VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

Bavarian Nordic

Status and phase: Completed; Phase 4

Conditions: Cholera (Disorder)

Treatments: Biological: VAXCHORA (Cholera Vaccine, Live, Oral); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03220737

PXVX-VC-200-006

Details and patient eligibility

About

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.

Full description

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

Enrollment: 550 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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550 participants in 7 patient groups, including a placebo group

Cohort 1 (active, 12-17 yrs)

Experimental group

Description:

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.

Treatment:

Biological: VAXCHORA (Cholera Vaccine, Live, Oral)

Cohort 1 (placebo, 12 - 17 yrs)

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Cohort 2 (active, 6 - 11 yrs)

Experimental group

Description:

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.

Treatment:

Biological: VAXCHORA (Cholera Vaccine, Live, Oral)

Cohort 2 (placebo, 6 - 11 yrs)

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Cohort 3 (active, 2 - 5 yrs)

Experimental group

Description:

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.

Treatment:

Biological: VAXCHORA (Cholera Vaccine, Live, Oral)

Cohort 3 (placebo, 2 - 5 yrs)

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Historical Control: Adult Bridging Population

Other group

Description:

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

Treatment:

Biological: VAXCHORA (Cholera Vaccine, Live, Oral)