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Study of Alternative Vaccination Schedule of Oral Cholera Vaccine

NCT01233362 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2013-09-25

No results posted yet for this study

Summary

The absence of a boosting response after a 14 day interval with the two-dose regimen of the modified killed oral cholera vaccine raises the possibility that a longer dosing interval may be required to observe a boost in the immune response. This study will compare the immune responses following 14-day and 28-day dosing intervals.

Conditions

  • Cholera
  • Diarrhoea
  • Vibrio Infection

Interventions

BIOLOGICAL

Modified killed oral cholera vaccine at 14 day interval

The modified killed bivalent (O1 and O139)whole cell based oral cholera vaccine is administered orally in 2 liquid doses (without need of any buffer solution) 14 days for individuals aged 1 year and above.

BIOLOGICAL

Modified killed oral cholera vaccine at 28 day interval

The modified killed bivalent (O1 and O139)whole cell based oral cholera vaccine is administered orally in 2 liquid doses (without need of any buffer solution) 28 days for individuals aged 1 year and above; as an alternate schedule.

Sponsors & Collaborators

  • National Institute of Cholera and Enteric Diseases, India

    collaborator OTHER

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • Shantha Biotechnics Limited

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Dipika Sur, MD, DPH · National Institute of Cholera and Enteric Diseases, Kolkata, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01233362 on ClinicalTrials.gov