Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).

Condition or disease	Intervention/treatment	Phase
Rotavirus Gastroenteritis; Rotavirus Vaccines	Biological: Rotarix™	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	522 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.
Study Start Date :	November 2008
Actual Primary Completion Date :	August 2009
Actual Study Completion Date :	August 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Rotarix Group; Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.	Biological: Rotarix™; Two oral doses, with at least 4 weeks interval in-between

Outcome Measures

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Primary Outcome Measures :

1. Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea [ Time Frame: During the 8-day solicited follow-up period ]

   Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.

   Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.

   Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.

Secondary Outcome Measures :

1. Number of Subjects Reporting Each Type of Solicited General Symptoms [ Time Frame: During the 8-day follow-up period ]
   Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.
2. Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day follow-up period ]
   Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
3. Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Throughout the study period (Day 0 to Month 3 or 4) ]
   SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	6 Weeks to 19 Weeks (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
• A male or female at least 6 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
• Any contraindication as stated in the updated and approved Prescribing Information

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Sri Lanka
GSK Investigational Site
Colombo, Sri Lanka, 03

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00779779 History of Changes
Other Study ID Numbers:	111664
First Posted:	October 24, 2008
Results First Posted:	July 30, 2010
Last Update Posted:	December 15, 2010
Last Verified:	November 2010

Keywords provided by GlaxoSmithKline:

Gastroenteritis

Additional relevant MeSH terms:

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases	Vaccines; Immunologic Factors; Physiological Effects of Drugs