Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
NCT ID: NCT00938327
Last Updated: 2018-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
332 participants
OBSERVATIONAL
2009-08-03
2010-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rotarix Group
Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
Rotarix™
Two doses of oral vaccine.
Interventions
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Rotarix™
Two doses of oral vaccine.
Eligibility Criteria
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Inclusion Criteria
* A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
Exclusion Criteria
* Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Acute disease at the time of enrolment.
* Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception.
* Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine.
* Gastroenteritis within 7 days preceding vaccination.
6 Weeks
167 Days
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Bangalore, , India
GSK Investigational Site
Bangalore, , India
GSK Investigational Site
Chennai, , India
GSK Investigational Site
Delhi, , India
GSK Investigational Site
Delhi, , India
GSK Investigational Site
Kolkata, , India
GSK Investigational Site
Kolkata, , India
GSK Investigational Site
Mumbai, , India
GSK Investigational Site
Mumbai, , India
GSK Investigational Site
Mumbai, , India
GSK Investigational Site
New Delhi, , India
GSK Investigational Site
Pune, , India
Countries
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References
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Kumar k et al. Safety and reactogenicity of RIX4414 live attenuated human rotavirus vaccine: An Indian post-marketing surveillance study. Abstract presented at the 48th National Conference of Indian Academy of Pediatrics (Pedicon). Jaipur, India, 19-23 January 2011.
Ruberu D et al. Post-marketing surveillance of a live-attenuated human rotavirus vaccine (Rotarix™) in India and Sri Lanka. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand, 18-20 October 2011.
Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, Bernardo R, Mehta S, Balasubramanian S, Karkada N, Htay Han H. Reactogenicity and safety of the human rotavirus vaccine, Rotarix in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280.
Other Identifiers
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112896
Identifier Type: -
Identifier Source: org_study_id
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