Infections, Meningococcal
Conditions
Keywords
immunogenicity, Meningococcal serogroups A, C, W-135 and/or Y disease, co-administration, meningococcal vaccine, lot-to-lot consistency, conjugate vaccine
Brief summary
The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612 given alone and the immunogenicity of GSK134612 given with Fluarix™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Multicentre study with 5 treatment groups. Three groups will receive three different manufactured lots of GSK134612, one group will receive one lot of GSK134612 given in an experimental co-administration with Fluarix™, the control group will receive Mencevax™. The study will be conducted in a double-blind manner with respect to the 3 lots of GSK134612 vaccine. The study will be 'open' between the groups receiving GSK134612 and the group receiving GSK134612 + Fluarix™ and the Mencevax™ group. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.
Interventions
BIOLOGICALMeningococcal vaccine GSK134612
One intramuscular dose
BIOLOGICALMencevax™ACWY
One subcutaneous dose
BIOLOGICALFluarix™
One intramuscular dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
For all subjects: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * A male or female between, and including, 18 and 55 years of age at the time of the vaccination. * Written informed consent obtained from the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Previously completed routine childhood vaccinations to the best of his/her knowledge. * If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test, and continue such precautions for 2 months after completion of the vaccination series.
Exclusion criteria
For all subjects: * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). * Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y within the last five previous years. * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y. * Previous vaccination with tetanus toxoid within the last month. * 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. * A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * History of reactions or allergic disease likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Pregnant or lactating female. * History of chronic alcohol consumption and/or drug abuse. * Female planning to become pregnant or planning to discontinue contraceptive precautions. Additional criteria for subjects receiving Fluarix™ co-administration: * History of hypersensitivity to a previous dose of influenza vaccine. * History of reactions or allergy likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate, or sodium deoxycholate. * History of administration of an influenza vaccine outside of this study, during current flu season.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | One month after vaccination (at Month 1) | Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C. |
| Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | One month after vaccination (at Month 1) | Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (\<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | One month after vaccination (at Month 1) | Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort). |
| Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Prior to and one month after vaccination (at Month 0 and Month 1). | Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B. |
| Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | One month after vaccination (at Month 1) | Seroconversion was defined as the percentage of subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination titer \>1:40, or a pre-vaccination titer \>1:10 and a minimum 4-fold increase at post-vaccination titer, for each vaccine strain. Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B. |
| Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | One month after vaccination (at Month 1) | Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B. |
| Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Prior to and one month after vaccination (at Month 0 and Month 1) | Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Prior to and one month after vaccination (at Month 0 and Month 1). | Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Prior to and one month after vaccination (at Month 0 and Month 1). | Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort | Prior to and one month after vaccination (at Month 0 and Month 1). | Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort | Prior to and one month after vaccination (at Month 0 and Month 1). | Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Prior to and one month after vaccination (at Month 0 and Month 1). | Meningococcal polysaccharide serogroups, A, C, W-135 and Y = PSA, PSC, PSW-135 & PSY. Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Prior to and one month after vaccination (at Month 0 and Month 1). | Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Prior to and one month after vaccination (at Month 0 and Month 1). | Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Prior to and one month after vaccination (at Month 0 and Month 1). | Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | During the 4-day (Days 0-3) follow-up period after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | During the 4-day (Days 0-3) follow-up period after meningococcal vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine | During the 4-day (Days 0-3) follow-up period after Fluarix vaccine administration | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine after the Fluarix vaccine administration. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | Prior to and one month after vaccination (at Month 0 and Month 1). | Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C. |
| Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | During the 4-day (Days 0-3) follow-up period after vaccination | Solicited general symptoms = fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5°C). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = \> 39.5°C. Symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | From Dose 1 (at Month 0) up to study end (at Month 6) | Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | From Dose 1 (at Month 0) up to study end (at Month 6) | NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | From Dose 1 (at Month 0) up to study end (at Month 6) | AEs resulting in ER visits were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort | From Dose 1 (at Month 0) up to study end (at Month 6) | Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort | From Dose 1 (at Month 0) up to study end (at Month 6) | NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort | From Dose 1 (at Month 0) up to study end (at Month 6) | AEs resulting in ER visits were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1) | An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Unsolicited AEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, B and C) or the Mencevax ACWY vaccine. |
| Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | From Dose 1 (at Month 0) up to study end (at Month 6) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort | From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1) | An unsolicited AE = any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. AEs were collected for subjects receiving Nimenrix vaccine lot A+Fluarix vaccine, Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort | From Dose 1 (at Month 0) up to study end (at Month 6) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | During the 4-day (Days 0-3) follow-up period after vaccination | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5 degrees Celsius). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = axillary temperature \> 39.5°C. Symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | Prior to vaccination (at Month 0). | Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Prior to and one month after vaccination (at Month 0 and Month 1). | Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | Prior to and one month after vaccination (at Month 0 and Month 1). | Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort). |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Prior to and one month after vaccination (at Month 0 and Month 1). | Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Prior to and one month after vaccination (at Month 0 and Month 1). | Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine. |
| Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | One month after vaccination (at Month 1) | Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (\<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥ 1:8). A seronegative subject had antibody titer \>1:8 and a seropositive subject had antibody titer ≥1:8 prior to vaccination. Vaccine response was assessed for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort). |
Countries
Lebanon, Philippines
Participant flow
Pre-assignment details
All subjects were included in 1 of the 2 cohorts: Flu vaccine cohort: in the 5 groups, subjects received Nimenrix vaccine (lots A, B or C) or Mencevax ACWY vaccine or Nimenrix lot A and Fluarix vaccines. Non-Flu vaccine cohort: in the 4 groups, subjects received Nimenrix vaccine (lots A, B or C) or Mencevax ACWY vaccine.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix A Group subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. | 311 |
| Nimenrix B Group subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. | 311 |
| Nimenrix C Group subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. | 313 |
| Mencevax ACWY Group subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm. | 312 |
| Nimenrix+Fluarix Group subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm. | 105 |
| Total | 1,352 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 5 | 6 | 2 | 0 |
Baseline characteristics
| Characteristic | Nimenrix A Group | Nimenrix B Group | Nimenrix C Group | Mencevax ACWY Group | Nimenrix+Fluarix Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 35.2 Years STANDARD_DEVIATION 10.48 | 35.1 Years STANDARD_DEVIATION 10.5 | 35.7 Years STANDARD_DEVIATION 10.75 | 34.9 Years STANDARD_DEVIATION 10.73 | 35.9 Years STANDARD_DEVIATION 10.4 | 35.4 Years STANDARD_DEVIATION 10.57 |
| Race/Ethnicity, Customized Asian - South east Asian heritage | 223 Participants | 223 Participants | 224 Participants | 224 Participants | 105 Participants | 999 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic / North African heritage | 88 Participants | 88 Participants | 87 Participants | 88 Participants | 0 Participants | 351 Participants |
| Race/Ethnicity, Customized White - Caucasian / European heritage | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 135 Participants | 139 Participants | 133 Participants | 151 Participants | 40 Participants | 598 Participants |
| Sex: Female, Male Male | 176 Participants | 172 Participants | 180 Participants | 161 Participants | 65 Participants | 754 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 935 | 0 / 312 | 0 / 105 |
| other Total, other adverse events | 330 / 935 | 89 / 312 | 49 / 105 |
| serious Total, serious adverse events | 7 / 935 | 1 / 312 | 0 / 105 |
Outcome results
Primary
Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Seroconversion was defined as the percentage of subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination titer \>1:40, or a pre-vaccination titer \>1:10 and a minimum 4-fold increase at post-vaccination titer, for each vaccine strain. Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Time frame: One month after vaccination (at Month 1)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H1N1 | 75 Participants |
| Nimenrix A Group | Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H3N2 | 65 Participants |
| Nimenrix A Group | Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-B | 78 Participants |
Primary
Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H1N1 [Month 0] | 68 Participants |
| Nimenrix A Group | Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H1N1 [Month 1] | 104 Participants |
| Nimenrix A Group | Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H3N2 [Month 0] | 57 Participants |
| Nimenrix A Group | Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H3N2 [Month 1] | 102 Participants |
| Nimenrix A Group | Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-B [Month 0] | 44 Participants |
| Nimenrix A Group | Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-B [Month 1] | 100 Participants |
Primary
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (\<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: One month after vaccination (at Month 1)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA seronegative | 25 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA seropositive | 151 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC seronegative | 64 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC seropositive | 201 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 seronegative | 53 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 seropositive | 189 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY seronegative | 32 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY seropositive | 195 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA total | 176 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC total | 265 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 total | 242 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY total | 227 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 total | 776 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA seronegative | 107 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY seronegative | 68 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA seropositive | 488 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC total | 777 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC seronegative | 198 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY seropositive | 682 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC seropositive | 579 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY total | 750 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 seronegative | 151 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA total | 595 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 seropositive | 625 Participants |
Primary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort)
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort).
