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    Clinical Trial Results:
    A Phase III, open, multicentre study to assess the long-term persistence of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine (Hib-MenC) compared to a booster dose of Infanrix™ hexa (combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Hib vaccine) when given to 14-month-old subjects who were primed in study 217744/097 (DTPa-HBV-IPV-097) and boosted in study Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097

    Summary
    EudraCT number
    		 2006-000518-19
    Trial protocol
    		 ES  
    Global end of trial date
    08 Sep 2010

    Results information
    Results version number
    		 v1
    This version publication date
    20 Jun 2016
    First version publication date
    22 May 2015
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    106672;106673;106675;106679;-80
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00322335
    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 Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Sep 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the persistence of Meningococcal C antibodies on a yearly basis for a period of 5.5 years after booster vaccination. To evaluate the persistence of Haemophilus influenzae type b antibodies on a yearly basis for a period of 5.5 years after booster vaccination
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the day of vaccination and the subsequent 30 days after the last vaccination administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 May 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 184
    Worldwide total number of subjects
    184
    EEA total number of subjects
    184
    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)
    184
    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.

    Pre-assignment period milestones
    Number of subjects started
    		 184
    Number of subjects completed
    		 184

    Period 1
    Period 1 title
    Month 18
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix/Pediarix Group Month 18
    Arm description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

    Investigational medicinal product name
    Infanrix™ penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

    Arm title
    		 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18
    Arm description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as a birth dose

    Investigational medicinal product name
    NeisVac-C™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

    Investigational medicinal product name
    Infanrix™ IPV/HIB
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 4 months of age.

    Arm title
    		 Infanrix hexa/Meningitec Group Month 18
    Arm description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

    Number of subjects in period 1
    		Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Infanrix hexa/Meningitec Group Month 18
    Started
    58
    123
    3
    Completed
    58
    123
    3
    Period 2
    Period 2 title
    Month 30
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix/Pediarix Group Month 30
    Arm description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

    Investigational medicinal product name
    Infanrix™ penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

    Arm title
    		 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30
    Arm description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as a birth dose

    Investigational medicinal product name
    NeisVac-C™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

    Investigational medicinal product name
    Infanrix™ IPV/HIB
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 4 months of age

    Arm title
    		 Infanrix hexa/Meningitec Group Month 30
    Arm description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

    Number of subjects in period 2 [1]
    		Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30
    Started
    54
    119
    3
    Completed
    54
    119
    57
    Joined
    0
    0
    54
         Late return to study visit
    -
    -
    54
    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: Not all subjects completing one period came to the next study visit; however, a subject missing a previous visit was allowed to return to a subsequent one. Thus, the number of subjects starting every study period is based on the actual rate of return.
    Period 3
    Period 3 title
    Month 42
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix/Pediarix Group Month 42
    Arm description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

    Investigational medicinal product name
    Infanrix™ penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

    Arm title
    		 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42
    Arm description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as a birth dose

    Investigational medicinal product name
    NeisVac-C™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

    Investigational medicinal product name
    Infanrix™ IPV/HIB
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 4 months of age.

    Arm title
    		 Infanrix hexa/Meningitec Group Month 42
    Arm description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

    Number of subjects in period 3 [2]
    		Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42
    Started
    51
    113
    56
    Completed
    51
    113
    56
    Notes
    [2] - 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: Not all subjects completing one period came to the next study visit; however, a subject missing a previous visit was allowed to return to a subsequent one. Thus, the number of subjects starting every study period is based on the actual rate of return.
    Period 4
    Period 4 title
    Month 54
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix/Pediarix Group Month 54
    Arm description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

    Investigational medicinal product name
    Infanrix™ penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

    Arm title
    		 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54
    Arm description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as a birth dose

    Investigational medicinal product name
    NeisVac-C™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

    Investigational medicinal product name
    Infanrix™ IPV/HIB
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 4 months of age.

    Arm title
    		 Infanrix hexa/Meningitec Group Month 54
    Arm description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

    Number of subjects in period 4 [3]
    		Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54
    Started
    50
    108
    56
    Completed
    50
    108
    56
    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: Not all subjects completing one period came to the next study visit; however, a subject missing a previous visit was allowed to return to a subsequent one. Thus, the number of subjects starting every study period is based on the actual rate of return.
    Period 5
    Period 5 title
    Month 66
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Menitorix/Pediarix Group Month 66
    Arm description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

    Investigational medicinal product name
    Infanrix™ penta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

    Arm title
    		 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66
    Arm description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menitorix™
    Investigational medicinal product code
    Other name
    Haemophilus influenzae type b- and meningococcal (vaccine)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

    Investigational medicinal product name
    Engerix-B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as a birth dose

    Investigational medicinal product name
    NeisVac-C™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

    Investigational medicinal product name
    Infanrix™ IPV/HIB
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 4 months of age.

    Arm title
    		 Infanrix hexa/Meningitec Group Month 66
    Arm description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

    Number of subjects in period 5 [4]
    		Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Started
    48
    104
    53
    Completed
    48
    104
    53
    Notes
    [4] - 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: Not all subjects completing one period came to the next study visit; however, a subject missing a previous visit was allowed to return to a subsequent one. Thus, the number of subjects starting every study period is based on the actual rate of return.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Menitorix/Pediarix Group Month 18
    Reporting group description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18
    Reporting group description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Meningitec Group Month 18
    Reporting group description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.

    Reporting group values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Infanrix hexa/Meningitec Group Month 18 Total
    Number of subjects
    		 58 123 3 184
    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)
    		 31.3 ± 0.54 31.4 ± 0.64 31.3 ± 0.58 -
    Gender categorical
    Units: Subjects
        Female
    		 27 55 1 83
        Male
    		 31 68 2 101

    End points

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    End points reporting groups
    Reporting group title
    Menitorix/Pediarix Group Month 18
    Reporting group description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18
    Reporting group description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Meningitec Group Month 18
    Reporting group description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
    Reporting group title
    Menitorix/Pediarix Group Month 30
    Reporting group description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30
    Reporting group description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Meningitec Group Month 30
    Reporting group description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
    Reporting group title
    Menitorix/Pediarix Group Month 42
    Reporting group description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42
    Reporting group description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Meningitec Group Month 42
    Reporting group description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
    Reporting group title
    Menitorix/Pediarix Group Month 54
    Reporting group description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54
    Reporting group description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Meningitec Group Month 54
    Reporting group description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
    Reporting group title
    Menitorix/Pediarix Group Month 66
    Reporting group description
    		 Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66
    Reporting group description
    		 Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.

    Reporting group title
    Infanrix hexa/Meningitec Group Month 66
    Reporting group description
    		 Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.

    Primary: Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titers equal to or above cut-off value of 1:8

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    End point title
    		 Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titers equal to or above cut-off value of 1:8 [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    18, 30, 42, 54 and 66 months after booster dose (Day 0)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis was only performed on groups with more than 0 subjects with available blood samples for the respective timepoint.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    45
    96
    48
    101
    45
    50
    110
    52
    49
    106
    51
    46
    101
    46
    Units: Subjects
    44
    93
    39
    96
    31
    39
    106
    33
    38
    103
    33
    38
    95
    28
    No statistical analyses for this end point

    Primary: Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titers equal to or above cut-off value of 1:32

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    End point title
    		 Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titers equal to or above cut-off value of 1:32 [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    18, 30, 42, 54 and 66 months after booster dose (Day 0)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [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: The analysis was only performed on groups with more than 0 subjects with available blood samples for the respective timepoint.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    45
    96
    48
    101
    45
    50
    110
    52
    49
    106
    51
    46
    101
    46
    Units: Subjects
    40
    93
    36
    94
    25
    38
    100
    30
    37
    100
    29
    37
    88
    25
    No statistical analyses for this end point

    Primary: Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titers equal to or above cut-off value of 1:128

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    End point title
    		 Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titers equal to or above cut-off value of 1:128 [5] [6]
    End point description
    End point type
    Primary
    End point timeframe
    18, 30, 42, 54 and 66 months after booster dose (Day 0)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis was only performed on groups with more than 0 subjects with available blood samples for the respective timepoint.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    45
    96
    48
    101
    45
    50
    110
    52
    49
    106
    51
    46
    101
    46
    Units: Subjects
    27
    82
    27
    80
    12
    30
    89
    13
    27
    86
    15
    28
    69
    18
    No statistical analyses for this end point

    Primary: rSBA-MenC titers

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    End point title
    		 rSBA-MenC titers [7] [8]
    End point description
    End point type
    Primary
    End point timeframe
    18, 30, 42, 54 and 66 months after booster dose (Day 0)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis was only performed on groups with more than 0 subjects with available blood samples for the respective timepoint.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    45
    96
    48
    101
    45
    50
    110
    52
    49
    106
    51
    46
    101
    46
    Units: Titers
        geometric mean (confidence interval 95%)
    221.5 (137.2 to 357.7)
    801.1 (570.3 to 1125.3)
    109.1 (61.9 to 192.3)
    441.7 (309.4 to 630.6)
    40.3 (21.9 to 74.1)
    98.9 (56.7 to 172.5)
    409.8 (297.7 to 564.2)
    36.1 (20.4 to 63.8)
    90.4 (52.8 to 154.8)
    344.6 (255.9 to 463.9)
    36.7 (21.1 to 64)
    121.5 (71 to 207.9)
    227.6 (160.2 to 323.3)
    42.7 (22.3 to 81.8)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-polyribosylribitol phosphate (Anti-PRP) concentrations equal to or above cut-off value of 0.15 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (Anti-PRP) concentrations equal to or above cut-off value of 0.15 µg/mL [9]
    End point description
    End point type
    Primary
    End point timeframe
    18, 30, 42, 54 and 66 months after the booster dose (Day 0)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Infanrix hexa/Meningitec Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    56
    122
    3
    53
    113
    53
    50
    110
    51
    49
    106
    52
    47
    101
    47
    Units: Subjects
    56
    121
    3
    53
    112
    53
    50
    109
    51
    49
    105
    52
    47
    101
    46
    No statistical analyses for this end point

    Primary: Number of subjects with anti-polyribosylribitol phosphate (Anti-PRP) concentrations equal to or above cut-off value of 1.0 µg/mL

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    End point title
    		 Number of subjects with anti-polyribosylribitol phosphate (Anti-PRP) concentrations equal to or above cut-off value of 1.0 µg/mL [10]
    End point description
    End point type
    Primary
    End point timeframe
    18, 30, 42, 54 and 66 months after the booster dose (Day 0)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Infanrix hexa/Meningitec Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    56
    122
    3
    53
    113
    53
    50
    110
    51
    49
    106
    52
    47
    101
    47
    Units: Subjects
    44
    112
    3
    36
    98
    40
    33
    91
    34
    27
    86
    35
    26
    84
    26
    No statistical analyses for this end point

    Primary: Anti-PRP concentrations

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    End point title
    		 Anti-PRP concentrations [11]
    End point description
    End point type
    Primary
    End point timeframe
    18, 30, 42, 54 and 66 months after the booster dose (Day 0)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Infanrix hexa/Meningitec Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    56
    122
    3
    53
    113
    53
    50
    110
    51
    49
    106
    52
    47
    101
    47
    Units: µg/mL
        geometric mean (confidence interval 95%)
    2.921 (2.15 to 3.968)
    5.45 (4.39 to 6.766)
    2.547 (0.39 to 16.651)
    1.914 (1.383 to 2.648)
    3.524 (2.813 to 4.415)
    2.224 (1.578 to 3.133)
    1.735 (1.243 to 2.423)
    2.986 (2.395 to 3.722)
    2.005 (1.365 to 2.946)
    1.552 (1.154 to 2.087)
    2.688 (2.149 to 3.361)
    1.799 (1.267 to 2.555)
    1.602 (1.107 to 2.32)
    2.625 (2.113 to 3.261)
    1.763 (1.17 to 2.657)
    No statistical analyses for this end point

    Primary: Number of subjects with anti-polysaccharide C (Anti-PSC) concentrations equal to or above cut-off value of 0.3 µg/mL

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    End point title
    		 Number of subjects with anti-polysaccharide C (Anti-PSC) concentrations equal to or above cut-off value of 0.3 µg/mL [12] [13]
    End point description
    End point type
    Primary
    End point timeframe
    18, 30, 42, 54 and 66 months after the booster dose (Day 0)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis was only performed on groups with more than 0 subjects with available blood samples for the respective timepoint.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    56
    122
    52
    108
    53
    49
    107
    52
    46
    105
    52
    45
    99
    45
    Units: Subjects
    38
    100
    19
    58
    19
    17
    52
    17
    14
    52
    17
    12
    34
    11
    No statistical analyses for this end point

    Primary: Number of subjects with anti-polysaccharide C (Anti-PSC) concentrations equal to or above cut-off value of 2.0 µg/mL

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    End point title
    		 Number of subjects with anti-polysaccharide C (Anti-PSC) concentrations equal to or above cut-off value of 2.0 µg/mL [14] [15]
    End point description
    End point type
    Primary
    End point timeframe
    18, 30, 42, 54 and 66 months after the booster dose (Day 0)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis was only performed on groups with more than 0 subjects with available blood samples for the respective timepoint.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    56
    122
    52
    108
    53
    49
    107
    52
    46
    105
    52
    45
    99
    45
    Units: Subjects
    1
    31
    1
    18
    3
    0
    14
    2
    1
    10
    1
    0
    8
    0
    No statistical analyses for this end point

    Primary: Number of subjects with serious adverse events

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    End point title
    		 Number of subjects with serious adverse events [16]
    End point description
    End point type
    Primary
    End point timeframe
    From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (Day 0)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Infanrix hexa/Meningitec Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    58
    123
    3
    54
    119
    57
    51
    113
    56
    50
    108
    56
    48
    104
    53
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Anti-PSC concentrations

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    End point title
    		 Anti-PSC concentrations [17] [18]
    End point description
    End point type
    Primary
    End point timeframe
    18, 30, 42, 54 and 66 months after the booster dose (Day 0)
    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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis was only performed on groups with more than 0 subjects with available blood samples for the respective timepoint.
    End point values
    		 Menitorix/Pediarix Group Month 18 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 18 Menitorix/Pediarix Group Month 30 Infanrix hexa/Infanrix IPV-Hib co-ad Group Month 30 Infanrix hexa/Meningitec Group Month 30 Menitorix/Pediarix Group Month 42 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 42 Infanrix hexa/Meningitec Group Month 42 Menitorix/Pediarix Group Month 54 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 54 Infanrix hexa/Meningitec Group Month 54 Menitorix/Pediarix Group Month 66 Infanrix hexa/Infanrix IPV/Hib co-ad Group Month 66 Infanrix hexa/Meningitec Group Month 66
    Number of subjects analysed
    56
    122
    52
    108
    53
    49
    107
    52
    46
    105
    52
    45
    99
    45
    Units: µg/mL
        geometric mean (confidence interval 95%)
    0.5 (0.39 to 0.64)
    1.01 (0.8 to 1.29)
    0.26 (0.21 to 0.33)
    0.47 (0.37 to 0.61)
    0.3 (0.23 to 0.39)
    0.25 (0.2 to 0.31)
    0.4 (0.32 to 0.51)
    0.28 (0.21 to 0.37)
    0.24 (0.19 to 0.3)
    0.36 (0.29 to 0.45)
    0.26 (0.2 to 0.32)
    0.22 (0.18 to 0.27)
    0.29 (0.23 to 0.36)
    0.22 (0.18 to 0.28)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (Day 0)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Menitorix/Pediarix Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix hexa/Meningitec Group
    Reporting group description
    		 -

    Serious adverse events
    		 Menitorix/Pediarix Group Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group Infanrix hexa/Meningitec Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 123 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Menitorix/Pediarix Group Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group Infanrix hexa/Meningitec Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 58 (0.00%)
    0 / 123 (0.00%)
    0 / 3 (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 non-serious adverse events were collected in this study.

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

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