Please select the arm or intervention descriptions that belong 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: Arm Label: Shanchol; Type: EXPERIMENTAL; Interventions: Biological: Shanchol | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Shanchol; Assigned to Arm(s): Shanchol | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Shanchol Dose-interval Group 1; Type: ACTIVE_COMPARATOR; Interventions: Biological: Oral Cholera Vaccine | Arm Label: Shanchol Dose-Interval Group 2; Type: EXPERIMENTAL; Interventions: Biological: Adjusted Dose Oral Cholera Vaccine | Intervention Type: BIOLOGICAL; Name: Oral Cholera Vaccine; Assigned to Arm(s): Shanchol Dose-interval Group 1 | Intervention Type: BIOLOGICAL; Name: Adjusted Dose Oral Cholera Vaccine; Assigned to Arm(s): Shanchol Dose-Interval Group 2
C: Arm Label: cholvax; Type: EXPERIMENTAL; Interventions: Biological: Cholvax | Arm Label: shanchol; Type: ACTIVE_COMPARATOR; Interventions: Biological: Shanchol | Intervention Type: BIOLOGICAL; Name: Cholvax; Assigned to Arm(s): cholvax | Intervention Type: BIOLOGICAL; Name: Shanchol; Assigned to Arm(s): shanchol
D: Arm Label: HL-OCV; Type: EXPERIMENTAL; Interventions: Biological: HL-OCV | Arm Label: Shanchol; Type: ACTIVE_COMPARATOR; Interventions: Biological: Shanchol | Intervention Type: BIOLOGICAL; Name: HL-OCV; Assigned to Arm(s): HL-OCV | Intervention Type: BIOLOGICAL; Name: Shanchol; Assigned to Arm(s): Shanchol

Answer: D