Time frame: One month after vaccination (at Month 1)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | rSBA-MenA | 2831.1 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | rSBA-MenC | 6579.5 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | rSBA-MenW-135 | 4394.8 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | rSBA-MenY | 5650.9 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | rSBA-MenY | 7464.1 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | rSBA-MenA | 3784.2 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | rSBA-MenW-135 | 6016.8 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort) | rSBA-MenC | 10130.8 Titers |
Primary
Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Time frame: One month after vaccination (at Month 1)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Nimenrix A Group | Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H1N1 | 9.9 Fold increase in serum HI GMTs |
| Nimenrix A Group | Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H3N2 | 5.6 Fold increase in serum HI GMTs |
| Nimenrix A Group | Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-B | 9.1 Fold increase in serum HI GMTs |
Primary
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
Time frame: One month after vaccination (at Month 1)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix A Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenY | 7872.7 Titers |
| Nimenrix A Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenA | 3913.1 Titers |
| Nimenrix A Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenW-135 | 5263.2 Titers |
| Nimenrix A Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenC | 9467.0 Titers |
| Nimenrix B Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenW-135 | 4890.6 Titers |
| Nimenrix B Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenY | 7235.7 Titers |
| Nimenrix B Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenC | 8118.7 Titers |
| Nimenrix B Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenA | 3503.5 Titers |
| Nimenrix C Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenY | 8041.4 Titers |
| Nimenrix C Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenC | 9051.0 Titers |
| Nimenrix C Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenW-135 | 5260.1 Titers |
| Nimenrix C Group | Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenA | 3470.8 Titers |
Primary
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix A Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H1N1 [Month 0] | 54.1 Titers |
| Nimenrix A Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H1N1 [Month 1] | 537.2 Titers |
| Nimenrix A Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H3N2 [Month 0] | 31.5 Titers |
| Nimenrix A Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-A/H3N2 [Month 1] | 177.8 Titers |
| Nimenrix A Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-B [Month 0] | 20.9 Titers |
| Nimenrix A Group | Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine. | Anti-B [Month 1] | 192.7 Titers |
Secondary
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort
Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSY [Month 1] | 25.39 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSA [Month 0] | 2.40 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSC [Month 1] | 9.05 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSY [Month 0] | 0.29 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSA [Month 1] | 56.47 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 [Month 0] | 0.21 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSC [Month 0] | 0.30 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 [Month 1] | 20.06 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSA [Month 1] | 142.33 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 [Month 1] | 26.44 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSY [Month 0] | 0.41 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSA [Month 0] | 4.08 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSY [Month 1] | 40.46 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSC [Month 0] | 0.41 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSC [Month 1] | 19.26 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 [Month 0] | 0.33 µg/mL |
| Nimenrix C Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSY [Month 1] | 24.67 µg/mL |
| Nimenrix C Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSA [Month 0] | 3.83 µg/mL |
| Nimenrix C Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSA [Month 1] | 56.43 µg/mL |
| Nimenrix C Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSC [Month 0] | 0.48 µg/mL |
| Nimenrix C Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSC [Month 1] | 46.30 µg/mL |
| Nimenrix C Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 [Month 0] | 0.25 µg/mL |
| Nimenrix C Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSY [Month 0] | 0.32 µg/mL |
| Nimenrix C Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 [Month 1] | 26.27 µg/mL |
Secondary
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 [Month 0] | 0.31 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA [Month 0] | 2.14 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 [Month 1] | 24.71 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC [Month 0] | 0.33 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY [Month 0] | 0.36 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA [Month 1] | 101.79 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY [Month 1] | 36.94 µg/mL |
