A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines

Sanofi

Status and phase: Completed; Phase 4

Conditions: Cholera

Treatments: Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Study type: Interventional

Funder types: Industry

Identifiers

NCT01949675

U1111-1127-7355 (Other Identifier)

SHC02

Details and patient eligibility

About

The aim of the study is to generate safety and immunogenicity data with Oral Cholera Vaccine (Shanchol™) in The Philippines

Objectives:

• To describe the safety after each dose of Shanchol vaccine.
• To describe the immunogenicity after each dose of Shanchol vaccine.

Full description

Healthy toddlers, children, adolescents and adults, aged 1 year and older will receive two doses of vaccine 14 days apart, and will be assessed baseline immunogenicity (pre-vaccination), and 14 days after each vaccine dose. Safety data will be collected for 14 days after the first dose and 30 days after the second dose.

Enrollment: 336 patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 1 year and older on the day of inclusion
• Subjects aged 1 through 17 years: informed consent form has been signed and dated by the subject's parent (and subject, if applicable by local Institution Ethics Committee (IEC) / Institution Review Board (IRB) or country regulations), or another legally acceptable representative (and independent witness, if required by local regulations), and the assent form has been signed and dated by the subject (if applicable by the local IEC / IRB or country regulations)
• Subjects aged 18 years and older: informed consent form has been signed and dated by the subject (and an independent witness, if required by local regulations).
• Subject and subject's parent / legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures
• Subjects aged less than 2 years only: Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 2.5 kg.

Exclusion criteria

• Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
• Participation at the time of study enrollment or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after any study vaccination
• Previous vaccination against cholera (in the previous 5 years) with either the trial vaccine or another vaccine
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• History of cholera infection, confirmed either clinically, serologically, or microbiologically
• At high risk for cholera infection during the trial (i.e., cholera outbreak situation or close contact to cholera case)
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• Intake of oral antibiotics within one week prior to enrollment
• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural, or adopted child) of the Investigator or employee with direct involvement in the proposed study
• Diarrhea (3 [or more] loose/watery stools within a 24-hours period) within 6 weeks prior to enrollment. A prospective subject should not be included in the study until the condition has resolved.
• Intake of anti-diarrhea medicine within one week prior to enrollment
• Abdominal pain or cramps, loss of appetite, nausea, or vomiting within 24 hours prior to enrollment. A prospective subject should not be included in the study until the condition has resolved.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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336 participants in 3 patient groups

Study Group 1

Experimental group

Description:

Participants aged 1 through 4 years at enrollment

Treatment:

Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Study Group 2

Experimental group

Description:

Participants aged 5 through 14 years at enrollment

Treatment:

Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Study Group 3

Experimental group

Description:

Participants aged 15 years and above at enrollment

Treatment:

Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell