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    Clinical Trial Results:
    Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in healthy females 9 to 15 years of age in India

    Summary
    EudraCT number
    		 2017-000111-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    04 Feb 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Feb 2017
    First version publication date
    25 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V501-029
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00380367
    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
    04 Feb 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Feb 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India. Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11, 16, and 18. mMU/mL = milli-Merck units/milliliter
    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
    03 May 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    India: 110
    Worldwide total number of subjects
    110
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    44
    Adolescents (12-17 years)
    66
    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
    		 First Patient In (FPI): 03 May 2007 Last Patient Out (LPO): 04 Feb 2008 Multi-center study. Seven sites participated in the study. All sites were medical centers located in Bangalore, Mumbai and Pune.

    Pre-assignment
    Screening details
    		 Open-label, single-arm, nonrandomized study. Females >9 to 15 years of age who at first vaccination had not had coitarche, did not plan on becoming sexually active through the course of the study, and who did not have a feverish feeling within 24 hours prior to the first injection, were included in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)
    Arm description
    		 Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent HPV VLP vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Quadrivalent HPV VLP Recombinant Vaccine (Types 6, 11, 16, 18)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.

    Number of subjects in period 1
    		Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)
    Started
    110
    Completed
    108
    Not completed
    2
         Consent withdrawn by subject
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)
    Reporting group description
    		 Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent HPV VLP vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.

    Reporting group values
    		 Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18) Total
    Number of subjects
    		 110 110
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.54 ± 1.67 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 110 110
        Male
    		 0 0
    Study Specific Characteristic | Body Mass Index (BMI)
    Units: Kg/m2
        arithmetic mean (standard deviation)
    		 16.76 ± 2.79 -
    Study Specific Characteristic | Height
    Units: Cm
        arithmetic mean (standard deviation)
    		 143.32 ± 9.58 -
    Study Specific Characteristic | Weight
    Units: Kg
        median (standard deviation)
    		 34.9 ± 8.81 -

    End points

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    End points reporting groups
    Reporting group title
    Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)
    Reporting group description
    		 Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent HPV VLP vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.

    Primary: Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7

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    End point title
    		 Percentage of Participants Who Seroconvert to Each HPV Serotype (Types 6, 11, 16, 18) at Month 7 [1]
    End point description
    Month 7 HPV competitive Luminex Immunoassay (cLIA) seroconversion rates among participants who received Quadrivalent HPV (Types 6, 11, 16, 18) Late 1 (L1) capsid protein VLP vaccine reported. Quadrivalent HPV competitive cLIA (v2.0) used to detect antibody to HPV VLPs serotypes 6, 11, 16, 18 before and after vaccination. Seropositivity cutoffs of HPV cLIAs assessed using a panel of sera from participants highly likely to be HPV naïve (children), and from participants highly likely to be seropositive. Samples with value < cutoffs = serostatus negative. Samples with values ≥ cutoff = serostatus positive. Cutoffs for HPV 6, 11, 16, and 18 cLIAs were 20 mMU/mL, 16 mMU/mL, 20 mMU/mL, and 24 mMU/mL, respectively. Analysis performed in all participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were sero-negative at Day 1 for the relevant HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
    End point type
    Primary
    End point timeframe
    One month post-dose 3 (Month 7)
    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: There was no formal efficacy hypothesis testing planned for this endpoint, and there were no between-group statistical comparisons performed.
    End point values
    		 Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)
    Number of subjects analysed
    105
    Units: percentage of participants
    number (confidence interval 95%)
        Anti-HPV 6 (n=99)
    96.97 (93.59 to 100.35)
        Anti-HPV 11 (n=105)
    99.05 (97.19 to 100.91)
        Anti-HPV 16 (n=105)
    99.05 (97.19 to 100.91)
        Anti-HPV 18 (n=105)
    99.05 (97.19 to 100.91)
    No statistical analyses for this end point

    Primary: Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study

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    End point title
    		 Number of Participants With Any Adverse Events (AEs), Injection-site AEs, Systemic AEs, or Vaccine-related AEs During the Study [2]
    End point description
    AE defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with use of SPONSOR’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition temporally associated with the use of the SPONSOR’s product, was also an AE. Pre-specified injection site AEs included pain, tenderness, erythema, and swelling. A vaccine-related AE was an AE considered by the investigator to be possibly, probably, or definitely related to the vaccine. All AEs collected on participant’s Vaccination Report Card daily for 14 days after each vaccination (Days 1-15). Number of participants experiencing ≥1 AE, number of participants experiencing ≥1 injection site AE, number of participants experiencing ≥1 systemic AE, and number of participants experiencing ≥1 vaccine-related AE were reported for the Safety Cohort (all enrolled participants who received ≥1 injection and had safety follow-up data).
    End point type
    Primary
    End point timeframe
    Up to 7 months
    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: There was no formal efficacy hypothesis testing planned for this endpoint, and there were no between-group statistical comparisons performed.
    End point values
    		 Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)
    Number of subjects analysed
    108 [3]
    Units: participants
        Any AE
    63
        Injection site AE
    50
        Systemic AE
    35
        Vaccine-related AE
    45
    Notes
    [3] - 2 participants did not have safety follow-up data and were excluded from safety analyses.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 7 months
    Adverse event reporting additional description
    Safety Cohort: All enrolled participants who received ≥1 injection and had safety follow-up data. Two participants did not have safety follow-up data and were excluded from safety analyses.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)
    Reporting group description
    		 Participants who were enrolled received a total of 3 intramuscular injections of Quadrivalent HPV VLP vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.

    Serious adverse events
    		 Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 108 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    63 / 108 (58.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 108 (4.63%)
         occurrences all number
    5
    Somnolence
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    25 / 108 (23.15%)
         occurrences all number
    25
    Injection site pain
         subjects affected / exposed
    46 / 108 (42.59%)
         occurrences all number
    83
    Injection site tenderness
         subjects affected / exposed
    25 / 108 (23.15%)
         occurrences all number
    41
    Injection site erythema
         subjects affected / exposed
    13 / 108 (12.04%)
         occurrences all number
    20
    Injection site swelling
         subjects affected / exposed
    10 / 108 (9.26%)
         occurrences all number
    16
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 108 (1.85%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 108 (3.70%)
         occurrences all number
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 108 (7.41%)
         occurrences all number
    8
    Pharyngitis
         subjects affected / exposed
    1 / 108 (0.93%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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