A Phase 4 interventional study of VAXCHORA (Cholera Vaccine, Live, Oral) and Placebo in Cholera (Disorder), sponsored by Bavarian Nordic. Completed at 10 sites in United States. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Bavarian Nordic · Phase 4, Interventional, and Prevention
VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18 through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase 4 study are to evaluate the safety and immunogenicity of a single dose of VAXCHORA (1 x 10e9 cfu/dose) in children ages 2 years to \<18 years of age in developed countries.
This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
This study's enrollment of 550 is above the median of 262 across 72 interventional studies indexed under Cholera.
Browse Cholera studies →Bavarian Nordic is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Other: Placebo
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Other: Placebo
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Other: Placebo
This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
Placebo control for this study is normal (0.9%) saline.
Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer
Time frame: Day 11
Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Time frame: Day 11
Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Time frame: Day 11
Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Time frame: Day 11
Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Time frame: Day 11
Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of18 and 45 years.
Time frame: Day 11
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Time frame: Day 29
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects
Time frame: Day 91
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects
Time frame: Day 181
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects
Time frame: Day 365
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects
Time frame: Day 547
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects
Time frame: Day 730
Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Time frame: Day 29
Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Time frame: Day 29
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 1
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 1 for the subjects in the active treatment group and the placebo crossover group
Time frame: Day 1
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 91
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 91 for the subjects in the active treatment group and the placebo crossover group
Time frame: Day 91
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 181
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 181 for the subjects in the active treatment group and the placebo crossover group
Time frame: Day 181
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 365
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 365 for the subjects in the active treatment group who participate in the substudy.
Time frame: Day 365
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 547
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 547 for the subjects in the active treatment group who participate in the substudy.
Time frame: Day 547
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 730
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 730 for the subjects in the active treatment group who participate in the substudy.
Time frame: Day 730
Safety - Solicited Adverse Events
Evaluate the safety and tolerability of VAXCHORA by collecting solicited adverse events (abdominal pain, headache, lack of appetite, tiredness, diarrhea, nausea, vomiting and fever) by age cohort and overall through Day 8
Time frame: Through Day 8
Safety - Unsolicited Adverse Events
Evaluate the safety and tolerability of VAXCHORA by collecting unsolicited adverse events by age cohort and overall through Day 29
Time frame: Through Day 29
Safety - Serious Adverse Events
Evaluate the safety and tolerability of VAXCHORA by collecting serious adverse events by age cohort and overall through Day 181
Time frame: Through Day 181
Acceptability
Evaluate the acceptability of VAXCHORA using the percent of subjects in each age cohort able to complete the dosing according to protocol.
Time frame: Day 1
This study included healthy volunteers (2 - 17 years) who were not previously immunized against cholera. A total of 574 subjects were screened, of which 24 were screen failures. A total of 550 subjects randomized, of which 471 received study treatment and 433 and 73 completed the main study for treatment and placebo, respectively. Recruitment July 2017-July 2018.
| Milestone | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) | Historical Control: Adult Bridging Population |
|---|---|---|---|---|---|---|---|
| Started | 163 | 26 | 158 | 27 | 150 | 26 | 2688 |
| Completed | 157 | 24 | 146 | 24 | 130 | 25 | 2687 |
| Not completed | 6 | 2 | 12 | 3 | 20 | 1 | 1 |
| Withdrew: Withdrawal by subject | 4 | 1 | 4 | 1 | 4 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 | 6 | 1 | 13 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 1 | 3 | 0 | 1 |
| Withdrew: Failed exl 8 and randomized in error | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Milestone | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) | Historical Control: Adult Bridging Population |
|---|---|---|---|---|---|---|---|
| Started | 13 | 0 | 11 | 0 | 7 | 0 | 0 |
| Completed | 13 | 0 | 11 | 0 | 5 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Milestone | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) | Historical Control: Adult Bridging Population |
|---|---|---|---|---|---|---|---|
| Started | 73 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 62 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 11 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Subject did not want lab drawn | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer
| percentage of participants | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12-17 Yrs) |
|---|---|---|
| Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | 99.4 (95.4 to 99.9) | 0 (0.0 to 14.3) |
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
| percentage of participants | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6-11 Yrs) |
|---|---|---|
| Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | 97.8 (92.5 to 99.4) | 4.2 (0.7 to 20.2) |
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
| percentage of participants | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2-5 Yrs) |
|---|---|---|
| Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | 98.1 (91.5 to 99.6) | 0 (0.0 to 16.1) |
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
| percentage of participants | Cohort 1 (Active, 12-17 Yrs) | Historical Control: Adult Bridging Population |
|---|---|---|
| Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | 99.4 (95.4 to 99.9) | 93.5 (92.3 to 94.6) |
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
| percentage of participants | Cohort 2 (Active, 6-11 Yrs) | Historical Control: Adult Bridging Population |
|---|---|---|
| Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | 97.8 (92.5 to 99.4) | 93.5 (92.3 to 94.6) |
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of18 and 45 years.
| percentage of participants | Cohort 3 (Active, 2-5 Yrs) | Historical Control: Adult Bridging Population |
|---|---|---|
| Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | 98.1 (91.5 to 99.6) | 93.5 (92.3 to 94.6) |
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
| percentage of participants | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12-17 Yrs) |
|---|---|---|
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29 | 100 (97.6 to 100) | 0 (0.0 to 14.3) |
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects
| percentage of participants | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12-17 Yrs) |
|---|---|---|
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91 | 85.6 (79.2 to 90.3) | 0 (0.0 to 14.3) |
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects
| percentage of participants | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12-17 Yrs) |
|---|---|---|
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181 | 73.5 (66.0 to 79.9) | 0 (0.0 to 15.5) |
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects
| percentage of participants | Cohort 1 (Active, 12-17 Yrs) |
|---|---|
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365 | 68.6 (57.0 to 78.2) |
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects
| percentage of participants | Cohort 1 (Active, 12-17 Yrs) |
|---|---|
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547 | 73.1 (61.5 to 82.3) |
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects
| percentage of participants | Cohort 1 (Active, 12-17 Yrs) |
|---|---|
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730 | 64.5 (52.1 to 75.3) |
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
| percentage of participants | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6-11 Yrs) |
|---|---|---|
| Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29 | 94.9 (89.9 to 97.5) | 4.3 (0.8 to 21.0) |
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
| percentage of participants | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2-5 Yrs) |
|---|---|---|
| Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29 | 93.9 (87.3 to 97.2) | 0 (0.0 to 17.6) |
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 1 for the subjects in the active treatment group and the placebo crossover group
Results for this outcome have not been posted.
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 91 for the subjects in the active treatment group and the placebo crossover group
Results for this outcome have not been posted.
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 181 for the subjects in the active treatment group and the placebo crossover group
Results for this outcome have not been posted.
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 365 for the subjects in the active treatment group who participate in the substudy.
Results for this outcome have not been posted.
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 547 for the subjects in the active treatment group who participate in the substudy.
Results for this outcome have not been posted.
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 730 for the subjects in the active treatment group who participate in the substudy.
Results for this outcome have not been posted.
Evaluate the safety and tolerability of VAXCHORA by collecting solicited adverse events (abdominal pain, headache, lack of appetite, tiredness, diarrhea, nausea, vomiting and fever) by age cohort and overall through Day 8
Results for this outcome have not been posted.
Evaluate the safety and tolerability of VAXCHORA by collecting unsolicited adverse events by age cohort and overall through Day 29
Results for this outcome have not been posted.
Evaluate the safety and tolerability of VAXCHORA by collecting serious adverse events by age cohort and overall through Day 181
Results for this outcome have not been posted.
Evaluate the acceptability of VAXCHORA using the percent of subjects in each age cohort able to complete the dosing according to protocol.
| percent of participants | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) |
|---|---|---|---|---|---|---|
| Acceptability | 99.4 | 100 | 91.0 | 96.2 | 79.5 | 73.1 |
Collected over All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 (Active, 12-17 Yrs) | 0/165 (0%) | 4/165 (2.4%) | 116/165 (70.3%) |
| Cohort 1 (Placebo, 12 - 17 Yrs) | 0/24 (0%) | 0/24 (0%) | 13/24 (54.2%) |
| Cohort 2 (Active, 6 - 11 Yrs) | 0/157 (0%) | 0/157 (0%) | 93/157 (59.2%) |
| Cohort 2 (Placebo, 6 - 11 Yrs) | 0/25 (0%) | 0/25 (0%) | 15/25 (60%) |
| Cohort 3 (Active, 2 - 5 Yrs) | 0/146 (0%) | 0/146 (0%) | 74/146 (50.7%) |
| Cohort 3 (Placebo, 2 - 5 Yrs) | 0/26 (0%) | 1/26 (3.8%) | 12/26 (46.2%) |
| Event | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) |
|---|---|---|---|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/165 | 0/24 | 0/157 | 0/25 | 0/146 | 1/26 |
| PneumoniaInfections and infestations | 0/165 | 0/24 | 0/157 | 0/25 | 0/146 | 1/26 |
| Lower Limb FractureInjury, poisoning and procedural complications | 1/165 | 0/24 | 0/157 | 0/25 | 0/146 | 0/26 |
| Intentional OverdoseInjury, poisoning and procedural complications | 1/165 | 0/24 | 0/157 | 0/25 | 0/146 | 0/26 |
| ConvulsionNervous system disorders | 1/165 | 0/24 | 0/157 | 0/25 | 0/146 | 0/26 |
| Local SwellingGeneral disorders | 1/165 | 0/24 | 0/157 | 0/25 | 0/146 | 0/26 |
| Event | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) |
|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 74/165 | 11/24 | 41/157 | 6/25 | 13/146 | 2/26 |
| FatigueGeneral disorders | 67/165 | 9/24 | 55/157 | 8/25 | 45/146 | 6/26 |
| Abdominal PainGastrointestinal disorders | 62/165 | 4/24 | 43/157 | 6/25 | 25/146 | 4/26 |
| Lack of AppetiteMetabolism and nutrition disorders | 48/165 | 3/24 | 24/157 | 5/25 | 28/146 | 3/26 |
| NauseaGastrointestinal disorders | 37/165 | 6/24 | 22/157 | 4/25 | 10/146 | 4/26 |
| Loose StoolGastrointestinal disorders | 23/165 | 5/24 | 18/157 | 0/25 | 8/146 | 2/26 |
| VomitingGastrointestinal disorders | 9/165 | 0/24 | 7/157 | 0/25 | 2/146 | 3/26 |
| Upper Respiratory Tract InfectionInfections and infestations | 7/165 | 0/24 | 0/157 | 0/25 | 6/146 | 3/26 |
| NasopharyngitisInfections and infestations | 0/165 | 0/24 | 0/157 | 2/25 | 3/146 | 0/26 |
| DiarrheaGastrointestinal disorders | 6/165 | 1/24 | 0/157 | 0/25 | 1/146 | 1/26 |
| Age, Categorical(Participants) | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) | Historical Control: Adult Bridging Population | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 163 | 26 | 158 | 27 | 150 | 26 | 0 | 550 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 | 0 | 2688 | 2688 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) | Historical Control: Adult Bridging Population | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 14.4 ± 1.7 | 14.3 ± 1.7 | 8.6 ± 1.8 | 8.7 ± 1.5 | 3.5 ± 1.1 | 3.6 ± 1.2 | 30.0 ± 7.8 | 9.0 ± 4.7 |
| Sex: Female, Male(Participants) | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) | Historical Control: Adult Bridging Population | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 75 | 12 | 81 | 10 | 69 | 17 | 1482 | 1746 |
| Male | 88 | 14 | 77 | 17 | 81 | 9 | 1206 | 1492 |
| Race (NIH/OMB)(Participants) | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) | Historical Control: Adult Bridging Population | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 | 1 | 0 | 11 | 14 |
| Asian | 1 | 0 | 4 | 0 | 0 | 0 | 56 | 61 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 8 |
| Black or African American | 28 | 4 | 53 | 5 | 67 | 14 | 671 | 842 |
| White | 121 | 21 | 86 | 18 | 71 | 12 | 1855 | 2184 |
| More than one race | 13 | 0 | 15 | 3 | 11 | 0 | 50 | 92 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 37 | 37 |
| Region of Enrollment(Participants) | Cohort 1 (Active, 12-17 Yrs) | Cohort 1 (Placebo, 12 - 17 Yrs) | Cohort 2 (Active, 6 - 11 Yrs) | Cohort 2 (Placebo, 6 - 11 Yrs) | Cohort 3 (Active, 2 - 5 Yrs) | Cohort 3 (Placebo, 2 - 5 Yrs) | Historical Control: Adult Bridging Population | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 163 | 26 | 158 | 27 | 150 | 26 | 2341 | 2891 |
| Australia | 0 | 0 | 0 | 0 | 0 | 0 | 347 | 347 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2017 to primary completion in Sep 2019, 25 months.
Results were first posted in Nov 2020, 1 year 2 months after primary completion.
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Studies of the drug tested here: Vaxchora