Clinical trial NCT01949675: A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines
Official title: Safety and Immunogenicity of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholera
Keywords: Cholera
Shanchol™
Cholera Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-09-24
Enrollment: 336
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants reporting unsolicited systemic adverse events; solicited systemic reactions including serious adverse events following administration Oral Cholera Vaccine (Shanchol™)
timeFrame: Day 0 up to Day 44 post oral vaccination
measure: Summary of titers of serum vibriocidal antibodies Before and 14 days after each Oral Cholera Vaccine (Shanchol™)
timeFrame: Day 0 (before) and Day 14 post oral vaccination
Secondary outcomes:
measure: Number of participants with 4-fold or greater rises in titers 14 days after each Oral Cholera Vaccine (Shanchol™) relative to baseline
timeFrame: Day 0 (before) and Day 14 post oral vaccination
Other outcomes:
Locations:
city: Manila
country: Philippines
city: Muntinlupa City
country: Philippines
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Capeding MRZ, Gonzales MLAM, Dhingra MS, D'Cor NA, Midde VJ, Patnaik BN, Thollot Y, Desauziers E. Safety and immunogenicity of the killed bivalent (O1 and O139) whole-cell cholera vaccine in the Philippines. Hum Vaccin Immunother. 2017 Oct 3;13(10):2232-2239. doi: 10.1080/21645515.2017.1342908.