A Phase 3 interventional study of Meningococcal vaccine GSK134612 and Mencevax™ACWY in Infections, Meningococcal, sponsored by GlaxoSmithKline. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-25.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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.
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.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 1,352 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
For all subjects:
Exclusion Criteria:
For all subjects:
Additional criteria for subjects receiving Fluarix™ co-administration:
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.
Biological: Meningococcal vaccine GSK134612
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.
Biological: Meningococcal vaccine GSK134612
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.
Biological: Meningococcal vaccine GSK134612
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.
Biological: Mencevax™ACWY
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.
Biological: Meningococcal vaccine GSK134612 · Biological: Fluarix™
One intramuscular dose
One subcutaneous dose
One intramuscular dose
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)
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)
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)
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).
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)
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)
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)
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).
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).
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).
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).
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).
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).
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)
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).
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).
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).
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).
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).
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).
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).
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).
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
| Milestone | Nimenrix A Group | Nimenrix B Group | Nimenrix C Group | Mencevax ACWY Group | Nimenrix+Fluarix Group |
|---|---|---|---|---|---|
| Started | 311 | 311 | 313 | 312 | 105 |
| Completed | 305 | 306 | 307 | 310 | 105 |
| Not completed | 6 | 5 | 6 | 2 | 0 |
| Withdrew: Lost to follow-up | 6 | 5 | 6 | 2 | 0 |
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.
| Titers | Nimenrix A Group | Nimenrix B Group | Nimenrix C Group |
|---|---|---|---|
| rSBA-MenA | 3913.1 (3468.9 to 4414.1) | 3503.5 (3083.0 to 3981.4) | 3470.8 (3051.7 to 3947.3) |
| rSBA-MenC | 9467.0 (7980.2 to 11230.7) | 8118.7 (6818.9 to 9666.3) | 9051.0 (7538.6 to 10866.8) |
| rSBA-MenW-135 | 5263.2 (4527.0 to 6119.1) | 4890.6 (4145.5 to 5769.6) | 5260.1 (4536.8 to 6098.7) |
| rSBA-MenY | 7872.7 (6849.0 to 9049.3) | 7235.7 (6257.6 to 8366.8) | 8041.4 (6952.1 to 9301.3) |
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.
| Participants | Mencevax ACWY Group | Nimenrix Group |
|---|---|---|
| rSBA-MenA seronegative | 25 | 107 |
| rSBA-MenA seropositive | 151 | 488 |
| rSBA-MenC seronegative | 64 | 198 |
| rSBA-MenC seropositive | 201 | 579 |
| rSBA-MenW-135 seronegative | 53 | 151 |
| rSBA-MenW-135 seropositive | 189 | 625 |
| rSBA-MenY seronegative | 32 | 68 |
| rSBA-MenY seropositive | 195 | 682 |
| rSBA-MenA total | 176 | 595 |
| rSBA-MenC total | 265 | 777 |
| rSBA-MenW-135 total | 242 | 776 |
| rSBA-MenY total | 227 | 750 |
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).
| Titers | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group |
|---|---|---|
| rSBA-MenA | 2831.1 (2282.4 to 3511.7) | 3784.2 (3326.3 to 4305.1) |
| rSBA-MenC | 6579.5 (4861.5 to 8904.6) | 10130.8 (8672.3 to 11834.5) |
| rSBA-MenW-135 | 4394.8 (3316.3 to 5824.0) | 6016.8 (5201.4 to 6960.2) |
| rSBA-MenY | 5650.9 (4530.9 to 7047.) | 7464.1 (6500.3 to 8570.8) |
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.
| Titers | Nimenrix+Fluarix Group |
|---|---|
| Anti-A/H1N1 [Month 0] | 54.1 (43.0 to 68.1) |
| Anti-A/H1N1 [Month 1] | 537.2 (446.9 to 645.8) |
| Anti-A/H3N2 [Month 0] | 31.5 (25.1 to 39.6) |
| Anti-A/H3N2 [Month 1] | 177.8 (150.0 to 210.7) |
| Anti-B [Month 0] | 20.9 (17.0 to 25.7) |
| Anti-B [Month 1] | 192.7 (156.4 to 237.6) |
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.
| Participants | Nimenrix+Fluarix Group |
|---|---|
| Anti-A/H1N1 | 75 |
| Anti-A/H3N2 | 65 |
| Anti-B | 78 |
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.
| Fold increase in serum HI GMTs | Nimenrix+Fluarix Group |
|---|---|
| Anti-A/H1N1 | 9.9 (7.5 to 13.1) |
| Anti-A/H3N2 | 5.6 (4.4 to 7.2) |
| Anti-B | 9.1 (7.1 to 11.6) |
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.
| Participants | Nimenrix+Fluarix Group |
|---|---|
| Anti-A/H1N1 [Month 0] | 68 |
| Anti-A/H1N1 [Month 1] | 104 |
| Anti-A/H3N2 [Month 0] | 57 |
| Anti-A/H3N2 [Month 1] | 102 |
| Anti-B [Month 0] | 44 |
| Anti-B [Month 1] | 100 |
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.
| Participants | Nimenrix A Group | Nimenrix B Group | Nimenrix C Group |
|---|---|---|---|
| rSBA-MenA >= 1:8 [Month 0] | 226 | 207 | 212 |
| rSBA-MenA >= 1:8 [Month 1] | 292 | 287 | 289 |
| rSBA-MenC >= 1:8 [Month 0] | 220 | 213 | 217 |
| rSBA-MenC >= 1:8 [Month 1] | 296 | 289 | 295 |
| rSBA-MenW-135 >= 1:8 [Month 0] | 238 | 231 | 238 |
| rSBA-MenW-135 >= 1:8 [Month 1] | 297 | 290 | 296 |
| rSBA-MenY >= 1:8 [Month 0] | 266 | 264 | 263 |
| rSBA-MenY >= 1:8 [Month 1] | 297 | 291 | 294 |
| rSBA-MenA >= 1:128 [Month 0] | 199 | 175 | 184 |
| rSBA-MenA >= 1:128 [Month 1] | 291 | 286 | 288 |
| rSBA-MenC >= 1:128 [Month 0] | 143 | 132 | 140 |
| rSBA-MenC >= 1:128 [Month 1] | 293 | 286 | 293 |
| rSBA-MenW-135 >= 1:128 [Month 0] | 165 | 178 | 171 |
| rSBA-MenW-135 >= 1:128 [Month 1] | 294 | 289 | 295 |
| rSBA-MenY >= 1:128 [Month 0] | 232 | 219 | 231 |
| rSBA-MenY >= 1:128 [Month 1] | 295 | 291 | 293 |
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.
| Titers | Nimenrix A Group | Nimenrix B Group | Nimenrix C Group |
|---|---|---|---|
| rSBA-MenA [Month 0] | 215.1 (174.2 to 265.6) | 172.6 (135.9 to 219.2) | 157.5 (125.3 to 198.0) |
| rSBA-MenC [Month 0] | 87.6 (69.2 to 110.9) | 83.2 (65.3 to 106.1) | 75.1 (59.5 to 94.7) |
| rSBA-MenW-135 [Month 0] | 111.7 (90.3 to 138.2) | 124.6 (98.8 to 157.2) | 115.1 (92.4 to 143.5) |
| rSBA-MenY [Month 0] | 275.8 (224.8 to 338.4) | 270.3 (223.6 to 326.7) | 315.6 (260.6 to 382.1) |
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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| rSBA-MenA >=1:8 [Month 0] | 81 | 219 | 82 |
| rSBA-MenA >=1:8 [Month 1] | 102 | 305 | 104 |
| rSBA-MenC >=1:8 [Month 0] | 84 | 225 | 84 |
| rSBA-MenC >=1:8 [Month 1] | 104 | 306 | 103 |
| rSBA-MenW-135 >=1:8 [Month 0] | 85 | 259 | 84 |
| rSBA-MenW-135 >=1:8 [Month 1] | 105 | 308 | 103 |
| rSBA-MenY >=1:8 [Month 0] | 96 | 277 | 88 |
| rSBA-MenY >=1:8 [Month 1] | 105 | 306 | 104 |
| rSBA-MenA >=1:128 [Month 0] | 64 | 180 | 69 |
| rSBA-MenA >=1:128 [Month 1] | 101 | 305 | 103 |
| rSBA-MenC >=1:128 [Month 0] | 58 | 154 | 54 |
| rSBA-MenC >=1:128 [Month 1] | 103 | 304 | 103 |
| rSBA-MenW-135 >=1:128 [Month 0] | 62 | 192 | 54 |
| rSBA-MenW-135 >=1:128 [Month 1] | 102 | 306 | 102 |
| rSBA-MenY >=1:128 [Month 0] | 82 | 228 | 79 |
| rSBA-MenY >=1:128 [Month 1] | 104 | 305 | 103 |
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).
| Titers | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| rSBA-MenA [Month 0] | 200.5 (145.3 to 276.8) | 154.8 (122.2 to 196.1) | 250.8 (182.0 to 345.6) |
| rSBA-MenA [Month 1] | 2831.1 (2282.4 to 3511.7) | 3784.2 (3326.3 to 4305.1) | 1826.9 (1492.3 to 2236.6) |
| rSBA-MenC [Month 0] | 139.1 (94.2 to 205.2) | 100.8 (78.4 to 129.6) | 120.0 (78.7 to 182.8) |
| rSBA-MenC [Month 1] | 6579.5 (4861.5 to 8904.6) | 10130.8 (8672.3 to 11834.5) | 8784.9 (6759.4 to 11417.3) |
| rSBA-MenW-135 [Month 0] | 121.0 (84.3 to 173.7) | 146.2 (119.5 to 178.8) | 86.2 (60.9 to 121.9) |
| rSBA-MenW-135 [Month 1] | 4394.8 (3316.3 to 5824.0) | 6016.8 (5201.4 to 6960.2) | 2361.1 (1757.7 to 3171.6) |
| rSBA-MenY [Month 0] | 309.6 (229.9 to 417.0) | 287.4 (236.2 to 349.6) | 209.9 (147.4 to 299.0) |
| rSBA-MenY [Month 1] | 5650.9 (4530.9 to 7047.7) | 7464.1 (6500.3 to 8570.8) | 3363.5 (2630.9 to 4300.1) |
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.
| Participants | Nimenrix Group | Mencevax ACWY Group |
|---|---|---|
| rSBA-MenA >=1:8 [Month 0] | 645 | 229 |
| rSBA-MenA >=1:8 [Month 1] | 868 | 291 |
| rSBA-MenC >=1:8 [Month 0] | 650 | 223 |
| rSBA-MenC >=1:8 [Month 1] | 880 | 291 |
| rSBA-MenW-135 >=1:8 [Month 0] | 707 | 227 |
| rSBA-MenW-135 >=1:8 [Month 1] | 883 | 292 |
| rSBA-MenY >=1:8 [Month 0] | 793 | 256 |
| rSBA-MenY >=1:8 [Month 1] | 882 | 294 |
| rSBA-MenA >=1:128 [Month 0] | 558 | 200 |
| rSBA-MenA >=1:128 [Month 1] | 865 | 290 |
| rSBA-MenC >=1:128 [Month 0] | 415 | 152 |
| rSBA-MenC >=1:128 [Month 1] | 872 | 289 |
| rSBA-MenW-135 >=1:128 [Month 0] | 514 | 155 |
| rSBA-MenW-135 >=1:128 [Month 1] | 878 | 288 |
| rSBA-MenY >=1:128 [Month 0] | 682 | 224 |
| rSBA-MenY >=1:128 [Month 1] | 879 | 293 |
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.
| Titers | Nimenrix Group | Mencevax ACWY Group |
|---|---|---|
| rSBA-MenA [Month 0] | 180.4 (158.4 to 205.6) | 216.3 (177.4 to 263.7) |
| rSBA-MenA [Month 1] | 3624.7 (3371.7 to 3896.8) | 2127.2 (1909.2 to 2370.1) |
| rSBA-MenC [Month 0] | 81.7 (71.3 to 93.7) | 91.2 (71.5 to 116.4) |
| rSBA-MenC [Month 1] | 8865.9 (8011.0 to 9812.0) | 7371.2 (6297.4 to 8628.2) |
| rSBA-MenW-135 [Month 0] | 117.0 (103.0 to 132.9) | 94.0 (75.2 to 117.4) |
| rSBA-MenW-135 [Month 1] | 5136.2 (4698.8 to 5614.3) | 2461.3 (2081.0 to 2911.0) |
| rSBA-MenY [Month 0] | 286.5 (256.0 to 320.6) | 262.2 (211.8 to 324.5) |
| rSBA-MenY [Month 1] | 7710.7 (7100.1 to 8373.8) | 4314.3 (3782.1 to 4921.5) |
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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| rSBA-MenA seronegative | 5 | 44 | 6 |
| rSBA-MenA seropositive | 60 | 168 | 50 |
| rSBA-MenC seronegative | 13 | 68 | 16 |
| rSBA-MenC seropositive | 73 | 193 | 72 |
| rSBA-MenW-135 seronegative | 15 | 40 | 17 |
| rSBA-MenW-135 seropositive | 74 | 235 | 72 |
| rSBA-MenY seronegative | 6 | 23 | 12 |
| rSBA-MenY seropositive | 77 | 236 | 61 |
| rSBA-MenA total | 65 | 212 | 56 |
| rSBA-MenC total | 86 | 261 | 88 |
| rSBA-MenW-135 total | 89 | 275 | 89 |
| rSBA-MenY total | 83 | 259 | 73 |
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.
| Participants | Nimenrix Group | Mencevax ACWY Group |
|---|---|---|
| Anti-tetanus [Month 0] | 454 | 153 |
| Anti-tetanus [Month 1] | 703 | 156 |
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.
| IU/mL | Nimenrix Group | Mencevax ACWY Group |
|---|---|---|
| Anti-tetanus [Month 0] | 0.245 (0.217 to 0.277) | 0.265 (0.214 to 0.329) |
| Anti-tetanus [Month 1] | 3.488 (2.949 to 4.126) | 0.279 (0.224 to 0.347) |
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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Anti-tetanus [Month 0] | 61 | 193 | 54 |
| Anti-tetanus [Month 1] | 84 | 254 | 53 |
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).
| IU/mL | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Anti-tetanus [Month 0] | 0.295 (0.206 to 0.421) | 0.418 (0.334 to 0.523) | 0.287 (0.197 to 0.419) |
| Anti-tetanus [Month 1] | 3.073 (1.937 to 4.874) | 4.655 (3.557 to 6.092) | 0.276 (0.190 to 0.402) |
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.
| Participants | Nimenrix Group | Mencevax ACWY Group |
|---|---|---|
| Anti-PSA >=0.3 µg/mL [Month 0] | 354 | 125 |
| Anti-PSA >=0.3 µg/mL [Month 1] | 432 | 144 |
| Anti-PSC >=0.3 µg/mL [Month 0] | 130 | 61 |
| Anti-PSC >=0.3 µg/mL [Month 1] | 422 | 141 |
| Anti-PSW-135 >=0.3 µg/mL [Month 0] | 135 | 38 |
| Anti-PSW-135 >=0.3 µg/mL [Month 1] | 439 | 144 |
| Anti-PSY >=0.3 µg/mL [Month 0] | 156 | 52 |
| Anti-PSY >=0.3 µg/mL [Month 1] | 442 | 145 |
| Anti-PSA >=2.0 µg/mL [Month 0] | 227 | 87 |
| Anti-PSA >=2.0 µg/mL [Month 1] | 428 | 144 |
| Anti-PSC >=2.0 µg/mL [Month 0] | 51 | 17 |
| Anti-PSC >=2.0 µg/mL [Month 1] | 398 | 141 |
| Anti-PSW-135 >=2.0 µg/mL [Month 0] | 41 | 11 |
| Anti-PSW-135 >=2.0 µg/mL [Month 1] | 408 | 136 |
| Anti-PSY >=2.0 µg/mL [Month 0] | 59 | 21 |
| Anti-PSY >=2.0 µg/mL [Month 1] | 420 | 142 |
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.
| µg/mL | Nimenrix Group | Mencevax ACWY Group |
|---|---|---|
| Anti-PSA [Month 0] | 2.14 (1.82 to 2.52) | 2.65 (2.05 to 3.43) |
| Anti-PSA [Month 1] | 101.79 (88.95 to 116.49) | 56.89 (46.73 to 69.26) |
| Anti-PSC [Month 0] | 0.33 (0.29 to 0.37) | 0.38 (0.30 to 0.49) |
| Anti-PSC [Month 1] | 20.96 (18.26 to 24.05) | 45.85 (37.97 to 55.35) |
| Anti-PSW-135 [Month 0] | 0.31 (0.27 to 0.35) | 0.26 (0.22 to 0.30) |
| Anti-PSW-135 [Month 1] | 24.71 (20.75 to 29.42) | 21.90 (16.86 to 28.44) |
| Anti-PSY [Month 0] | 0.36 (0.32 to 0.41) | 0.35 (0.28 to 0.44) |
| Anti-PSY [Month 1] | 36.94 (31.10 to 43.87) | 30.41 (22.94 to 40.30) |
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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Anti-PSA >=0.3 µg/mL [Month 0] | 46 | 136 | 51 |
| Anti-PSA >=0.3 µg/mL [Month 1] | 49 | 151 | 52 |
| Anti-PSC >=0.3 µg/mL [Month 0] | 16 | 50 | 24 |
| Anti-PSC >=0.3 µg/mL [Month 1] | 48 | 145 | 51 |
| Anti-PSW-135 >=0.3 µg/mL [Month 0] | 12 | 53 | 11 |
| Anti-PSW-135 >=0.3 µg/mL [Month 1] | 51 | 153 | 49 |
| Anti-PSY >=0.3 µg/mL [Month 0] | 13 | 61 | 17 |
| Anti-PSY >=0.3 µg/mL [Month 1] | 53 | 156 | 51 |
| Anti-PSA >=2.0 µg/mL [Month 0] | 30 | 100 | 37 |
| Anti-PSA >=2.0 µg/mL [Month 1] | 49 | 149 | 52 |
| Anti-PSC >=2.0 µg/mL [Month 0] | 5 | 24 | 8 |
| Anti-PSC >=2.0 µg/mL [Month 1] | 42 | 133 | 51 |
| Anti-PSW-135 >=2.0 µg/mL [Month 0] | 1 | 13 | 4 |
| Anti-PSW-135 >=2.0 µg/mL [Month 1] | 46 | 142 | 48 |
| Anti-PSY >=2.0 µg/mL [Month 0] | 6 | 25 | 6 |
| Anti-PSY >=2.0 µg/mL [Month 1] | 51 | 147 | 50 |
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).
| µg/mL | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Anti-PSA [Month 0] | 2.40 (1.61 to 3.58) | 4.08 (3.16 to 5.26) | 3.83 (2.64 to 5.56) |
| Anti-PSA [Month 1] | 56.47 (35.76 to 89.19) | 142.33 (113.63 to 178.28) | 56.43 (40.72 to 78.18) |
| Anti-PSC [Month 0] | 0.30 (0.22 to 0.41) | 0.41 (0.31 to 0.53) | 0.48 (0.30 to 0.76) |
| Anti-PSC [Month 1] | 9.05 (5.70 to 14.36) | 19.26 (15.22 to 24.37) | 46.30 (32.29 to 66.39) |
| Anti-PSW-135 [Month 0] | 0.21 (0.18 to 0.26) | 0.33 (0.27 to 0.40) | 0.25 (0.18 to 0.35) |
| Anti-PSW-135 [Month 1] | 20.06 (12.27 to 32.81) | 26.44 (19.66 to 35.55) | 26.27 (17.54 to 39.35) |
| Anti-PSY [Month 0] | 0.29 (0.20 to 0.43) | 0.41 (0.32 to 0.52) | 0.32 (0.22 to 0.46) |
| Anti-PSY [Month 1] | 25.39 (15.71 to 41.01) | 40.46 (30.00 to 54.57) | 24.67 (15.03 to 40.51) |
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.
| Participants | Nimenrix Group | Mencevax ACWY Group |
|---|---|---|
| Any pain | 180 | 42 |
| Grade 3 pain | 4 | 1 |
| Any redness | 82 | 14 |
| Redness > 50 mm | 12 | 0 |
| Any swelling | 73 | 6 |
| Swelling > 50 mm | 10 | 0 |
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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Any pain | 23 | 84 | 16 |
| Grade 3 pain | 1 | 0 | 0 |
| Any redness | 6 | 38 | 5 |
| Redness > 50 mm | 0 | 1 | 0 |
| Any swelling | 4 | 32 | 1 |
| Swelling > 50 mm | 0 | 3 | 0 |
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.
| Participants | Nimenrix+Fluarix Group |
|---|---|
| Any pain | 29 |
| Grade 3 pain | 1 |
| Any redness | 7 |
| Redness > 50 mm | 0 |
| Any swelling | 7 |
| Swelling > 50 mm | 1 |
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.
| Participants | Nimenrix Group | Mencevax ACWY Group |
|---|---|---|
| Any fatigue | 114 | 30 |
| Grade 3 fatigue | 8 | 0 |
| Fever >= 37.5°C | 37 | 14 |
| Fever > 39.5°C | 2 | 2 |
| Any gastrointestinal symptoms | 43 | 10 |
| Grade 3 gastrointestinal symptoms | 2 | 1 |
| Any headache | 151 | 44 |
| Grade 3 headache | 14 | 5 |
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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Any fatigue | 10 | 33 | 12 |
| Grade 3 fatigue | 0 | 0 | 0 |
| Fever >= 37.5°C | 3 | 10 | 3 |
| Fever > 39.5°C | 0 | 1 | 0 |
| Any gastrointestinal symptoms | 2 | 15 | 2 |
| Grade 3 gastrointestinal symptoms | 0 | 0 | 0 |
| Any headache | 14 | 47 | 12 |
| Grade 3 headache | 0 | 1 | 0 |
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.
| Participants | Nimenrix Group | Mencevax ACWY Group |
|---|---|---|
| Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines. | 10 | 3 |
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.
| Participants | Nimenrix Group | Mencevax ACWY 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 | 0 |
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.
| Participants | Nimenrix Group | Mencevax ACWY 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 | 1 |
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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort | 0 | 3 | 0 |
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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort | 0 | 0 | 0 |
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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort | 0 | 0 | 0 |
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.
| Participants | Nimenrix Group | Mencevax ACWY 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 | 47 |
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.
| Participants | Nimenrix Group | Mencevax ACWY 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 | 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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort | 13 | 50 | 20 |
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).
| Participants | Nimenrix+Fluarix Group | Nimenrix (Flu Cohort) Group | Mencevax ACWY (Flu Cohort) Group |
|---|---|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort | 0 | 4 | 0 |
Collected over SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nimenrix Group | 0/935 (0%) | 7/935 (0.7%) | 330/935 (35.3%) |
| Mencevax ACWY Group | 0/312 (0%) | 1/312 (0.3%) | 89/312 (28.5%) |
| Nimenrix+Fluarix Group | 0/105 (0%) | 0/105 (0%) | 49/105 (46.7%) |
| Event | Nimenrix Group | Mencevax ACWY Group | Nimenrix+Fluarix Group |
|---|---|---|---|
| ArrhythmiaCardiac disorders | 0/935 | 1/312 | 0/105 |
| GastritisGastrointestinal disorders | 2/935 | 0/312 | 0/105 |
| Abdominal painGastrointestinal disorders | 1/935 | 0/312 | 0/105 |
| Acute myocardial infarctionCardiac disorders | 1/935 | 0/312 | 0/105 |
| Ankle fractureInjury, poisoning and procedural complications | 1/935 | 0/312 | 0/105 |
| BronchitisInfections and infestations | 1/935 | 0/312 | 0/105 |
| Hypertensive heart diseaseCardiac disorders | 1/935 | 0/312 | 0/105 |
| OrchitisInfections and infestations | 1/935 | 0/312 | 0/105 |
| PharyngotonsillitisInfections and infestations | 1/935 | 0/312 | 0/105 |
| PneumoniaInfections and infestations | 1/935 | 0/312 | 0/105 |
| Event | Nimenrix Group | Mencevax ACWY Group | Nimenrix+Fluarix Group |
|---|---|---|---|
| PainGeneral disorders | 180/935 | 42/312 | 37/105 |
| HeadacheGeneral disorders | 151/935 | 44/312 | 14/105 |
| FatigueGeneral disorders | 114/935 | 30/312 | 10/105 |
| RednessGeneral disorders | 82/935 | 14/312 | 11/105 |
| SwellingGeneral disorders | 73/935 | 6/312 | 10/105 |
| Age, Continuous(Years) | Nimenrix A Group | Nimenrix B Group | Nimenrix C Group | Mencevax ACWY Group | Nimenrix+Fluarix Group | Total |
|---|---|---|---|---|---|---|
| Mean | 35.2 ± 10.48 | 35.1 ± 10.50 | 35.7 ± 10.75 | 34.9 ± 10.73 | 35.9 ± 10.40 | 35.4 ± 10.57 |
| Sex: Female, Male(Participants) | Nimenrix A Group | Nimenrix B Group | Nimenrix C Group | Mencevax ACWY Group | Nimenrix+Fluarix Group | Total |
|---|---|---|---|---|---|---|
| Female | 135 | 139 | 133 | 151 | 40 | 598 |
| Male | 176 | 172 | 180 | 161 | 65 | 754 |
| Race/Ethnicity, Customized(Participants) | Nimenrix A Group | Nimenrix B Group | Nimenrix C Group | Mencevax ACWY Group | Nimenrix+Fluarix Group | Total |
|---|---|---|---|---|---|---|
| Asian - South east Asian heritage | 223 | 223 | 224 | 224 | 105 | 999 |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 1 | 0 | 0 | 1 |
| White - Arabic / North African heritage | 88 | 88 | 87 | 88 | 0 | 351 |
| White - Caucasian / European heritage | 0 | 0 | 1 | 0 | 0 | 1 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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