Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants (NCT00548054) | Clinical Trial Compass
UnknownPhase 2
Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants
India300 participantsStarted 2015-12
Plain-language summary
In order to assess whether the bivalent killed oral cholera vaccine may be used safely among infants who are most at risk for cholera, the investigators need to determine the safety and immunogenicity of the killed oral cholera vaccine among infants less than 1 year of age when given with the expanded program on immunization (EPI) vaccines including diptheria, pertussis and tetanus (DPT), oral polio vaccine (OPV), Hepatitis B vaccines and measles vaccine. Furthermore, the investigators also need to make sure that immune interference does not occur among all the other vaccine antigens given at the same time. Findings from this study will pave the way for the possible use of the killed whole cell oral cholera vaccine (OCV).
Who can participate
Age range10 Weeks – 11 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female infants aged from birth to 2 months who the investigator believes will comply with the requirements of the protocol (i.e., available for follow-up visits and specimen collection)
✓. Written informed consent obtained from their parents/guardians
✓. Healthy subjects as determined by:
✓. Male or female infants aged from 9 months to less than 12 months who the investigator believes will comply with the requirements of the protocol (i.e., available for follow-up visits and specimen collection)
✓. Written informed consent obtained from their parents/guardians
✓. Healthy subjects as determined by:
Exclusion criteria
✕. Ongoing serious chronic disease
✕. Immunocompromising condition or therapy
✕. Diarrhea (having more frequent watery stools than usual within a 24 hour period) 6 weeks prior to enrollment
What they're measuring
1
Safety: proportion of subjects with diarrhea
Timeframe: entire study period
2
Immunogenicity: proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline
✕. Intake of any anti-diarrheal medicine in the past week
✕. Irritability, loss of appetite, general ill-feeling or vomiting in the past 24 hours
✕. Acute disease one week prior to enrollment, with or without fever. Temperature =\>38C (oral) or axillary temperature =\>37.5C warrants deferral of the vaccination pending recovery of the subject