Infections, Meningococcal
Conditions
Keywords
Immunogenicity, Booster, Healthy, Vaccine response, Safety, Neisseria meningiditis, Antibody persistence, Meningococcal conjugate vaccine
Brief summary
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 years after MenACWY-TT booster vaccination. This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).
Interventions
BIOLOGICALMeningococcal conjugate vaccine GSK134612
Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
84 Months to 95 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | At Month 73, one month post-booster vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | At Month 73, one month post-booster vaccination | Antibody titers were presented as geometric mean titers (GMTs). |
| Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values | At Month 73, one month post-booster vaccination | 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. |
| Antibody Concentrations Against Tetanus (Anti-T) Antigen | At Month 73, one month post-booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). |
| Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY | At Month 96, 24 months post-booster vaccination | Antibody titers were presented as geometric mean titers (GMTs). |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | At Month 73, one month post-booster vaccination | The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128. |
| Number of Subjects With Any Solicited General Symptoms | During the 4-day (Days 0-3) post-booster vaccination period at Month 72 | 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. |
| Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | During the 31-day (Days 0-30) post-booster vaccination period at Month 72 | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-booster vaccination period at Month 72 | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the 31-day (Days 0-30) post-booster vaccination period at Month 72 | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any Solicited Local Symptoms | During the 4-day (Days 0-3) post-booster vaccination period at Month 72 | Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
Countries
Australia
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 119 |
| 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. | 37 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Blood draw refusal at Visit 3 | 1 | 0 |
| Overall Study | Lost to Follow-up | 7 | 2 |
| Overall Study | Migrated/moved from study area | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | Menitorix Group | Meningitec + Hiberix Group | Total |
|---|---|---|---|
| Age, Continuous | 7.0 Years STANDARD_DEVIATION 0.2 | 7.0 Years STANDARD_DEVIATION 0 | 7.0 Years STANDARD_DEVIATION 0.17 |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-East Asian Heritage | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-South East Asian Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Unspecified | 7 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Caucasian/European Heritage | 109 Participants | 36 Participants | 145 Participants |
| Sex: Female, Male Female | 57 Participants | 14 Participants | 71 Participants |
| Sex: Female, Male Male | 62 Participants | 23 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 37 |
| other Total, other adverse events | 95 / 119 | 28 / 37 |
| serious Total, serious adverse events | 0 / 119 | 0 / 37 |
Outcome results
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.
Time frame: At Month 73, one month post-booster vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menitorix Group | 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) | rSBA-MenA | 102 Participants |
| Menitorix Group | 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) | rSBA-MenC | 101 Participants |
| Menitorix Group | 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) | rSBA-MenW-135 | 102 Participants |
| Menitorix Group | 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) | rSBA-MenY | 101 Participants |
| Meningitec + Hiberix Group | 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) | rSBA-MenY | 33 Participants |
| Meningitec + Hiberix Group | 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) | rSBA-MenA | 33 Participants |
| Meningitec + Hiberix Group | 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) | rSBA-MenW-135 | 33 Participants |
| Meningitec + Hiberix Group | 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) | rSBA-MenC | 33 Participants |
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).
Time frame: At Month 73, one month post-booster vaccination
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menitorix Group | Antibody Concentrations Against Tetanus (Anti-T) Antigen | 15.6 IU/mL |
| Meningitec + Hiberix Group | Antibody Concentrations Against Tetanus (Anti-T) Antigen | 12.5 IU/mL |
Secondary
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 96, 24 months post-booster vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY | rSBA-MenA | 174.9 Titers |
| Menitorix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY | rSBA-MenC | 333.1 Titers |
| Menitorix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY | rSBA-MenW-135 | 1002.9 Titers |
| Menitorix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY | rSBA-MenY | 929.3 Titers |
| Meningitec + Hiberix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY | rSBA-MenY | 512.0 Titers |
| Meningitec + Hiberix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY | rSBA-MenA | 79.0 Titers |
| Meningitec + Hiberix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY | rSBA-MenW-135 | 941.5 Titers |
| Meningitec + Hiberix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY | rSBA-MenC | 175.4 Titers |
Secondary
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 73, one month post-booster vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenW-135 | 17166.5 Titer |
| Menitorix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenA | 3421.4 Titer |
| Menitorix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenY | 4871 Titer |
| Menitorix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenC | 11819.2 Titer |
| Meningitec + Hiberix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenY | 3495.9 Titer |
| Meningitec + Hiberix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenC | 7419.7 Titer |
| Meningitec + Hiberix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenW-135 | 15747.7 Titer |
| Meningitec + Hiberix Group | Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | rSBA-MenA | 2925.1 Titer |
Secondary
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menitorix Group | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
| Meningitec + Hiberix Group | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
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.
Time frame: At Month 73, one month post-booster vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values | Anti-T ≥ 0.1 IU/mL | 103 Participants |
| Menitorix Group | Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values | Anti-T ≥ 1 IU/mL | 102 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values | Anti-T ≥ 0.1 IU/mL | 34 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values | Anti-T ≥ 1 IU/mL | 33 Participants |
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.
Time frame: During the 4-day (Days 0-3) post-booster vaccination period at Month 72
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Any Solicited General Symptoms | Any Fatigue | 31 Participants |
| Menitorix Group | Number of Subjects With Any Solicited General Symptoms | Any Headache | 29 Participants |
| Menitorix Group | Number of Subjects With Any Solicited General Symptoms | Any Gastrointestinal symptoms | 29 Participants |
| Menitorix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever | 6 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever | 1 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any Fatigue | 10 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any Gastrointestinal symptoms | 5 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any Headache | 6 Participants |
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.
Time frame: During the 4-day (Days 0-3) post-booster vaccination period at Month 72
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 69 Participants |
| Menitorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 56 Participants |
| Menitorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 30 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 15 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 19 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 8 Participants |
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.
Time frame: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menitorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 36 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 7 Participants |
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.
Time frame: At Month 73, one month post-booster vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenA, ≥ 1:8 | 102 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenC, ≥ 1:128 | 102 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenA, ≥ 1:128 | 102 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenC, ≥ 1:8 | 102 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenW-135, ≥ 1:8 | 102 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenW-135, ≥ 1:128 | 102 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenY, ≥ 1:8 | 103 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenY, ≥ 1:128 | 103 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenY, ≥ 1:128 | 34 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenW-135, ≥ 1:8 | 35 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenA, ≥ 1:8 | 35 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenY, ≥ 1:8 | 34 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenA, ≥ 1:128 | 35 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenW-135, ≥ 1:128 | 35 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenC, ≥ 1:8 | 35 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenC, ≥ 1:128 | 34 Participants |
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.
Time frame: At Month 96, 24 months post-booster vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenA, ≥ 1:8 | 72 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenA, ≥ 1:128 | 67 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenC, ≥ 1:8 | 100 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenC, ≥ 1:128 | 90 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenW-135, ≥ 1:8 | 96 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenW-135, ≥ 1:128 | 96 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenY, ≥ 1:8 | 95 Participants |
| Menitorix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenY, ≥ 1:128 | 95 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenY, ≥ 1:128 | 29 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenA, ≥ 1:8 | 21 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenW-135, ≥ 1:8 | 30 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenA, ≥ 1:128 | 17 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenY, ≥ 1:8 | 29 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenC, ≥ 1:8 | 31 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenW-135, ≥ 1:128 | 30 Participants |
| Meningitec + Hiberix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | rSBA-MenC, ≥ 1:128 | 26 Participants |
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.
Time frame: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: From Month 72 up to study end, at Month 96
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Meningitec + Hiberix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |