Clinical Trial Results:
A Phase I/II, randomised, observer-blind, controlled multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of GSK Biologicals’ investigational RSV vaccine (GSK3003891A), in healthy pregnant women aged 18 to 40 years and infants born to vaccinated mothers
Summary
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EudraCT number |
2016-002733-30 |
Trial protocol |
GB ES FI |
Global end of trial date |
14 Jul 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jan 2019
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First version publication date |
05 Jan 2019
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Other versions |
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Summary report(s) |
Cancelled before Active Statement |
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 |
204810
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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, B-1330
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Public contact |
Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Disclosure Advisor, 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 |
14 Jul 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Jul 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
• To evaluate the safety and reactogenicity of a single intramuscular (IM) dose of study vaccine in pregnant women up to 6 months after delivery (Month 6).
• To assess the safety of a single intramuscular (IM) dose of study vaccine in pregnant women, in terms of pregnancy outcomes.
• To evaluate the safety in infants born to mothers who were vaccinated with a single IM dose of study vaccine up to 6 months after birth (Month 6).
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Protection of trial subjects |
The study was cancelled before active (see attached statement). No patient entered the study, therefore no results/data are available.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Jul 2017
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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 |
Spain: 33333
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Country: Number of subjects enrolled |
United Kingdom: 33333
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Country: Number of subjects enrolled |
Finland: 33333
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
50000
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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) |
49999
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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 |
99999 is "Not Applicable" value or '0' participants. The study was cancelled before active (see attached statement). No patient entered the study, therefore no results/data are available. | ||||||||||
Pre-assignment
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Screening details |
The study was cancelled before active (see attached statement). | ||||||||||
Period 1
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Period 1 title |
Cancelled before active period (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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No-Arm | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
RSV vaccine (GSK3003891A) formulation
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
The product was not administered as the study was cancelled before active.
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End points reporting groups
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Reporting group title |
No-Arm
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Reporting group description |
- |
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End point title |
No end point results [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
The study was cancelled before active (see attached statement).
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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 study was cancelled before active (see attached statement). |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
The study was cancelled before active (see attached statement).
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
20.0
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The study was cancelled before active (see attached statement). |
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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? Yes | |||||||
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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 |