., Dukoral, Shanchol) or ETEC vaccine
Prior receipt of a blood transfusion or blood products, including immunoglobulins
Current use of iron or zinc supplements within the past 7 days; current use of antacids (H2 blockers, omeprazole, OTC agents) or immunosuppressive drug
Any condition which, in the opinion of the investigator, might jeopardize the safety of study participants or interfere with the evaluation of the study objectives
Receipt of antimicrobial drugs for any reason within 14 days before vaccination
History of diarrhea during the 7 days before vaccination (see Protocol definition of diarrhea))
Culture positive for ETEC, Shigella, V. cholerae, Salmonella or Rotavirus (the latter for all children <5 years of age) within 7 days of vaccination
Acute disease at the time of enrollment or 3 days prior to enrollment
Known or suspected impairment of immunological function based on medical history and physical examination
Participant's parents/guardians not able, available or willing to accept active weekly follow-up by the study staff
History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study
Any medical condition in the child/infant that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent
Medically significant malnutrition, defined as moderate malnutrition (wt-for-ht z-score between -3.0 and -2.0) and severe malnutrition (wt-for-ht z-score <-3.0 or edema)
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
6 Months
Maximum Age
45 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
International Centre for Diarrheal Disease, Bangladesh (icddr,b)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
FG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
FG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
FG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
FG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
FG005
24-59 Months: ETVAX (Full)
24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
FG006
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
FG007
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
FG008
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
FG009
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
FG010
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
FG011
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
FG012
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
FG013
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
FG014
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
FG015
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
FG016
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
FG017
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
FG018
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
FG019
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
FG020
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Periods
Title
Milestones
Reasons Not Completed
Received Vaccination 1
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00115 subjects
FG00215 subjects
FG00315 subjects
FG00415 subjects
FG0053 subjects
FG00615 subjects
FG00715 subjects
FG00815 subjects
FG00952 subjects
FG01015 subjects
FG01115 subjects
FG01215 subjects
FG01315 subjects
FG01440 subjects
FG01530 subjects
FG01630 subjects
FG01730 subjects
FG01830 subjects
FG01930 subjects
FG02050 subjects
COMPLETED
FG00015 subjects
FG00115 subjects
FG00215 subjects
FG00315 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Received Vaccination 2
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG00115 subjects
FG00215 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
BG001
Adult: ETVAX (Full)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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 and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity
Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. The solicited AEs of nausea (adults only), abdominal pain/stomach ache (adults and children 24-59 months only), fever, vomiting and diarrhea were evaluated daily for 7 days post vaccination.
Posted
Count of Participants
Participants
7 days after each vaccination (Day 7 and Day 21)
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
Adverse Events Module
Frequency Threshold
0
Time Frame
6 months ± 14 days after the first dose for unsolicited adverse events, 7 days for solicited events (fever, vomiting, loose stools, diarrhea, acute systemic allergic reaction; plus nausea and abdominal pain/stomach ache for adults/children 24-59 months)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Other: Bicarbonate Buffer
24-59 months: ETVAX (1/2) + 2.5 ug dmLT
Experimental
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Biological: dmLT
Other: Bicarbonate Buffer
24-59 months: ETVAX (1/2) + 5 ug dmLT
Experimental
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Biological: dmLT
Other: Bicarbonate Buffer
24-59 months: ETVAX (1/2) + 10 ug dmLT
Experimental
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Biological: dmLT
Other: Bicarbonate Buffer
24-59 months: Placebo
Placebo Comparator
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Other: Bicarbonate Buffer
12-23 months: ETVAX (1/4)
Experimental
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Other: Bicarbonate Buffer
12-23 months: ETVAX (1/2)
Experimental
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Other: Bicarbonate Buffer
12-23 months: ETVAX (1/2) + 2.5 ug dmLT
Experimental
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Biological: dmLT
Other: Bicarbonate Buffer
12-23 months: ETVAX (1/2) + 5 ug dmLT
Experimental
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Biological: dmLT
Other: Bicarbonate Buffer
12-23 months: Placebo
Placebo Comparator
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Other: Bicarbonate Buffer
6-11 months: ETVAX (1/8)
Experimental
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Other: Bicarbonate Buffer
6-11 months: ETVAX (1/4)
Experimental
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Other: Bicarbonate Buffer
6-11 months: ETVAX (1/2)
Experimental
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Other: Bicarbonate Buffer
6-11 months: ETVAX (1/4) + 2.5 ug dmLT
Experimental
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Biological: dmLT
Other: Bicarbonate Buffer
6-11 month olds: ETVAX (1/4) + 5 ug dmLT
Experimental
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
Biological: ETVAX
Biological: dmLT
Other: Bicarbonate Buffer
6-11 month olds: Placebo
Placebo Comparator
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Other: Bicarbonate Buffer
12-23 months: ETVAX (1/2)
12-23 months: ETVAX (1/2) + 2.5 ug dmLT
12-23 months: ETVAX (1/2) + 5 ug dmLT
12-23 months: ETVAX (1/4)
24-59 months: ETVAX (1/2)
24-59 months: ETVAX (1/2) + 10 ug dmLT
24-59 months: ETVAX (1/2) + 2.5 ug dmLT
24-59 months: ETVAX (1/2) + 5 ug dmLT
24-59 months: ETVAX (1/4)
24-59 months: ETVAX (full)
6-11 month olds: ETVAX (1/4) + 5 ug dmLT
6-11 months: ETVAX (1/2)
6-11 months: ETVAX (1/4)
6-11 months: ETVAX (1/4) + 2.5 ug dmLT
6-11 months: ETVAX (1/8)
Adult: ETVAX (Full)
Adult: ETVAX (Full) + 10 ug dmLT
dmLT
Biological
Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
12-23 months: ETVAX (1/2) + 2.5 ug dmLT
12-23 months: ETVAX (1/2) + 5 ug dmLT
24-59 months: ETVAX (1/2) + 10 ug dmLT
24-59 months: ETVAX (1/2) + 2.5 ug dmLT
24-59 months: ETVAX (1/2) + 5 ug dmLT
6-11 month olds: ETVAX (1/4) + 5 ug dmLT
6-11 months: ETVAX (1/4) + 2.5 ug dmLT
Adult: ETVAX (Full) + 10 ug dmLT
double mutant heat labile toxin, LT(R192G/L211A)
Bicarbonate Buffer
Other
Sodium bicarbonate buffer dissolved in 150 ml of potable water
12-23 months: ETVAX (1/2)
12-23 months: ETVAX (1/2) + 2.5 ug dmLT
12-23 months: ETVAX (1/2) + 5 ug dmLT
12-23 months: ETVAX (1/4)
12-23 months: Placebo
24-59 months: ETVAX (1/2)
24-59 months: ETVAX (1/2) + 10 ug dmLT
24-59 months: ETVAX (1/2) + 2.5 ug dmLT
24-59 months: ETVAX (1/2) + 5 ug dmLT
24-59 months: ETVAX (1/4)
24-59 months: ETVAX (full)
24-59 months: Placebo
6-11 month olds: ETVAX (1/4) + 5 ug dmLT
6-11 month olds: Placebo
6-11 months: ETVAX (1/2)
6-11 months: ETVAX (1/4)
6-11 months: ETVAX (1/4) + 2.5 ug dmLT
6-11 months: ETVAX (1/8)
Adult: ETVAX (Full)
Adult: ETVAX (Full) + 10 ug dmLT
Adult: Placebo
19 days
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
19 days
Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
19 days
Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
19 days
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a two-fold rise at any of these time points. Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
28 days
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a four-fold rise at any of these time points. Antigens in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
28 days
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
28 days
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
28 days
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
19 days
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
19 days
Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
19 days
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
19 days
Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).
19 days
Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).
19 days
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).
19 days
Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.
19 days
Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose
Measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.
19 days
Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose
Between baseline and after vaccination (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.
19 days
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects
19 days
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects
19 days
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen
Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
7 days
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen
Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
7 days
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen
Fecal secretion was measured on Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
7 days
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen
Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
7 days
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen
Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Day 19
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen
Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigens in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
19 days
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen
Fecal secretion was measured on Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
19 days
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen
Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
19 days
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen
Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
28 days
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen
Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigens in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
28 days
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen
Fecal secretion was measured on Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
28 days
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen
Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
28 days
Derived
Qadri F, Akhtar M, Bhuiyan TR, Chowdhury MI, Ahmed T, Rafique TA, Khan A, Rahman SIA, Khanam F, Lundgren A, Wiklund G, Kaim J, Lofstrand M, Carlin N, Bourgeois AL, Maier N, Fix A, Wierzba T, Walker RI, Svennerholm AM. Safety and immunogenicity of the oral, inactivated, enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi children and infants: a double-blind, randomised, placebo-controlled phase 1/2 trial. Lancet Infect Dis. 2020 Feb;20(2):208-219. doi: 10.1016/S1473-3099(19)30571-7. Epub 2019 Nov 19.
Akhtar M, Chowdhury MI, Bhuiyan TR, Kaim J, Ahmed T, Rafique TA, Khan A, Rahman SIA, Khanam F, Begum YA, Sharif MZ, Islam LN, Carlin N, Maier N, Fix A, Wierzba TF, Walker RI, Bourgeois AL, Svennerholm AM, Qadri F, Lundgren A. Evaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses. Vaccine. 2019 Sep 3;37(37):5645-5656. doi: 10.1016/j.vaccine.2018.11.040. Epub 2018 Nov 22.
15 subjects
FG0053 subjects
FG00615 subjects
FG00715 subjects
FG00815 subjects
FG00952 subjects
FG01015 subjects
FG01115 subjects
FG01215 subjects
FG01315 subjects
FG01440 subjects
FG01530 subjects
FG01630 subjects
FG01730 subjects
FG01830 subjects
FG01930 subjects
FG02050 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
15 subjects
FG00415 subjects
FG0053 subjects
FG00615 subjects
FG00715 subjects
FG00815 subjects
FG00952 subjects
FG01015 subjects
FG01115 subjects
FG01215 subjects
FG01315 subjects
FG01440 subjects
FG01530 subjects
FG01630 subjects
FG01730 subjects
FG01830 subjects
FG01930 subjects
FG02050 subjects
COMPLETED
FG00015 subjects
FG00115 subjects
FG00214 subjects
FG00315 subjects
FG00415 subjects
FG0050 subjects
FG00615 subjects
FG00715 subjects
FG00815 subjects
FG00949 subjects
FG01013 subjects
FG01115 subjects
FG01213 subjects
FG01313 subjects
FG01439 subjects
FG01530 subjects
FG01630 subjects
FG01726 subjects
FG01827 subjects
FG01929 subjects
FG02049 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
FG0102 subjects
FG0110 subjects
FG0122 subjects
FG0132 subjects
FG0141 subjects
FG0150 subjects
FG0160 subjects
FG0174 subjects
FG0183 subjects
FG0191 subjects
FG0201 subjects
Type
Comment
Reasons
Medication interfering with study taken
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0181 subjects
FG0190 subjects
FG0200 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
BG002
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
BG003
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
BG004
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
BG005
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
BG006
24-59 Months: ETVAX (Full)
24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
BG007
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
BG008
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
BG009
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
BG010
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
BG011
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
BG012
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
BG013
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
BG014
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
BG015
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
BG016
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
BG017
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
BG018
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
BG019
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
BG020
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
BG021
Total
Total of all reporting groups
15
BG00115
BG00215
BG00352
BG00415
BG00515
BG0063
BG00715
BG00815
BG00915
BG01040
BG01115
BG01215
BG01315
BG01415
BG01550
BG01630
BG01730
BG01830
BG01930
BG02030
BG021475
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00031.5± 5.58
BG00130.1± 6.96
BG00229.4± 6.96
BG0033.7± 0.77
BG0044.1± 0.62
BG0053.4± 0.68
BG0064.2± 0.59
BG0073.4± 0.86
BG0083.6± 0.91
BG0093.4± 0.73
BG0101.4± 0.27
BG0111.3± 0.21
BG0121.5± 0.30
BG0131.6± 0.28
BG0141.4± 0.27
BG0150.7± 0.13
BG0160.7± 0.15
BG0170.7± 0.14
BG0180.7± 0.11
BG0190.7± 0.15
BG0200.6± 0.10
BG0214.4± 8.7
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG0018
BG00211
BG00326
BG00410
BG0056
BG0062
BG0076
BG0087
BG0099
BG01020
BG0116
BG0125
BG0137
BG01410
BG01523
BG01614
BG01719
BG01816
BG01918
BG02016
BG021249
Male
BG0005
BG0017
BG0024
BG00326
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
Asian
BG00015
BG00115
BG00215
BG00352
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0000
BG0010
BG0020
BG0030
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Height
Mean
Standard Deviation
centimeters
Title
Denominators
Categories
Title
Measurements
BG000154.69± 8.01
BG001155.29± 9.38
BG002154.26± 10.16
BG00397.02± 6.84
BG00497.73± 5.33
BG00593.73± 7.08
BG00696.67± 2.52
BG00790.33± 6.11
BG00894.13± 7.27
BG00992.2± 6.59
BG01077.83± 4.60
BG01176.27± 2.99
BG01279.33± 4.27
BG01379.2± 4.69
BG01476.6± 2.59
BG01567.64± 3.44
BG01668.83± 3.04
BG01767.77± 3.45
BG01868.83± 3.04
BG01966.73± 3.14
BG02067.57± 2.58
BG02185.6± 25.6
Weight
Mean
Standard Deviation
kilograms
Title
Denominators
Categories
Title
Measurements
BG00056.65± 9.867
BG00156.86± 11.776
BG00255.25± 11.441
BG00313.71± 2.043
BG00413.59± 1.488
BG00513.61± 1.914
BG00612.43± 0.513
BG00712.1± 1.465
BG00813.35± 1.957
BG00912.61± 1.936
BG0109.47± 1.226
BG0119.23± 0.959
BG0129.64± 0.946
BG0139.5± 1.271
BG0149.24± 0.998
BG0157.66± 0.958
BG0167.84± 1.006
BG0177.37± 0.728
BG0187.85± 1.226
BG0197.41± 0.876
BG0207.76± 0.598
BG02114.2± 14.3
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (Full)
24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG009
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG010
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG014
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG015
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG020
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00215
OG00315
OG00415
OG0053
OG00615
OG00715
OG00815
OG00952
OG01015
OG01115
OG01215
OG01315
OG01440
OG01530
OG01630
OG01730
OG01830
OG01930
OG02050
Title
Denominators
Categories
Elevated oral temperature
Title
Measurements
None
OG00015
OG00114
OG00215
OG00315
OG00414
OG0053
OG00612
OG00715
OG00815
OG00950
OG01014
OG01115
OG01212
OG01314
OG01439
OG01528
OG01628
OG01728
OG01828
OG01927
OG02048
Mild
OG0000
OG0011
OG0020
OG0030
OG004
Moderate
OG0000
OG0010
OG0020
OG0030
OG004
Vomiting
Title
Measurements
None
OG00015
OG00115
OG00215
OG003
Loose stools
Title
Measurements
None
OG00015
OG00115
OG00215
OG003
Abdominal pain/stomach ache
Title
Measurements
None
OG00015
OG00115
OG00215
OG003
Diarrhea
Title
Measurements
None
OG00015
OG00115
OG00215
OG003
Acute systemic allergic reaction
Title
Measurements
None
OG00015
OG00115
OG00215
OG003
Nausea
Title
Measurements
None
OG00015
OG00115
OG00215
OG003
Any symptom
Title
Measurements
None
OG00015
OG00114
OG00215
OG003
Primary
Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine
Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. Unsolicited AEs were assessed through Day 42 and serious adverse events (SAEs) were assessed over the entire duration of the study.
