Clinical Trial Results:
Open, multi-centric, post-marketing surveillance (PMS) to evaluate the reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, Rotarix when administered according to a 0, 2 month schedule to Sri Lankan infants aged at least 6 weeks at the time of first vaccination.
Summary
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EudraCT number |
2015-001546-28 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
26 Aug 2009
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Results information
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Results version number |
v2(current) |
This version publication date |
11 Aug 2022
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First version publication date |
10 Jul 2015
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Other versions |
v1 |
Version creation reason |
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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 |
111664
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00779779 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 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 |
13 Jan 2010
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
25 May 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Aug 2009
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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 a 8-day follow-up period after each vaccine dose.
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Protection of trial subjects |
The subjects were observed closely for at least 30 minutes following the administration of vaccines, with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Nov 2008
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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 |
Sri Lanka: 522
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Worldwide total number of subjects |
522
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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) |
522
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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 |
- | ||||||||||||||||
Pre-assignment
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Screening details |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. | ||||||||||||||||
Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
Arms
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Arm title
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Rotarix Group | ||||||||||||||||
Arm description |
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. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Rotarix
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Investigational medicinal product code |
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Other name |
HRV
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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 oral doses, with at least 4 weeks interval in-between.
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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 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 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. |
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End point title |
Number of subjects with at least one >= Grade "2" fever, vomiting or diarrhoea [1] | ||||||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
During the 8-day solicited follow-up period after each vaccine dose (Dose 1 and Dose 2)
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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 analysis of the primary endpoint was descriptive i.e. 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 each type of solicited general symptoms | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting. Any = occurrence of the symptom regardless of intensity and relationship to vaccination. Grade 3 Cough and Irritability = symptoms which prevented normal everyday activities. Grade 3 Diarrhoea = = 6 looser than normal stools/day. Grade 3 Loss of appetite = Not eating at all.
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End point type |
Secondary
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End point timeframe |
During the 8-day follow-up period after each vaccine dose (Dose 1 and Dose 2)
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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 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.
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End point type |
Secondary
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End point timeframe |
During the 31-day follow-up period after each vaccine dose
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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, 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
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End point type |
Secondary
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End point timeframe |
Throughout the study period (Day 0 to Month 3 or 4)
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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 |
Solicited general symptoms: during the 8-day (Day 0 - Day7) post-vaccination period. Unsolicited AEs: during the 31-day (Day 0 - Day 30) post-vaccination period and SAEs during the entire period (Day 0 to Month 3 or 4).
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.1
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Reporting groups
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Reporting group title |
Rotarix Group
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 4.6% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |