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    Clinical Trial Results:
    Prospective Multicentre Randomized Double-Blind Placebo-Controlled Parallel Group Study on the Efficacy and Tolerability of StroVac® in Patients With Recurrent Symptomatic Bacterial Urinary Tract Infections

    Summary
    EudraCT number
    		 2010-020882-25
    Trial protocol
    		 DE  
    Global end of trial date
    19 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Feb 2018
    First version publication date
    24 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SU5.6
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Strathmann GmbH & Co. KG
    Sponsor organisation address
    Sellhopsweg 1, Hamburg, Germany, 22459
    Public contact
    Medizinisch-Wissenschaftliche Abteilung, Strathmann GmbH & Co. KG, +49 (0)40559050, Verteiler_MW@strathmann.de
    Scientific contact
    Medizinisch-Wissenschaftliche Abteilung, Strathmann GmbH & Co. KG, +49 (0)40559050, Verteiler_MW@strathmann.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the clinical efficacy and tolerability of the inactivated germs of specified enterobacteria contained in StroVac® in recurrent acute uncomplicated symptomatic bacterial urinary tract infections as compared to placebo.
    Protection of trial subjects
    This trial was conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association. The planning and conduct of this trial followed the respective national laws in Germany, the principles and guidelines for good clinical practice laid down in Directives 2001/20/EC [9] and 2005/28/EC [10] of the European Parliament and the Consensus paper of the International Conference on Harmonisation on good clinical practice (ICH-GCP) and the Pharmalog SOPs that are based on the ICH-GCP guidelines. The risk profile of StroVac® has been well established in more than 25 years both in published studies and via spontaneous reporting. Two large non-interventional studies including more than 2.000 patients treated with StroVac® showed that the product is efficacious and well tolerated under medical routine conditions. Placebo is considered to be an adequate comparator to study the effect of immunization as compared to the natural course without immunization. In case of intolerability to the first or second vaccination the patient was withdrawn from the study. In addition, in compliance with GCP patients were free to leave the study at any time they wish. In order to follow the risks adequately the Investigator saw the patients frequently or was in telephone contact with them according to the study scheme provided in protocol. The study protocol included study withdrawal criteria on patient and study basis to reduce individual risks.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jan 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 376
    Worldwide total number of subjects
    376
    EEA total number of subjects
    376
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    304
    From 65 to 84 years
    72
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult outpatients with the inclusion diagnosis “history of at least one year of confirmed recurrent uncomplicated symptomatic bacterial urinary tract infections” were eligible for study participation if they meet all of the inclusion and exclusion criteria.

    Period 1
    Period 1 title
    Screening assessments
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 No arms defined yet
    Arm description
    		 Prior to randomisation, the Investigator must ensure that the patient meets the inclusion diagnosis “history of at least one year of confirmed recurrent uncomplicated symptomatic bacterial urinary tract infections” and all of the corresponding inclusion and exclusion criteria. No arms defined yet.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		No arms defined yet
    Started
    376
    Completed
    376
    Period 2
    Period 2 title
    Immunization
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    To ensure balancing regarding known and unknown influencing factors for both treatments, a randomized block design stratification by menopausal condition (pre-/ and postmenopausal) of the patients was used to allocate StroVac® or placebo to the patient. Male patients were included in the premenopausal stratum.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 StroVac®
    Arm description
    		 Basic suspension and dried active substance for the preparation of a suspension for injection purposes. One unit of dried active substance contains at least 10**9 inactivated germs including Escherichia coli 7.5 x 10**8, Morganella morganii 3.75 x 10**7, Proteus mirabilis 3.75 x 10**7, Klebsiella pneumoniae 1.5 x 10**8, and Enteroccocus faecalis 2.5 x 10**7
    Arm type
    		 Experimental

    Investigational medicinal product name
    StroVac®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three single injections every two weeks ± 7 days

    Arm title
    		 Placebo
    Arm description
    		 Basic suspension and dried placebo substance for the preparation of a suspension for injection purposes. One unit of dried placebo substance contains excipients only.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo suspension for i.m. injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Three single injections every two weeks ± 7 days

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Baseline period starts with Visit 2 (=randomisation date). Prior to randomisation (=Period 1, screening assessments), the Investigator must ensure that the patient meets the inclusion diagnosis “history of at least one year of confirmed recurrent uncomplicated symptomatic bacterial urinary tract infections” and all of the corresponding in- and exclusion criteria (e.g. at least 5 UTIs during a period of 12 months prior to study inclusion = baseline value)
    Number of subjects in period 2
    		StroVac® Placebo
    Started
    188
    188
    Completed
    184
    187
    Not completed
    4
    1
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    1
    -
         Poor compliance
    1
    -
    Period 3
    Period 3 title
    Post- Immunization
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    No further IMP dispensed. Blinding and randomization of period 2 was kept.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 StroVac®
    Arm description
    		 Same arm like in Period 2 / no further injections
    Arm type
    		 Experimental

    Investigational medicinal product name
    StroVac®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Same arm like in Period 2 / no further injections

    Arm title
    		 Placebo
    Arm description
    		 Same arm like in Period 2 / no further injections
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo suspension for i.m. injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Same arm like in Period 2 / no further injections

    Number of subjects in period 3
    		StroVac® Placebo
    Started
    184
    187
    Completed
    167
    170
    Not completed
    17
    17
         Consent withdrawn by subject
    4
    5
         Administrative
    1
    1
         Poor compliance
    2
    1
         Lost to follow-up
    2
    4
         Lack of efficacy
    1
    1
         Protocol deviation
    7
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    StroVac®
    Reporting group description
    		 Basic suspension and dried active substance for the preparation of a suspension for injection purposes. One unit of dried active substance contains at least 10**9 inactivated germs including Escherichia coli 7.5 x 10**8, Morganella morganii 3.75 x 10**7, Proteus mirabilis 3.75 x 10**7, Klebsiella pneumoniae 1.5 x 10**8, and Enteroccocus faecalis 2.5 x 10**7

    Reporting group title
    Placebo
    Reporting group description
    		 Basic suspension and dried placebo substance for the preparation of a suspension for injection purposes. One unit of dried placebo substance contains excipients only.

    Reporting group values
    		 StroVac® Placebo Total
    Number of subjects
    		 188 188 376
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        age (≥18 and ≤80 years)
    		 188 188 376
    Gender categorical
    Units: Subjects
        Female
    		 186 184 370
        Male
    		 2 4 6

    End points

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    End points reporting groups
    Reporting group title
    No arms defined yet
    Reporting group description
    		 Prior to randomisation, the Investigator must ensure that the patient meets the inclusion diagnosis “history of at least one year of confirmed recurrent uncomplicated symptomatic bacterial urinary tract infections” and all of the corresponding inclusion and exclusion criteria. No arms defined yet.
    Reporting group title
    StroVac®
    Reporting group description
    		 Basic suspension and dried active substance for the preparation of a suspension for injection purposes. One unit of dried active substance contains at least 10**9 inactivated germs including Escherichia coli 7.5 x 10**8, Morganella morganii 3.75 x 10**7, Proteus mirabilis 3.75 x 10**7, Klebsiella pneumoniae 1.5 x 10**8, and Enteroccocus faecalis 2.5 x 10**7

    Reporting group title
    Placebo
    Reporting group description
    		 Basic suspension and dried placebo substance for the preparation of a suspension for injection purposes. One unit of dried placebo substance contains excipients only.
    Reporting group title
    StroVac®
    Reporting group description
    		 Same arm like in Period 2 / no further injections

    Reporting group title
    Placebo
    Reporting group description
    		 Same arm like in Period 2 / no further injections

    Primary: Number of bacterial urinary tract recurrences with confirmed bacterial origin over a period of 13.5 months

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    End point title
    		 Number of bacterial urinary tract recurrences with confirmed bacterial origin over a period of 13.5 months
    End point description
    The primary endpoint was compared statistically in a confirmatory test approach on superiority of StroVac® compared to placebo. The respective statistical test was performed using the generalized linear model (GLM) in the following form: It was assumed that the number of confirmed infection recurrences during exposure time t=13.5 months could be described by Poisson distributions where the recurrence rate depended on treatment and disease severity at baseline, which was defined as confirmed UTI recurrences in the 12 months previous to study start.
    End point type
    Primary
    End point timeframe
    Over a period of 13.5 months starting after randomization.
    End point values
    		 StroVac® Placebo
    Number of subjects analysed
    187
    188
    Units: no. of bacterial UTIs
    1024
    1018
    Statistical analysis title
    		 Main analysis
    Comparison groups
    Placebo v StroVac®
    Number of subjects included in analysis
    375
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.6324
    Method
    		 Poisson regression
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.0595
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3031
         upper limit
    		 0.1842
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1243
    Notes
    [1] - superiority of StroVac® compared to placebo

    Post-hoc: Analysis of patients with No. of UTIs above average

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    End point title
    		 Analysis of patients with No. of UTIs above average
    End point description
    An additional post-hoc analysis of patients with infections above average prior to randomisation versus UTIs during the study was performed. 13.9 % of the patients had 7 or more infections prior randomisation in the StroVac® group and in the placebo group 17.0 % of the patients, in mean 7.4 UTIs. In the period of 13.5 months after randomisation (= after start of first vaccination) 7 or more UTIs prior to inclusion reduced in the StroVac® group to 2.3 UTIs compared to 4.4 UTIs during placebo treatment with significant differences in the ITT (p-value 0.0482). This significance was verified in the FAS and PP (p-value 0.0487 and 0.0286, respectively). Furthermore a significant difference could also be shown in the period of 12 months (=after completion of vaccination) in the PP (p-value 0.0469).
    End point type
    Post-hoc
    End point timeframe
    In the period of 13.5 months after randomisation
    End point values
    		 StroVac® Placebo
    Number of subjects analysed
    26
    32
    Units: No. of bacterial UTIs
    189
    242
    Statistical analysis title
    		 Analysis of pts with No. of UTIs above average
    Comparison groups
    Placebo v StroVac®
    Number of subjects included in analysis
    58
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.0482
    Method
    		 Poisson regression
    Parameter type
    		 Median difference (final values)
    Point estimate
    -0.555
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1056
         upper limit
    		 -0.0044
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2809

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1) “Within the treatment period”: start date on/after Day 1 (=V2, start of immunization) until the last day of the immunization period (V5–1 day). 2) “after the treatment period”: start on on the first day of the post-immunization period (V5)
    Adverse event reporting additional description
    According to the study protocol fever > 38.5 °C occurring up to 72 hours after the injection and chills were to be documented as SAEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Within the treatment period / StroVac®
    Reporting group description
    		 -

    Reporting group title
    Within the treatment period / Placebo
    Reporting group description
    		 -

    Reporting group title
    After the treatment period / StroVac®
    Reporting group description
    		 -

    Reporting group title
    After the treatment period / Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Within the treatment period / StroVac® Within the treatment period / Placebo After the treatment period / StroVac® After the treatment period / Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 188 (12.77%)
    5 / 188 (2.66%)
    15 / 188 (7.98%)
    10 / 188 (5.32%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer female
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 188 (0.53%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    1 / 188 (0.53%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian operation
         subjects affected / exposed
    1 / 188 (0.53%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicectomy
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystocele repair
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal resection
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salpingectomy
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillectomy
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transurethral bladder resection
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Haemorrhage in pregnancy
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labour pain
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    14 / 188 (7.45%)
    2 / 188 (1.06%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    15 / 15
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    8 / 188 (4.26%)
    2 / 188 (1.06%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    8 / 8
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaccination site swelling
         subjects affected / exposed
    1 / 188 (0.53%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Intentional self-injury
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Multiple injuries
         subjects affected / exposed
    1 / 188 (0.53%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 188 (0.53%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis acute
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Helicobacter gastritis
         subjects affected / exposed
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    2 / 188 (1.06%)
    1 / 188 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Within the treatment period / StroVac® Within the treatment period / Placebo After the treatment period / StroVac® After the treatment period / Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    115 / 188 (61.17%)
    83 / 188 (44.15%)
    81 / 188 (43.09%)
    84 / 188 (44.68%)
    Investigations
    Body temperature increased
         subjects affected / exposed
    11 / 188 (5.85%)
    2 / 188 (1.06%)
    2 / 188 (1.06%)
    2 / 188 (1.06%)
         occurrences all number
    14
    2
    2
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 188 (7.98%)
    11 / 188 (5.85%)
    1 / 188 (0.53%)
    8 / 188 (4.26%)
         occurrences all number
    16
    13
    1
    17
    General disorders and administration site conditions
    Feeling cold
         subjects affected / exposed
    6 / 188 (3.19%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    8
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    22 / 188 (11.70%)
    9 / 188 (4.79%)
    10 / 188 (5.32%)
    7 / 188 (3.72%)
         occurrences all number
    27
    9
    14
    11
    Pyrexia
         subjects affected / exposed
    15 / 188 (7.98%)
    5 / 188 (2.66%)
    3 / 188 (1.60%)
    6 / 188 (3.19%)
         occurrences all number
    17
    5
    3
    7
    Vaccination site erythema
         subjects affected / exposed
    13 / 188 (6.91%)
    2 / 188 (1.06%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences all number
    21
    2
    1
    0
    Vaccination site pain
         subjects affected / exposed
    70 / 188 (37.23%)
    10 / 188 (5.32%)
    1 / 188 (0.53%)
    0 / 188 (0.00%)
         occurrences all number
    124
    15
    1
    0
    Vaccination site reaction
         subjects affected / exposed
    9 / 188 (4.79%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    16
    0
    0
    0
    Vaccination site swelling
         subjects affected / exposed
    12 / 188 (6.38%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
    0 / 188 (0.00%)
         occurrences all number
    17
    0
    0
    0
    Chills
         subjects affected / exposed
    14 / 188 (7.45%)
    2 / 188 (1.06%)
    1 / 188 (0.53%)
    1 / 188 (0.53%)
         occurrences all number
    16
    2
    1
    1
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    4 / 188 (2.13%)
    6 / 188 (3.19%)
    3 / 188 (1.60%)
    7 / 188 (3.72%)
         occurrences all number
    5
    6
    4
    8
    Nausea
         subjects affected / exposed
    8 / 188 (4.26%)
    4 / 188 (2.13%)
    3 / 188 (1.60%)
    6 / 188 (3.19%)
         occurrences all number
    9
    5
    3
    8
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    6 / 188 (3.19%)
    2 / 188 (1.06%)
    0 / 188 (0.00%)
    2 / 188 (1.06%)
         occurrences all number
    6
    2
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 188 (0.00%)
    2 / 188 (1.06%)
    3 / 188 (1.60%)
    8 / 188 (4.26%)
         occurrences all number
    0
    2
    3
    8
    Nasopharyngitis
         subjects affected / exposed
    9 / 188 (4.79%)
    12 / 188 (6.38%)
    9 / 188 (4.79%)
    8 / 188 (4.26%)
         occurrences all number
    10
    13
    12
    11
    Vulvovaginal mycotic infection
         subjects affected / exposed
    2 / 188 (1.06%)
    6 / 188 (3.19%)
    4 / 188 (2.13%)
    7 / 188 (3.72%)
         occurrences all number
    2
    8
    4
    9

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jan 2013
    Amendment No. 2, valid since 07 JAN 2013 (forming integrated CSP, Version 3.0, 04 DEC 2012): The age limit was extended up to 80 years provided that people elder than 70 years are physically and mentally able to participate in the study in the opinion of the investigator. Participating investigators confirmed that several patients elder than 70 years would be eligible and access to study participation should be possible. Exclusion criterion no. 18 was extended by “e.g. patients are physically or mentally not able to collect a qualitative sample of midstream urine or to complete the diary” in the opinion of the investigator. From previous studies where patients elder than 70 years were treated with StroVac® no indication for different tolerability or response to the immunisation were obvious. If a sufficient number of patients (per treatment group) with an age ≥ 70 years was included in this study a corresponding subgroup analyses was conducted. The subgroup analysis of male patients was added. Due to the delayed recruitment rate the blinded sample size review was performed with less patients in order to be able to make decisions regarding the sample size correspondingly to the results of the analysis in a timely manner and the recruitment period was prolonged.
    26 Nov 2013
    Amendment No. 3, valid since 26 NOV 2013 (forming integrated CSP, Version 4.0, 11 OCT 2013): Changes due to Amendment No. 3 referred mainly to the statistical analyses and adapted this protocol part to the “charter to the interim analysis”. The reason for the change of section 13.1 in the protocol (primary endpoint) regarded minor changes in wording and some more details to the endpoint evaluation applied during this analysis. The change of section 13.3 in the protocol (blinded sample size review- blinded interim analysis) described the results and consequences of the blinded sample size review for the further conduct of the study. Section 13.6 in the protocol (initial sample size estimation) had also minor changes in wording and some more details to the initial sample size estimation.

    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
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