Dose Ranging Study of Combined Haemophilus Influenzae Typ... | NCT00127855

ID	Type	Description	Link
792014/002	Other Identifier	GSK

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MenHibrix Formulation 1 Group	Experimental	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Biological: Hib-MenCY-TT vaccine (MenHibrix) Biological: Infanrix® Penta Biological: Prevenar® Biological: Mencevax® ACWY Biological: PRP (Polyribosyl Ribitol Phosphate)
MenHibrix Formulation 2 Group	Experimental	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Biological: Hib-MenCY-TT vaccine (MenHibrix) Biological: Infanrix® Penta Biological: Prevenar® Biological: Mencevax® ACWY Biological: PRP (Polyribosyl Ribitol Phosphate)
MenHibrix Formulation 3 Group	Experimental	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	Biological: Hib-MenCY-TT vaccine (MenHibrix) Biological: Infanrix® Penta Biological: Prevenar® Biological: Mencevax® ACWY Biological: PRP (Polyribosyl Ribitol Phosphate)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hib-MenCY-TT vaccine (MenHibrix)	Biological	Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively	MenHibrix Formulation 1 Group

Measure	Description	Time Frame
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter	The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).	One month after primary vaccination (Month 5)
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.	One month after primary vaccination (Month 5)
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.	One month after primary vaccination (Month 5)

Measure	Description	Time Frame
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8	The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.	Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

Eligibility Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		North Adelaide	South Australia	5006	Australia
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
21806393	Background	Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
17996996	Background	Nolan T, Lambert S, Roberton D, Marshall H, Richmond P, Streeton C, Poolman J, Boutriau D. A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007 Dec 12;25(51):8487-99. doi: 10.1016/j.vaccine.2007.10.013. Epub 2007 Oct 25.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
792014/001	Study Protocol	View IPD

ID	Title	Description
FG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
FG001

Arm/Group Information

ID	Title	Description
BG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
BG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
BG002	MenHibrix Formulation 3 Group	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
BG003	Menjugate Group	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
BG004	ActHIB Group	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
BG005	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter

The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.

Posted

Number

Subjects

One month after primary vaccination (Month 5)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002	MenHibrix Formulation 3 Group	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG003	Menjugate Group	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG004	ActHIB Group	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Units	Counts
Participants	OG00074 OG00176 OG00270 OG003

Title

Denominators

Categories

Title	Measurements
	OG00072 OG00175 OG00265 OG003

Primary

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8

The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Posted

Number

Subjects

One month after primary vaccination (Month 5)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Primary

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8

The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

Posted

Number

Subjects

One month after primary vaccination (Month 5)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8

The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Posted

Number

Subjects

Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers

Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Posted

Geometric Mean

95% Confidence Interval

Titer

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8

The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Posted

Number

Subjects

Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002

Secondary

Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers

Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Posted

Geometric Mean

95% Confidence Interval

Titer

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)

The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Posted

Number

Subjects

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti-polysaccharide C (PSC) Antibody Concentration

Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Posted

Geometric Mean

95% Confidence Interval

microgram per milliliter (µg/mL)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)

The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Posted

Number

Subjects

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti-polysaccharide Y (PSY) Antibody Concentration

Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Posted

Geometric Mean

95% Confidence Interval

Microgram per milliliter (µg/mL)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values

The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Posted

Number

Subjects

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti-PRP Antibody Concentration

Concentrations are presented as GMCs and expressed as µg/mL.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.

Posted

Geometric Mean

95% Confidence Interval

Microgram per milliliter (µg/mL)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002

Secondary

Number of Subjects Seroprotected for Anti-diphtheria Antibodies

Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.

Posted

Number

Subjects

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti-diphtheria Antibody Concentrations

Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).

Posted

Geometric Mean

95% Confidence Interval

International Units per Milliliter

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Number of Subjects Seroprotected for Anti-tetanus Antibodies

Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).

Posted

Number

Subjects

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti-tetanus Antibody Concentrations

Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).

Posted

Geometric Mean

95% Confidence Interval

International Units per Milliliter

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies

Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

Posted

Number

Subjects

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti- FHA Antibody Concentrations

Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Posted

Geometric Mean

95% Confidence Interval

ELISA Units per Milliliter (EL.U/mL)

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002

Secondary

Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies

Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

Posted

Number

Subjects

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti-PRN Antibody Concentrations

Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Posted

Geometric Mean

95% Confidence Interval

ELISA Units per Milliliter (EL.U/mL)

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002

Secondary

Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies

Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

Posted

Number

Subjects

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti- PT Antibody Concentrations

Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Posted

Geometric Mean

95% Confidence Interval

ELISA Units per Milliliter (EL.U/mL)

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002

Secondary

Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies

Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).

Posted

Number

Subjects

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti- HBs Antibody Concentrations

Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Posted

Geometric Mean

95% Confidence Interval

Milli-International Units per Milliliter

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002	MenHibrix Formulation 3 Group

Secondary

Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies

Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.

Posted

Number

Subjects

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti-poliovirus Types 1, 2 and 3 Antibody Titers

Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Posted

Geometric Mean

95% Confidence Interval

Titer

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002	MenHibrix Formulation 3 Group

Secondary

Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values

Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).

Posted

Number

Subjects

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Anti-pneumococcal Antibody Concentrations

Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.

Posted

Geometric Mean

95% Confidence Interval

Micrograms per milliliter (µg/mL)

Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.

Secondary

Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course

Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).

The analysis was performed on the Total Vaccinated Cohort, on subjects having completed the symptom sheet.

Posted

Number

Subjects

During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination course

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002

Secondary

Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose

The analysis was performed on the Booster Total Vaccinated Cohort, on subjects having completed the symptom sheet.

Posted

Number

Subjects

During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dose

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002

Secondary

Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course

Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

The analysis was performed on the Total Vaccinated Cohort.

Posted

Number

Subjects

During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination course

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002	MenHibrix Formulation 3 Group

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose

The analysis was performed on the Booster Total Vaccinated Cohort.

Posted

Number

Subjects

During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dose

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002	MenHibrix Formulation 3 Group

Secondary

Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course

Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

The analysis was performed on the Total Vaccinated Cohort.

Posted

Number

Subjects

Up to one month after the 3-dose primary vaccination course (Month 5)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002	MenHibrix Formulation 3 Group

Secondary

Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose

The analysis was performed on the Booster Total Vaccinated Cohort.

Posted

Number

Subjects

Up to one month following administration of the polysaccharide challenge dose (Month 11)

ID	Title	Description
OG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
OG002	MenHibrix Formulation 3 Group

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MenHibrix Formulation 1 Group	Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	5	82	81	82
EG001	MenHibrix Formulation 2 Group	Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	5	82	81	82
EG002	MenHibrix Formulation 3 Group	Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	2	80	77	80
EG003	Menjugate Group	Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	4	81	81	81
EG004	ActHIB Group	Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.	6	82	82	82

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Balanitis	Reproductive system and breast disorders	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0010 affected82 at risk EG0020 affected80 at risk EG0030 affected81 at risk EG004
Bronchiolitis	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG0001 affected82 at risk EG0011 affected82 at risk EG0021 affected80 at risk EG003
Convulsion	Nervous system disorders	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0010 affected82 at risk EG0020 affected80 at risk EG003
Croup infectious	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0011 affected82 at risk EG0020 affected80 at risk EG003
Deafness	Ear and labyrinth disorders	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0010 affected82 at risk EG0020 affected80 at risk EG003
Escherichia urinary tract infection	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0010 affected82 at risk EG0020 affected80 at risk EG003
Gastroenteritis	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG0001 affected82 at risk EG0010 affected82 at risk EG0020 affected80 at risk EG003
Gastroenteritis viral	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG0002 affected82 at risk EG0010 affected82 at risk EG0020 affected80 at risk EG003
Haematemesis	Gastrointestinal disorders	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0011 affected82 at risk EG0020 affected80 at risk EG003
Influenza	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0011 affected82 at risk EG0020 affected80 at risk EG003
Lobar pneumonia	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG0001 affected82 at risk EG0010 affected82 at risk EG0020 affected80 at risk EG003
Milk allergy	Immune system disorders	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0011 affected82 at risk EG0020 affected80 at risk EG003
Pneumonia	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0011 affected82 at risk EG0020 affected80 at risk EG003
Sudden infant death syndrome	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0010 affected82 at risk EG0021 affected80 at risk EG003
Tachycardia	Cardiac disorders	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0010 affected82 at risk EG0020 affected80 at risk EG003
Bronchiolitis	Infections and infestations	Non-systematic Assessment	Following challenge dose administration	EG0000 affected80 at risk EG0010 affected79 at risk EG0020 affected77 at risk EG003
Pneumonia	Infections and infestations	Non-systematic Assessment	Following challenge dose administration	EG0000 affected80 at risk EG0010 affected79 at risk EG0020 affected77 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG00019 affected82 at risk EG00124 affected82 at risk EG00224 affected80 at risk EG00325 affected81 at risk EG004
Injection site bruising	General disorders	Non-systematic Assessment	Following primary vaccination	EG00012 affected82 at risk EG00112 affected82 at risk EG00215 affected80 at risk EG003
Irritability	Psychiatric disorders	Non-systematic Assessment	Following primary vaccination	EG00013 affected82 at risk EG0016 affected82 at risk EG0029 affected80 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	Following primary vaccination	EG0006 affected82 at risk EG0019 affected82 at risk EG0024 affected80 at risk EG003
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	Following primary vaccination	EG0006 affected82 at risk EG0019 affected82 at risk EG0027 affected80 at risk EG003
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	Following primary vaccination	EG0006 affected82 at risk EG00110 affected82 at risk EG0026 affected80 at risk EG003
Pyrexia	General disorders	Non-systematic Assessment	Following primary vaccination	EG0007 affected82 at risk EG0018 affected82 at risk EG0023 affected80 at risk EG003
Teething	Gastrointestinal disorders	Non-systematic Assessment	Following primary vaccination	EG0007 affected82 at risk EG0016 affected82 at risk EG0023 affected80 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	Following primary vaccination	EG0004 affected82 at risk EG0015 affected82 at risk EG0024 affected80 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	Following primary vaccination	EG0008 affected82 at risk EG0012 affected82 at risk EG0027 affected80 at risk EG003
Gingival pain	Gastrointestinal disorders	Non-systematic Assessment	Following primary vaccination	EG0001 affected82 at risk EG0013 affected82 at risk EG0023 affected80 at risk EG003
Bronchiolitis	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG0003 affected82 at risk EG0014 affected82 at risk EG0023 affected80 at risk EG003
Rhinitis	Infections and infestations	Non-systematic Assessment	Following primary vaccination	EG0000 affected82 at risk EG0013 affected82 at risk EG0024 affected80 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	Following primary vaccination	EG0004 affected82 at risk EG0016 affected82 at risk EG0022 affected80 at risk EG003
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	Following challenge dose administration	EG00012 affected80 at risk EG00110 affected79 at risk EG00214 affected77 at risk EG003
Injection site haemorrhage	General disorders	Non-systematic Assessment	Following challenge dose administration	EG0007 affected80 at risk EG0019 affected79 at risk EG0023 affected77 at risk EG003
Irritability	Psychiatric disorders	Non-systematic Assessment	Following challenge dose administration	EG0005 affected80 at risk EG0016 affected79 at risk EG0028 affected77 at risk EG003
Rhinorhea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	Following challenge dose administration	EG0004 affected80 at risk EG0016 affected79 at risk EG0025 affected77 at risk EG003
Pyrexia	General disorders	Non-systematic Assessment	Following challenge dose administration	EG0002 affected80 at risk EG0014 affected79 at risk EG00210 affected77 at risk EG003
Teething	Gastrointestinal disorders	Non-systematic Assessment	Following challenge dose administration	EG0002 affected80 at risk EG0015 affected79 at risk EG0024 affected77 at risk EG003
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	Following challenge dose administration	EG0004 affected80 at risk EG0014 affected79 at risk EG0023 affected77 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	Following challenge dose administration	EG0002 affected80 at risk EG0016 affected79 at risk EG0023 affected77 at risk EG003
Otitis media	Infections and infestations	Non-systematic Assessment	Following challenge dose administration	EG0005 affected80 at risk EG0013 affected79 at risk EG0023 affected77 at risk EG003
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	Following challenge dose administration	EG0004 affected80 at risk EG0010 affected79 at risk EG0022 affected77 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	Following challenge dose administration	EG0000 affected80 at risk EG0011 affected79 at risk EG0024 affected77 at risk EG003
Insomnia	Psychiatric disorders	Non-systematic Assessment	Following challenge dose administration	EG0000 affected80 at risk EG0011 affected79 at risk EG0021 affected77 at risk EG003
Pain at the injection site	General disorders	Systematic Assessment	Following primary vaccination	EG00054 affected81 at risk EG00150 affected82 at risk EG00253 affected79 at risk EG003
Redness at the injection site	General disorders	Systematic Assessment	Following primary vaccination	EG00067 affected81 at risk EG00167 affected82 at risk EG00264 affected79 at risk EG003
Swelling at the injection site	General disorders	Systematic Assessment	Following primary vaccination	EG00053 affected81 at risk EG00164 affected82 at risk EG00256 affected79 at risk EG003
Drowsiness	General disorders	Systematic Assessment	Following primary vaccination	EG00065 affected81 at risk EG00172 affected82 at risk EG00258 affected78 at risk EG003
Irritability	General disorders	Systematic Assessment	Following primary vaccination	EG00076 affected81 at risk EG00179 affected82 at risk EG00276 affected78 at risk EG003
Loss of appetite	General disorders	Systematic Assessment	Following primary vaccination	EG00057 affected81 at risk EG00156 affected82 at risk EG00249 affected78 at risk EG003
Fever	General disorders	Systematic Assessment	Following primary vaccination	EG00065 affected81 at risk EG00164 affected82 at risk EG00264 affected78 at risk EG003
Pain at the injection site	General disorders	Systematic Assessment	Following challenge dose administration	EG00019 affected80 at risk EG00115 affected79 at risk EG00218 affected77 at risk EG003
Redness at the injection site	General disorders	Systematic Assessment	Following challenge dose administration	EG00039 affected80 at risk EG00127 affected79 at risk EG00227 affected77 at risk EG003
Swelling at the injection site	General disorders	Systematic Assessment	Following challenge dose administration	EG00015 affected80 at risk EG00115 affected79 at risk EG00213 affected77 at risk EG003
Drowsiness	General disorders	Systematic Assessment	Following challenge dose administration	EG00026 affected80 at risk EG00125 affected79 at risk EG00217 affected77 at risk EG003
Irritability	General disorders	Systematic Assessment	Following challenge dose administration	EG00048 affected80 at risk EG00148 affected79 at risk EG00245 affected77 at risk EG003
Loss of appetite	General disorders	Systematic Assessment	Following challenge dose administration	EG00026 affected80 at risk EG00127 affected79 at risk EG00225 affected77 at risk EG003
Fever	General disorders	Systematic Assessment	Following challenge dose administration	EG00029 affected80 at risk EG00120 affected79 at risk EG00227 affected77 at risk EG003

ID	Term
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
C527605	Hib-MenCY-TT vaccine
C055753	Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
C451839	DTPa-HBV-IPV combined vaccine
D000069443	Heptavalent Pneumococcal Conjugate Vaccine

ID	Term
D022242	Pneumococcal Vaccines
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D017778	Vaccines, Combined