Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Phase I/II Study to Evaluate Safety & Reactogenicity of Heat Stable Rotavirus Vaccine, in Healthy Adult; Followed by Evaluation of the Safety, Reactogenicity & Immunogenicity of a 3-dose Series in Infants Age 6-8 Weeks
Brief Summary: Rotaviruses are the leading cause of severe, dehydrating diarrhoea and related deaths in children aged less than 5 years worldwide and are reported to infect nearly every child by the age of 5 years. About 90% of all rotavirus-associated fatalities occur in low income countries in Africa and Asia and are related to poor health care. In view of high global RVGE burden, the World Health Organization (WHO) on 5th June 2009, recommended the inclusion of rotavirus vaccine in all the national immunization programs.

Currently available rotavirus vaccines, RotaTeq® and Rotarix®, are WHO prequalified vaccines which are stable for recommended duration at storage temperature between 2-8 °C. However, if these vaccine are exposed to temperatures above 30 °C, the vaccine has to be discarded due to lost potency. It is very difficult to maintain the cold chain required to conserve the vaccine potency particularly in developing and low income countries, resulting in large amount of vaccine being wasted and in worst case scenario, endangering the lives of potential recipients. The WHO estimates that nearly half of freeze-dried and quarter of liquid vaccines are wasted each year. One of the biggest contributors to this wastage is disruption of the cold chain systems.

Hilleman Labs new Rotavirus vaccine is a lyophilized heat stable rotavirus vaccine comprising of five live attenuated reassortant rotaviruses similar to RotaTeq®. The new heat stable rotavirus vaccine (HSRV) formulation offers a stability profile of 9 months at 45 °C and 12 months at 37 °C. This new heat stable formulation (HSRV) could be transported in non-refrigerated supply chain significantly reducing the cost and complications associated with transporting vaccine to remote corners of the developing world. Heat-stable rotavirus vaccine (HSRV) has a potential to sustain high temperatures frequently encountered in regions where majority of rotavirus burden exists and has potential to partially or completely eliminate cold chain dependence.

The current study has been designed to test for the first time in humans, the safety and tolerability of the new heat stable rotavirus vaccine (HSRV) in adults; followed by safety and immunogenicity in infants of age 6-8 weeks, as compared to the licensed RotaTeq® vaccine.


Options:
A: Arm Label: Heat Stable Rotavirus (HSRV) Vaccine; Type: EXPERIMENTAL; Interventions: Biological: Heat Stable Rotavirus (HSRV) Vaccine | Arm Label: Placebo for Heatstable Rotavirus vaccine; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo for Heatstable Rotavirus vaccine | Arm Label: Heat Stable Rotavirus Vaccine; Type: EXPERIMENTAL; Interventions: Biological: Heat Stable Rotavirus (HSRV) Vaccine | Arm Label: RotaTeq; Type: ACTIVE_COMPARATOR; Interventions: Biological: RotaTeq® | Intervention Type: BIOLOGICAL; Name: Heat Stable Rotavirus (HSRV) Vaccine; Assigned to Arm(s): Heat Stable Rotavirus (HSRV) Vaccine, Heat Stable Rotavirus Vaccine | Intervention Type: BIOLOGICAL; Name: Placebo for Heatstable Rotavirus vaccine; Assigned to Arm(s): Placebo for Heatstable Rotavirus vaccine | Intervention Type: BIOLOGICAL; Name: RotaTeq®; Assigned to Arm(s): RotaTeq
B: Intervention Type: BIOLOGICAL; Name: Rotavirus (vaccine); Assigned to Arm(s): N/A
C: Intervention Type: BIOLOGICAL; Name: HRV vaccine; Assigned to Arm(s): N/A
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Biological: Rotavirus Vaccine (ROTARIX) | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BIOLOGICAL; Name: Rotavirus Vaccine (ROTARIX); Assigned to Arm(s): 1

Answer: A