Clinical Trial Results:
A phase II, randomised, observer-blind, controlled, study to assess the reactogenicity and safety of a single intramuscular dose of GlaxoSmithKline (GSK) Biologicals’ investigational respiratory syncytial virus (RSV) vaccine (GSK3003891A) in 18 to 45 year-old healthy non-pregnant women.
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Summary
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EudraCT number |
2015-005742-58 |
Trial protocol |
BE |
Global end of trial date |
28 Jun 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jun 2017
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First version publication date |
29 Jun 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 |
204813
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02753413 | ||
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, B-1330
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Sep 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Jun 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Jun 2016
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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 evaluate the reactogenicity and safety of a single dose of the investigational RSV vaccine in healthy non-pregnant women during the study period.
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Protection of trial subjects |
All subjects were supervised closely for at least 30 minutes following vaccination 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. Subjects were followed-up for one month (minimum 30 days) following administration of the study vaccine.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Apr 2016
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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 |
Belgium: 102
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Worldwide total number of subjects |
102
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EEA total number of subjects |
102
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
102
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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 |
A total of 102 subject numbers were screened, but only 100 subjects were randomized and received vaccination. | |||||||||
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Pre-assignment
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Screening details |
NA | |||||||||
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Period 1
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Period 1 title |
Overall Period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Blinding implementation details |
Given the different appearance and presentation of the investigational RSV vaccine, and Boostrix, double blinding was not possible and data was collected in an observer-blind manner: during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint were unaware of which vaccine was administered. Vaccine preparation and administration was done by authorised medical personnel who did not participate in any of the study clinical evaluation assays.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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GSK3003891A Group | |||||||||
Arm description |
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
GSK3003891A
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Investigational medicinal product code |
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Other name |
60 µg PreF
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Pharmaceutical forms |
Powder for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0.
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Arm title
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Boostrix Group | |||||||||
Arm description |
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0. | |||||||||
Arm type |
Active comparator | |||||||||
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 |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0.
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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: A total of 102 subject numbers were screened, but only 100 subjects were randomized and received vaccination. |
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Baseline characteristics reporting groups
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Reporting group title |
GSK3003891A Group
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Reporting group description |
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Boostrix Group
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Reporting group description |
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
GSK3003891A Group
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Reporting group description |
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | ||
Reporting group title |
Boostrix Group
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Reporting group description |
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0. | ||
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End point title |
Number of subjects with abnormal biochemical laboratory parameter values by maximum grading [1] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
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End point type |
Primary
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End point timeframe |
From Day 7 up to Day 30
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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 with abnormal haematological laboratory parameter values by maximum grading [2] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
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End point type |
Primary
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End point timeframe |
From Day 7 up to Day 30
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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 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 with abnormal haematological laboratory parameter values by maximum grading [3] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
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End point type |
Primary
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End point timeframe |
From Day 7 up to Day 30
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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 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 with haematology change from baseline by maximum grade [4] | ||||||||||||||||||||||||
End point description |
Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.
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End point type |
Primary
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End point timeframe |
From Day 7 up 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 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 with solicited local symptoms [5] | |||||||||||||||||||||||||||
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 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.
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End point type |
Primary
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End point timeframe |
During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
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| Notes [5] - 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 with solicited general symptoms [6] | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above [≥] 37.5 degrees Celsius [°C] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °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 |
During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
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| Notes [6] - 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 with unsolicited adverse events (AEs) [7] | ||||||||||||
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 out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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End point type |
Primary
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End point timeframe |
During a 30-day follow-up period (from Day 0 to Day 29) after vaccination
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| Notes [7] - 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 with serious adverse events (SAEs) [8] | ||||||||||||
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 |
From vaccination (Day 0) up to study end (Day 30)
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| Notes [8] - 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 with Abnormal Biochemical Laboratory Values. [9] | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.
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End point type |
Primary
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End point timeframe |
At Day 7
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| Notes [9] - 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 with Abnormal Biochemical Laboratory Values. [10] | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.
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End point type |
Primary
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End point timeframe |
At Day 30
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| Notes [10] - 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 with Abnormal Haematological Laboratory Values. [11] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.
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End point type |
Primary
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End point timeframe |
At Day 7
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| Notes [11] - 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 with Abnormal Haematological Laboratory Values. [12] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.
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End point type |
Primary
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End point timeframe |
At Day 30
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| Notes [12] - 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 with Abnormal Haematological Laboratory Values. [13] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT
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End point type |
Primary
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End point timeframe |
At Day 7
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| Notes [13] - 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 with Abnormal Haematological Laboratory Values. [14] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT.
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End point type |
Primary
|
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End point timeframe |
At Day 30
|
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| Notes [14] - 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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Adverse events information
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Timeframe for reporting adverse events |
Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
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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 |
19.0
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Reporting groups
|
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Reporting group title |
GSK3003891A Group
|
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Reporting group description |
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Boostrix Group
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Reporting group description |
Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
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Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
