Infections, Meningococcal
Conditions
Keywords
non-inferiority, adolescents, meningococcal vaccine
Brief summary
This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.
Detailed description
All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Interventions
BIOLOGICALNimenrix (Meningococcal vaccine 134612)
Single dose intramuscular injection
BIOLOGICALTwinrix
3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol * A male or female between, and including, 11 and 17 years of age at the time of the first dose of vaccine. * Written informed consent obtained from the subject/ from the parent or guardian of 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/the parents'/guardians' knowledge. * If the subject is female and of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine. * Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years. * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y. * Previous vaccination with tetanus toxoid within the last month. * Previous vaccination with hepatitis A and/or hepatitis B vaccine. * Seropositivity for hepatitis A IgG, hepatitis B surface antigen, hepatitis B core antibody and/or hepatitis B surface antigen at screening. * History of hepatitis A, hepatitis B and/or Neisseria meningitidis infection. * Known exposure to hepatitis A and/or hepatitis B virus within three months preceding the first dose of study vaccine. * 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 either 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroconverted for Hepatitis A | At 1 month after the third dose of Twinrix vaccine (Month 7) | A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects. |
| Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | At 1 month after vaccination with Nimenrix vaccine (Month 1) | The rSBA titers were expressed as geometric mean titers (GMTs). |
| Number of Subjects Seroprotected for Hepatitis B | At 1 month after the third dose of Twinrix vaccine (Month 7) | A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) | The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL. |
| Anti-Tetanus Toxoid (TT) Antibody Concentrations | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) | Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL). |
| Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) | The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL). |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | At 7 months after vaccination with Nimenrix (At Month 7) | The rSBA titers were expressed as geometric mean titers. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | At 7 months after vaccination with Nimenrix (At Month 7) | The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128. |
| Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | At 7 months after vaccination with Nimenrix (At Month 7) | Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL). |
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | At 7 months after vaccination with Nimenrix (At Month 7) | The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL. |
| Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) | Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL). |
| Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) | The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL). |
| Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | At 1 month after vaccination with Nimenrix vaccine (Month 1) | Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative \[rSBA titer below1:8\] and as a 4-fold increase in titer in subjects initially seropositive \[rSBA titre greater than or equal to 1:8\]. |
| Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) | The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL). |
| Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination | During a 4-day period (Days 0-3) after Nimenrix vaccination | Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses | Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects Reporting Any Solicited General Symptoms | During a 4-day period (Days 0-3) after each vaccine dose and across doses | Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Up to 1 month after each vaccine dose | Unsolicited AE covers any AE 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. |
| Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses | During the entire study (up to Month 7) | Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies. |
| Number of Subjects Reporting Any Rash | During the entire study (up to Month 7) | Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae. |
| Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits | During the entire study (up to Month 7) | — |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | During the entire study (up to Month 7) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
| IgG Anti-HBs Antibody Concentrations | Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) | Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL). |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) | The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128. |
| Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) | Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL). |
Countries
Denmark, Sweden
Participant flow
Pre-assignment details
During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix + Twinrix Group Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6. | 367 |
| Nimenrix Group Subjects received 1 dose of Nimenrix vaccine at Month 0. | 122 |
| Twinrix Group Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6. | 122 |
| Total | 611 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Nimenrix Group | Twinrix Group | Total | Nimenrix + Twinrix Group |
|---|---|---|---|---|
| Age, Continuous | 14.3 Years STANDARD_DEVIATION 1.84 | 14.3 Years STANDARD_DEVIATION 1.94 | 14.3 Years STANDARD_DEVIATION 1.89 | 14.3 Years STANDARD_DEVIATION 1.89 |
| Race/Ethnicity, Customized African heritage/African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - central/south Asian heritage | 2 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - east Asian heritage | 2 Participants | 0 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - south east Asian heritage | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not specified | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/north African heritage | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Caucasian/European heritage | 117 Participants | 121 Participants | 599 Participants | 361 Participants |
| Sex: Female, Male Female | 61 Participants | 68 Participants | 324 Participants | 195 Participants |
| Sex: Female, Male Male | 61 Participants | 54 Participants | 287 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 367 | 0 / 122 | 0 / 122 |
| other Total, other adverse events | 312 / 367 | 82 / 122 | 100 / 122 |
| serious Total, serious adverse events | 4 / 367 | 0 / 122 | 1 / 122 |
Outcome results
Primary
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
The rSBA titers were expressed as geometric mean titers (GMTs).
Time frame: At 1 month after vaccination with Nimenrix vaccine (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenA | 5263.9 Titer |
| Nimenrix + Twinrix Group | Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenC | 4344.6 Titer |
| Nimenrix + Twinrix Group | Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenW-135 | 8922.1 Titer |
| Nimenrix + Twinrix Group | Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenY | 9291.5 Titer |
| Nimenrix Group | Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenY | 9492.8 Titer |
| Nimenrix Group | Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenA | 5211.7 Titer |
| Nimenrix Group | Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenW-135 | 8987.7 Titer |
| Nimenrix Group | Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers | rSBA-MenC | 4926.9 Titer |
Comparison: To assess the Non-inferiority in term of rSBA-MenA GMT of the Nimenrix + Twinrix group compared to Nimenrix one, two-sided 95% confidence interval (CI) from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.95% CI: [0.8, 1.22]ANCOVA
Comparison: To assess the Non-inferiority in term of rSBA-MenC GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.95% CI: [0.68, 1.21]ANCOVA
Comparison: To assess the Non-inferiority in term of rSBA-MenW-135 GMT of the Nimenrix+Twinrixg roup compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.95% CI: [0.87, 1.19]ANCOVA
Comparison: To assess the Non-inferiority in term of rSBA-MenY GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.95% CI: [0.85, 1.19]ANCOVA
Primary
Number of Subjects Seroconverted for Hepatitis A
A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
Time frame: At 1 month after the third dose of Twinrix vaccine (Month 7)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on initially seronegative subjects in those groups that received the Twinrix vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects Seroconverted for Hepatitis A | 321 Participants |
| Nimenrix Group | Number of Subjects Seroconverted for Hepatitis A | 95 Participants |
Comparison: To assess the Non-inferiority of the Nimenrix+Twinrix group compared to Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroconversion rates for hepatitis A (Nimenrix+Twinrix group minus Twinrix group) was computed.95% CI: [-1.19, 3.9]
Primary
Number of Subjects Seroprotected for Hepatitis B
A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
Time frame: At 1 month after the third dose of Twinrix vaccine (Month 7)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects Seroprotected for Hepatitis B | 327 Participants |
| Nimenrix Group | Number of Subjects Seroprotected for Hepatitis B | 97 Participants |
Comparison: To assess the Non-inferiority of the Nimenrix+Twinrix group compared to the Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroprotection rates for hepatitis B (Nimenrix+Twinrix group minus Twinrix group) was computed.95% CI: [-2.64, 2.92]
Secondary
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
Population: The analysis was performed on the ATP cohort for immunogenicity post Dose 2 and 3, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by ELISA for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | Anti-PSA | 4.14 micrograms per milliliter (µg/mL) |
| Nimenrix + Twinrix Group | Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | Anti-PSC | 3.28 micrograms per milliliter (µg/mL) |
| Nimenrix + Twinrix Group | Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | Anti-PSW-135 | 2.46 micrograms per milliliter (µg/mL) |
| Nimenrix + Twinrix Group | Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | Anti-PSY | 3.76 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | Anti-PSY | 4.28 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | Anti-PSA | 3.88 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | Anti-PSW-135 | 3.08 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7 | Anti-PSC | 4.15 micrograms per milliliter (µg/mL) |
Secondary
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Population: The analysis was performed on the ATP cohort for immunogenicity post Dose 1, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by Enzyme-linked Immunosorbent assay (ELISA) for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSW-135 [Month 1] | 6.78 micrograms per milliliter (µg/mL) |
| Nimenrix + Twinrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSC [Month 1] | 18.58 micrograms per milliliter (µg/mL) |
| Nimenrix + Twinrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSA [Month 1] | 27.23 micrograms per milliliter (µg/mL) |
| Nimenrix + Twinrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSA [Month 0] | 0.25 micrograms per milliliter (µg/mL) |
| Nimenrix + Twinrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSY [Month 0] | 0.22 micrograms per milliliter (µg/mL) |
| Nimenrix + Twinrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSC [Month 0] | 0.22 micrograms per milliliter (µg/mL) |
| Nimenrix + Twinrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSY [Month 1] | 14.04 micrograms per milliliter (µg/mL) |
| Nimenrix + Twinrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSW-135 [Month 0] | 0.19 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSY [Month 1] | 12.50 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSW-135 [Month 0] | 0.16 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSA [Month 0] | 0.24 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSA [Month 1] | 18.47 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSC [Month 0] | 0.26 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSC [Month 1] | 21.15 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSW-135 [Month 1] | 6.72 micrograms per milliliter (µg/mL) |
| Nimenrix Group | Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations | Anti-PSY [Month 0] | 0.17 micrograms per milliliter (µg/mL) |
Secondary
Anti-Tetanus Toxoid (TT) Antibody Concentrations
Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Anti-Tetanus Toxoid (TT) Antibody Concentrations | Month 0 | 0.800 International Units per milliliter |
| Nimenrix + Twinrix Group | Anti-Tetanus Toxoid (TT) Antibody Concentrations | Month 1 | 16.794 International Units per milliliter |
| Nimenrix Group | Anti-Tetanus Toxoid (TT) Antibody Concentrations | Month 0 | 1.020 International Units per milliliter |
| Nimenrix Group | Anti-Tetanus Toxoid (TT) Antibody Concentrations | Month 1 | 17.252 International Units per milliliter |
Secondary
IgG Anti-HBs Antibody Concentrations
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Twinrix Group | IgG Anti-HBs Antibody Concentrations | Month 0 | 1.7 milli-Internatinal Units per Milliliter |
| Nimenrix + Twinrix Group | IgG Anti-HBs Antibody Concentrations | Month 7 | 6088.2 milli-Internatinal Units per Milliliter |
| Nimenrix Group | IgG Anti-HBs Antibody Concentrations | Month 7 | 7654.7 milli-Internatinal Units per Milliliter |
| Nimenrix Group | IgG Anti-HBs Antibody Concentrations | Month 0 | 1.7 milli-Internatinal Units per Milliliter |
Secondary
Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations | Month 0 | 7.9 milli-Internatinal Units per Milliliter |
| Nimenrix + Twinrix Group | Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations | Month 7 | 5876.7 milli-Internatinal Units per Milliliter |
| Nimenrix Group | Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations | Month 7 | 6739.0 milli-Internatinal Units per Milliliter |
| Nimenrix Group | Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations | Month 0 | 7.6 milli-Internatinal Units per Milliliter |
Secondary
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits
Time frame: During the entire study (up to Month 7)
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits | 1 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits | 0 Participants |
| Twinrix Group | Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits | 0 Participants |
Secondary
Number of Subjects Reporting Any Rash
Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: During the entire study (up to Month 7)
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Rash | 5 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Rash | 0 Participants |
| Twinrix Group | Number of Subjects Reporting Any Rash | 1 Participants |
Secondary
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the entire study (up to Month 7)
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 4 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| Twinrix Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects Reporting Any Solicited General Symptoms
Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group.
Time frame: During a 4-day period (Days 0-3) after each vaccine dose and across doses
Population: The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Fatigue, Dose 2 | 47 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Fatigue, Across doses | 149 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary), Dose 2 | 4 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary), Across doses | 17 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Headache, Dose 1 | 88 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary), Dose 3 | 6 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 3 | 21 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Headache, Dose 3 | 53 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Gastrointestinal symptoms, Across doses | 72 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 28 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Headache, Across doses | 126 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 44 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Fatigue, Dose 1 | 101 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary), Dose 1 | 9 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Headache, Dose 2 | 49 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Fatigue, Dose 3 | 63 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary), Dose 1 | 1 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 10 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Headache, Dose 1 | 26 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Fatigue, Dose 1 | 30 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 3 | 7 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary), Dose 1 | 0 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary), Dose 2 | 1 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 2 | 8 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Headache, Dose 2 | 13 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Fatigue, Dose 3 | 21 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary), Dose 3 | 3 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Headache, Dose 3 | 23 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Fatigue, Across doses | 48 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Temperature (Axillary), Across doses | 4 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Gastrointestinal symptoms, Across doses | 23 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Headache, Across doses | 48 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Gastrointestinal symptoms, Dose 1 | 15 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Headache, Dose 1 | 32 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Fatigue, Dose 2 | 15 Participants |
| Twinrix Group | Number of Subjects Reporting Any Solicited General Symptoms | Any Fatigue, Dose 1 | 33 Participants |
Secondary
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During a 4-day period (Days 0-3) after Nimenrix vaccination
Population: The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Nimenrix were assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination | Pain | 181 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination | Redness | 75 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination | Swelling | 71 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination | Pain | 58 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination | Redness | 19 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination | Swelling | 18 Participants |
Secondary
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses
Population: The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Twinrix were assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Swelling, Dose 2 | 12 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Swelling, Dose 1 | 18 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Pain, Dose 3 | 143 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Redness, Across doses | 63 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Redness, Dose 3 | 30 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Pain, Dose 2 | 99 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Swelling, Dose 3 | 29 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Redness, Dose 1 | 36 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Pain, Across doses | 228 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Redness, Dose 2 | 27 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Swelling, Across doses | 49 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Pain, Dose 1 | 143 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Swelling, Across doses | 19 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Pain, Dose 1 | 52 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Redness, Dose 1 | 9 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Swelling, Dose 1 | 4 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Pain, Dose 2 | 34 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Redness, Dose 2 | 6 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Swelling, Dose 2 | 5 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Pain, Dose 3 | 41 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Redness, Dose 3 | 14 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Swelling, Dose 3 | 15 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Redness, Across doses | 19 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination | Any Pain, Across doses | 73 Participants |
Secondary
Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses
Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.
Time frame: During the entire study (up to Month 7)
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses | 5 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses | 0 Participants |
| Twinrix Group | Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses | 2 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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.
Time frame: Up to 1 month after each vaccine dose
Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Post Dose 2 | 26 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Post Dose 1 | 62 Participants |
| Nimenrix + Twinrix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Post Dose 3 | 52 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Post Dose 2 | NA Participants |
| Nimenrix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Post Dose 1 | 13 Participants |
| Nimenrix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Post Dose 3 | NA Participants |
| Twinrix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Post Dose 1 | 18 Participants |
| Twinrix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Post Dose 3 | 16 Participants |
| Twinrix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Post Dose 2 | 7 Participants |
Secondary
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Population: The analysis was performed on the ATP cohort for immunogenicity post Dose 1, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by Enzyme-linked Immunosorbent assay (ELISA) for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSW-135 ≥ 2.0 µg/mL [Month 0] | 3 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSW-135 ≥ 0.3 µg/mL [Month 0] | 19 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSA ≥ 0.3 µg/mL [Month 0] | 45 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSW-135 ≥ 0.3 µg/mL [Month 1] | 176 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSY ≥ 2.0 µg/mL [Month 0] | 10 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSY ≥ 0.3 µg/mL [Month 0] | 24 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSA ≥ 0.3 µg/mL [Month 1] | 179 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSY ≥ 0.3 µg/mL [Month 1] | 178 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSW-135 ≥ 2.0 µg/mL [Month 1] | 146 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSA ≥ 2.0 µg/mL [Month 0] | 14 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSC ≥ 0.3 µg/mL [Month 0] | 32 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSA ≥ 2.0 µg/mL [Month 1] | 178 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSY ≥ 2.0 µg/mL [Month 1] | 172 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSC ≥ 2.0 µg/mL [Month 0] | 10 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSC ≥ 0.3 µg/mL [Month 1] | 179 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSC ≥ 2.0 µg/mL [Month 1] | 176 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSC ≥ 0.3 µg/mL [Month 1] | 54 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSW-135 ≥ 2.0 µg/mL [Month 0] | 0 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSW-135 ≥ 2.0 µg/mL [Month 1] | 48 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSY ≥ 2.0 µg/mL [Month 0] | 2 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSY ≥ 2.0 µg/mL [Month 1] | 51 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSA ≥ 0.3 µg/mL [Month 0] | 13 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSA ≥ 0.3 µg/mL [Month 1] | 54 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSC ≥ 0.3 µg/mL [Month 0] | 13 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSC ≥ 2.0 µg/mL [Month 1] | 53 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSW-135 ≥ 0.3 µg/mL [Month 0] | 2 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSW-135 ≥ 0.3 µg/mL [Month 1] | 56 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSY ≥ 0.3 µg/mL [Month 0] | 2 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSY ≥ 0.3 µg/mL [Month 1] | 54 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSA ≥ 2.0 µg/mL [Month 0] | 3 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSA ≥ 2.0 µg/mL [Month 1] | 52 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values | Anti-PSC ≥ 2.0 µg/mL [Month 0] | 6 Participants |
Secondary
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
Population: The analysis was performed on the ATP cohort for immunogenicity post Dose 2 and 3, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by ELISA for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSA ≥ 0.3 µg/mL | 160 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSC ≥ 0.3 µg/mL | 157 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSW-135 ≥ 0.3 µg/mL | 157 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSY ≥ 0.3 µg/mL | 154 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSA ≥ 2.0 µg/mL | 110 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSC ≥ 2.0 µg/mL | 94 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSW-135 ≥ 2.0 µg/mL | 93 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSY ≥ 2.0 µg/mL | 104 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSY ≥ 2.0 µg/mL | 37 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSA ≥ 0.3 µg/mL | 52 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSA ≥ 2.0 µg/mL | 34 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSC ≥ 0.3 µg/mL | 52 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSW-135 ≥ 2.0 µg/mL | 41 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSW-135 ≥ 0.3 µg/mL | 51 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSC ≥ 2.0 µg/mL | 35 Participants |
| Nimenrix Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7 | Anti-PSY ≥ 0.3 µg/mL | 53 Participants |
Secondary
Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value
The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value | Month 0 | 293 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value | Month 1 | 354 Participants |
| Nimenrix Group | Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value | Month 0 | 111 Participants |
| Nimenrix Group | Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value | Month 1 | 112 Participants |
Secondary
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative \[rSBA titer below1:8\] and as a 4-fold increase in titer in subjects initially seropositive \[rSBA titre greater than or equal to 1:8\].
Time frame: At 1 month after vaccination with Nimenrix vaccine (Month 1)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | rSBA-MenA | 246 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | rSBA-MenW-135 | 346 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | rSBA-MenC | 333 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | rSBA-MenY | 335 Participants |
| Nimenrix Group | Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | rSBA-MenC | 101 Participants |
| Nimenrix Group | Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | rSBA-MenA | 76 Participants |
| Nimenrix Group | Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | rSBA-MenY | 105 Participants |
| Nimenrix Group | Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135 | rSBA-MenW-135 | 112 Participants |
Secondary
Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value
The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value | Month 0 | 10 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value | Month 7 | 331 Participants |
| Nimenrix Group | Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value | Month 0 | 2 Participants |
| Nimenrix Group | Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value | Month 7 | 97 Participants |
Secondary
Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value
The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value | Month 0 | 1 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value | Month 7 | 327 Participants |
| Nimenrix Group | Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value | Month 0 | 0 Participants |
| Nimenrix Group | Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value | Month 7 | 97 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenA ≥ 1:128 [Month 0] | 91 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenC ≥ 1:8 [Month 1] | 359 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenA ≥ 1:128 [Month 1] | 352 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenA ≥ 1:8 [Month 1] | 352 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenC ≥ 1:128 [Month 0] | 122 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenW-135 ≥ 1:8 [Month 0] | 277 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenC ≥ 1:128 [Month 1] | 358 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenA ≥ 1:8 [Month 0] | 105 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenW-135 ≥ 1:128 [Month 0] | 180 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenW-135 ≥ 1:8 [Month 1] | 360 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenW-135 ≥ 1:128 [Month 1] | 359 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenC ≥ 1:8 [Month 0] | 187 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenY ≥ 1:128 [Month 0] | 218 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenY ≥ 1:8 [Month 1] | 359 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenY ≥ 1:128 [Month 1] | 359 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenY ≥ 1:8 [Month 0] | 275 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenY ≥ 1:128 [Month 1] | 115 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenA ≥ 1:8 [Month 0] | 33 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenA ≥ 1:8 [Month 1] | 113 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenC ≥ 1:8 [Month 0] | 67 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenC ≥ 1:8 [Month 1] | 114 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenW-135 ≥ 1:8 [Month 0] | 96 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenY ≥ 1:8 [Month 0] | 95 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenY ≥ 1:8 [Month 1] | 115 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenA ≥ 1:128 [Month 0] | 30 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenA ≥ 1:128 [Month 1] | 113 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenC ≥ 1:128 [Month 0] | 44 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenC ≥ 1:128 [Month 1] | 113 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenW-135 ≥ 1:128 [Month 0] | 64 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenW-135 ≥ 1:128 [Month 1] | 115 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenY ≥ 1:128 [Month 0] | 80 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values | rSBA-MenW-135 ≥ 1:8 [Month 1] | 115 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenA ≥ 1:8 | 330 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenC ≥ 1:8 | 332 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenW-135 ≥ 1:8 | 334 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenY ≥ 1:8 | 333 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenA ≥ 1:128 | 329 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenC ≥ 1:128 | 318 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenW-135 ≥ 1:128 | 333 Participants |
| Nimenrix + Twinrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenY ≥ 1:128 | 332 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenY ≥ 1:128 | 112 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenA ≥ 1:8 | 107 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenA ≥ 1:128 | 107 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenC ≥ 1:8 | 110 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenW-135 ≥ 1:128 | 112 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenW-135 ≥ 1:8 | 112 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenC ≥ 1:128 | 108 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7 | rSBA-MenY ≥ 1:8 | 112 Participants |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
The rSBA titers were expressed as geometric mean titers.
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix + Twinrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | rSBA-MenA | 2121.6 Titer |
| Nimenrix + Twinrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | rSBA-MenC | 952.4 Titer |
| Nimenrix + Twinrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | rSBA-MenW-135 | 3283.4 Titer |
| Nimenrix + Twinrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | rSBA-MenY | 4432.7 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | rSBA-MenY | 4455.6 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | rSBA-MenA | 2298.3 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | rSBA-MenW-135 | 3497.7 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7 | rSBA-MenC | 1053.9 Titer |