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CompletedNCT03220737Updated Jun 28, 2023Results posted

VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

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

Phase
Phase 4
Study type
Interventional
Enrollment
550
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
01

Study summary

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.

Read the detailed description

This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.

02

Conditions studied

  • Cholera (Disorder)

Browse trials for

03

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or Female
  • Between 2 and \<18 years of age on Day 1
  • In general good health
  • Able and willing to provide informed assent for study participation
  • Primary caregiver is able and willing to provide informed consent for study participation
  • (for females of childbearing potential) Using an acceptable method of contraception through Day 29

Exclusion criteria

Exclusion Criteria:

  • Current acute gastrointestinal illness or loose stools within 3 days of Day 1 visit
  • Current acute febrile illness
  • History of cholera infection
  • History of cholera vaccination
  • History of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA
  • Congenital or acquired immunodeficiency
  • Pregnancy (for females of childbearing potential)
  • Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject
  • Any other condition that, in the opinion of the Investigator, will interfere with the conduct of the study or the validity of the data
  • Duration of >2 weeks of abnormal stool pattern, defined as \<3 stools per week or >2 stools per day in the past 6 months
  • Regular use of laxatives in the past 6 months
  • History of enterotoxigenic E. coli infection
  • Travel to cholera-endemic area in the previous 5 years
  • Nursing/Breastfeeding
  • Received or plans to receive the following from 14 days prior to the study vaccination through 11 days after vaccination: Any other licensed vaccines, antibiotics, or chloroquine
  • Received or plans to receive any other investigational agent throughout the main study (Day 181)
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
550 participants (actual)

Study arms

  • Experimental
    Cohort 1 (active, 12-17 yrs)

    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)

  • Placebo comparator
    Cohort 1 (placebo, 12 - 17 yrs)

    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

  • Experimental
    Cohort 2 (active, 6 - 11 yrs)

    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)

  • Placebo comparator
    Cohort 2 (placebo, 6 - 11 yrs)

    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

  • Experimental
    Cohort 3 (active, 2 - 5 yrs)

    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)

  • Placebo comparator
    Cohort 3 (placebo, 2 - 5 yrs)

    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

  • Other
    Historical Control: Adult Bridging Population

    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)

Interventions

  • BiologicalVAXCHORA (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.

  • OtherPlacebo

    Placebo control for this study is normal (0.9%) saline.

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  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

  9. 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

  10. 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

06

Results

Posted Nov 19, 2020

Participant flow

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.

Main Study (Day 1 - 181)
Participant flow — Main Study (Day 1 - 181)
MilestoneCohort 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
Started1632615827150262688
Completed1572414624130252687
Not completed621232011
Withdrew: Withdrawal by subject4141400
Withdrew: Lost to follow-up21611310
Withdrew: Protocol violation0011301
Withdrew: Failed exl 8 and randomized in error0010000
Placebo Crossover (Day 181-365)
Participant flow — Placebo Crossover (Day 181-365)
MilestoneCohort 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
Started130110700
Completed130110500
Not completed0000200
Withdrew: Lost to follow-up0000200
Long-term Follow-up (Day 365-730)
Participant flow — Long-term Follow-up (Day 365-730)
MilestoneCohort 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
Started73000000
Completed62000000
Not completed11000000
Withdrew: Withdrawal by subject1000000
Withdrew: Lost to follow-up9000000
Withdrew: Subject did not want lab drawn1000000

Outcome measures

PrimaryCohort 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
Reported as:
Number · percentage of participants
Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
percentage of participantsCohort 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. Cholerae99.4 (95.4 to 99.9)0 (0.0 to 14.3)
Statistical analysis
  • Cohort 1 (Active, 12-17 Yrs) · Proportion: 0.985
PrimaryCohort 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
Reported as:
Number · percentage of participants
Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
percentage of participantsCohort 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. Cholerae97.8 (92.5 to 99.4)4.2 (0.7 to 20.2)
Statistical analysis
  • Cohort 2 (Active, 6 - 11 Yrs) vs Cohort 2 (Placebo, 6-11 Yrs) · Proportion: 0.985
PrimaryCohort 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
Reported as:
Number · percentage of participants
Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
percentage of participantsCohort 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. Cholerae98.1 (91.5 to 99.6)0 (0.0 to 16.1)
Statistical analysis
  • Cohort 3 (Active, 2 - 5 Yrs) vs Cohort 3 (Placebo, 2-5 Yrs) · Proportion: 0.985
PrimaryCohort 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
Reported as:
Number · percentage of participants
Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
percentage of participantsCohort 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 Years99.4 (95.4 to 99.9)93.5 (92.3 to 94.6)
Statistical analysis
  • Cohort 1 (Active, 12-17 Yrs) vs Historical Control: Adult Bridging Population · Risk difference (rd): 5.8 · 96.7% CI 2.4 to 7.1Newcombe method of determining the difference between two independent binomial distributions
PrimaryCohort 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
Reported as:
Number · percentage of participants
Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
percentage of participantsCohort 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 Years97.8 (92.5 to 99.4)93.5 (92.3 to 94.6)
Statistical analysis
  • Cohort 2 (Active, 6-11 Yrs) vs Historical Control: Adult Bridging Population · Risk difference (rd): 4.3 · 96.7% CI -0.3 to 6.2
PrimaryCohort 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
Reported as:
Number · percentage of participants
Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
percentage of participantsCohort 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 Years98.1 (91.5 to 99.6)93.5 (92.3 to 94.6)
Statistical analysis
  • Cohort 3 (Active, 2-5 Yrs) vs Historical Control: Adult Bridging Population · Risk difference (rd): 4.5 · 96.7% CI -1.1 to 6.4
SecondaryCohort 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
Reported as:
Number · percentage of participants
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29
percentage of participantsCohort 1 (Active, 12-17 Yrs)Cohort 1 (Placebo, 12-17 Yrs)
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29100 (97.6 to 100)0 (0.0 to 14.3)
Statistical analysis
  • Cohort 1 (Active, 12-17 Yrs) vs Cohort 1 (Placebo, 12-17 Yrs) · Fisher Exact · p = <0.0001
SecondaryCohort 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
Reported as:
Number · percentage of participants
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91
percentage of participantsCohort 1 (Active, 12-17 Yrs)Cohort 1 (Placebo, 12-17 Yrs)
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 9185.6 (79.2 to 90.3)0 (0.0 to 14.3)
Statistical analysis
  • Cohort 1 (Active, 12-17 Yrs) vs Cohort 1 (Placebo, 12-17 Yrs) · Fisher Exact · p = <0.0001
SecondaryCohort 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
Reported as:
Number · percentage of participants
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181
percentage of participantsCohort 1 (Active, 12-17 Yrs)Cohort 1 (Placebo, 12-17 Yrs)
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 18173.5 (66.0 to 79.9)0 (0.0 to 15.5)
Statistical analysis
  • Cohort 1 (Active, 12-17 Yrs) vs Cohort 1 (Placebo, 12-17 Yrs) · Fisher Exact · p = <0.0001
SecondaryCohort 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
Reported as:
Number · percentage of participants
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365
percentage of participantsCohort 1 (Active, 12-17 Yrs)
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 36568.6 (57.0 to 78.2)
SecondaryCohort 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
Reported as:
Number · percentage of participants
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547
percentage of participantsCohort 1 (Active, 12-17 Yrs)
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 54773.1 (61.5 to 82.3)
SecondaryCohort 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
Reported as:
Number · percentage of participants
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730
percentage of participantsCohort 1 (Active, 12-17 Yrs)
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 73064.5 (52.1 to 75.3)
SecondaryCohort 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
Reported as:
Number · percentage of participants
Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29
percentage of participantsCohort 2 (Active, 6 - 11 Yrs)Cohort 2 (Placebo, 6-11 Yrs)
Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 2994.9 (89.9 to 97.5)4.3 (0.8 to 21.0)
Statistical analysis
  • Cohort 2 (Active, 6 - 11 Yrs) vs Cohort 2 (Placebo, 6-11 Yrs) · Fisher Exact · p = <0.0001
SecondaryCohort 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
Reported as:
Number · percentage of participants
Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29
percentage of participantsCohort 3 (Active, 2 - 5 Yrs)Cohort 3 (Placebo, 2-5 Yrs)
Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 2993.9 (87.3 to 97.2)0 (0.0 to 17.6)
Statistical analysis
  • Cohort 3 (Active, 2 - 5 Yrs) vs Cohort 3 (Placebo, 2-5 Yrs) · Fisher Exact · p = <0.0001
Other pre-specifiedCohort 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

Results for this outcome have not been posted.

Other pre-specifiedCohort 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

Results for this outcome have not been posted.

Other pre-specifiedCohort 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

Results for this outcome have not been posted.

Other pre-specifiedCohort 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

Results for this outcome have not been posted.

Other pre-specifiedCohort 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

Results for this outcome have not been posted.

