Status:
TERMINATED
Safety and Immunogenicity of Peru-15 Vaccine When Given With Measles Vaccine in Healthy Indian and Bangladeshi Infants
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Christian Medical College, Vellore, India
Conditions:
Cholera
Diarrhea
Eligibility:
All Genders
9-12 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to confirm the safety and immunogenicity of Peru-15 vaccine in infants when given simultaneously with measles vaccine.
Detailed Description
Cholera is an important public health problem worldwide, remaining endemic in most of the developing world at the same time causing outbreaks in areas where lapses in sanitation occur. In 2005, 131 94...
Eligibility Criteria
Inclusion
- Healthy male and female infants aged 9 - 12 months will be recruited from Vellore, India and Dhaka, Bangladesh.
- All subjects must satisfy the following criteria at study entry:
- Male or female infants aged 9 - 12 months whose parents or primary caretaker have given the written informed consent prior to study entry
- Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).
- Healthy subjects as determined by:
- Medical history
- Physical examination
- Clinical judgment of the investigator
Exclusion
- Parents or primary caregiver are unwilling or unable to give written informed consent to participate in the study
- Ongoing serious chronic disease
- Immunocompromising condition or therapy
- Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
- Intake of any anti-diarrheal medicine in the past week
- Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC (oral) or axillary temperature ≥ 37.5ºC warrants deferral of the vaccination pending recovery of the subject
- Receipt of antibiotics in the past 2 weeks
- Receipt of live or killed enteric vaccine in the last 4 weeks
- Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
- One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
- One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
- Receipt of killed oral cholera vaccine
- Have previously received a dose of a measles-containing vaccine (MCV)
- Have previously presented with a disease potentially related to measles
- Receipt of blood, blood products or a parenteral immunoglobulin preparation in the previous 3 months
- History of anaphylaxis, any serious vaccine reaction, allergy to eggs, egg products or to any measles vaccine component
- any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00624975
Start Date
November 1 2008
End Date
July 1 2012
Last Update
August 1 2012
Active Locations (2)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
2
Christian Medical College
Vellore, India