Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)

    Summary
    EudraCT number
    		 2017-001820-22
    Trial protocol
    		 GB   DE   FI   BE  
    Global end of trial date
    01 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jan 2023
    First version publication date
    14 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Sci-B-Vac–002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03408730
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VBI Vaccines
    Sponsor organisation address
    310 Hunt Club East, Nepean, Canada, K1V 1C1
    Public contact
    Bebi Yassin-Rajkumar, VBI Vaccines Inc., +1 613749-4200 151, byassin-rajkumar@vbivaccines.com
    Scientific contact
    Dr Francisco Diaz-Mitoma, VBI Vaccines Inc., +1 613749-4200 151, fdiazmitoma@vbivaccines.com
    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
    14 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the manufacturing equivalence, in terms of immunogenicity, of three independent consecutive lots of the Sci-B-Vac™ 4 weeks after the third vaccination on Study Day 196. This objective will be met if the following condition is satisfied if the upper and lower bound of the two sided 95% confidence interval (CI) of the geometric mean concentration (GMC) of anti-HBs ratios 4 weeks after the third injection, for all three pairwise comparisons (GMC of anti-HBs in group A/GMC of anti-HBs in group B, GMC of anti-HBs in group A/ GMC of anti-HBs in group C, GMC of anti-HBs in group B/ GMC of anti-HBs in group C), are within [0.67, 1.5]
    Protection of trial subjects
    An independent Data Monitoring Committee (DMC) was established to monitor subject safety. Subjects were provided with a 28-day diary card to record vaccine reactions. Subjects recorded solicited local and systemic AEs on the day of vaccination and for the next 6 days. A safety follow-up telephone call was made 7 days after each vaccination to inquire about local and systemic reactions. Subjects were followed a minimum of 48 weeks after receiving the first vaccination at Study Day 0, with at least a 24-week follow-up safety assessments after receiving the third vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 Engerix-B is approved for active immunization against hepatitis B virus infection (HBV) caused by all known subtypes in non immune subjects.
    Actual start date of recruitment
    23 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 750
    Country: Number of subjects enrolled
    Canada: 121
    Country: Number of subjects enrolled
    European Union: 1965
    Worldwide total number of subjects
    2836
    EEA total number of subjects
    0
    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)
    2836
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were recruited through radio and newspaper advertisements.

    Pre-assignment
    Screening details
    		 Screening was conducted within 28 days (4 weeks) prior to the first vaccination.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    This was a double-blind study. Both subjects and the study center staff performing outcome measurement were blinded. Randomization and administration of study vaccine was by unblinded qualified health personnel not involved in assessment of outcome measures, whose sole role was to prepare and administer the allocated study vaccine and to perform activities requiring vial handling.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Engerix-B®
    Arm description
    		 Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Engerix-B®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Engerix-B® Hepatitis B Vaccination, 20ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Arm title
    		 Sci-B-Vac® Lot A
    Arm description
    		 Sci-B-Vac Lot A Hepatitis B Vaccination Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sci-B-Vac® Lot A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Arm title
    		 Sci-B-Vac® Lot B
    Arm description
    		 Sci-B-Vac Lot B Hepatitis B Vaccination Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sci-B-Vac® Lot B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Arm title
    		 Sci-B-Vac® Lot C
    Arm description
    		 Sci-B-Vac Lot C Hepatitis B Vaccination Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sci-B-Vac® Lot C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Arm title
    		 Pooled Sci-B-Vac
    Arm description
    		 Pooled Sci-B-Vac® includes the Sci-B-Vac® Lot A, Sci-B-Vac® Lot B and Sci-B-Vac® Lot C
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sci-B-Vac® Lot A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Investigational medicinal product name
    Sci-B-Vac® Lot B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Investigational medicinal product name
    Sci-B-Vac® Lot C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Number of subjects in period 1
    		Engerix-B® Sci-B-Vac® Lot A Sci-B-Vac® Lot B Sci-B-Vac® Lot C Pooled Sci-B-Vac
    Started
    712
    711
    708
    705
    2124
    Completed
    643
    636
    637
    625
    1898
    Not completed
    69
    75
    71
    80
    226
         Moved from study area
    5
    3
    1
    3
    7
         Consent withdrawn by subject
    12
    15
    13
    17
    45
         Physician decision
    -
    -
    1
    -
    1
         Request of regulatory agency, sponsor or investiga
    1
    -
    -
    -
    -
         Other
    1
    -
    -
    -
    -
         Pregnancy
    1
    3
    2
    6
    11
         Non-serious adverse event
    1
    2
    3
    1
    6
         Serious adverse event
    -
    2
    -
    -
    2
         Lost to follow-up
    48
    49
    51
    51
    151
         Change in subject's medical condition
    -
    1
    -
    -
    1
         Protocol deviation
    -
    -
    -
    2
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Engerix-B®
    Reporting group description
    		 Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination

    Reporting group title
    Sci-B-Vac® Lot A
    Reporting group description
    		 Sci-B-Vac Lot A Hepatitis B Vaccination Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Reporting group title
    Sci-B-Vac® Lot B
    Reporting group description
    		 Sci-B-Vac Lot B Hepatitis B Vaccination Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Reporting group title
    Sci-B-Vac® Lot C
    Reporting group description
    		 Sci-B-Vac Lot C Hepatitis B Vaccination Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Reporting group title
    Pooled Sci-B-Vac
    Reporting group description
    		 Pooled Sci-B-Vac® includes the Sci-B-Vac® Lot A, Sci-B-Vac® Lot B and Sci-B-Vac® Lot C

    Reporting group values
    		 Engerix-B® Sci-B-Vac® Lot A Sci-B-Vac® Lot B Sci-B-Vac® Lot C Pooled Sci-B-Vac Total
    Number of subjects
    		 712 711 708 705 2124
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.4 ± 8.1 33.8 ± 7.96 32.9 ± 8 33.9 ± 7.91 33.5 ± 7.97 -
    Gender categorical
    Units: Subjects
        Female
    		 421 408 395 414 1217 1638
        Male
    		 291 303 313 291 907 1198
    Subject analysis sets

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the All Enrolled Set who received at least 1 vaccination. Subjects were analyzed as vaccinated, ie, a subject was assigned according to the vaccine received. In case of vaccination error, subjects were analyzed as treated.

    Subject analysis set title
    Per Protocol Set (PPS) 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per-Protocol Set 1 (PPS1): All subjects in the Full Analysis Set who received all 3 vaccinations, had evaluable serum immunogenicity samples at baseline and at the timepoint of interest, were seronegative at baseline, and had no major protocol deviations leading to exclusion as identified prior to unblinding.

    Subject analysis set title
    Per Protocol Set (PPS) 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Set 2 included all subjects in Per Protocol Set 1 excluding subjects who attended visits outside of windows including Visit 3/Day 168 (±28 days) and Visit 44/Day 196 (-7/+14 days)

    Subject analysis sets values
    		 Safety Set Per Protocol Set (PPS) 1 Per Protocol Set (PPS) 2
    Number of subjects
    2836
    2511
    2381
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    33.5 ± 8
    33.5 ± 7.95
    33.6 ± 7.93
    Gender categorical
    Units: Subjects
        Female
    1638
    1458
    1385
        Male
    1198
    1053
    996

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Engerix-B®
    Reporting group description
    		 Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168. Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination

    Reporting group title
    Sci-B-Vac® Lot A
    Reporting group description
    		 Sci-B-Vac Lot A Hepatitis B Vaccination Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Reporting group title
    Sci-B-Vac® Lot B
    Reporting group description
    		 Sci-B-Vac Lot B Hepatitis B Vaccination Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Reporting group title
    Sci-B-Vac® Lot C
    Reporting group description
    		 Sci-B-Vac Lot C Hepatitis B Vaccination Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168.

    Reporting group title
    Pooled Sci-B-Vac
    Reporting group description
    		 Pooled Sci-B-Vac® includes the Sci-B-Vac® Lot A, Sci-B-Vac® Lot B and Sci-B-Vac® Lot C

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the All Enrolled Set who received at least 1 vaccination. Subjects were analyzed as vaccinated, ie, a subject was assigned according to the vaccine received. In case of vaccination error, subjects were analyzed as treated.

    Subject analysis set title
    Per Protocol Set (PPS) 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per-Protocol Set 1 (PPS1): All subjects in the Full Analysis Set who received all 3 vaccinations, had evaluable serum immunogenicity samples at baseline and at the timepoint of interest, were seronegative at baseline, and had no major protocol deviations leading to exclusion as identified prior to unblinding.

