Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Dose-escalation Study to Evaluate Safety, Tolerability and Immunogenicity of '2-dose Primary Series' Single Strain (Hikojima Serotype) Inactivated Oral Cholera Vaccine Formulations (Two Formulations Based on Total O1 LPS Content), in Sequential Age Descending Population of Healthy Adults and Children
Brief Summary: Cholera, a rapidly dehydrating watery diarrheal disease transmitted through water or food contaminated with the bacterium, Vibrio cholerae, is a major cause of morbidity and mortality in low income countries like Bangladesh. In our country, Cholera disease burden consists of both cholera outbreaks and endemic cholera comprising at least 300,000 severe cases and 1.2 million infections each year. To combat this situation, Vaccination against cholera has been proved effective both in endemic and epidemic settings. But, the WHO recommended Dukoral and Prequalified Shanchol are quite expensive for our country perspective. Therefore, locally manufactured OCV can improve the cost effectiveness and make it affordable for all. The hypothesis of this proposal is that Locally produced orally administered whole cell inactivated HL-OCV test formulations A and B are safe and immunogenic in adults and children in Bangladesh as compared to ShancholTM. The results of the study will allow us to understand the safety and immunogenicity outcome of the HL-OCV compared to Shanchol vaccine. The total sample size will be 840 healthy participants. 840 healthy participants (360 adults, 240 Children and Adolescent and 240 young children) of 18-45 years, 5- less than 18 years and 1 year to less than 5 years will be enrolled in the study. Children whose parents/guardians give voluntary consent will be enrolled in the study. The investigators will provide 2 dose of vaccine for three groups in 14 days interval. Test formulations will be locally manufactured and the comparator group will get Shanchol. The Investigators propose to collect three blood samples (Day 0, 14 and 28).


Options:
A: Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection (7 days to 6 months)
B: Change in Vibriocidal GMT (6 months)
C: Number of participants with vaccine related reactogenicity as assessed by study personnel (Within 30 minutes after administration of vaccine); Number of participants with solicited adverse events as assessed by study personnel (Within 7 days after administration of vaccine); Number of participants with unsolicited adverse event including serious adverse event as assessed by study physician (Within 6 months after administration of vaccine); Number of participants showing seroconversion against sero group V. cholerae O1 (7 days after administration of vaccine)
D: Number of participants with vaccine related reactogenicity as assessed by study personnel. (Within 30 minutes after administration of vaccine); Number of participants with solicited adverse events as assessed by study personnel (Within 7 days after administration of vaccine); Number of participants with unsolicited adverse event including serious adverse event as assessed by study personnel. (Within 14 days after administration of vaccine.)

Answer: D