Other pre-specifiedCohort 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

Results for this outcome have not been posted.

Other pre-specifiedSafety - 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

Results for this outcome have not been posted.

Other pre-specifiedSafety - 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

Results for this outcome have not been posted.

Other pre-specifiedSafety - 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

Results for this outcome have not been posted.

Other pre-specifiedAcceptability

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
Reported as:
Number · percent of participants
Acceptability
percent of participantsCohort 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)
Acceptability99.410091.096.279.573.1

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
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%)
Most frequent serious events
Most frequent serious events
EventCohort 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 disorders0/1650/240/1570/250/1461/26
PneumoniaInfections and infestations0/1650/240/1570/250/1461/26
Lower Limb FractureInjury, poisoning and procedural complications1/1650/240/1570/250/1460/26
Intentional OverdoseInjury, poisoning and procedural complications1/1650/240/1570/250/1460/26
ConvulsionNervous system disorders1/1650/240/1570/250/1460/26
Local SwellingGeneral disorders1/1650/240/1570/250/1460/26
Most frequent other events
Showing 10 of 27
Most frequent other events
EventCohort 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 disorders74/16511/2441/1576/2513/1462/26
FatigueGeneral disorders67/1659/2455/1578/2545/1466/26
Abdominal PainGastrointestinal disorders62/1654/2443/1576/2525/1464/26
Lack of AppetiteMetabolism and nutrition disorders48/1653/2424/1575/2528/1463/26
NauseaGastrointestinal disorders37/1656/2422/1574/2510/1464/26
Loose StoolGastrointestinal disorders23/1655/2418/1570/258/1462/26
VomitingGastrointestinal disorders9/1650/247/1570/252/1463/26
Upper Respiratory Tract InfectionInfections and infestations7/1650/240/1570/256/1463/26
NasopharyngitisInfections and infestations0/1650/240/1572/253/1460/26
DiarrheaGastrointestinal disorders6/1651/240/1570/251/1461/26

Baseline characteristics

Age, Categorical
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 PopulationTotal
<=18 years1632615827150260550
Between 18 and 65 years00000026882688
>=65 years00000000
Age, Continuous
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 PopulationTotal
Mean14.4 ± 1.714.3 ± 1.78.6 ± 1.88.7 ± 1.53.5 ± 1.13.6 ± 1.230.0 ± 7.89.0 ± 4.7
Sex: Female, Male
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 PopulationTotal
Female75128110691714821746
Male8814771781912061492
Race (NIH/OMB)
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 PopulationTotal
American Indian or Alaska Native0101101114
Asian1040005661
Native Hawaiian or Other Pacific Islander00000088
Black or African American2845356714671842
White121218618711218552184
More than one race1301531105092
Unknown or Not Reported0000003737
Region of Enrollment
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 PopulationTotal
United States16326158271502623412891
Australia000000347347
07

Study locations

10 sites
  • Emory University
    Atlanta, Georgia 30322, United States
  • Johnson County Clin-Trials, Inc.
    Lenexa, Kansas 66219, United States
  • Heartland Research Associates, LLC
    Wichita, Kansas 67207, United States
  • University of Kentucky
    Lexington, Kentucky 40536, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • The Center for Pharmaceutical Research
    Kansas City, Missouri 64114, United States
  • Rochester Clinical Research, Inc.
    Rochester, New York 14609, United States
  • Aventiv Research Inc.
    Columbus, Ohio 43123, United States
  • Coastal Carolina Research Center
    Mount Pleasant, South Carolina 29464, United States
  • Clinical Research Associates, Inc.
    Nashville, Tennessee 37203, United States
08

References and documents

Publications

  • McCarty JM, Gierman EC, Bedell L, Lock MD, Bennett S. Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Children and Adolescents Aged 6-17 Years. Am J Trop Med Hyg. 2020 Jan;102(1):48-57. doi: 10.4269/ajtmh.19-0241. PubMed 31769402 ↗

Study documents

  • Study protocol · Nov 15, 2017
  • Statistical analysis plan · Nov 28, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03220737
Lead sponsor
Bavarian Nordic
Collaborators
Emergent BioSolutions
Responsible party
Sponsor
First posted
Jul 18, 2017
Start date
Jul 21, 2017
Primary completion
Sep 10, 2019
Completion
Mar 6, 2020
Results posted
Nov 19, 2020
Last update
Jun 28, 2023

Study contacts

Paul Andre de Lame, MD
study director · Emergent BioSolutions

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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