| Nimenrix A Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC [Month 1] | 20.96 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY [Month 1] | 30.41 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA [Month 0] | 2.65 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA [Month 1] | 56.89 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC [Month 0] | 0.38 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 [Month 0] | 0.26 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 [Month 1] | 21.90 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY [Month 0] | 0.35 µg/mL |
| Nimenrix B Group | Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC [Month 1] | 45.85 µg/mL |
Secondary
Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort
Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix A Group | Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 0] | 0.295 IU/mL |
| Nimenrix A Group | Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 1] | 3.073 IU/mL |
| Nimenrix B Group | Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 0] | 0.418 IU/mL |
| Nimenrix B Group | Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 1] | 4.655 IU/mL |
| Nimenrix C Group | Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 0] | 0.287 IU/mL |
| Nimenrix C Group | Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 1] | 0.276 IU/mL |
Secondary
Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix A Group | Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-tetanus [Month 0] | 0.245 IU/mL |
| Nimenrix A Group | Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-tetanus [Month 1] | 3.488 IU/mL |
| Nimenrix B Group | Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-tetanus [Month 0] | 0.265 IU/mL |
| Nimenrix B Group | Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-tetanus [Month 1] | 0.279 IU/mL |
Secondary
Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort
AEs resulting in ER visits were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: From Dose 1 (at Month 0) up to study end (at Month 6)
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix A Group | Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort | 0 Participants |
| Nimenrix B Group | Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort | 0 Participants |
| Nimenrix C Group | Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort | 0 Participants |
Secondary
Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
AEs resulting in ER visits were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: From Dose 1 (at Month 0) up to study end (at Month 6)
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix A Group | Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 13 Participants |
| Nimenrix B Group | Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 1 Participants |
Secondary
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort
NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: From Dose 1 (at Month 0) up to study end (at Month 6)
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix A Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort | 0 Participants |
| Nimenrix B Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort | 0 Participants |
| Nimenrix C Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort | 0 Participants |
Secondary
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: From Dose 1 (at Month 0) up to study end (at Month 6)
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix A Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 0 Participants |
| Nimenrix B Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 0 Participants |
Secondary
Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort
Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: From Dose 1 (at Month 0) up to study end (at Month 6)
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix A Group | Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort | 0 Participants |
| Nimenrix B Group | Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort | 3 Participants |
| Nimenrix C Group | Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort | 0 Participants |
Secondary
Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: From Dose 1 (at Month 0) up to study end (at Month 6)
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix A Group | Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 10 Participants |
| Nimenrix B Group | Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 3 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: From Dose 1 (at Month 0) up to study end (at Month 6)
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix A Group | Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort | 0 Participants |
| Nimenrix B Group | Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort | 4 Participants |
| Nimenrix C Group | Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort | 0 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: From Dose 1 (at Month 0) up to study end (at Month 6)
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix A Group | Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 7 Participants |
| Nimenrix B Group | Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 1 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort
An unsolicited AE = any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. AEs were collected for subjects receiving Nimenrix vaccine lot A+Fluarix vaccine, Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix A Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort | 13 Participants |
| Nimenrix B Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort | 50 Participants |
| Nimenrix C Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort | 20 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Unsolicited AEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, B and C) or the Mencevax ACWY vaccine.
Time frame: From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix A Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 135 Participants |
| Nimenrix B Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 47 Participants |
Secondary
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Meningococcal polysaccharide serogroups, A, C, W-135 and Y = PSA, PSC, PSW-135 & PSY. Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA >=0.3 µg/mL [Month 0] | 354 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA >=0.3 µg/mL [Month 1] | 432 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC >=0.3 µg/mL [Month 0] | 130 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC >=0.3 µg/mL [Month 1] | 422 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 >=0.3 µg/mL [Month 0] | 135 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 >=0.3 µg/mL [Month 1] | 439 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY >=0.3 µg/mL [Month 0] | 156 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY >=0.3 µg/mL [Month 1] | 442 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA >=2.0 µg/mL [Month 0] | 227 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA >=2.0 µg/mL [Month 1] | 428 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC >=2.0 µg/mL [Month 0] | 51 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC >=2.0 µg/mL [Month 1] | 398 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 >=2.0 µg/mL [Month 0] | 41 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 >=2.0 µg/mL [Month 1] | 408 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY >=2.0 µg/mL [Month 0] | 59 Participants |
| Nimenrix A Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY >=2.0 µg/mL [Month 1] | 420 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY >=2.0 µg/mL [Month 1] | 142 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA >=0.3 µg/mL [Month 0] | 125 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA >=2.0 µg/mL [Month 0] | 87 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA >=0.3 µg/mL [Month 1] | 144 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 >=2.0 µg/mL [Month 0] | 11 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC >=0.3 µg/mL [Month 0] | 61 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSA >=2.0 µg/mL [Month 1] | 144 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC >=0.3 µg/mL [Month 1] | 141 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY >=2.0 µg/mL [Month 0] | 21 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 >=0.3 µg/mL [Month 0] | 38 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC >=2.0 µg/mL [Month 0] | 17 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 >=0.3 µg/mL [Month 1] | 144 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSW-135 >=2.0 µg/mL [Month 1] | 136 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY >=0.3 µg/mL [Month 0] | 52 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSC >=2.0 µg/mL [Month 1] | 141 Participants |
| Nimenrix B Group | Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-PSY >=0.3 µg/mL [Month 1] | 145 Participants |
Secondary
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=2.0 µg/mL [Month 0] | 5 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=0.3 µg/mL [Month 1] | 51 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=2.0 µg/mL [Month 1] | 51 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=2.0 µg/mL [Month 1] | 46 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=2.0 µg/mL [Month 1] | 49 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=0.3 µg/mL [Month 1] | 53 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=0.3 µg/mL [Month 1] | 49 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=2.0 µg/mL [Month 0] | 30 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=0.3 µg/mL [Month 0] | 13 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=2.0 µg/mL [Month 0] | 1 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=2.0 µg/mL [Month 0] | 6 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=0.3 µg/mL [Month 1] | 48 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=0.3 µg/mL [Month 0] | 16 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=2.0 µg/mL [Month 1] | 42 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=0.3 µg/mL [Month 0] | 12 Participants |
| Nimenrix A Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=0.3 µg/mL [Month 0] | 46 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=0.3 µg/mL [Month 1] | 145 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=0.3 µg/mL [Month 0] | 136 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=0.3 µg/mL [Month 1] | 151 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=0.3 µg/mL [Month 0] | 50 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=0.3 µg/mL [Month 0] | 53 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=0.3 µg/mL [Month 1] | 153 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=0.3 µg/mL [Month 0] | 61 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=0.3 µg/mL [Month 1] | 156 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=2.0 µg/mL [Month 0] | 100 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=2.0 µg/mL [Month 1] | 149 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=2.0 µg/mL [Month 0] | 24 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=2.0 µg/mL [Month 1] | 133 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=2.0 µg/mL [Month 0] | 13 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=2.0 µg/mL [Month 1] | 142 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=2.0 µg/mL [Month 0] | 25 Participants |
| Nimenrix B Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=2.0 µg/mL [Month 1] | 147 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=2.0 µg/mL [Month 0] | 8 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=0.3 µg/mL [Month 1] | 51 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=2.0 µg/mL [Month 1] | 50 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=2.0 µg/mL [Month 1] | 51 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=0.3 µg/mL [Month 1] | 52 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=2.0 µg/mL [Month 0] | 6 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=2.0 µg/mL [Month 0] | 4 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=0.3 µg/mL [Month 0] | 51 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=0.3 µg/mL [Month 1] | 51 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=0.3 µg/mL [Month 1] | 49 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=2.0 µg/mL [Month 0] | 37 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSY >=0.3 µg/mL [Month 0] | 17 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=2.0 µg/mL [Month 1] | 48 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSA >=2.0 µg/mL [Month 1] | 52 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSW-135 >=0.3 µg/mL [Month 0] | 11 Participants |
| Nimenrix C Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | Anti-PSC >=0.3 µg/mL [Month 0] | 24 Participants |
Secondary
Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort
Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 0] | 61 Participants |
| Nimenrix A Group | Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 1] | 84 Participants |
| Nimenrix B Group | Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 0] | 193 Participants |
| Nimenrix B Group | Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 1] | 254 Participants |
| Nimenrix C Group | Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 0] | 54 Participants |
| Nimenrix C Group | Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort | Anti-tetanus [Month 1] | 53 Participants |
Secondary
Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-tetanus [Month 0] | 454 Participants |
| Nimenrix A Group | Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-tetanus [Month 1] | 703 Participants |
| Nimenrix B Group | Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-tetanus [Month 0] | 153 Participants |
| Nimenrix B Group | Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Anti-tetanus [Month 1] | 156 Participants |
Secondary
Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort
Solicited general symptoms = fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5°C). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = \> 39.5°C. Symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Any fatigue | 10 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Grade 3 fatigue | 0 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Fever >= 37.5°C | 3 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Fever > 39.5°C | 0 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Any gastrointestinal symptoms | 2 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Grade 3 gastrointestinal symptoms | 0 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Any headache | 14 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Grade 3 headache | 0 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Fever >= 37.5°C | 10 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Any headache | 47 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Fever > 39.5°C | 1 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Any gastrointestinal symptoms | 15 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Grade 3 gastrointestinal symptoms | 0 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Any fatigue | 33 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Grade 3 fatigue | 0 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Grade 3 headache | 1 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Fever >= 37.5°C | 3 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Grade 3 fatigue | 0 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Any fatigue | 12 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Fever > 39.5°C | 0 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Any headache | 12 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Grade 3 gastrointestinal symptoms | 0 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Any gastrointestinal symptoms | 2 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort | Grade 3 headache | 0 Participants |
Secondary
Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5 degrees Celsius). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = axillary temperature \> 39.5°C. Symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any fatigue | 114 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Grade 3 fatigue | 8 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Fever >= 37.5°C | 37 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Fever > 39.5°C | 2 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any gastrointestinal symptoms | 43 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Grade 3 gastrointestinal symptoms | 2 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any headache | 151 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Grade 3 headache | 14 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Grade 3 headache | 5 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any fatigue | 30 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any gastrointestinal symptoms | 10 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Grade 3 fatigue | 0 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any headache | 44 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Fever >= 37.5°C | 14 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Grade 3 gastrointestinal symptoms | 1 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Fever > 39.5°C | 2 Participants |
Secondary
Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: During the 4-day (Days 0-3) follow-up period after meningococcal vaccination
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Any pain | 23 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Grade 3 pain | 1 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Any redness | 6 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Redness > 50 mm | 0 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Any swelling | 4 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Swelling > 50 mm | 0 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Swelling > 50 mm | 3 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Any pain | 84 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Redness > 50 mm | 1 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Any swelling | 32 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Grade 3 pain | 0 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Any redness | 38 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Grade 3 pain | 0 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Any redness | 5 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Swelling > 50 mm | 0 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Redness > 50 mm | 0 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Any pain | 16 Participants |
| Nimenrix C Group | Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines. | Any swelling | 1 Participants |
Secondary
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine after the Fluarix vaccine administration.
Time frame: During the 4-day (Days 0-3) follow-up period after Fluarix vaccine administration
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine | Any pain | 29 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine | Grade 3 pain | 1 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine | Any redness | 7 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine | Redness > 50 mm | 0 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine | Any swelling | 7 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine | Swelling > 50 mm | 1 Participants |
Secondary
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any pain | 180 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Grade 3 pain | 4 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any redness | 82 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Redness > 50 mm | 12 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any swelling | 73 Participants |
| Nimenrix A Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Swelling > 50 mm | 10 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any swelling | 6 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any pain | 42 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Redness > 50 mm | 0 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Grade 3 pain | 1 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Swelling > 50 mm | 0 Participants |
| Nimenrix B Group | Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | Any redness | 14 Participants |
Secondary
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (\<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥ 1:8). A seronegative subject had antibody titer \>1:8 and a seropositive subject had antibody titer ≥1:8 prior to vaccination. Vaccine response was assessed for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: One month after vaccination (at Month 1)
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenA seronegative | 5 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenA seropositive | 60 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenC seronegative | 13 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenC seropositive | 73 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 seronegative | 15 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 seropositive | 74 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenY seronegative | 6 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenY seropositive | 77 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenA total | 65 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenC total | 86 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 total | 89 Participants |
| Nimenrix A Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenY total | 83 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenY total | 259 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenA seronegative | 44 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenY seronegative | 23 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenA total | 212 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenA seropositive | 168 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 seropositive | 235 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 total | 275 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenC seronegative | 68 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenY seropositive | 236 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 seronegative | 40 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenC seropositive | 193 Participants |
| Nimenrix B Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenC total | 261 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenC seropositive | 72 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 seronegative | 17 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenC total | 88 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 seropositive | 72 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenY seronegative | 12 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenY seropositive | 61 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 total | 89 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenA seronegative | 6 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenA seropositive | 50 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenA total | 56 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenC seronegative | 16 Participants |
| Nimenrix C Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort | rSBA-MenY total | 73 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:8 [Month 0] | 85 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:8 [Month 1] | 102 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:8 [Month 0] | 84 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:8 [Month 1] | 104 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:8 [Month 0] | 81 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:8 [Month 1] | 105 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:8 [Month 0] | 96 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:8 [Month 1] | 105 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:128 [Month 0] | 64 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:128 [Month 1] | 101 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:128 [Month 0] | 58 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:128 [Month 1] | 103 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:128 [Month 0] | 62 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:128 [Month 1] | 102 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:128 [Month 0] | 82 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:128 [Month 1] | 104 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:8 [Month 1] | 308 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:8 [Month 0] | 277 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:8 [Month 1] | 306 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:128 [Month 1] | 306 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:128 [Month 0] | 180 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:128 [Month 1] | 305 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:128 [Month 1] | 305 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:128 [Month 0] | 154 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:8 [Month 0] | 219 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:128 [Month 0] | 228 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:8 [Month 1] | 305 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:128 [Month 1] | 304 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:8 [Month 0] | 225 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:8 [Month 1] | 306 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:8 [Month 0] | 259 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:128 [Month 0] | 192 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:128 [Month 0] | 54 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:8 [Month 1] | 103 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:128 [Month 0] | 54 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:8 [Month 0] | 84 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:8 [Month 0] | 88 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:128 [Month 1] | 103 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:8 [Month 0] | 82 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:8 [Month 1] | 104 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:128 [Month 1] | 103 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:8 [Month 0] | 84 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:128 [Month 0] | 69 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 >=1:128 [Month 1] | 102 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:8 [Month 1] | 104 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenA >=1:128 [Month 1] | 103 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenC >=1:8 [Month 1] | 103 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort | rSBA-MenY >=1:128 [Month 0] | 79 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:128 [Month 0] | 143 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:8 [Month 1] | 296 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:128 [Month 1] | 293 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:128 [Month 0] | 165 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:8 [Month 1] | 292 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:128 [Month 1] | 294 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:8 [Month 0] | 238 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:128 [Month 0] | 232 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:128 [Month 1] | 295 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:8 [Month 1] | 297 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:8 [Month 0] | 266 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:8 [Month 0] | 220 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:8 [Month 1] | 297 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:128 [Month 0] | 199 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:8 [Month 0] | 226 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:128 [Month 1] | 291 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:128 [Month 1] | 286 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:8 [Month 1] | 290 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:8 [Month 0] | 207 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:128 [Month 1] | 286 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:8 [Month 1] | 289 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:128 [Month 0] | 175 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:128 [Month 0] | 178 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:8 [Month 0] | 264 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:128 [Month 1] | 291 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:128 [Month 1] | 289 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:128 [Month 0] | 132 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:8 [Month 1] | 291 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:128 [Month 0] | 219 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:8 [Month 0] | 231 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:8 [Month 0] | 213 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:8 [Month 1] | 287 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:128 [Month 1] | 288 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:8 [Month 0] | 212 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:8 [Month 1] | 289 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:8 [Month 0] | 217 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:8 [Month 1] | 295 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:8 [Month 0] | 238 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:8 [Month 1] | 296 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:8 [Month 0] | 263 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:8 [Month 1] | 294 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenA >= 1:128 [Month 0] | 184 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:128 [Month 0] | 140 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenC >= 1:128 [Month 1] | 293 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:128 [Month 0] | 171 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenW-135 >= 1:128 [Month 1] | 295 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:128 [Month 0] | 231 Participants |
| Nimenrix C Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups. | rSBA-MenY >= 1:128 [Month 1] | 293 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA >=1:8 [Month 0] | 645 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA >=1:8 [Month 1] | 868 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC >=1:8 [Month 0] | 650 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC >=1:8 [Month 1] | 880 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 >=1:8 [Month 0] | 707 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 >=1:8 [Month 1] | 883 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY >=1:8 [Month 0] | 793 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY >=1:8 [Month 1] | 882 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA >=1:128 [Month 0] | 558 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA >=1:128 [Month 1] | 865 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC >=1:128 [Month 0] | 415 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC >=1:128 [Month 1] | 872 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 >=1:128 [Month 0] | 514 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 >=1:128 [Month 1] | 878 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY >=1:128 [Month 0] | 682 Participants |
| Nimenrix A Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY >=1:128 [Month 1] | 879 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY >=1:128 [Month 1] | 293 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA >=1:8 [Month 0] | 229 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA >=1:128 [Month 0] | 200 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA >=1:8 [Month 1] | 291 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 >=1:128 [Month 0] | 155 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC >=1:8 [Month 0] | 223 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA >=1:128 [Month 1] | 290 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC >=1:8 [Month 1] | 291 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY >=1:128 [Month 0] | 224 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 >=1:8 [Month 0] | 227 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC >=1:128 [Month 0] | 152 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 >=1:8 [Month 1] | 292 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 >=1:128 [Month 1] | 288 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY >=1:8 [Month 0] | 256 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC >=1:128 [Month 1] | 289 Participants |
| Nimenrix B Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY >=1:8 [Month 1] | 294 Participants |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenA [Month 0] | 200.5 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenA [Month 1] | 2831.1 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenC [Month 0] | 139.1 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenC [Month 1] | 6579.5 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 [Month 0] | 121.0 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 [Month 1] | 4394.8 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenY [Month 0] | 309.6 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenY [Month 1] | 5650.9 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenC [Month 0] | 100.8 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenY [Month 0] | 287.4 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenC [Month 1] | 10130.8 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 [Month 0] | 146.2 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 [Month 1] | 6016.8 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenA [Month 0] | 154.8 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenA [Month 1] | 3784.2 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenY [Month 1] | 7464.1 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenC [Month 0] | 120.0 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenA [Month 1] | 1826.9 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenA [Month 0] | 250.8 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenC [Month 1] | 8784.9 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenY [Month 0] | 209.9 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 [Month 1] | 2361.1 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenW-135 [Month 0] | 86.2 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort | rSBA-MenY [Month 1] | 3363.5 Titers |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
Time frame: Prior to vaccination (at Month 0).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenA [Month 0] | 215.1 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenC [Month 0] | 87.6 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenW-135 [Month 0] | 111.7 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenY [Month 0] | 275.8 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenY [Month 0] | 270.3 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenA [Month 0] | 172.6 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenW-135 [Month 0] | 124.6 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenC [Month 0] | 83.2 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenY [Month 0] | 315.6 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenC [Month 0] | 75.1 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenW-135 [Month 0] | 115.1 Titers |
| Nimenrix C Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups. | rSBA-MenA [Month 0] | 157.5 Titers |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Time frame: Prior to and one month after vaccination (at Month 0 and Month 1).
Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA [Month 0] | 180.4 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA [Month 1] | 3624.7 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC [Month 0] | 81.7 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC [Month 1] | 8865.9 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 [Month 0] | 117.0 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 [Month 1] | 5136.2 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY [Month 0] | 286.5 Titers |
| Nimenrix A Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY [Month 1] | 7710.7 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY [Month 1] | 4314.3 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA [Month 0] | 216.3 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 [Month 0] | 94.0 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenA [Month 1] | 2127.2 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenY [Month 0] | 262.2 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC [Month 0] | 91.2 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenW-135 [Month 1] | 2461.3 Titers |
| Nimenrix B Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | rSBA-MenC [Month 1] | 7371.2 Titers |