Clinical Trial Results:
An open, single group, multi-centric, post marketing surveillance (PMS) to monitor the reactogenicity and safety of oral live attenuated human rotavirus (HRV) vaccine, Rotarix™ when administered according to the Prescribing Information (PI) to Indian infants
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Summary
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EudraCT number |
2017-000451-14 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
23 Apr 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Dec 2017
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First version publication date |
20 Dec 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
112896
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00938327 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l'Institut 89, Rixensart, Belgium,
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, +((44)2089 904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, +((44)2089 904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Apr 2010
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Feb 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Apr 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the reactogenicity of Rotarix in terms of occurrence of at least one Grade “2” or Grade “3” fever, vomiting or diarrhoea within the 8-day (Day 0-Day 7) follow-up period after any Rotarix vaccination
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Protection of trial subjects |
The subjects were observed closely for at least 30 minutes following the administration of vaccine, with appropriate medical treatment readily available in case of a rare anaphylactic reaction
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Aug 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
India: 332
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Worldwide total number of subjects |
332
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
332
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||
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Pre-assignment
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Screening details |
- | ||||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
332 | ||||||||||||||||||||
Number of subjects completed |
332 | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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Rotarix Group | ||||||||||||||||||||
Arm description |
Subjects who had 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. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Rotarix™
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Investigational medicinal product code |
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Other name |
GSK Biologicals’ oral live attenuated HRV vaccine
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Pharmaceutical forms |
Powder and solvent for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Two doses of Rotarix administered orally. First dose administered from the age of 6 weeks. Second dose administered at least 4 weeks after Dose 1. Vaccination course completed by 24 weeks of age
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Baseline characteristics reporting groups
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Reporting group title |
Rotarix Group
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Reporting group description |
Subjects who had 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. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Rotarix Group
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Reporting group description |
Subjects who had 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. | ||
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End point title |
Number of subjects reporting Grade 2 or 3 symptoms (fever, vomiting or diarrhoea) [1] | ||||||||
End point description |
Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day.
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End point type |
Primary
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End point timeframe |
During the 8-day (Day 0 – Day 7) follow-up period after each vaccination.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary end point was descriptive, no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of subjects reporting solicited general symptoms | ||||||||||||||||||
End point description |
Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day
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End point type |
Secondary
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End point timeframe |
During the 8-day (Day 0 – Day 7) follow-up period after each vaccination
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of subjects reporting unsolicited adverse events (AEs) | ||||||||
End point description |
Unsolicited AE covers 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.
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End point type |
Secondary
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End point timeframe |
During the 31-day (Day 0 – Day 30) follow-up period after each vaccination
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of subjects reporting serious adverse events (SAEs) | ||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are 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.
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End point type |
Secondary
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End point timeframe |
Throughout the study period (from Day 0 up to Day 30)
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Serious adverse events: throughout the study period (Day 0-Day 30). Other adverse avents: during the 8-day (Day 0-Day 7) follow-up period after each vaccination.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.0
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Reporting groups
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Reporting group title |
Rotarix Group
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
