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CholeraPhase 4NCT01949675

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

A Phase 4 study testing Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell in people with Cholera, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year and olderHealthy volunteers can take part
Conditions the study is for
Cholera
What is being tested?
Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
2 sitesPhilippines
Study dates
Mar 2014to Aug 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
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  • 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 locations and contacts

2 sites in 1 country.

Philippines2 sites

  • Study site

    City of Muntinlupa

  • Study site

    Manila

Other trials in Philippines

About this study

Official title: Safety and Immunogenicity of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines

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.
Read the 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.

Conditions
Cholera
Being tested
Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
Keywords
Cholera, Shanchol™, Cholera Vaccine
Medical subject headings
Cholera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole CellBiological

    Also called Shanchol™

    1.5 mL, Oral administration

  • Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole CellBiological

    Also called Shanchol™

    1.5 mL, Oral administration

  • Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole CellBiological

    Also called Shanchol™

    1.5 mL, Oral administration

Study groups in NCT01949675
Study groupRoleWhat they receive
Study Group 1ExperimentalParticipants aged 1 through 4 years at enrollment
Receives: Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
Study Group 2ExperimentalParticipants aged 5 through 14 years at enrollment
Receives: Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
Study Group 3ExperimentalParticipants aged 15 years and above at enrollment
Receives: Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants reporting unsolicited systemic adverse events; solicited systemic reactions including serious adverse events following administration Oral Cholera Vaccine (Shanchol™)

    Solicited systemic reaction: Vomiting, Diarrhea, Fever (temperature), Abdominal pain, Itching, Rash, Weakness, Cough, Vertigo, and Dryness of Mouth

    Measured: Day 0 up to Day 44 post oral vaccination

  2. Summary of titers of serum vibriocidal antibodies Before and 14 days after each Oral Cholera Vaccine (Shanchol™)

    Serum vibriocidal antibody (against V. cholerae O1 Inaba serogroup, V. cholerae O1 Ogawa serogroup, and V. cholerae O139 serogroup) will be assessed using the microtiter technique.

    Measured: Day 0 (before) and Day 14 post oral vaccination

Secondary outcomes (1)

  1. Number of participants with 4-fold or greater rises in titers 14 days after each Oral Cholera Vaccine (Shanchol™) relative to baseline

    Serum vibriocidal antibody (against V. cholerae O1 Inaba serogroup, V. cholerae O1 Ogawa serogroup, and V. cholerae O139 serogroup) will be assessed using the microtiter technique.

    Measured: Day 0 (before) and Day 14 post oral vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionFeb 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949675
Sponsor's protocol ID
SHC02
Other IDs
U1111-1127-7355
Status last verified
Mar 2018
First submitted
20 Sep 2013
Last updated
23 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28910563

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell in people with Cholera, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants reporting unsolicited systemic adverse events; solicited systemic reactions including serious adverse events following administration Oral Cholera Vaccine (Shanchol™) (time frame: Day 0 up to Day 44 post oral vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01949675, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.

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