Posted
Count of Participants
Participants
6 months ± 14 days after the first dose
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (Full)
24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG009
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG010
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG014
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG015
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG020
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00215
OG003
Title
Denominators
Categories
Leukocytosis
Title
Measurements
Mild
OG0000
OG0010
OG0020
OG003
Secondary
Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00214
ParticipantsOG003
Secondary
Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00214
ParticipantsOG003
Secondary
Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
titer
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00214
ParticipantsOG003
Secondary
Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
fold change
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00214
ParticipantsOG003
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a two-fold rise at any of these time points. Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
28 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00215
ParticipantsOG003
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a four-fold rise at any of these time points. Antigens in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
28 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00215
ParticipantsOG003
Secondary
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
titer
28 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00216
ParticipantsOG003
Secondary
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen
Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
fold change
28 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00215
ParticipantsOG003
Secondary
Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00214
ParticipantsOG003
Secondary
Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00214
ParticipantsOG003
Secondary
Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
titer
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00214
ParticipantsOG003
Secondary
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
fold change
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00015
ParticipantsOG00115
ParticipantsOG00214
ParticipantsOG003
Secondary
Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
Title
Denominators
Categories
≥Two-fold
Title
Measurements
Yes
OG00011
OG00110
OG0021
No
Secondary
Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
titer
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
Title
Denominators
Categories
Title
Measurements
OG000177(109 to 287)
OG001166(92.0 to 301)
OG00230.9(17.2 to 55.7)
Secondary
Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
fold change
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00215
Title
Denominators
Categories
Title
Measurements
OG0003.15(2.27 to 4.37)
OG0014.66(2.21 to 9.84)
OG0020.976(0.609 to 1.56)
Secondary
Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose
Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
≥Two-fold
Title
Measurements
Yes
OG00014
OG00113
OG0022
OG003
Secondary
Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose
Measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
titer
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG0001582(989 to 2530)
OG0011125(589 to 2148)
OG00285.1(41.2 to 176)
OG003
Secondary
Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose
Between baseline and after vaccination (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
fold change
19 days
ID
Title
Description
OG000
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG009
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG010
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG014
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG015
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.53(3.92 to 10.9)
OG00110.3(5.69 to 18.6)
OG0021.11(0.807 to 1.53)
OG003
Secondary
Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects
Posted
Count of Participants
Participants
19 days
ID
Title
Description
OG000
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG001
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG003
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG004
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG009
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG010
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG014
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG015
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
Units
Counts
Participants
OG00014
OG00115
OG00215
OG003
Title
Denominators
Categories
≥Two-fold
Title
Measurements
5 antigens
OG0000
OG00115
OG00215
OG003
Secondary
Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects
Participants with results for all antigens (CFA/I, CS3, CS5, CS6, LTB) tested for.
Posted
Count of Participants
Participants
19 days
ID
Title
Description
OG000
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG001
Adult: ETVAX (Full)
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) added to bicarbonate buffer solution administered orally on Day 0 and 14
OG002
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
OG003
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG004
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG006
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG007
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG008
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG009
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG010
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG011
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG012
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG013
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG014
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
OG015
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG016
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG017
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG018
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG019
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
Units
Counts
Participants
OG00013
OG00113
OG00214
OG003
Title
Denominators
Categories
≥Two-fold
Title
Measurements
5 antigens
OG0000
OG0015
OG0028
OG003
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen
Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
7 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG003
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen
Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
7 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG003
Secondary
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen
Fecal secretion was measured on Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
titer
7 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG003
Secondary
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen
Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
fold change
7 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG003
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen
Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
Day 19
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00215
ParticipantsOG003
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen
Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigens in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
19 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00215
ParticipantsOG003
Secondary
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen
Fecal secretion was measured on Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
titer
19 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00215
ParticipantsOG003
Secondary
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen
Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
fold change
19 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00215
ParticipantsOG003
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen
Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
28 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00012
ParticipantsOG00116
ParticipantsOG00211
ParticipantsOG003
Secondary
Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen
Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigens in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Count of Participants
Participants
28 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00012
ParticipantsOG00116
ParticipantsOG00211
ParticipantsOG003
Secondary
Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen
Fecal secretion was measured on Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
titer
28 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00012
ParticipantsOG00116
ParticipantsOG00211
ParticipantsOG003
Secondary
Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen
Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:
E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin
Subjects who received both vaccinations and had valid baseline and endline immunologic samples.
Posted
Geometric Mean
95% Confidence Interval
fold change
28 days
ID
Title
Description
OG000
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
OG001
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG002
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
OG003
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG004
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
OG005
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
Units
Counts
Participants
OG00023
OG00123
OG00216
OG003
Title
Denominators
Categories
CFA/I
ParticipantsOG00012
ParticipantsOG00116
ParticipantsOG00211
ParticipantsOG003
0
15
0
15
0
15
EG001
Adult: ETVAX (Full) + 10 ug dmLT
Adult arm (18-45 year olds) receiving the full dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) with 10 ug dmLT added to bicarbonate buffer solution administered orally on Day 0 and 14
0
15
0
15
4
15
EG002
Adult: Placebo
Adult arm (18-45 year olds) receiving a placebo on days 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
0
15
0
15
1
15
EG003
24-59 Months: ETVAX (1/4)
24-59 month old children receiving a quarter adult dose (2.5 x 10^10 inactivated E. coli bacteria) of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
0
15
0
15
2
15
EG004
24-59 Months: ETVAX (1/2)
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
0
15
0
15
1
15
EG005
24-59 Months: ETVAX (Full)
24-59 month old children receiving a full adult dose of ETVAX vaccine (10^11 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
0
3
0
3
2
3
EG006
24-59 Months: ETVAX (1/2) + 2.5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
0
15
0
15
4
15
EG007
24-59 Months: ETVAX (1/2) + 5 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
0
15
0
15
1
15
EG008
24-59 Months: ETVAX (1/2) + 10 ug dmLT
24-59 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 10 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
0
15
0
15
3
15
EG009
24-59 Months: Placebo
24-59 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
0
52
1
52
4
52
EG010
12-23 Months: ETVAX (1/4)
12-23 month old children receiving a quarter adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
0
15
1
15
5
15
EG011
12-23 Months: ETVAX (1/2)
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
0
15
0
15
2
15
EG012
12-23 Months: ETVAX (1/2) + 2.5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
0
15
0
15
6
15
EG013
12-23 Months: ETVAX (1/2) + 5 ug dmLT
12-23 month old children receiving a half adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
0
15
0
15
9
15
EG014
12-23 Months: Placebo
12-23 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water
0
40
0
40
5
40
EG015
6-11 Months: ETVAX (1/8)
6-11 month old children receiving an eighth of an adult dose of ETVAX vaccine in bicarbonate buffer solution administered orally on Day 0 and 14
0
30
0
30
4
30
EG016
6-11 Months: ETVAX (1/4)
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
0
30
0
30
8
30
EG017
6-11 Months: ETVAX (1/2)
6-11 month old children receiving a half of an adult dose of ETVAX vaccine (5 x 10^10 inactivated E. coli bacteria) in bicarbonate buffer solution administered orally on Day 0 and 14
0
30
1
30
13
30
EG018
6-11 Months: ETVAX (1/4) + 2.5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 2.5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
0
30
0
30
9
30
EG019
6-11 Month Olds: ETVAX (1/4) + 5 ug dmLT
6-11 month old children receiving a quarter of an adult dose of ETVAX vaccine (2.5 x 10^10 inactivated E. coli bacteria) plus 5 ug dmLT in bicarbonate buffer solution administered orally on Day 0 and 14
0
30
0
30
8
30
EG020
6-11 Month Olds: Placebo
6-11 month old children receiving a placebo of bicarbonate buffer solution administered orally on Day 0 and 14
Bicarbonate Buffer: Sodium bicarbonate buffer dissolved in 150 ml of potable water