    Subject analysis set title
    Per Protocol Set (PPS) 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Set 2 included all subjects in Per Protocol Set 1 excluding subjects who attended visits outside of windows including Visit 3/Day 168 (±28 days) and Visit 44/Day 196 (-7/+14 days)

    Primary: Geometric mean concentration (GMC) of anti-HBs at day 196 for lot-to-lot consistency (Per Protocol Set 1)

    		 Close Top of page
    End point title
    		 Geometric mean concentration (GMC) of anti-HBs at day 196 for lot-to-lot consistency (Per Protocol Set 1) [1]
    End point description
    To demonstrate the manufacturing equivalence, in terms of immunogenicity, as measured by GMC of antibodies, of 3 independent consecutive lots of the Sci-B-Vac® 4 weeks after the third vaccination. Lot-to-lot manufacturing consistency of Sci-B-Vac® is demonstrated if the 95% CIs of the adjusted anti-HBs GMC ratios between lots are within the pre-specified range of [0.67, 1.5].
    End point type
    Primary
    End point timeframe
    4 weeks after third vaccination (Study Day 196)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The Engerix-B® arm and the Pooled Sci-B-Vac arm, which is a pool of data from the three Sci-B-Vac arms, are not included in this analysis as the intent is to demonstrate consistency among the three lots of Sci-B-Vac.
    End point values
    		 Sci-B-Vac® Lot A Sci-B-Vac® Lot B Sci-B-Vac® Lot C
    Number of subjects analysed
    611
    610
    619
    Units: mIU/mL
        geometric mean (standard deviation)
    5883.93 ± 5.423
    4824.06 ± 6.293
    5505.98 ± 5.975
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Lot A to Lot B Consistency of Sci-B-Vac
    Comparison groups
    Sci-B-Vac® Lot A v Sci-B-Vac® Lot B
    Number of subjects included in analysis
    1221
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1
    Notes
    [2] - Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5]
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Lot A to Lot C Consistency of Sci-B-Vac
    Comparison groups
    Sci-B-Vac® Lot A v Sci-B-Vac® Lot C
    Number of subjects included in analysis
    1230
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.15
    Notes
    [3] - Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5]
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Lot B to Lot C Consistency of Sci-B-Vac
    Comparison groups
    Sci-B-Vac® Lot C v Sci-B-Vac® Lot B
    Number of subjects included in analysis
    1229
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC Ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.41
    Notes
    [4] - Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5]

    Secondary: Seroprotection rate (SPR) of anti-HBs at day 196 for Sci-B-Vac® compared to day 196 for Engerix-B® (Per Protocol Set 2)

    		 Close Top of page
    End point title
    		 Seroprotection rate (SPR) of anti-HBs at day 196 for Sci-B-Vac® compared to day 196 for Engerix-B® (Per Protocol Set 2) [5]
    End point description
    The difference in proportions [SPR(Sci-B-Vac®)–SPR(Engerix-B®)] and two-sided 95% CIs were summarized. If the lower bound of the 95% CI was > 5%, Sci-B-Vac® was to be declared non-inferior to Engerix-B®
    End point type
    Secondary
    End point timeframe
    4 weeks after third vaccination (Study Day 196)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The arms for individual Sci-B-Vac lots are not included in this analysis as the intent is to compare results for the Engerix-B® arm with those of the Pooled Sci-B-Vac arm.
    End point values
    		 Engerix-B® Pooled Sci-B-Vac
    Number of subjects analysed
    592
    1753
    Units: Number of Subjects
        number (not applicable)
    561
    1753
    Statistical analysis title
    		 Secondary1
    Statistical analysis description
    Seroprotection rate (SPR) at Study Day 196 in PPS2
    Comparison groups
    Engerix-B® v Pooled Sci-B-Vac
    Number of subjects included in analysis
    2345
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in proportions
    Point estimate
    4.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.9
         upper limit
    		 6.63

    Secondary: Number of subjects reporting solicited local adverse events day 1 through day 7 after any vaccination

    		 Close Top of page
    End point title
    		 Number of subjects reporting solicited local adverse events day 1 through day 7 after any vaccination [6]
    End point description
    Analysis of local solicited adverse events with an interval of onset of Day 1 to Day 7 after any vaccination with either Sci-B-Vac® or Engerix-B®, in adults ≥18 years old.
    End point type
    Secondary
    End point timeframe
    Day of vaccine administration and six subsequent days
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The Pooled Sci-B-Vac arm, which is a pool of data from the three Sci-B-Vac arms, is not included in this analysis as the intent is to demonstrate consistency among the three lots of Sci-B-Vac and Engerix-B®.
    End point values
    		 Engerix-B® Sci-B-Vac® Lot A Sci-B-Vac® Lot B Sci-B-Vac® Lot C
    Number of subjects analysed
    712
    711
    708
    705
    Units: Number of events
    469
    589
    602
    614
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited systemic adverse events day 1 through day 7 after any vaccination

    		 Close Top of page
    End point title
    		 Number of subjects reporting solicited systemic adverse events day 1 through day 7 after any vaccination [7]
    End point description
    Analysis of systemic solicited adverse events with an interval of onset of Day 1 to Day 7 after any vaccination with either Sci-B-Vac® or Engerix-B®, in adults ≥18 years old
    End point type
    Secondary
    End point timeframe
    Day of vaccine administration and six subsequent days
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The Pooled Sci-B-Vac arm, which is a pool of data from the three Sci-B-Vac arms, is not included in this analysis as the intent is to demonstrate safety among the three lots of Sci-B-Vac and Engerix-B®.
    End point values
    		 Engerix-B® Sci-B-Vac® Lot A Sci-B-Vac® Lot B Sci-B-Vac® Lot C
    Number of subjects analysed
    712
    711
    708
    705
    Units: Number of events
    428
    451
    498
    496
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events through end of study

    		 Close Top of page
    End point title
    		 Number of subjects reporting unsolicited adverse events through end of study [8]
    End point description
    Summary of unsolicited treatment-emergent adverse events reported in ≥1% of subjects after vaccination with either Sci-B-Vac® Lots A, B or C or with Engerix-B®, in adults ≥18 years old.
    End point type
    Secondary
    End point timeframe
    Through end of study (day 336)
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The Pooled Sci-B-Vac arm, which is a pool of data from the three Sci-B-Vac arms, is not included in this analysis as the intent is to demonstrate consistency among the three lots of Sci-B-Vac and Engerix-B®.
    End point values
    		 Engerix-B® Sci-B-Vac® Lot A Sci-B-Vac® Lot B Sci-B-Vac® Lot C
    Number of subjects analysed
    712
    711
    708
    705
    Units: Number of events
    371
    362
    380
    386
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events through end of study

    		 Close Top of page
    End point title
    		 Number of subjects reporting serious adverse events through end of study [9]
    End point description
    Summary of unsolicited serious adverse events reported after vaccination with either Sci-B-Vac® Lots A, B and C or with Engerix-B®, in adults ≥18 years old.
    End point type
    Secondary
    End point timeframe
    Through end of study (day 336)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The Pooled Sci-B-Vac arm, which is a pool of data from the three Sci-B-Vac arms, is not included in this analysis as the intent is to demonstrate consistency among the three lots of Sci-B-Vac and Engerix-B®.
    End point values
    		 Engerix-B® Sci-B-Vac® Lot A Sci-B-Vac® Lot B Sci-B-Vac® Lot C
    Number of subjects analysed
    712
    711
    708
    705
    Units: Number of events
    4
    15
    20
    12
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Includes serious adverse events collected throughout the trial and non adverse events starting from Day 1 to Day 28 post any vaccination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Sci-B-Vac® Lot A
    Reporting group description
    		 Sci-B-Vac® Lot A Hepatitis B Vaccination Sci-B-Vac® Hepatitis B vaccination, 10 ug, intramuscular (IM) injection at Days 1, 28, and 168

    Reporting group title
    Sci-B-Vac® Lot B
    Reporting group description
    		 Sci-B-Vac® Lot B Hepatitis B Vaccination Sci-B-Vac® Hepatitis B vaccination, 10 ug, intramuscular (IM) injection at Days 1, 28, and 168

    Reporting group title
    Sci-B-Vac® Lot C
    Reporting group description
    		 Sci-B-Vac® Lot C Hepatitis B Vaccination Sci-B-Vac® Hepatitis B vaccination, 10 ug, intramuscular (IM) injection at Days 1, 28, and 168

    Reporting group title
    Engerix-B®
    Reporting group description
    		 Engerix-B® (hepatitis B vaccine) Hepatitis B vaccination, Solution, 20 ug, IM injection at Days 0, 28, and 168

    Serious adverse events
    		 Sci-B-Vac® Lot A Sci-B-Vac® Lot B Sci-B-Vac® Lot C Engerix-B®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 711 (1.69%)
    18 / 708 (2.54%)
    12 / 705 (1.70%)
    3 / 712 (0.42%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    1 / 712 (0.14%)
         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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Sudden cardiac death
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    0 / 712 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Ankle fracture
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Concussion
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Head injury
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Humerus fracture
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    0 / 712 (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
    Joint dislocation
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Lower limb fracture
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Spinal compression fracture
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Tendon rupture
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    0 / 712 (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
    Tibia fracture
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Upper limb fracture
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    1 / 712 (0.14%)
         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
    Congenital, familial and genetic disorders
    Gastrointestinal arteriovenous malformation
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Cardiac disorders
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Seizure
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Syncope
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Vertigo positional
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Gastrointestinal disorders
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    1 / 712 (0.14%)
         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
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Skin and subcutaneous tissue disorders
    Skin necrosis
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    1 / 712 (0.14%)
         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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 711 (0.14%)
    2 / 708 (0.28%)
    0 / 705 (0.00%)
    0 / 712 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    0 / 712 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    0 / 712 (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
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    0 / 712 (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
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 711 (0.14%)
    1 / 708 (0.14%)
    1 / 705 (0.14%)
    0 / 712 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Chlamydial infection
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Infectious mononucleosis
         subjects affected / exposed
    0 / 711 (0.00%)
    0 / 708 (0.00%)
    1 / 705 (0.14%)
    0 / 712 (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
    Laryngitis
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    0 / 712 (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
    Pneumonia
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    0 / 712 (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
    Pyelonephritis
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Pyelonephritis acute
         subjects affected / exposed
    0 / 711 (0.00%)
    1 / 708 (0.14%)
    0 / 705 (0.00%)
    0 / 712 (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
    Tonsillitis
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    0 / 712 (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
    Vestibular neuronitis
         subjects affected / exposed
    1 / 711 (0.14%)
    0 / 708 (0.00%)
    0 / 705 (0.00%)
    0 / 712 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Sci-B-Vac® Lot A Sci-B-Vac® Lot B Sci-B-Vac® Lot C Engerix-B®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    618 / 711 (86.92%)
    640 / 708 (90.40%)
    636 / 705 (90.21%)
    559 / 712 (78.51%)
    Nervous system disorders
    Headache
    Additional description: Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE
         subjects affected / exposed
    273 / 711 (38.40%)
    307 / 708 (43.36%)
    303 / 705 (42.98%)
    289 / 712 (40.59%)
         occurrences all number
    460
    489
    486
    485
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    266 / 711 (37.41%)
    296 / 708 (41.81%)
    292 / 705 (41.42%)
    284 / 712 (39.89%)
         occurrences all number
    449
    481
    485
    466
    Injection site pain
    Additional description: Injection site pain events that occurred after 7 days post-vaccination were considered as unsolicited AE
         subjects affected / exposed
    590 / 711 (82.98%)
    598 / 708 (84.46%)
    608 / 705 (86.24%)
    461 / 712 (64.75%)
         occurrences all number
    1381
    1400
    1445
    897
    Injection site pruritus
    Additional description: Injection site pruritus events that occurred after 7 days post-vaccination were considered as unsolicited AE
         subjects affected / exposed
    84 / 711 (11.81%)
    105 / 708 (14.83%)
    92 / 705 (13.05%)
    88 / 712 (12.36%)
         occurrences all number
    102
    143
    126
    120
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Diarrhoea events that occurred after 7 days post-vaccination were considered as unsolicited AE
         subjects affected / exposed
    97 / 711 (13.64%)
    90 / 708 (12.71%)
    100 / 705 (14.18%)
    106 / 712 (14.89%)
         occurrences all number
    118
    114
    129
    141
    Nausea
    Additional description: Nausea events that occurred after 7 days post-vaccination were considered as unsolicited AE
         subjects affected / exposed
    87 / 711 (12.24%)
    88 / 708 (12.43%)
    80 / 705 (11.35%)
    86 / 712 (12.08%)
         occurrences all number
    103
    114
    101
    101
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    28 / 711 (3.94%)
    23 / 708 (3.25%)
    40 / 705 (5.67%)
    31 / 712 (4.35%)
         occurrences all number
    50
    31
    60
    46
    Musculoskeletal and connective tissue disorders
    Myalgia
    Additional description: Myalgia events that occurred after 7 days post-vaccination were considered as unsolicited AE
         subjects affected / exposed
    289 / 711 (40.65%)
    317 / 708 (44.77%)
    338 / 705 (47.94%)
    235 / 712 (33.01%)
         occurrences all number
    474
    524
    575
    348
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    61 / 711 (8.58%)
    69 / 708 (9.75%)
    66 / 705 (9.36%)
    63 / 712 (8.85%)
         occurrences all number
    73
    79
    71
    78
    Nasopharyngitis
         subjects affected / exposed
    30 / 711 (4.22%)
    36 / 708 (5.08%)
    38 / 705 (5.39%)
    45 / 712 (6.32%)
         occurrences all number
    32
    38
    42
    50

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 02:18:05 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA