Immunogenicity, Reactogenicity and Safety of GlaxoSmithKl... | NCT01777308

ID	Type	Description	Link
2012-002575-34	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Menitorix Group	Experimental	Subjects who were primed with Menitorix™ (Hib-MenC-TT) + Priorix™ (MMR) vaccines in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1). The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.	Biological: Meningococcal conjugate vaccine GSK134612
Meningitec + Hiberix Group	Experimental	Subjects who were primed with Meningitec™ (MCC) + Hiberix™ (Hib) + Priorix™ (MMR) vaccine in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1). The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.	Biological: Meningococcal conjugate vaccine GSK134612

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meningococcal conjugate vaccine GSK134612	Biological	Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm	Meningitec + Hiberix Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)	Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.	At Month 73, one month post-booster vaccination

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values	The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.	At Month 73, one month post-booster vaccination
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects' parent(s)/Legally Acceptable Representative(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
A male or female between, and including, 84 and 95 months of age at the time of the booster vaccination.
Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations.
Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
Having completed the vaccination in the study [Hib-MenC-TT-016 (106445)] as per protocol.

Exclusion Criteria:

Child in care.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the Hib-MenC-TT-016 study.
History of meningococcal disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV)infection, based on medical history and physical examination (no laboratory testing required).
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s).
Major congenital defects or serious chronic illness.
History of any neurological disorders or seizures, including GBS. History of a simple, single febrile seizure is permitted.
Acute disease and/or fever at the time of enrollment.
- Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e. between Visit 1 and Visit 2) and within 3 months preceding the blood sampling at Visit 3.

The following criteria should be checked for the long-term persistence phase at two years after booster vaccination (Visit 3):

In case an exclusion criterion becomes applicable, the subject will not enter the long-term follow-up and the reason will be documented.

Previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in the primary study and the booster vaccination in this particular study.
History of meningococcal disease.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Garran	Australian Capital Territory	2606	Australia
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
31116180	Derived	Nolan T, Booy R, Marshall HS, Richmond P, Nissen M, Ziegler JB, Baine Y, Traskine M, Jastorff A, Van der Wielen M. Immunogenicity and Safety of a Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine 6 Years After MenC Priming as Toddlers. Pediatr Infect Dis J. 2019 Jun;38(6):643-650. doi: 10.1097/INF.0000000000002334.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
BG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000119 BG00137 BG002156

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 Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)

Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Month 73, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month post-vaccination.

Posted

Count of Participants

Participants

At Month 73, one month post-booster vaccination

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Units	Counts
Participants	OG000104 OG00134

Title

Denominators

Categories

rSBA-MenA

Title	Measurements
	OG000102 OG00133

rSBA-MenC

Title	Measurements
	OG000

Secondary

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values

The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.

The analysis was performed on the Adapted ATP cohort at Month 73, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month post-vaccination.

Posted

Count of Participants

Participants

At Month 73, one month post-booster vaccination

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Secondary

Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY

Antibody titers were presented as geometric mean titers (GMTs).

Posted

Geometric Mean

95% Confidence Interval

Titer

At Month 73, one month post-booster vaccination

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values

The cut-off values for anti-T concentrations were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.

Posted

Count of Participants

Participants

At Month 73, one month post-booster vaccination

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Secondary

Antibody Concentrations Against Tetanus (Anti-T) Antigen

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 73, one month post-booster vaccination

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values

The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.

The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Month 96, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen at 24 months post booster vaccination.

Posted

Count of Participants

Participants

At Month 96, 24 months post-booster vaccination

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Secondary

Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY

Antibody titers were presented as geometric mean titers (GMTs).

Posted

Geometric Mean

95% Confidence Interval

Titers

At Month 96, 24 months post-booster vaccination

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With Any Solicited Local Symptoms

Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) post-booster vaccination period at Month 72

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With Any Solicited General Symptoms

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) post-booster vaccination period at Month 72

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

Posted

Count of Participants

Participants

During the 31-day (Days 0-30) post-booster vaccination period at Month 72

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Posted

Count of Participants

Participants

During the 31-day (Days 0-30) post-booster vaccination period at Month 72

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Posted

Count of Participants

Participants

During the 31-day (Days 0-30) post-booster vaccination period at Month 72

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Posted

Count of Participants

Participants

From Month 72 up to study end, at Month 96

ID	Title	Description
OG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
OG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Menitorix Group	Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.	0	119	0	119	95	119
EG001	Meningitec + Hiberix Group	Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.	0	37	0	37	28	37

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00056 events56 affected119 at risk EG00119 events19 affected37 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG00031 events31 affected119 at risk EG00110 events10 affected37 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00029 events29 affected119 at risk EG0015 events5 affected37 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00030 events30 affected119 at risk EG0019 events7 affected37 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG00069 events69 affected119 at risk EG00115 events15 affected37 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0006 events6 affected119 at risk EG0012 events2 affected37 at risk
Swelling	General disorders	MedDRA 19.0	Systematic Assessment	EG00030 events30 affected119 at risk EG0018 events8 affected37 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0007 events7 affected119 at risk EG0012 events2 affected37 at risk

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections