Clinical Trial Results:
A phase III, single-group, open-label study to assess the safety and reactogenicity of GSK Biologicals’ combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine Boostrix administered as a booster vaccine dose in healthy Vietnamese children.
Summary
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EudraCT number |
2013-003859-37 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
10 May 2014
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Results information
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Results version number |
v2(current) |
This version publication date |
18 May 2018
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First version publication date |
13 May 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 |
115739
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
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,
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, 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 |
24 Jul 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 May 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
10 May 2014
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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 safety and reactogenicity of the study vaccine in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs).
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Protection of trial subjects |
All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Feb 2014
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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 |
Vietnam: 302
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Worldwide total number of subjects |
302
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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) |
0
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Children (2-11 years) |
302
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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 |
Out of the 302 subjects enrolled into the study, 2 were excluded due to developing allergic reactions and hence only 300 started the study. | ||||||
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. | ||||||
Pre-assignment period milestones
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Number of subjects started |
302 | ||||||
Number of subjects completed |
300 | ||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Excluded due to allergic reaction: 2 | ||||||
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 |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Boostrix Group | ||||||
Arm description |
Subjects received a single dose of Boostrix vaccine at 6-10 years of age. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Boostrix
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Investigational medicinal product code |
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Other name |
dTpa
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single-dose administered, on day 0, intramuscularly in the deltoid region of non-dominant arm.
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Two subjects were excluded from the study due to an allergic reaction. |
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Baseline characteristics reporting groups
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Reporting group title |
Boostrix Group
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Reporting group description |
Subjects received a single dose of Boostrix vaccine at 6-10 years of age. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Boostrix Group
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Reporting group description |
Subjects received a single dose of Boostrix vaccine at 6-10 years of age. |
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End point title |
Numbers of subjects with any and grade 3 solicited local symptoms [1] | ||||||||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
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End point type |
Primary
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End point timeframe |
Within 4 days (Days 0-3) post vaccination period
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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 with any, grade 3 and related solicited general symptoms [2] | ||||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
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End point type |
Primary
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End point timeframe |
Within 4 days (Days 0-3) post vaccination period
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Notes [2] - 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 with unsolicited adverse events (AEs) [3] | ||||||||
End point description |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 |
Primary
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End point timeframe |
Within 31 days (Days 0-30) post vaccination period
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Notes [3] - 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 with serious adverse events (SAEs) [4] | ||||||||
End point description |
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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End point type |
Primary
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End point timeframe |
During the entire study period (From Day 0 to Day 30)
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Notes [4] - 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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Adverse events information
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Timeframe for reporting adverse events |
Solicited symptoms during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs during the 31-day (Days 0-30) post-vaccination period, SAEs during the entire study period (from Day 0 to Day 30).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
Boostrix Group
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Reporting group description |
Subjects received a single dose of Boostrix vaccine at 6-10 years of age. | ||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||
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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 |