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    Clinical Trial Results:
    A phase II, open, controlled, multicenter study to evaluate the long-term antibody persistence at 1, 3 and 5 years after the administration of a four dose vaccination series of Hib-MenCY-TT vaccine compared to ActHIB in subjects given a four dose vaccination series in study Hib-MenCY-TT-005/006.

    Summary
    EudraCT number
    		 2012-004060-22
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 Aug 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    12 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    107824/107826/107829
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00359983
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupport@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupport@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
    14 Feb 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To evaluate the long-term antibody persistence induced by 4 doses of Hib-MenCY-TT as compared to 4 doses of ActHIB given at 2, 4, 6, and 12 to 15 months of age in terms of the percentage of subjects with antibody to anti-PRP >= 0.15 µg/mL. •To evaluate the long-term antibody persistence induced by 4 doses of Hib-MenCY-TT given at 2, 4, 6, and 12 to 15 months of age in terms of percentage of subjects with hSBA-MenC and hSBA-MenY titers >= 1:8. •To evaluate the long-term antibody persistence induced by 3 doses of ActHIB given at 2, 4, 6 months of age, and a single dose of Hib-MenCY-TT at 12 to 15 months of age in terms of the percentage of subjects with anti-PRP concen-trations 0.15 µg/mL, hSBA-MenC and hSBA-MenY titers >= 1:8. Note: The hSBA-MenC and hSBA-MenY endpoint of titers >= 1:8 reflect the primary endpoint for the analysis of persistence years 3 and 5.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Apr 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 181
    Worldwide total number of subjects
    181
    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)
    181
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Year 1 Persistence Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenHibrix 4-dose Group
    Arm description
    		 Subjects between 22 to 36 months of age received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenHibrix
    Investigational medicinal product code
    Other name
    Hib-MenCY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 intramuscular doses of Pediarix co-administered with MenHibrix

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 intramuscular doses, 3 co-administered with MenHibrix and Pediarix and 1 dose co-administered with MenHibrix .

    Arm title
    		 ActHIB 4-dose group
    Arm description
    		 Subjects between 22 to 36 months of age received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ActHIB
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of ActHIB co-administered with Pediarix and Prevnar, administered intramuscularly.

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 intramuscular doses of Pediarix co-administered with ActHIB and Prevnar

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 doses administered intramuscularly, 3 co-administered with Pediarix and ActHIB and 1 co-administered with ActHIB.

    Arm title
    		 ActHIB 3-dose + MenHibrix 4th-dose group
    Arm description
    		 Subjects between 22 to 36 months of age received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ActHIB
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of ActHIB co-administered with Pediarix and Prevnar, administered intramuscularly.

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of Pediarix co-administered with ActHIB and Prevnar

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramusculalry and co-administered with ActHIB and Pediarix and a dose co-administered with MenHibrix

    Investigational medicinal product name
    MenHibrix
    Investigational medicinal product code
    Other name
    Hib-MenCY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly and co-administered with Prevnar.

    Number of subjects in period 1
    		MenHibrix 4-dose Group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Started
    138
    70
    62
    Completed
    138
    70
    62
    Period 2
    Period 2 title
    Year 3 Persistence Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenHibrix 4-dose group
    Arm description
    		 Subjects between 44 to 60 months of age received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenHibrix
    Investigational medicinal product code
    Other name
    Hib-MenCY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly and co-administered with MenHibrix and Prevnar

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 intramuscular doses, 3 doses co-administered with Pediarix and MenHibrix, and a dose co-administered with MenHibrix

    Arm title
    		 ActHIB 4-dose group
    Arm description
    		 Subjects between 44 to 60 months of age received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ActHIB
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of ActHIB co-administered with Pediarix and Prevnar

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly and co-administered with Prevnar and ActHIB

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 intramuscular doses, 3 co-administered with ActHIB and Pediarix, and 1 co-administered with ActHIB

    Arm title
    		 ActHIB 3-dose + MenHibrix 4th-dose group
    Arm description
    		 Subjects between 44 to 60 months of age received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ActHIB
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of ActHIB co-administered with Pediarix and Prevnar

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses of Pediarix co-administered with ActHIB and Prevnar

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 intramuscular doses,3 doses co-administered with Pediarix and ActHIB and 1 dose co-administered with MenHibrix

    Investigational medicinal product name
    MenHibrix
    Investigational medicinal product code
    Other name
    Hib-MenCY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of MenHibrix co-administered with Prevnar

    Number of subjects in period 2 [1]
    		MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Started
    103
    47
    51
    Completed
    103
    47
    51
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects not returning for a specific visit were not withdrawn and could participate in the subsequent follow-up study. Actual enrolment differed depending on the rate of return for the follow-up study, so not all enrolled subjects came to each visit.
    Period 3
    Period 3 title
    Year 5 Persistence Follow-up
    Is this the baseline period?
    		 Yes [2]
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenHibrix 4-dose group
    Arm description
    		 Subjects aged 5 years post-dose 4 +/- 8 weeks received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenHibrix
    Investigational medicinal product code
    Other name
    Hib-MenCY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar vaccine

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly and co-administered with Prevnar and MenHibrix vaccine

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 doses administered intramuscularly, 3 doses co-administered with Pediarix and MenHibrix, and 1 dose co-administered with MenHibrix vaccine

    Arm title
    		 ActHIB 4-dose group
    Arm description
    		 Subjects aged 5 years post-dose 4 +/- 8 weeks received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ActHIB
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of ActHIB co-administered with Pediarix and Prevnar vaccine

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly and co-administered with Prevnar and ActHIB

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 doses administered intramuscularly, 3 co-administered with Pediarix and ActHIB, and 1 co-administered with ActHIB

    Arm title
    		 ActHIB 3-dose + MenHibrix 4th-dose group
    Arm description
    		 Subjects aged 5 years post-dose 4 +/- 8 weeks received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ActHIB
    Investigational medicinal product code
    Other name
    Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 3 doses of ActHIB co-administered with Pediarix and Prevnar

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses administered intramuscularly and co-administered with Prevnar and ActHIB vaccine

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    7Pn
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 doses administered intramuscularly, 3 doses co-administered with Pediarix and ActHIB and 1 dose co-administered with MenHibrix vaccine

    Investigational medicinal product name
    MenHibrix
    Investigational medicinal product code
    Other name
    Hib-MenCY-TT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly and co-administered with Prevnar

    Notes
    [2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Subjects not returning for a specific visit were not withdrawn and could participate in the subsequent follow-up study. Actual enrolment differed depending on the rate of return for the follow-up study, so not all enrolled subjects came to each visit.
    Number of subjects in period 3 [3]
    		MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Started
    95
    44
    42
    Completed
    95
    44
    42
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects not returning for a specific visit were not withdrawn and could participate in the subsequent follow-up study. Actual enrolment differed depending on the rate of return for the follow-up study, so not all enrolled subjects came to each visit.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    MenHibrix 4-dose group
    Reporting group description
    		 Subjects aged 5 years post-dose 4 +/- 8 weeks received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group title
    ActHIB 4-dose group
    Reporting group description
    		 Subjects aged 5 years post-dose 4 +/- 8 weeks received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group title
    ActHIB 3-dose + MenHibrix 4th-dose group
    Reporting group description
    		 Subjects aged 5 years post-dose 4 +/- 8 weeks received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group Total
    Number of subjects
    		 95 44 42 181
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 71.9 ( 1.37 ) 72 ( 1.62 ) 71.9 ( 1.49 ) -
    Gender categorical
    Units: Subjects
        Female
    		 43 22 19 84
        Male
    		 52 22 23 97

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    MenHibrix 4-dose Group
    Reporting group description
    		 Subjects between 22 to 36 months of age received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group title
    ActHIB 4-dose group
    Reporting group description
    		 Subjects between 22 to 36 months of age received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group title
    ActHIB 3-dose + MenHibrix 4th-dose group
    Reporting group description
    		 Subjects between 22 to 36 months of age received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Reporting group title
    MenHibrix 4-dose group
    Reporting group description
    		 Subjects between 44 to 60 months of age received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group title
    ActHIB 4-dose group
    Reporting group description
    		 Subjects between 44 to 60 months of age received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group title
    ActHIB 3-dose + MenHibrix 4th-dose group
    Reporting group description
    		 Subjects between 44 to 60 months of age received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
    Reporting group title
    MenHibrix 4-dose group
    Reporting group description
    		 Subjects aged 5 years post-dose 4 +/- 8 weeks received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group title
    ActHIB 4-dose group
    Reporting group description
    		 Subjects aged 5 years post-dose 4 +/- 8 weeks received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group title
    ActHIB 3-dose + MenHibrix 4th-dose group
    Reporting group description
    		 Subjects aged 5 years post-dose 4 +/- 8 weeks received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Primary: Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter

    		 Close Top of page
    End point title
    		 Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter [1]
    End point description
    End point type
    Primary
    End point timeframe
    One year after the fourth dose vaccination.
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose Group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    109
    51
    47
    Units: Subjects
        Year 1, Post Fourth dose [N=109;51;47]
    109
    51
    47
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter

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    End point title
    		 Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter [2]
    End point description
    End point type
    Primary
    End point timeframe
    Three years after the fourth dose vaccination.
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    55
    27
    34
    Units: Subjects
        Year 3, Post Fourth dose [N=55;27;34]
    55
    27
    34
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter

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    End point title
    		 Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter [3]
    End point description
    End point type
    Primary
    End point timeframe
    Five years after the fourth dose vaccination.
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    77
    35
    31
    Units: Subjects
        Year 5, Post Fourth dose [N=77;35;31]
    77
    35
    31
    No statistical analyses for this end point

    Primary: Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)

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    End point title
    		 Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA) [4]
    End point description
    End point type
    Primary
    End point timeframe
    One year after the fourth dose vaccination.
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose Group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    35
    19
    14
    Units: Subjects
        Year 1, hSBA-MenC, Post Fourth dose [N=35;19;14]
    33
    1
    14
    No statistical analyses for this end point

    Primary: Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)

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    End point title
    		 Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA) [5]
    End point description
    End point type
    Primary
    End point timeframe
    Three years after the fourth dose vaccination.
    Notes
    [5] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    19
    10
    14
    Units: Subjects
        Year 3, hSBA-MenC, Post Fourth dose [N=19;10;14]
    19
    0
    12
    No statistical analyses for this end point

    Primary: Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)

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    End point title
    		 Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA) [6]
    End point description
    End point type
    Primary
    End point timeframe
    Five years after the fourth dose vaccination.
    Notes
    [6] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    24
    13
    11
    Units: Subjects
        Year 5, hSBA-MenC, Post Fourth dose [N=24;13;11]
    23
    1
    11
    No statistical analyses for this end point

    Primary: Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)

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    End point title
    		 Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA) [7]
    End point description
    End point type
    Primary
    End point timeframe
    One year after the fourth dose vaccination.
    Notes
    [7] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose Group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    35
    19
    14
    Units: Subjects
        Year 1, hSBA-MenY, Post Fourth dose [N=35;19;14]
    33
    1
    8
    No statistical analyses for this end point

    Primary: Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA)

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    End point title
    		 Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) [8]
    End point description
    End point type
    Primary
    End point timeframe
    Three years after the fourth dose vaccination.
    Notes
    [8] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    20
    10
    14
    Units: Subjects
        Year 3, hSBA-MenY, Post Fourth dose [N=20;10;14]
    20
    0
    9
    No statistical analyses for this end point

    Primary: Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)

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    End point title
    		 Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA) [9]
    End point description
    End point type
    Primary
    End point timeframe
    Five years after the fourth dose vaccination.
    Notes
    [9] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    24
    13
    11
    Units: Subjects
        Year 5, hSBA-MenY, Post Fourth dose [N=24;13;11]
    22
    1
    8
    No statistical analyses for this end point

    Primary: Anti-PRP Geometric Mean Concentrations (GMCs)

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    End point title
    		 Anti-PRP Geometric Mean Concentrations (GMCs) [10]
    End point description
    End point type
    Primary
    End point timeframe
    One year after the fourth dose vaccination.
    Notes
    [10] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose Group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    109
    51
    47
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Year 1, Post Fourth dose [N=109;51;47]
    27.215 (22.253 to 33.283)
    19.92 (14.337 to 27.678)
    10.098 (7.215 to 14.131)
    No statistical analyses for this end point

    Primary: Anti-PRP Geometric Mean Concentrations (GMCs)

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    End point title
    		 Anti-PRP Geometric Mean Concentrations (GMCs) [11]
    End point description
    End point type
    Primary
    End point timeframe
    Three years after the fourth dose vaccination.
    Notes
    [11] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    55
    27
    34
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Year 3, Post Fourth dose [N=55;27;34]
    27.345 (21.411 to 34.924)
    17.542 (11.951 to 25.748)
    12.596 (8.59 to 18.471)
    No statistical analyses for this end point

    Primary: Anti-PRP Geometric Mean Concentrations (GMCs)

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    End point title
    		 Anti-PRP Geometric Mean Concentrations (GMCs) [12]
    End point description
    End point type
    Primary
    End point timeframe
    Five years after the fourth dose vaccination.
    Notes
    [12] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    77
    35
    31
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Year 5, Post Fourth dose [N=77;35;31]
    28.349 (22.749 to 35.328)
    22.854 (15.174 to 34.422)
    10.693 (7.083 to 16.142)
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter

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    End point title
    		 Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter [13]
    End point description
    End point type
    Primary
    End point timeframe
    One year after the fourth dose vaccination.
    Notes
    [13] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose Group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    109
    51
    47
    Units: Subjects
        Year 1, Post Fourth dose [N=109;51;47]
    108
    51
    47
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter

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    End point title
    		 Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter [14]
    End point description
    End point type
    Primary
    End point timeframe
    Three years after the fourth dose vaccination.
    Notes
    [14] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    55
    27
    34
    Units: Subjects
        Year 3, Post Fourth dose [N=55;27;34]
    55
    27
    34
    No statistical analyses for this end point

    Primary: Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter

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    End point title
    		 Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter [15]
    End point description
    End point type
    Primary
    End point timeframe
    Five years after the fourth dose vaccination.
    Notes
    [15] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    77
    35
    31
    Units: Subjects
        Year 5, Post Fourth dose [N=77;35;31]
    77
    35
    30
    No statistical analyses for this end point

    Primary: hSBA-MenC Geometric Mean Titers (GMTs)

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    End point title
    		 hSBA-MenC Geometric Mean Titers (GMTs) [16]
    End point description
    End point type
    Primary
    End point timeframe
    One year after the fourth dose vaccination.
    Notes
    [16] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose Group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    35
    19
    14
    Units: Titer
    geometric mean (confidence interval 95%)
        Year 1, hSBA-MenC, Post Fourth dose [N=35;19;14]
    783.9 (416.1 to 1477)
    3.2 (1.3 to 7.6)
    73.3 (45 to 119.2)
    No statistical analyses for this end point

    Primary: hSBA-MenC Geometric Mean Titers (GMTs)

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    End point title
    		 hSBA-MenC Geometric Mean Titers (GMTs) [17]
    End point description
    End point type
    Primary
    End point timeframe
    Three years after the fourth dose vaccination.
    Notes
    [17] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    19
    10
    14
    Units: Titer
    geometric mean (confidence interval 95%)
        Year 3, hSBA-MenC, Post Fourth dose [N=19;10;14]
    1002.8 (600.1 to 1675.8)
    2 (2 to 2)
    75.2 (27.6 to 204.7)
    No statistical analyses for this end point

    Primary: hSBA-MenC Geometric Mean Titers (GMTs)

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    End point title
    		 hSBA-MenC Geometric Mean Titers (GMTs) [18]
    End point description
    End point type
    Primary
    End point timeframe
    Five years after the fourth dose vaccination.
    Notes
    [18] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    24
    13
    11
    Units: Titer
    geometric mean (confidence interval 95%)
        Year 5, hSBA-MenC, Post Fourth dose [N=24;13;11]
    623.8 (320.9 to 1212.6)
    3.9 (1.1 to 14.7)
    89 (45.6 to 173.7)
    No statistical analyses for this end point

    Primary: Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4

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    End point title
    		 Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 [19]
    End point description
    End point type
    Primary
    End point timeframe
    One year after the fourth dose vaccination.
    Notes
    [19] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose Group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    35
    19
    14
    Units: Subjects
        Year 1, hSBA-MenC, Post Fourth dose [N=35;19;14]
    33
    2
    14
    No statistical analyses for this end point

    Primary: Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4

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    End point title
    		 Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 [20]
    End point description
    End point type
    Primary
    End point timeframe
    Three years after the fourth dose vaccination.
    Notes
    [20] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    19
    10
    14
    Units: Subjects
        Year 3, hSBA-MenC, Post Fourth dose [N=19;10;14]
    19
    0
    12
    No statistical analyses for this end point

    Primary: Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4

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    End point title
    		 Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 [21]
    End point description
    End point type
    Primary
    End point timeframe
    Five years after the fourth dose vaccination.
    Notes
    [21] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    24
    13
    11
    Units: Subjects
        Year 5, hSBA-MenC, Post Fourth dose [N=24;13;11]
    23
    2
    11
    No statistical analyses for this end point

    Primary: hSBA-MenY Geometric Mean Titers (GMTs)

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    End point title
    		 hSBA-MenY Geometric Mean Titers (GMTs) [22]
    End point description
    End point type
    Primary
    End point timeframe
    One year after the fourth dose vaccination.
    Notes
    [22] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose Group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    35
    19
    14
    Units: Titer
    geometric mean (confidence interval 95%)
        Year 1, hSBA-MenY, Post Fourth dose [N=35;19;14]
    245.7 (139.8 to 431.6)
    2.7 (1.4 to 5.3)
    12.2 (4.7 to 31.7)
    No statistical analyses for this end point

    Primary: hSBA-MenY Geometric Mean Titers (GMTs)

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    End point title
    		 hSBA-MenY Geometric Mean Titers (GMTs) [23]
    End point description
    End point type
    Primary
    End point timeframe
    Three years after the fourth dose vaccination.
    Notes
    [23] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    20
    10
    14
    Units: Titer
    geometric mean (confidence interval 95%)
        Year 3, hSBA-MenY, Post Fourth dose [N=20;10;14]
    325.4 (197.7 to 535.6)
    2 (2 to 2)
    15.3 (5.9 to 39.4)
    No statistical analyses for this end point

    Primary: hSBA-MenY Geometric Mean Titers (GMTs)

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    End point title
    		 hSBA-MenY Geometric Mean Titers (GMTs) [24]
    End point description
    End point type
    Primary
    End point timeframe
    Five years after the fourth dose vaccination.
    Notes
    [24] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    24
    13
    11
    Units: Titer
    geometric mean (confidence interval 95%)
        Year 5, hSBA-MenY, Post Fourth dose [N=24;13;11]
    162.4 (75.5 to 349.6)
    3.2 (1.2 to 8.7)
    18.3 (6.4 to 52.4)
    No statistical analyses for this end point

    Primary: Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4

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    End point title
    		 Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 [25]
    End point description
    End point type
    Primary
    End point timeframe
    One year after the fourth dose vaccination.
    Notes
    [25] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose Group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    35
    19
    14
    Units: Subjects
        Year 1, hSBA-MenY, Post Fourth dose [N=35;19;14]
    33
    1
    9
    No statistical analyses for this end point

    Primary: Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4

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    End point title
    		 Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 [26]
    End point description
    End point type
    Primary
    End point timeframe
    Three years after the fourth dose vaccination.
    Notes
    [26] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    20
    10
    14
    Units: Subjects
        Year 3, hSBA-MenY, Post Fourth dose [N=20;10;14]
    20
    0
    9
    No statistical analyses for this end point

    Primary: Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4

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    End point title
    		 Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 [27]
    End point description
    End point type
    Primary
    End point timeframe
    Five years after the fourth dose vaccination.
    Notes
    [27] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 MenHibrix 4-dose group ActHIB 4-dose group ActHIB 3-dose + MenHibrix 4th-dose group
    Number of subjects analysed
    24
    13
    11
    Units: Subjects
        Year 5, hSBA-MenY, Post Fourth dose [N=24;13;11]
    22
    1
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAEs were collected during the entire study period, up to 5 years post fourth vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    MenHibrix 4-dose Group
    Reporting group description
    		 Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group title
    ActHIB 4-dose Group
    Reporting group description
    		 Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Reporting group title
    ActHIB 3-dose + MenHibrix 4th-dose Group
    Reporting group description
    		 Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

    Serious adverse events
    		 MenHibrix 4-dose Group ActHIB 4-dose Group ActHIB 3-dose + MenHibrix 4th-dose Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 70 (0.00%)
    0 / 62 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MenHibrix 4-dose Group ActHIB 4-dose Group ActHIB 3-dose + MenHibrix 4th-dose Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 138 (0.00%)
    0 / 70 (0.00%)
    0 / 62 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No information on solicited or unsolicited adverse events was collected during this study.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Sep 2009
    Vaccination with GSK Biologicals’ Hib-MenCY-TT conjugate vaccine was previously shown to be immunogenic and well tolerated. Results from clinical studies have demonstrated that Hib-MenCY-TT vaccine induced an immune response against the three vaccine components when a four dose series of the vaccine is administered at 2, 4, 6 and 12 to 15 months of age. In study Hib-MenCY-TT-005, subjects received either Hib-MenCY-TT vaccine or ActHIB at 2, 4, and 6 months of age. A vaccination was administered in study Hib-MenCY-TT-006 at 12 to 15 months of age: subjects that received Hib-MenCY-TT vaccine at 2, 4 and 6 months of age received a fourth dose of Hib-MenCY-TT vaccine: subjects that received ActHIB at 2, 4 and 6 months of age were re-randomized 1:1 to receive a vaccination with either Hib-MenCY-TT vaccine or ActHIB. The purpose of this study extension is to evaluate the antibody persistence at approximately 1, 3, and 5 years post-dose 4 (i.e., at 2, 4 and 6 years of age) in subjects vaccinated in study Hib-MenCY-TT-005/006.

    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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