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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants

    Summary
    EudraCT number
    2016-005159-25
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 Jun 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Aug 2018
    First version publication date
    03 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V260-024
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02062385
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    11 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study assessed the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo were to be enrolled and randomized (1:1) to receive either V260 or placebo. Participants were also to receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either staggered or concomitantly with V260 or placebo. All participants were followed for efficacy and safety. Immune responses to OPV and DTaP were evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 May 2014
    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
    China: 4040
    Worldwide total number of subjects
    4040
    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)
    4040
    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
    A total of 4173 participants were screened, 4040 were randomized, and 4037 received at least one dose of study vaccination.

    Pre-assignment
    Screening details
    The study enrolled healthy Chinese infants.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    V260 with Staggered EPI
    Arm description
    V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered China Expanded Program on Immunization (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
    Arm type
    Experimental

    Investigational medicinal product name
    V260
    Investigational medicinal product code
    Other name
    RotaTeq™; live, oral, pentavalent rotavirus vaccine
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    2 mL oral solution

    Investigational medicinal product name
    Diphtheria, tetanus, acellular pertussis vaccine (DTaP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 intramuscular injection

    Investigational medicinal product name
    Oral poliovirus vaccine (OPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    1 gram oral solution

    Arm title
    Placebo with Staggered EPI
    Arm description
    Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    2 mL oral solution

    Investigational medicinal product name
    Oral poliovirus vaccine (OPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    1 gram oral solution

    Investigational medicinal product name
    Diphtheria, tetanus, acellular pertussis vaccine (DTaP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 intramuscular injection

    Arm title
    V260 with Concomitant EPI
    Arm description
    V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
    Arm type
    Experimental

    Investigational medicinal product name
    V260
    Investigational medicinal product code
    Other name
    RotaTeq™; live, oral, pentavalent rotavirus vaccine
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    2 mL oral solution

    Investigational medicinal product name
    Oral poliovirus vaccine (OPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    1 gram oral solution

    Investigational medicinal product name
    Diphtheria, tetanus, acellular pertussis vaccine (DTaP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 intramuscular injection

    Arm title
    Placebo with Concomitant EPI
    Arm description
    Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    2 mL oral solution

    Investigational medicinal product name
    Oral poliovirus vaccine (OPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    1 gram oral solution

    Investigational medicinal product name
    Diphtheria, tetanus, acellular pertussis vaccine (DTaP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 intramuscular injection

    Number of subjects in period 1
    V260 with Staggered EPI Placebo with Staggered EPI V260 with Concomitant EPI Placebo with Concomitant EPI
    Started
    1620
    1620
    400
    400
    Received Vaccination 1
    1618
    1619
    400
    400
    Received Vaccination 2
    1554
    1566
    392
    393
    Received Vaccination 3
    1543
    1554 [1]
    389
    392
    Completed
    1542
    1555
    388
    391
    Not completed
    78
    65
    12
    9
         Protocol deviation
    1
    -
    -
    -
         Moved
    10
    11
    1
    -
         Adverse event, serious fatal
    -
    -
    -
    1
         Adverse event, non-fatal
    19
    13
    1
    -
         Incomplete EPI by database lock
    2
    -
    -
    -
         Lost to follow-up
    -
    -
    1
    -
         Withdrawn by parent/guardian
    46
    41
    9
    8
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: One participant did not receive the third vaccination but continued in the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V260 with Staggered EPI
    Reporting group description
    V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered China Expanded Program on Immunization (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.

    Reporting group title
    Placebo with Staggered EPI
    Reporting group description
    Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.

    Reporting group title
    V260 with Concomitant EPI
    Reporting group description
    V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.

    Reporting group title
    Placebo with Concomitant EPI
    Reporting group description
    Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.

    Reporting group values
    V260 with Staggered EPI Placebo with Staggered EPI V260 with Concomitant EPI Placebo with Concomitant EPI Total
    Number of subjects
    1620 1620 400 400 4040
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    1620 1620 400 400 4040
    Age Continuous
    Units: days
        arithmetic mean (standard deviation)
    57.5 ± 10.0 57.2 ± 9.7 68.3 ± 5.7 68.5 ± 5.7 -
    Gender, Male/Female
    Units: Subjects
        Female
    806 775 185 183 1949
        Male
    814 845 215 217 2091

    End points

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    End points reporting groups
    Reporting group title
    V260 with Staggered EPI
    Reporting group description
    V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered China Expanded Program on Immunization (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.

    Reporting group title
    Placebo with Staggered EPI
    Reporting group description
    Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.

    Reporting group title
    V260 with Concomitant EPI
    Reporting group description
    V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.

    Reporting group title
    Placebo with Concomitant EPI
    Reporting group description
    Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.

    Subject analysis set title
    V260 with Staggered or Concomitant EPI
    Subject analysis set type
    Per protocol
    Subject analysis set description
    V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.

    Subject analysis set title
    Placebo with Staggered or Concomitant EPI
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.

    Subject analysis set title
    V260 with Staggered or Concomitant EPI
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.

    Subject analysis set title
    Placebo with Staggered or Concomitant EPI
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.

    Primary: Number of Participants with Any Severity of Rotavirus Gastroenteritis

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    End point title
    Number of Participants with Any Severity of Rotavirus Gastroenteritis
    End point description
    The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms. The population was participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.
    End point type
    Primary
    End point timeframe
    From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)
    End point values
    V260 with Staggered or Concomitant EPI Placebo with Staggered or Concomitant EPI
    Number of subjects analysed
    1927
    1937
    Units: Participants
    34
    109
    Statistical analysis title
    Vaccine Efficacy
    Comparison groups
    V260 with Staggered or Concomitant EPI v Placebo with Staggered or Concomitant EPI
    Number of subjects included in analysis
    3864
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    < 0.001 [2]
    Method
    Poisson distribution
    Parameter type
    Vaccine efficacy
    Point estimate
    69.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    54.5
         upper limit
    79.7
    Notes
    [1] - V260 will be considered efficacious if the lower bound of the two-sided confidence interval for efficacy is >0% at the final analysis
    [2] - To calculate the confidence interval and associated p-value, an exact conditional method based on a Poisson distribution was used.

    Secondary: Percentage of Participants with Elevated Temperature

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    End point title
    Percentage of Participants with Elevated Temperature
    End point description
    Elevated temperature (temperature >=37.5°C axillary or equivalent) was noted by the guardian and recorded on the Vaccination Report Card during Day 1 to Day 14 after each dose of vaccination. Elevated temperature reported by the guardian was also collected as an adverse event (pyrexia) during Day 15 to Day 30 after each dose of vaccination. The percentage of participants with axillary temperature >=37.5 °C or an adverse event of pyrexia was assessed. The population was All Subjects as Treated with follow-up specific to the endpoint.
    End point type
    Secondary
    End point timeframe
    Up to 30 days after any dose of V260 or Placebo
    End point values
    V260 with Staggered or Concomitant EPI Placebo with Staggered or Concomitant EPI
    Number of subjects analysed
    2015
    2019
    Units: Percentage of participants
        number (not applicable)
    21.84
    22.83
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Vomiting or Diarrhea

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    End point title
    Percentage of Participants with Vomiting or Diarrhea
    End point description
    Episodes of vomiting and diarrhea were noted by the guardian and recorded on the Vaccination Record Card during Day 1 to Day 14 after each dose of vaccination. Vomiting and diarrhea reported by the guardian were also collected as an adverse event during Day 15 to Day 30 after any dose of vaccination. The percentage of participants with an episode or an adverse event of vomiting or diarrhea was assessed. The population was All Subjects as Treated with follow-up specific to the endpoint.
    End point type
    Secondary
    End point timeframe
    Up to 30 days after any dose of V260 or Placebo
    End point values
    V260 with Staggered or Concomitant EPI Placebo with Staggered or Concomitant EPI
    Number of subjects analysed
    2015
    2019
    Units: Percentage of participants
    number (not applicable)
        Vomiting
    2.68
    3.52
        Diarrhea
    20.15
    20.11
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Intussusception

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    End point title
    Percentage of Participants with Intussusception
    End point description
    Episodes of intussusception were collected from the time of written consent until the end of study. The percentage of participants with an episode of intussusception was assessed. The population was All Subjects as Treated with follow-up specific to the endpoint.
    End point type
    Secondary
    End point timeframe
    Up to 15 months
    End point values
    V260 with Staggered or Concomitant EPI Placebo with Staggered or Concomitant EPI
    Number of subjects analysed
    2015
    2019
    Units: Percentage of participants
        number (not applicable)
    0.10
    0.00
    No statistical analyses for this end point

    Secondary: Number of Participants with Severe Rotavirus Gastroenteritis

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    End point title
    Number of Participants with Severe Rotavirus Gastroenteritis
    End point description
    The number of participants with severe rotavirus gastroenteritis (RVGE) caused by naturally-occurring wildtype rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms. Severe RVGE was defined as >=11 on the Vesikari Scoring System, a composite of the seven parameters related to symptoms and treatment with an overall range from 0 to 20. The population was participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.
    End point type
    Secondary
    End point timeframe
    From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)
    End point values
    V260 with Staggered or Concomitant EPI Placebo with Staggered or Concomitant EPI
    Number of subjects analysed
    1926 [3]
    1937
    Units: Participants
    11
    52
    Notes
    [3] - 1 participant was excluded because the severity of RVGE was unknown
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3

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    End point title
    Percentage of Participants who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 [4]
    End point description
    The percentage of participants who achieved seroprotection against poliovirus Type 1, 2, or 3 was assessed. Seroprotection was defined as a neutralizing antibody titer >=1:8. This outcome was evaluated only in participants receiving concomitant administration of V260 and OPV. The population was participants in the concomitant EPI groups who receive their scheduled doses of OPV without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.
    End point type
    Secondary
    End point timeframe
    Baseline and between 28 and 56 days after the third OPV vaccination
    Notes
    [4] - 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: This endpoint was evaluated only in participants receiving concomitant administration of V260 and OPV.
    End point values
    V260 with Concomitant EPI Placebo with Concomitant EPI
    Number of subjects analysed
    187
    192
    Units: Percentage of participants
    number (confidence interval 95%)
        Poliovirus Type 1: Baseline, n=186, 190
    44.09 (36.83 to 51.54)
    38.95 (31.97 to 46.27)
        Poliovirus Type 1: Post OPV #3, n=187, 192
    98.93 (96.19 to 99.87)
    100.00 (98.10 to 100.00)
        Poliovirus Type 2: Baseline, n=186, 190
    44.09 (36.83 to 51.54)
    41.58 (34.49 to 48.94)
        Poliovirus Type 2: Post OPV #3, n=187, 192
    100.00 (98.05 to 100.00)
    100.00 (98.10 to 100.00)
        Poliovirus Type 3: Baseline, n=186, 190
    25.27 (19.20 to 32.15)
    21.05 (15.49 to 27.54)
        Poliovirus Type 3: Post OPV #3, n=187, 192
    98.93 (96.19 to 99.87)
    98.96 (96.29 to 99.87)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Any Adverse Event

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    End point title
    Percentage of Participants with Any Adverse Event
    End point description
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the sponsor’s product, is also an adverse event. The population was All Subjects as Treated with safety follow-up.
    End point type
    Secondary
    End point timeframe
    Up to 30 days after any dose of V260 or Placebo
    End point values
    V260 with Staggered or Concomitant EPI Placebo with Staggered or Concomitant EPI
    Number of subjects analysed
    2015
    2019
    Units: Percentage of participants
        number (not applicable)
    53.5
    53.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens

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    End point title
    Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens [5]
    End point description
    The percentage of participants seropositive to diphtheria, pertussis, or tetanus antigens was assessed. Seropositive was defined as the following: 1) anti-diphtheria antibody titers >=0.1 International Units (IU)/mL, 2) anti-tetanus antibody titers >=0.1 IU/mL, 3) antipertussis toxin antibody titers >=20 Enzyme-linked Immunosorbent Assay (ELISA) Units (EU)/mL, 4) anti-pertussis filamentous hemagglutinin (FHA) antibody titers >=20 EU/mL. This outcome was evaluated only in participants receiving concomitant administration of V260 or placebo and EPI. The population was participants in the concomitant EPI groups who receive their scheduled doses of DTaP without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.
    End point type
    Secondary
    End point timeframe
    Baseline and between 28 and 51 days after the third DTaP vaccination
    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: This endpoint was evaluated only in participants receiving concomitant administration of V260 or placebo and EPI.
    End point values
    V260 with Concomitant EPI Placebo with Concomitant EPI
    Number of subjects analysed
    187
    194
    Units: Percentage of participants
    number (confidence interval 95%)
        Diphtheria: Baseline, n=181, 186
    3.31 (1.23 to 7.08)
    2.69 (0.88 to 6.16)
        Diphtheria: Post DTaP #3, n=187, 194
    99.47 (97.06 to 99.99)
    99.48 (97.16 to 99.99)
        Pertussis FHA: Baseline, n=181, 186
    0.00 (0.00 to 2.02)
    0.00 (0.00 to 1.96)
        Pertussis FHA: Post DTaP #3, n=187, 194
    44.92 (37.65 to 52.35)
    43.81 (36.72 to 51.10)
        Pertussis Toxin: Baseline, n=181, 186
    1.66 (0.34 to 4.77)
    1.08 (0.13 to 3.83)
        Pertussis Toxin, Post DTaP #3, n=187, 194
    95.19 (91.06 to 97.78)
    94.33 (90.08 to 97.14)
        Tetanus: Baseline, n=181, 186
    12.15 (7.78 to 17.82)
    12.37 (8.00 to 17.97)
        Tetanus: Post DTaP #3, n=187, 194
    100.00 (98.05 to 100.00)
    100.00 (98.12 to 100.00)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events: up to 30 days after any V260 or placebo vaccination; Serious Adverse Events: from the time of written consent until the end of the study (up to 15 months)
    Adverse event reporting additional description
    The at-risk population was All Subjects as Treated. Adverse events are reported for participants who received V260 or placebo without regard to staggered or concomitant EPI administration.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Placebo with Staggered or Concomitant EPI
    Reporting group description
    Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.

    Reporting group title
    V260 with Staggered or Concomitant EPI
    Reporting group description
    V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.

    Serious adverse events
    Placebo with Staggered or Concomitant EPI V260 with Staggered or Concomitant EPI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    338 / 2019 (16.74%)
    339 / 2015 (16.82%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Transient hypogammaglobulinaemia of infancy
         subjects affected / exposed
    1 / 2019 (0.05%)
    2 / 2015 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Developmental delay
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye contusion
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiomyopathy
         subjects affected / exposed
    1 / 2019 (0.05%)
    1 / 2015 (0.05%)
         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
    Developmental hip dysplasia
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Talipes
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalassaemia
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thalassaemia beta
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    9 / 2019 (0.45%)
    17 / 2015 (0.84%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 2019 (0.05%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulocytopenia
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Central nervous system lesion
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    3 / 2019 (0.15%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 2019 (0.45%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    41 / 2019 (2.03%)
    47 / 2015 (2.33%)
         occurrences causally related to treatment / all
    0 / 42
    0 / 52
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Functional gastrointestinal disorder
         subjects affected / exposed
    2 / 2019 (0.10%)
    2 / 2015 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    6 / 2019 (0.30%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 2019 (0.00%)
    2 / 2015 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis diaper
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 2019 (0.00%)
    2 / 2015 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rickets
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    5 / 2019 (0.25%)
    9 / 2015 (0.45%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 2019 (0.05%)
    2 / 2015 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    101 / 2019 (5.00%)
    84 / 2015 (4.17%)
         occurrences causally related to treatment / all
    0 / 108
    0 / 89
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    141 / 2019 (6.98%)
    129 / 2015 (6.40%)
         occurrences causally related to treatment / all
    0 / 158
    0 / 144
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    3 / 2019 (0.15%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    21 / 2019 (1.04%)
    20 / 2015 (0.99%)
         occurrences causally related to treatment / all
    1 / 22
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    1 / 2019 (0.05%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 2019 (0.15%)
    3 / 2015 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    1 / 2019 (0.05%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    24 / 2019 (1.19%)
    7 / 2015 (0.35%)
         occurrences causally related to treatment / all
    1 / 24
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis shigella
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingivitis
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    10 / 2019 (0.50%)
    19 / 2015 (0.94%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    2 / 2019 (0.10%)
    13 / 2015 (0.65%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes virus infection
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Omphalitis
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    3 / 2019 (0.15%)
    2 / 2015 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral infection
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    23 / 2019 (1.14%)
    21 / 2015 (1.04%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis bacterial
         subjects affected / exposed
    5 / 2019 (0.25%)
    2 / 2015 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    14 / 2019 (0.69%)
    30 / 2015 (1.49%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 2019 (0.05%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 2019 (0.00%)
    1 / 2015 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    3 / 2019 (0.15%)
    3 / 2015 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxoplasmosis
         subjects affected / exposed
    1 / 2019 (0.05%)
    0 / 2015 (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
    18 / 2019 (0.89%)
    16 / 2015 (0.79%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo with Staggered or Concomitant EPI V260 with Staggered or Concomitant EPI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    931 / 2019 (46.11%)
    938 / 2015 (46.55%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    92 / 2019 (4.56%)
    115 / 2015 (5.71%)
         occurrences all number
    109
    133
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    419 / 2019 (20.75%)
    414 / 2015 (20.55%)
         occurrences all number
    481
    492
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    406 / 2019 (20.11%)
    406 / 2015 (20.15%)
         occurrences all number
    504
    487
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    233 / 2019 (11.54%)
    228 / 2015 (11.32%)
         occurrences all number
    268
    248
    Upper respiratory tract infection
         subjects affected / exposed
    103 / 2019 (5.10%)
    91 / 2015 (4.52%)
         occurrences all number
    114
    98

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Mar 2014
    Amendment 1: the participant cohorts were reorganized as "Staggered Use" and Concomitant Use" groups; randomization ratio was clarified as 1:1 for V260:Placebo; sample sizes for study subgroups were changed; clarified that OPV and DTaP will be provided through routine health care (China EPI); changes to the timing and volumes of certain blood draws; changes to certain AE collection times; clarification of temperature assessment method; updated power calculations to reflect reduced subgroup sample sizes.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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