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    Clinical Trial Results:
    A phase III, observer-blind, randomized, multi-country study to assess the reactogenicity and safety of the Porcine circovirus (PCV) free liquid formulation of GSK’s oral live attenuated human rotavirus (HRV) vaccine as compared to the lyophilized formulation of the GSK’s HRV vaccine, when administered as a 2-dose vaccination in infants starting at age 6-12 weeks.

    Summary
    EudraCT number
    		 2018-001986-18
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    30 Nov 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    13 Mar 2022
    First version publication date
    10 Jun 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor changes implemented in the full study results to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    208236
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03954743
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the reactogenicity of the liquid HRV vaccine and lyophilized HRV vaccine in terms of solicited adverse events (AEs) during the 8-day (Day 1-Day 8) follow-up period after each vaccination. • To assess the safety of the liquid HRV vaccine and lyophilized HRV vaccine in terms of unsolicited AEs during the 31-day (Day 1-Day 31) follow-up period after each vaccination and serious adverse events (SAEs) during the entire study period.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of the vaccines, with appropriate medical treatment readily available in case of anaphylaxis and syncope.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jul 2019
    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
    Canada: 239
    Country: Number of subjects enrolled
    Hong Kong: 364
    Country: Number of subjects enrolled
    Taiwan: 215
    Country: Number of subjects enrolled
    Turkey: 275
    Country: Number of subjects enrolled
    United States: 258
    Worldwide total number of subjects
    1351
    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)
    1351
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in 5 countries/regions (Canada, Hong Kong, Taiwan, Turkey and United States).

    Pre-assignment
    Screening details
    		 All 1351 participants enrolled in the study, received a study vaccination and were included in the Exposed Set.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Data were collected in an observer-blind manner. By observer-blind, it is meant that during the study period, the vaccine(s) recipient and those responsible for the evaluation of any study endpoint (e.g. safety and reactogenicity) were all unaware of which vaccine was administered.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HRV PCV-free Liq Group
    Arm description
    		 Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PCV-free liquid formulation of GSK Biologicals’ oral live attenuated HRV vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.

    Arm title
    		 HRV Lyo Group
    Arm description
    		 Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lyophilized formulation of GSK’s oral live attenuated HRV vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.

    Number of subjects in period 1
    		HRV PCV-free Liq Group HRV Lyo Group
    Started
    677
    674
    Completed
    653
    657
    Not completed
    24
    17
         Adverse event, non-fatal
    1
    -
         MIGRATED / MOVED FROM THE STUDY AREA
    3
    1
         Lost to follow-up
    6
    4
         Protocol deviation
    1
    -
         CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT
    13
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HRV PCV-free Liq Group
    Reporting group description
    		 Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.

    Reporting group title
    HRV Lyo Group
    Reporting group description
    		 Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.

    Reporting group values
    		 HRV PCV-free Liq Group HRV Lyo Group Total
    Number of subjects
    		 677 674 1351
    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)
    		 677 674 1351
        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 continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 9.0 ± 1.5 9.0 ± 1.5 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 336 357 693
        Male
    		 341 317 658
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian Or Alaska Native
    		 2 1 3
        Asian
    		 302 301 603
        Black Or African American
    		 14 10 24
        Native Hawaiian Or Other Pacific Islander
    		 0 2 2
        Other, Not specified
    		 20 14 34
        White
    		 339 346 685

    End points

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    End points reporting groups
    Reporting group title
    HRV PCV-free Liq Group
    Reporting group description
    		 Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.

    Reporting group title
    HRV Lyo Group
    Reporting group description
    		 Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.

    Primary: Number of subjects with any solicited general adverse events (AEs) after the first vaccination

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    End point title
    		 Number of subjects with any solicited general adverse events (AEs) after the first vaccination [1]
    End point description
    Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
    End point type
    Primary
    End point timeframe
    During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 HRV PCV-free Liq Group HRV Lyo Group
    Number of subjects analysed
    677
    674
    Units: Subjects
        Cough / Runny Nose, Any
    139
    166
        Diarrhea, Any
    41
    47
        Fever, ≥ 38.0°C
    27
    21
        Irritability / Fussiness, Any
    431
    428
        Loss of appetite, Any
    201
    186
        Vomiting, Any
    113
    122
    No statistical analyses for this end point

    Primary: Number of subjects with any solicited general adverse events (AEs) after the second vaccination

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    End point title
    		 Number of subjects with any solicited general adverse events (AEs) after the second vaccination [2]
    End point description
    Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
    End point type
    Primary
    End point timeframe
    During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 HRV PCV-free Liq Group HRV Lyo Group
    Number of subjects analysed
    663
    657
    Units: Subjects
        Cough / Runny Nose, Any
    147
    145
        Diarrhea, Any
    28
    36
        Fever, ≥ 38.0°C
    46
    40
        Irritability / Fussiness, Any
    368
    362
        Loss of appetite, Any
    170
    168
        Vomiting, Any
    82
    88
    No statistical analyses for this end point

    Primary: Number of subjects with any unsolicited AEs

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    End point title
    		 Number of subjects with any unsolicited AEs [3]
    End point description
    An unsolicited AE is defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
    End point type
    Primary
    End point timeframe
    During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 HRV PCV-free Liq Group HRV Lyo Group
    Number of subjects analysed
    677
    674
    Units: Subjects
    201
    206
    No statistical analyses for this end point

    Primary: Number of subjects with any serious adverse events (SAEs)

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    End point title
    		 Number of subjects with any serious adverse events (SAEs) [4]
    End point description
    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
    End point type
    Primary
    End point timeframe
    Throughout the study period (from Day 1 up to Month 7 or Month 8)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 HRV PCV-free Liq Group HRV Lyo Group
    Number of subjects analysed
    677
    674
    Units: Subjects
    39
    38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    HRV PCV-free Liq Group
    Reporting group description
    		 Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.

    Reporting group title
    HRV Lyo Group
    Reporting group description
    		 Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.

    Serious adverse events
    		 HRV PCV-free Liq Group HRV Lyo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    39 / 677 (5.76%)
    38 / 674 (5.64%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear canal abrasion
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Osteogenesis imperfecta
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scaphocephaly
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 677 (0.15%)
    3 / 674 (0.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    2 / 677 (0.30%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    3 / 677 (0.44%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Citrobacter infection
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    2 / 677 (0.30%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    3 / 677 (0.44%)
    3 / 674 (0.45%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 677 (0.30%)
    4 / 674 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis enteroviral
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    3 / 677 (0.44%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Human bocavirus infection
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    3 / 677 (0.44%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis streptococcal
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 677 (0.15%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Picornavirus infection
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 677 (0.44%)
    3 / 674 (0.45%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    5 / 677 (0.74%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 677 (0.15%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Roseola
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 677 (0.74%)
    6 / 674 (0.89%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    6 / 677 (0.89%)
    4 / 674 (0.59%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 677 (0.30%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Lactose intolerance
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HRV PCV-free Liq Group HRV Lyo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    591 / 677 (87.30%)
    571 / 674 (84.72%)
    Pregnancy, puerperium and perinatal conditions
    Weight decrease neonatal
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Discomfort
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Face oedema
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Ill-defined disorder
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 677 (0.15%)
    3 / 674 (0.45%)
         occurrences all number
    1
    3
    Injection site pain
         subjects affected / exposed
    2 / 677 (0.30%)
    2 / 674 (0.30%)
         occurrences all number
    2
    2
    Irritability postvaccinal
         subjects affected / exposed
    2 / 677 (0.30%)
    0 / 674 (0.00%)
         occurrences all number
    2
    0
    Pain
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    92 / 677 (13.59%)
    70 / 674 (10.39%)
         occurrences all number
    103
    79
    Swelling
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Swelling face
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Vaccination site pain
         subjects affected / exposed
    5 / 677 (0.74%)
    4 / 674 (0.59%)
         occurrences all number
    6
    5
    Immune system disorders
    Milk allergy
         subjects affected / exposed
    0 / 677 (0.00%)
    3 / 674 (0.45%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 677 (0.30%)
    0 / 674 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    241 / 677 (35.60%)
    239 / 674 (35.46%)
         occurrences all number
    295
    323
    Nasal congestion
         subjects affected / exposed
    5 / 677 (0.74%)
    4 / 674 (0.59%)
         occurrences all number
    5
    4
    Productive cough
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 677 (0.30%)
    10 / 674 (1.48%)
         occurrences all number
    2
    12
    Sneezing
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Stridor
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Wheezing
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    512 / 677 (75.63%)
    487 / 674 (72.26%)
         occurrences all number
    812
    796
    Investigations
    Body temperature increased
         subjects affected / exposed
    2 / 677 (0.30%)
    1 / 674 (0.15%)
         occurrences all number
    2
    1
    Cardiac murmur
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Vaccination complication
         subjects affected / exposed
    7 / 677 (1.03%)
    9 / 674 (1.34%)
         occurrences all number
    7
    9
    Congenital, familial and genetic disorders
    Ankyloglossia congenital
         subjects affected / exposed
    2 / 677 (0.30%)
    1 / 674 (0.15%)
         occurrences all number
    2
    1
    Developmental hip dysplasia
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Buried penis syndrome
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Hydrocele
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Nervous system disorders
    Lethargy
         subjects affected / exposed
    1 / 677 (0.15%)
    2 / 674 (0.30%)
         occurrences all number
    1
    3
    Somnolence
         subjects affected / exposed
    2 / 677 (0.30%)
    5 / 674 (0.74%)
         occurrences all number
    3
    6
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences all number
    1
    1
    Eye disorders
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Blepharitis
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Keratitis
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Eye discharge
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 677 (0.15%)
    3 / 674 (0.45%)
         occurrences all number
    1
    3
    Abnormal faeces
         subjects affected / exposed
    2 / 677 (0.30%)
    0 / 674 (0.00%)
         occurrences all number
    2
    0
    Anal fissure
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Change of bowel habit
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    61 / 677 (9.01%)
    81 / 674 (12.02%)
         occurrences all number
    76
    100
    Constipation
         subjects affected / exposed
    10 / 677 (1.48%)
    3 / 674 (0.45%)
         occurrences all number
    10
    3
    Faeces discoloured
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Eructation
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    2 / 677 (0.30%)
    7 / 674 (1.04%)
         occurrences all number
    2
    7
    Gastrointestinal pain
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 677 (0.74%)
    3 / 674 (0.45%)
         occurrences all number
    5
    3
    Haematochezia
         subjects affected / exposed
    2 / 677 (0.30%)
    4 / 674 (0.59%)
         occurrences all number
    3
    4
    Infantile spitting up
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Infantile colic
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Mucous stools
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences all number
    1
    1
    Infrequent bowel movements
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Salivary hypersecretion
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    153 / 677 (22.60%)
    170 / 674 (25.22%)
         occurrences all number
    198
    219
    Teething
         subjects affected / exposed
    7 / 677 (1.03%)
    7 / 674 (1.04%)
         occurrences all number
    9
    8
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    2 / 677 (0.30%)
    4 / 674 (0.59%)
         occurrences all number
    2
    4
    Dermatitis allergic
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    6 / 677 (0.89%)
    2 / 674 (0.30%)
         occurrences all number
    6
    2
    Dermatitis contact
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Dermatitis diaper
         subjects affected / exposed
    6 / 677 (0.89%)
    5 / 674 (0.74%)
         occurrences all number
    6
    6
    Dry skin
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Eczema infantile
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    16 / 677 (2.36%)
    8 / 674 (1.19%)
         occurrences all number
    17
    8
    Erythema
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences all number
    1
    1
    Petechiae
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    10 / 677 (1.48%)
    9 / 674 (1.34%)
         occurrences all number
    11
    9
    Rash erythematous
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Rash macular
         subjects affected / exposed
    0 / 677 (0.00%)
    4 / 674 (0.59%)
         occurrences all number
    0
    4
    Seborrhoeic dermatitis
         subjects affected / exposed
    3 / 677 (0.44%)
    3 / 674 (0.45%)
         occurrences all number
    3
    3
    Musculoskeletal and connective tissue disorders
    Acquired plagiocephaly
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    8 / 677 (1.18%)
    9 / 674 (1.34%)
         occurrences all number
    8
    9
    Candida nappy rash
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Croup infectious
         subjects affected / exposed
    2 / 677 (0.30%)
    3 / 674 (0.45%)
         occurrences all number
    2
    3
    Conjunctivitis
         subjects affected / exposed
    3 / 677 (0.44%)
    7 / 674 (1.04%)
         occurrences all number
    3
    7
    Conjunctivitis viral
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Enterovirus infection
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences all number
    1
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 677 (0.15%)
    3 / 674 (0.45%)
         occurrences all number
    1
    3
    Gastroenteritis viral
         subjects affected / exposed
    0 / 677 (0.00%)
    2 / 674 (0.30%)
         occurrences all number
    0
    2
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    2 / 677 (0.30%)
    1 / 674 (0.15%)
         occurrences all number
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    30 / 677 (4.43%)
    22 / 674 (3.26%)
         occurrences all number
    31
    24
    Omphalitis
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
         subjects affected / exposed
    3 / 677 (0.44%)
    2 / 674 (0.30%)
         occurrences all number
    4
    2
    Otitis externa
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    8 / 677 (1.18%)
    3 / 674 (0.45%)
         occurrences all number
    9
    3
    Paronychia
         subjects affected / exposed
    0 / 677 (0.00%)
    3 / 674 (0.45%)
         occurrences all number
    0
    3
    Otitis media acute
         subjects affected / exposed
    1 / 677 (0.15%)
    3 / 674 (0.45%)
         occurrences all number
    1
    3
    Pharyngitis
         subjects affected / exposed
    6 / 677 (0.89%)
    2 / 674 (0.30%)
         occurrences all number
    7
    2
    Pneumonia viral
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Pustule
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    47 / 677 (6.94%)
    46 / 674 (6.82%)
         occurrences all number
    52
    53
    Rhinovirus infection
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Skin infection
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Tinea barbae
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Tinea capitis
         subjects affected / exposed
    1 / 677 (0.15%)
    0 / 674 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    26 / 677 (3.84%)
    34 / 674 (5.04%)
         occurrences all number
    31
    35
    Viral rash
         subjects affected / exposed
    0 / 677 (0.00%)
    2 / 674 (0.30%)
         occurrences all number
    0
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 677 (0.00%)
    2 / 674 (0.30%)
         occurrences all number
    0
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 677 (0.15%)
    1 / 674 (0.15%)
         occurrences all number
    1
    1
    Suspected COVID-19
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    290 / 677 (42.84%)
    261 / 674 (38.72%)
         occurrences all number
    371
    361
    Increased appetite
         subjects affected / exposed
    0 / 677 (0.00%)
    1 / 674 (0.15%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Sep 2019
    The protocol was amended primarily to include the possibility of home visit at Visit 3 (Month 2-4) safety assessments for authorized Canadian sites only. In addition, other administrative and editorial changes required in the protocol were also updated.
    30 Mar 2020
    This protocol amendment outlines measures that may be applicable during special circumstances (e.g., COVID-19 pandemic). The purpose of the amendment is to protect participant’s welfare and safety, and as far as possible ensure the potential benefit to the participant and promote data integrity.

    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.

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