Meningoccocal Disease, Meningococcal Meningitis
Conditions
Keywords
Meningococcal B disease,, Antibody persistence
Brief summary
The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in groups I to III of the parent V72\_28 study. This study will also explore the antibody persistence 24 to 36 months after two catch-up doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10 years old) in group IV of the parent V72\_28 study.
Interventions
BIOLOGICALBexsero® vaccine (1 dose at study month zero)
BIOLOGICALBexsero® vaccine (2 doses 1 month apart)
Sponsors
GlaxoSmithKline
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Months to 12 Years
Healthy volunteers
Yes
Inclusion criteria
For naïve subjects newly enrolled: 1. Healthy infants and children according to the following age groups: 1. Healthy subjects from 35 to 47 months of age, (only applicable to group K) (The age window is defined as the first day the subject turns 35 months of age up to the day before the subject turns 48 months of age), 2. Healthy subjects 4 to 7 years of age (only applicable to group L) (The age window is defined as the first day the subject turns 4 years of age up to the day before the subject turns 8 years of age). 3. Healthy subjects 8 to 12 years of age (only applicable to group M) (The age window is defined as the first day the subject turns 8 years of age up to the day before the subject turns 13 years of age). 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study; 4. in good health as determined by medical history, physical examination, clinical judgment of the investigator. For Subjects who participated in the V72\_28 study (Follow-on Subjects): 1. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 2. for whom a parent/legal guardian confirmed availability for the visit scheduled in the study; 3. in good health as determined by medical history, physical examination, clinical judgment of the investigator 4. who have completed the vaccination course in the V72\_28 study and have received their last vaccination 24 to 36 months before enrollment in V72\_28E1
Exclusion criteria
For naïve subjects newly enrolled: 1. History of any serogroup B meningococcal vaccine administration; 2. Previous known or suspected disease caused by N. meningitidis; 3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization; 4. History of severe allergic reaction after previous vaccinations or hypersensitivity to any component of the vaccine; 5. Pregnancy or nursing (breastfeeding) mothers; 6. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, congenital sterility or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry; 7. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example): * Receipt of any chronic immunosuppressive therapy * Receipt of any chronic immunostimulants * Immune deficiency disorder, or known HIV infection 8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited febrile seizure is acceptable). 9. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time. 10. Subject's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study. 11. Intent to participate in another clinical study during this study. 12. Family members and household members of study staff; 13. History or any illness/condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or pose additional risk to the subjects due to participation in the study. 14. Any significant chronic infection. 15. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). For Subjects who participated in the V72\_28 study (Follow-on Subjects):
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects | The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline. The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA). |
| Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects | The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline. |
| The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects | The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline. |
| The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | At Day 1 in this study over one month after the completion of the vaccination course in the parent study | The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported. |
| The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. | At Day 1 in this study over visit 1 in the vaccination course in the parent study | The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | At Visit 1 and one month post booster vaccination (Day 31) | The hSBA antibody titers in subjects after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the 1st dose of Bexsero® vaccine in age matched vaccine-naïve subjects in terms of GMTs. |
| The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | At Day 31 versus Day 1 | The within-subjects GMR of hSBA antibody titers (one month post booster vaccination versus pre vaccination) after Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the within-subject GMR for the 1st dose of rMenB+OMV NZ vaccination of age matched naïve subjects. |
| Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | At Baseline and One month post second vaccination (Day 61) | The percentage of vaccine-naïve subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and ≥ 5 against M10713 strain, one month after receiving two catch up doses of Bexsero® booster vaccination in this study. |
| Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | At Baseline and One month post second vaccination (Day 61) | The percentage of vaccine-naïve subjects with hSBA titers ≥8, one month after receiving two catch up doses of Bexsero® booster vaccination in this study are reported. |
| Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | One month post second vaccination (Day 61) | The percentage of vaccine-naïve subjects with a four-fold rise in hSBA titers from baseline, one month after receiving two catch up doses of Bexsero® booster vaccination in comparison to prevaccination in this study are reported. |
| The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | At Baseline and One month post second vaccination (Day 61) | The hSBA antibody titers in vaccine-naïve subjects , after receiving two catch up doses of Bexsero® vaccination in this study, are reported in terms of GMTs. |
| Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | At 24-36 months (Visit 1) and one month after booster vaccination (Day 31) | The percentage of subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and with hSBA titers ≥ 5 against M10713 strain, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study), alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects. |
| Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | From day 1 (6 hr) through day 7 after vaccination | The number of subjects (35 months to 7 years of age) with solicited local and systemic adverse events after receiving Bexsero® booster vaccine in the present study. |
| Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | From day 1 (6 hr) through day 7 after vaccination | The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study. |
| Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | From day 1 (6 hr) through day 7 after vaccination | Number of subjects (8 to 12 years of age) reporting solicited local and systemic adverse events after receiving Bexsero® booster vaccine. |
| Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | From day 1(6 hr) through day 7 after vaccination | The number newly recruited naïve subjects (aged 8 to12 years of age) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study. |
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | From day 1 through day 7 after any vaccination | The number of subjects reporting unsolicited adverse events after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) or two cach up schedule of Bexsero® vaccine is reported. |
| Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Throughout the entire study period (up to 2 months) | The number of subjects reporting unsolicited SAEs, medically attended AEs and AEs leading to withdrawal after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in the parent study) or two catch-up schedule of Bexsero® vaccine is reported. |
| The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | At one month after receiving second vaccination (Day 61) versus baseline (Day 1) | The within-subject GMRs of hSBA titers at one month after receiving the second catch up dose to hSBA titers at baseline, for naïve subjects who received two catch up doses of Bexsero® vaccination in this study are reported. |
| Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | At 24-36 months (Visit 1) and one month after booster vaccination (Day 31) | The percentage of subjects with hSBA titers ≥ 8, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects. |
| Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | One month after booster vaccination (day 31)/24-36 months (Visit 1) | The percentage of subjects with a four-fold rise in hSBA titers 1 month after receiving Bexsero® booster vaccination in this study to pre vaccination at visit 1 (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects. |
| Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | From post primary visit in the parent study to visit 2 in this extension study | The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination (visit 2) in this study to post primary visit in the parent study V72\_28(1 month after last vaccination in the parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects. |
| Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. | From pre primary visit in the parent study (Visit 1) to visit 2 in this extension study | The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination in this study to pre primary visit in parent study V72\_28 (Visit 1). This outcome measure was analysed only for subjects belonging to groups 02\_2\_5\_V and 02\_6\_10\_V |
Countries
Hungary, Spain
Participant flow
Recruitment details
Subjects were recruited from 9 study sites in Hungary and 8 study sites in Spain.
Pre-assignment details
All enrolled subjects were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| 2H3H511_V In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. The subjects in this group received a 5th dose of Bexsero® vaccine in the present study. | 98 |
| 2H3H511_NV In the parent study V72\_28 (NCT01339923), subjects received three primary doses and one booster dose of Bexsero® vaccine at 2.5, 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. | 47 |
| 3H5_11_V In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study. | 89 |
| 3H5_11_NV In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 3.5 and 5 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. | 43 |
| 68_11_V In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects received a 4th dose of Bexsero® vaccine in the present study. | 81 |
| 68_11_NV In the parent study V72\_28 (NCT01339923), subjects received two primary doses and one booster dose of Bexsero® vaccine at 6 and 8 months and at 11 months of age, respectively. These subjects were evaluated only for persistence. | 39 |
| 02_2_5_V In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study. | 32 |
| 02_2_5_NV In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence. | 36 |
| 02_6_10_V In the parent study V72\_28 (NCT01339923), these subjects received two catch-up doses of Bexsero® vaccine, two months apart. These subjects received a 3rd dose of Bexsero® vaccine in the present study. | 91 |
| 02_6_10_NV In the parent study V72\_28 (NCT01339923), these subjects received two catchup doses of Bexsero® vaccine, two months apart. These subjects were evaluated only for persistence. | 90 |
| NAIVE 123 Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. | 100 |
| NAIVE_4A Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. | 55 |
| NAIVE_4B Newly recruited naïve subjects who received two catch-up doses of Bexsero® vaccine, one month apart, in the present study. | 50 |
| Total | 851 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other-Unspecified | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 2H3H511_V | 2H3H511_NV | 3H5_11_V | 3H5_11_NV | 68_11_V | 68_11_NV | 02_2_5_V | 02_2_5_NV | 02_6_10_V | 02_6_10_NV | NAIVE 123 | NAIVE_4A | NAIVE_4B | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 3.1 Years STANDARD_DEVIATION 0.2 | 3 Years STANDARD_DEVIATION 0.18 | 3.1 Years STANDARD_DEVIATION 0.23 | 3.1 Years STANDARD_DEVIATION 0.22 | 3.2 Years STANDARD_DEVIATION 0.29 | 3.2 Years STANDARD_DEVIATION 0.26 | 6.5 Years STANDARD_DEVIATION 1.15 | 6.7 Years STANDARD_DEVIATION 1.16 | 10.4 Years STANDARD_DEVIATION 1.43 | 10.4 Years STANDARD_DEVIATION 1.44 | 3.4 Years STANDARD_DEVIATION 0.29 | 5.8 Years STANDARD_DEVIATION 1.12 | 9.7 Years STANDARD_DEVIATION 1.38 | 5.6 Years STANDARD_DEVIATION 3.2 |
| Sex: Female, Male Female | 44 Participants | 27 Participants | 48 Participants | 22 Participants | 35 Participants | 23 Participants | 19 Participants | 15 Participants | 44 Participants | 46 Participants | 46 Participants | 26 Participants | 27 Participants | 422 Participants |
| Sex: Female, Male Male | 54 Participants | 20 Participants | 41 Participants | 21 Participants | 46 Participants | 16 Participants | 13 Participants | 21 Participants | 47 Participants | 44 Participants | 54 Participants | 29 Participants | 23 Participants | 429 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 89 | 0 / 80 | 0 / 32 | 0 / 91 | 0 / 100 | 0 / 55 | 0 / 50 |
| other Total, other adverse events | 91 / 97 | 84 / 89 | 75 / 80 | 31 / 32 | 86 / 91 | 97 / 100 | 55 / 55 | 50 / 50 |
| serious Total, serious adverse events | 0 / 97 | 0 / 89 | 0 / 80 | 0 / 32 | 0 / 91 | 0 / 100 | 0 / 55 | 0 / 50 |
Outcome results
Primary
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains
The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.
Time frame: At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects
Population: Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | H44/76 | 28 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | 5/99 | 80 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | M10713 | 24 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | NZ98/254 | 21 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | 5/99 | 82 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | NZ98/254 | 18 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | M10713 | 22 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | H44/76 | 26 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | NZ98/254 | 29 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | M10713 | 28 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | H44/76 | 32 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | 5/99 | 89 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | 5/99 | 2 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | M10713 | 26 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | H44/76 | 18 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | NZ98/254 | 0 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | NZ98/254 | 15 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | 5/99 | 73 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | M10713 | 31 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | H44/76 | 24 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | 5/99 | 4 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | H44/76 | 16 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | NZ98/254 | 2 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | M10713 | 36 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | 5/99 | 66 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | NZ98/254 | 28 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | M10713 | 54 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | H44/76 | 34 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | M10713 | 49 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | 5/99 | 6 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | NZ98/254 | 0 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains | H44/76 | 10 Percentage of subjects |
Primary
Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains
The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline. The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).
Time frame: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
Population: Analysis was done on Full Analysis Set (FAS)-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | 5/99 | 84 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | M10713 | 31 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | NZ98/254 | 45 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | H44/76 | 51 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | H44/76 | 53 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | M10713 | 36 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | NZ98/254 | 38 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | 5/99 | 88 Percentage of subjects |
| 68_11 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | M10713 | 39 Percentage of subjects |
| 68_11 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | 5/99 | 93 Percentage of subjects |
| 68_11 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | H44/76 | 61 Percentage of subjects |
| 68_11 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | NZ98/254 | 56 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | NZ98/254 | 2 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | 5/99 | 3 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | M10713 | 37 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | H44/76 | 38 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | M10713 | 34 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | H44/76 | 52 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | 5/99 | 79 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | NZ98/254 | 29 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | M10713 | 38 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | H44/76 | 27 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | NZ98/254 | 7 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | 5/99 | 4 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | H44/76 | 58 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | 5/99 | 85 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | NZ98/254 | 50 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | M10713 | 61 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | M10713 | 55 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | NZ98/254 | 6 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | H44/76 | 20 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains | 5/99 | 8 Percentage of subjects |
Primary
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study.
The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported.
Time frame: At Day 1 in this study over one month after the completion of the vaccination course in the parent study
Population: Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1. The number of participants analyzed is the number of subjects assessed for this particular endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | M10713 | 0.19 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | H44/76 | 0.029 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | NZ98/254 | 0.059 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | 5/99 | 0.023 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | 5/99 | 0.031 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | NZ98/254 | 0.038 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | H44/76 | 0.022 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | M10713 | 0.16 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | M10713 | 0.19 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | 5/99 | 0.054 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | NZ98/254 | 0.07 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | H44/76 | 0.03 Ratio |
| NAIVE 123 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | 5/99 | 0.045 Ratio |
| NAIVE 123 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | H44/76 | 0.028 Ratio |
| NAIVE 123 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | NZ98/254 | 0.061 Ratio |
| NAIVE 123 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | M10713 | 0.17 Ratio |
| 02_2_5 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | H44/76 | 0.042 Ratio |
| 02_2_5 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | 5/99 | 0.049 Ratio |
| 02_2_5 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | M10713 | 0.24 Ratio |
| 02_2_5 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study. | NZ98/254 | 0.095 Ratio |
Primary
The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study.
The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported.
Time frame: At Day 1 in this study over visit 1 in the vaccination course in the parent study
Population: Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.This outcome measure applies to only groups 02\_2\_5 \& 02\_6\_10 as the GMRs were calculated at 24-36 months after completion of vaccination course in the parent study over subjects belonging to groups 02\_2\_5 \& 02\_6\_10.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. | H44/76 | 1.88 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. | 5/99 | 20 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. | NZ98/254 | 2.48 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. | M10713 | 0.89 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. | M10713 | 0.94 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. | H44/76 | 2.94 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. | NZ98/254 | 3.06 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study. | 5/99 | 14 Ratio |
Primary
The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains
The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.
Time frame: 24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects
Population: Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1. The number of participants analyzed is the number of subjects assessed for this particular endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2H3H511 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | NZ98/254 | 3.48 Titers |
| 2H3H511 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | 5/99 | 44 Titers |
| 2H3H511 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | H44/76 | 4.17 Titers |
| 2H3H511 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | M10713 | 2.77 Titers |
| 3H5_11 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | NZ98/254 | 2.98 Titers |
| 3H5_11 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | M10713 | 3.03 Titers |
| 3H5_11 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | H44/76 | 4.48 Titers |
| 3H5_11 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | 5/99 | 52 Titers |
| 68_11 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | 5/99 | 83 Titers |
| 68_11 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | H44/76 | 5.62 Titers |
| 68_11 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | M10713 | 3.17 Titers |
| 68_11 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | NZ98/254 | 4.86 Titers |
| NAIVE 123 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | H44/76 | 2.79 Titers |
| NAIVE 123 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | 5/99 | 1.15 Titers |
| NAIVE 123 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | M10713 | 3.3 Titers |
| NAIVE 123 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | NZ98/254 | 1.14 Titers |
| 02_2_5 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | NZ98/254 | 2.81 Titers |
| 02_2_5 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | M10713 | 3.53 Titers |
| 02_2_5 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | 5/99 | 21 Titers |
| 02_2_5 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | H44/76 | 3.97 Titers |
| NAIVE_4A | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | NZ98/254 | 1.37 Titers |
| NAIVE_4A | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | M10713 | 4.26 Titers |
| NAIVE_4A | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | 5/99 | 1.2 Titers |
| NAIVE_4A | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | H44/76 | 2.33 Titers |
| 02_6_10 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | 5/99 | 21 Titers |
| 02_6_10 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | H44/76 | 5.75 Titers |
| 02_6_10 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | NZ98/254 | 4.57 Titers |
| 02_6_10 | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | M10713 | 7.82 Titers |
| NAIVE_4B | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | 5/99 | 1.38 Titers |
| NAIVE_4B | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | H44/76 | 1.93 Titers |
| NAIVE_4B | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | M10713 | 6.95 Titers |
| NAIVE_4B | The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains | NZ98/254 | 1.22 Titers |
Secondary
Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine.
The number newly recruited naïve subjects (aged 8 to12 years of age) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.
Time frame: From day 1(6 hr) through day 7 after vaccination
Population: Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Medically-Attended Fever (2nd vacc.) | 0 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Prevention of Pain and/or Fever (2nd vacc.) | 3 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Treatment of Pain and/or Fever (2nd vacc.) | 12 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Any local AEs (1st vacc.) | 49 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Erythema (1st vacc.) | 31 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Induration (1st vacc.) | 19 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Swelling (1st vacc.) | 29 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Pain (1st vacc.) | 47 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Any systemic AEs (1st vacc.) | 24 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Arthralgia (1st vacc.) | 6 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Chills (1st vacc.) | 4 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Headache (1st vacc.) | 15 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Malaise (1st vacc.) | 7 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Myalgia (1st vacc.) | 12 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Nausea (1st vacc.) | 5 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Rash (1st vacc.) | 1 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Fever (>38.0° C) (1st vacc.) | 3 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Medically-Attended Fever (1st vacc.) | 0 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Prevention of Pain and/or Fever (1st vacc.) | 2 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Treatment of Pain and/or Fever (1st vacc.) | 21 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Any local AEs (2nd vacc.) | 43 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Erythema (2nd vacc.) | 21 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Induration (2nd vacc.) | 17 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Swelling (2nd vacc.) | 21 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Pain (2nd vacc.) | 41 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Any systemic AEs (2nd vacc.) | 25 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Arthralgia (2nd vacc.) | 3 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Chills (2nd vacc.) | 5 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Headache (2nd vacc.) | 10 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Malaise (2nd vacc.) | 13 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Myalgia (2nd vacc.) | 8 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Nausea (2nd vacc.) | 4 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Rash (2nd vacc.) | 3 Subjects |
| 2H3H511 | Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine. | Fever (>38.0° C) (2nd vacc.) | 1 Subjects |
Secondary
Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine.
The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.
Time frame: From day 1 (6 hr) through day 7 after vaccination
Population: Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Change in Eating Habits (2nd vacc.) | 15 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Erythema (1st vacc.) | 54 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Induration (1st vacc.) | 38 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Swelling (1st vacc.) | 40 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Tenderness (1st vacc.) | 87 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Any systemic AEs (1st vacc.) | 64 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Change in Eating Habits (1st vacc.) | 31 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Diarrhea (1st vacc.) | 4 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Irritability (1st vacc.) | 40 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Persistent Crying (1st vacc.) | 15 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Rash (1st vacc.) | 5 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Sleepiness (1st vacc.) | 18 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Vomiting (1st vacc.) | 7 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Vomiting (2nd vacc.) | 4 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Fever (>38.0° C) (2nd vacc.) | 12 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Fever (>38.0° C) (1st vacc.) | 15 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Medically-Attended Fever (1st vacc.) | 1 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Prevention of Pain/Fever (1st vacc.) | 18 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Treatment of Pain/Fever (1st vacc.) | 41 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Any local AEs (2nd vacc.) | 79 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Erythema (2nd vacc.) | 44 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Induration (2nd vacc.) | 29 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Swelling (2nd vacc.) | 32 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Tenderness (2nd vacc.) | 77 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Medically-Attended Fever (2nd vacc.) | 0 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Any systemic AEs (2nd vacc.) | 46 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Any local AEs (1st vacc.) | 88 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Diarrhea (2nd vacc.) | 2 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Irritability (2nd vacc.) | 25 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Persistent Crying (2nd vacc.) | 13 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Rash (2nd vacc.) | 2 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Sleepiness (2nd vacc.) | 12 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Prevention of Pain/Fever (2nd vacc.) | 21 Subjects |
| 2H3H511 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Treatment of Pain/Fever (2nd vacc.) | 30 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Rash (2nd vacc.) | 1 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Any local AEs (1st vacc.) | 55 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Prevention of Pain/Fever (1st vacc.) | 3 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Erythema (1st vacc.) | 28 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Change in Eating Habits (2nd vacc.) | 9 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Induration (1st vacc.) | 17 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Treatment of Pain/Fever (1st vacc.) | 22 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Swelling (1st vacc.) | 24 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Prevention of Pain/Fever (2nd vacc.) | 4 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Tenderness (1st vacc.) | 55 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Any local AEs (2nd vacc.) | 51 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Any systemic AEs (1st vacc.) | 24 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Diarrhea (2nd vacc.) | 3 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Change in Eating Habits (1st vacc.) | 5 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Erythema (2nd vacc.) | 32 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Diarrhea (1st vacc.) | 3 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Sleepiness (2nd vacc.) | 5 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Irritability (1st vacc.) | 16 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Induration (2nd vacc.) | 22 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Persistent Crying (1st vacc.) | 4 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Irritability (2nd vacc.) | 11 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Rash (1st vacc.) | 3 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Swelling (2nd vacc.) | 25 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Sleepiness (1st vacc.) | 9 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Medically-Attended Fever (2nd vacc.) | 1 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Vomiting (1st vacc.) | 2 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Persistent Crying (2nd vacc.) | 6 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Vomiting (2nd vacc.) | 2 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Tenderness (2nd vacc.) | 51 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Fever (>38.0° C) (2nd vacc.) | 3 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Treatment of Pain/Fever (2nd vacc.) | 13 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Fever (>38.0° C) (1st vacc.) | 2 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Any systemic AEs (2nd vacc.) | 18 Subjects |
| 3H5_11 | Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine. | Medically-Attended Fever (1st vacc.) | 0 Subjects |
Secondary
Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.
The number of subjects (35 months to 7 years of age) with solicited local and systemic adverse events after receiving Bexsero® booster vaccine in the present study.
Time frame: From day 1 (6 hr) through day 7 after vaccination
Population: Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Rash | 13 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Any systemic AEs | 66 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Tenderness | 84 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Prevention of Pain and/or Fever | 23 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Swelling | 49 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Fever (>38.0° C) | 17 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Diarrhea | 4 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Treatment of Pain and/or Fever | 38 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Induration | 48 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Persistent Crying | 31 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Sleepiness | 28 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Any local AEs | 87 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Irritability | 54 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Vomiting | 5 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Change in eating habits | 31 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Erythema | 60 Subjects |
| 2H3H511 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Medically-Attended Fever | 1 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Erythema | 63 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Any systemic AEs | 63 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Induration | 48 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Persistent Crying | 24 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Swelling | 50 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Tenderness | 80 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Irritability | 52 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Fever (>38.0° C) | 18 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Medically-Attended Fever | 0 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Sleepiness | 23 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Diarrhea | 8 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Prevention of Pain and/or Fever | 14 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Rash | 1 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Treatment of Pain and/or Fever | 39 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Change in eating habits | 32 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Any local AEs | 81 Subjects |
| 3H5_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Vomiting | 5 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Swelling | 37 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Rash | 3 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Sleepiness | 26 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Vomiting | 2 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Fever (>38.0° C) | 11 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Medically-Attended Fever | 2 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Prevention of Pain and/or Fever | 15 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Treatment of Pain and/or Fever | 41 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Any local AEs | 73 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Erythema | 42 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Induration | 33 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Tenderness | 71 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Any systemic AEs | 54 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Change in eating habits | 30 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Diarrhea | 5 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Irritability | 46 Subjects |
| 68_11 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Persistent Crying | 25 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Any systemic AEs | 18 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Any local AEs | 31 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Treatment of Pain and/or Fever | 13 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Sleepiness | 5 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Change in eating habits | 5 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Prevention of Pain and/or Fever | 1 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Medically-Attended Fever | 0 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Rash | 5 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Diarrhea | 0 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Fever (>38.0° C) | 2 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Vomiting | 1 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Swelling | 20 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Persistent Crying | 4 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Tenderness | 31 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Induration | 15 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Erythema | 22 Subjects |
| NAIVE 123 | Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Irritability | 9 Subjects |
Secondary
Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.
Number of subjects (8 to 12 years of age) reporting solicited local and systemic adverse events after receiving Bexsero® booster vaccine.
Time frame: From day 1 (6 hr) through day 7 after vaccination
Population: Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Any local AEs | 85 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Erythema | 57 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Induration | 44 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Swelling | 52 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Pain | 84 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Any systemic AEs | 57 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Arthralgia | 18 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Chills | 23 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Headache | 27 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Malaise | 35 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Myalgia | 24 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Nausea | 12 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Rash | 10 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Fever (>38.0° C) | 10 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Medically-Attended Fever | 0 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Prevention of Pain and/or Fever | 12 Subjects |
| 2H3H511 | Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine. | Treatment of Pain and/or Fever | 47 Subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination.
The number of subjects reporting unsolicited adverse events after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) or two cach up schedule of Bexsero® vaccine is reported.
Time frame: From day 1 through day 7 after any vaccination
Population: Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Possibly or Probably Related AEs | 9 Subjects |
| 2H3H511 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | AEs leading to Premature Withdrawal | 0 Subjects |
| 2H3H511 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Any AEs | 26 Subjects |
| 3H5_11 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Possibly or Probably Related AEs | 7 Subjects |
| 3H5_11 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Any AEs | 19 Subjects |
| 3H5_11 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | AEs leading to Premature Withdrawal | 0 Subjects |
| 68_11 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Possibly or Probably Related AEs | 10 Subjects |
| 68_11 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Any AEs | 26 Subjects |
| 68_11 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | AEs leading to Premature Withdrawal | 0 Subjects |
| NAIVE 123 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | AEs leading to Premature Withdrawal | 0 Subjects |
| NAIVE 123 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Possibly or Probably Related AEs | 6 Subjects |
| NAIVE 123 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Any AEs | 9 Subjects |
| 02_2_5 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Possibly or Probably Related AEs | 11 Subjects |
| 02_2_5 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Any AEs | 14 Subjects |
| 02_2_5 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | AEs leading to Premature Withdrawal | 0 Subjects |
| NAIVE_4A | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | AEs leading to Premature Withdrawal | 1 Subjects |
| NAIVE_4A | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Any AEs | 43 Subjects |
| NAIVE_4A | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Possibly or Probably Related AEs | 12 Subjects |
| 02_6_10 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Possibly or Probably Related AEs | 10 Subjects |
| 02_6_10 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Any AEs | 25 Subjects |
| 02_6_10 | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | AEs leading to Premature Withdrawal | 0 Subjects |
| NAIVE_4B | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Possibly or Probably Related AEs | 6 Subjects |
| NAIVE_4B | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | Any AEs | 12 Subjects |
| NAIVE_4B | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination. | AEs leading to Premature Withdrawal | 0 Subjects |
Secondary
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period.
The number of subjects reporting unsolicited SAEs, medically attended AEs and AEs leading to withdrawal after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in the parent study) or two catch-up schedule of Bexsero® vaccine is reported.
Time frame: Throughout the entire study period (up to 2 months)
Population: Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
| 2H3H511 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Any SAEs | 0 Subjects |
| 3H5_11 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
| 3H5_11 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Any SAEs | 0 Subjects |
| 68_11 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
| 68_11 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Any SAEs | 0 Subjects |
| NAIVE 123 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Any SAEs | 0 Subjects |
| NAIVE 123 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
| 02_2_5 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Any SAEs | 0 Subjects |
| 02_2_5 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
| NAIVE_4A | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Any SAEs | 0 Subjects |
| NAIVE_4A | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
| 02_6_10 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Any SAEs | 0 Subjects |
| 02_6_10 | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
| NAIVE_4B | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Any SAEs | 0 Subjects |
| NAIVE_4B | Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
Secondary
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study.
The percentage of subjects with a four-fold rise in hSBA titers 1 month after receiving Bexsero® booster vaccination in this study to pre vaccination at visit 1 (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time frame: One month after booster vaccination (day 31)/24-36 months (Visit 1)
Population: Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2(1 month post booster dose) \& received all scheduled vaccinations in V72\_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | NZ98/254 (Day 31/PRE) | 92 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | 5/99 (Day 31/PRE) | 98 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | M10713 (Day 31/PRE) | 41 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | H44/76 (Day 31/PRE) | 95 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | NZ98/254 (Day 31/PRE) | 95 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | H44/76 (Day 31/PRE) | 95 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | 5/99 (Day 31/PRE) | 98 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | M10713 (Day 31/PRE) | 50 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | H44/76 (Day 31/PRE) | 97 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | M10713 (Day 31/PRE) | 68 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | 5/99 (Day 31/PRE) | 95 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | NZ98/254 (Day 31/PRE) | 93 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | NZ98/254 (Day 31/PRE) | 94 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | 5/99 (Day 31/PRE) | 100 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | M10713 (Day 31/PRE) | 72 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | H44/76 (Day 31/PRE) | 94 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | 5/99 (Day 31/PRE) | 98 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | NZ98/254 (Day 31/PRE) | 86 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | H44/76 (Day 31/PRE) | 97 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | M10713 (Day 31/PRE) | 53 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | H44/76 (Day 31/PRE) | 43 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | M10713 (Day 31/PRE) | 11 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | 5/99 (Day 31/PRE) | 77 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | NZ98/254 (Day 31/PRE) | 34 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | H44/76 (Day 31/PRE) | 53 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | 5/99 (Day 31/PRE) | 76 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | NZ98/254 (Day 31/PRE) | 54 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | M10713 (Day 31/PRE) | 20 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | H44/76 (Day 31/PRE) | 46 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | 5/99 (Day 31/PRE) | 60 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | M10713 (Day 31/PRE) | 13 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study. | NZ98/254 (Day 31/PRE) | 40 Percentage of subjects |
Secondary
Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination.
The percentage of vaccine-naïve subjects with a four-fold rise in hSBA titers from baseline, one month after receiving two catch up doses of Bexsero® booster vaccination in comparison to prevaccination in this study are reported.
Time frame: One month post second vaccination (Day 61)
Population: Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | H44/76 | 94 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | M10713 | 37 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 | 94 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | 5/99 | 100 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | M10713 | 28 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 | 91 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | 5/99 | 100 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | H44/76 | 89 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 | 94 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | 5/99 | 98 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | H44/76 | 94 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination. | M10713 | 22 Percentage of subjects |
Secondary
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study
The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination (visit 2) in this study to post primary visit in the parent study V72\_28(1 month after last vaccination in the parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time frame: From post primary visit in the parent study to visit 2 in this extension study
Population: Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2(1 month post booster dose) \& received all scheduled vaccinations in V72\_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | NZ98/254 | 25 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | H44/76 | 5 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | M10713 | 15 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | 5/99 | 19 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | H44/76 | 5 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | M10713 | 21 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | 5/99 | 27 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | NZ98/254 | 15 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | M10713 | 24 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | H44/76 | 13 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | 5/99 | 37 Percentage of subjects |
| 68_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | NZ98/254 | 27 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | H44/76 | 22 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | NZ98/254 | 13 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | M10713 | 21 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | 5/99 | 66 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | 5/99 | 72 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | H44/76 | 17 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | NZ98/254 | 18 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study | M10713 | 11 Percentage of subjects |
Secondary
Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study.
The percentage of subjects with a four-fold rise in hSBA titers one month after receiving Bexsero® booster vaccination in this study to pre primary visit in parent study V72\_28 (Visit 1). This outcome measure was analysed only for subjects belonging to groups 02\_2\_5\_V and 02\_6\_10\_V
Time frame: From pre primary visit in the parent study (Visit 1) to visit 2 in this extension study
Population: Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2(1 month post booster dose) \& received all scheduled vaccinations in V72\_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. | NZ98/254 | 94 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. | 5/99 | 100 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. | M10713 | 67 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. | H44/76 | 97 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. | M10713 | 55 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. | H44/76 | 96 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. | 5/99 | 100 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With Four-fold Rise in hSBA Titers, One Month After Receiving Bexsero® Vaccination in This Study. | NZ98/254 | 97 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination
The percentage of vaccine-naïve subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and ≥ 5 against M10713 strain, one month after receiving two catch up doses of Bexsero® booster vaccination in this study.
Time frame: At Baseline and One month post second vaccination (Day 61)
Population: Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | 5/99 (Day 61) | 100 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | NZ98/254 (baseline) | 2 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | H44/76 (baseline) | 38 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | M10713 (baseline) | 34 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | NZ98/254 (Day 61) | 100 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | H44/76 (Day 61) | 100 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | M10713 (Day 61) | 75 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | 5/99 (baseline) | 3 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | NZ98/254 (Day 61) | 100 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | 5/99 (baseline) | 4 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | NZ98/254 (baseline) | 7 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | 5/99 (Day 61) | 100 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | M10713 (Day 61) | 69 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | H44/76 (Day 61) | 98 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | M10713 (baseline) | 40 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | H44/76 (baseline) | 26 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | M10713 (Day 61) | 76 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | NZ98/254 (baseline) | 6 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | NZ98/254 (Day 61) | 100 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | M10713 (baseline) | 55 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | H44/76 (baseline) | 20 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | H44/76 (Day 61) | 100 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | 5/99 (baseline) | 6 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination | 5/99 (Day 61) | 100 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.
The percentage of subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and with hSBA titers ≥ 5 against M10713 strain, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study), alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time frame: At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)
Population: Analysis was done on FAS - booster: All subjects in the Enrolled Set who receive a study vaccination and provide an evaluable serum sample at visit 2 (one month after the booster dose administration) and received all scheduled vaccinations in the parent study V72\_28 (excluding naïve groups).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 84 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 99 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 70 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 45 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 48 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 99 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 36 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (post-vacc.) | 99 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 91 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 51 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 99 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 42 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (post-vacc.) | 100 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 35 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 100 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 81 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 45 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 95 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 97 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 64 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 97 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 100 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (post-vacc.) | 100 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 52 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (post-vacc.) | 100 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 97 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 21 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 74 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 39 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 97 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 25 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 100 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 47 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 100 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 99 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 96 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 63 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 59 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (post-vacc.) | 100 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 86 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 88 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 2 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (post-vacc.) | 78 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 39 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 47 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 95 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 3 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 39 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 27 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 41 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 93 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 7 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 91 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 4 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 59 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (post-vacc.) | 85 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 59 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 60 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (post-vacc.) | 70 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 6 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 8 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 20 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 80 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 80 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination.
The percentage of vaccine-naïve subjects with hSBA titers ≥8, one month after receiving two catch up doses of Bexsero® booster vaccination in this study are reported.
Time frame: At Baseline and One month post second vaccination (Day 61)
Population: Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | H44/76 (baseline) | 17 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | H44/76 (Day 61) | 99 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | 5/99 (baseline) | 2 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | 5/99 (Day 61) | 100 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (baseline) | 0 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (Day 61) | 96 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | M10713 (baseline) | 25 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | M10713 (Day 61) | 65 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | 5/99 (baseline) | 4 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | M10713 (baseline) | 38 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | 5/99 (Day 61) | 100 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (baseline) | 2 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (Day 61) | 93 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | H44/76 (baseline) | 15 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | H44/76 (Day 61) | 96 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | M10713 (Day 61) | 63 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | 5/99 (baseline) | 4 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | H44/76 (Day 61) | 98 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | H44/76 (baseline) | 10 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | 5/99 (Day 61) | 98 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | M10713 (baseline) | 49 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (Day 61) | 94 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (baseline) | 0 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination. | M10713 (Day 61) | 69 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study.
The percentage of subjects with hSBA titers ≥ 8, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.
Time frame: At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)
Population: Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2(1 month post booster dose) \& received all scheduled vaccinations in V72\_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 97 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 28 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 22 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/54 (post-vacc.) | 97 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 99 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 64 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 79 Percentage of subjects |
| 2H3H511 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 26 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 85 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 31 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 22 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 98 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 99 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 19 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 71 Percentage of subjects |
| 3H5_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/54 (post-vacc.) | 98 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 97 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 28 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 33 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 99 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 91 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/54 (post-vacc.) | 100 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 34 Percentage of subjects |
| 68_11 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 94 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 100 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 71 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 97 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 19 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 17 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/54 (post-vacc.) | 97 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 90 Percentage of subjects |
| NAIVE 123 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 13 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 92 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 97 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 68 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 55 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 100 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 26 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/54 (post-vacc.) | 97 Percentage of subjects |
| 02_2_5 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 30 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 68 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 77 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 18 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 0 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/54 (post-vacc.) | 34 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 34 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 2 Percentage of subjects |
| NAIVE_4A | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 27 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 2 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/54 (post-vacc.) | 54 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 4 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 16 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 78 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 51 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 71 Percentage of subjects |
| 02_6_10 | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 39 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (pre-vacc.) | 52 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | M10713 (post-vacc.) | 57 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (pre-vacc.) | 10 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (pre-vacc.) | 6 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | H44/76 (post-vacc.) | 60 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/254 (pre-vacc.) | 0 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | NZ98/54 (post-vacc.) | 40 Percentage of subjects |
| NAIVE_4B | Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study. | 5/99 (post-vacc.) | 60 Percentage of subjects |
Secondary
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
The within-subjects GMR of hSBA antibody titers (one month post booster vaccination versus pre vaccination) after Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the within-subject GMR for the 1st dose of rMenB+OMV NZ vaccination of age matched naïve subjects.
Time frame: At Day 31 versus Day 1
Population: Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2 (1 month post booster dose) \& received all scheduled vaccinations in V72\_28 (excluding naïve groups). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 (Day 31/PRE) | 41 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 (Day 31/PRE) | 4.07 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 (Day 31/PRE) | 28 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 (Day 31/PRE) | 75 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 (Day 31/PRE) | 29 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 (Day 31/PRE) | 43 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 (Day 31/PRE) | 67 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 (Day 31/PRE) | 5.65 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 (Day 31/PRE) | 11 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 (Day 31/PRE) | 46 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 (Day 31/PRE) | 41 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 (Day 31/PRE) | 27 Ratio |
| NAIVE 123 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 (Day 31/PRE) | 50 Ratio |
| NAIVE 123 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 (Day 31/PRE) | 160 Ratio |
| NAIVE 123 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 (Day 31/PRE) | 24 Ratio |
| NAIVE 123 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 (Day 31/PRE) | 13 Ratio |
| 02_2_5 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 (Day 31/PRE) | 42 Ratio |
| 02_2_5 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 (Day 31/PRE) | 135 Ratio |
| 02_2_5 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 (Day 31/PRE) | 18 Ratio |
| 02_2_5 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 (Day 31/PRE) | 6.85 Ratio |
| NAIVE_4A | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 (Day 31/PRE) | 4.81 Ratio |
| NAIVE_4A | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 (Day 31/PRE) | 6.07 Ratio |
| NAIVE_4A | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 (Day 31/PRE) | 34 Ratio |
| NAIVE_4A | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 (Day 31/PRE) | 1.38 Ratio |
| 02_6_10 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 (Day 31/PRE) | 7.08 Ratio |
| 02_6_10 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 (Day 31/PRE) | 2.06 Ratio |
| 02_6_10 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 (Day 31/PRE) | 22 Ratio |
| 02_6_10 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 (Day 31/PRE) | 9.58 Ratio |
| NAIVE_4B | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 (Day 31/PRE) | 1.55 Ratio |
| NAIVE_4B | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 (Day 31/PRE) | 6.87 Ratio |
| NAIVE_4B | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 (Day 31/PRE) | 14 Ratio |
| NAIVE_4B | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 (Day 31/PRE) | 7.01 Ratio |
Secondary
The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
The within-subjects GMR of hSBA antibody titers (one month post booster vaccination in this study versus 1 month post last vaccination visit (post-primary vaccination visit) in parent study V72\_28.
Time frame: Visit 2 (day 31 in extension study) versus post primary vaccination visit in parent study
Population: Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2 (1 month post booster dose) \& received all scheduled vaccinations in V72\_28 (excluding naïve groups). The number of participants analyzed is the number of subjects assessed for this particular endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 | 1.06 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 | 1.01 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 | 1.60 Ratio |
| 2H3H511 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 | 1.66 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 | 2.07 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 | 1.10 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 | 1.37 Ratio |
| 3H5_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 | 0.90 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | M10713 | 2.35 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | H44/76 | 1.37 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 5/99 | 2.33 Ratio |
| 68_11 | The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | NZ98/254 | 1.75 Ratio |
Secondary
The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline.
The within-subject GMRs of hSBA titers at one month after receiving the second catch up dose to hSBA titers at baseline, for naïve subjects who received two catch up doses of Bexsero® vaccination in this study are reported.
Time frame: At one month after receiving second vaccination (Day 61) versus baseline (Day 1)
Population: Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2H3H511 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | H44/76 | 46 Ratio |
| 2H3H511 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | 5/99 | 558 Ratio |
| 2H3H511 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | NZ98/254 | 30 Ratio |
| 2H3H511 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | M10713 | 3.86 Ratio |
| 3H5_11 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | M10713 | 2.93 Ratio |
| 3H5_11 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | H44/76 | 34 Ratio |
| 3H5_11 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | NZ98/254 | 27 Ratio |
| 3H5_11 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | 5/99 | 373 Ratio |
| 68_11 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | M10713 | 2.2 Ratio |
| 68_11 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | 5/99 | 242 Ratio |
| 68_11 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | NZ98/254 | 29 Ratio |
| 68_11 | The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline. | H44/76 | 41 Ratio |
Secondary
The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.
The hSBA antibody titers in subjects after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the 1st dose of Bexsero® vaccine in age matched vaccine-naïve subjects in terms of GMTs.
Time frame: At Visit 1 and one month post booster vaccination (Day 31)
Population: Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination \& provide an evaluable serum sample at visit 2(1 month post booster dose) \& received all scheduled vaccinations in V72\_28(excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2H3H511 | The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 3.91 Titers |
| 3H5_11 | The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 4.84 Titers |
| 68_11 | The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 6.21 Titers |
| NAIVE 123 | The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 3.14 Titers |
| 02_2_5 | The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 6.15 Titers |
| NAIVE_4A | The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 2.82 Titers |
| 02_6_10 | The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 2.33 Titers |
| NAIVE_4B | The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study. | 1.93 Titers |
Secondary
The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination.
The hSBA antibody titers in vaccine-naïve subjects , after receiving two catch up doses of Bexsero® vaccination in this study, are reported in terms of GMTs.
Time frame: At Baseline and One month post second vaccination (Day 61)
Population: Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2H3H511 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | H44/76 (baseline) | 2.3 Titers |
| 2H3H511 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | H44/76 (Day 61) | 107 Titers |
| 2H3H511 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | 5/99 (baseline) | 1.13 Titers |
| 2H3H511 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | 5/99 (Day 61) | 631 Titers |
| 2H3H511 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (baseline) | 1.11 Titers |
| 2H3H511 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (Day 61) | 34 Titers |
| 2H3H511 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | M10713 (baseline) | 2.9 Titers |
| 2H3H511 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | M10713 (Day 61) | 12 Titers |
| 3H5_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | 5/99 (baseline) | 1.13 Titers |
| 3H5_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | M10713 (baseline) | 4.12 Titers |
| 3H5_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | 5/99 (Day 61) | 421 Titers |
| 3H5_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (baseline) | 1.34 Titers |
| 3H5_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (Day 61) | 37 Titers |
| 3H5_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | H44/76 (baseline) | 2.15 Titers |
| 3H5_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | H44/76 (Day 61) | 74 Titers |
| 3H5_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | M10713 (Day 61) | 11 Titers |
| 68_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | 5/99 (baseline) | 1.31 Titers |
| 68_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | H44/76 (Day 61) | 63 Titers |
| 68_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | H44/76 (baseline) | 1.56 Titers |
| 68_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | 5/99 (Day 61) | 317 Titers |
| 68_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | M10713 (baseline) | 6.4 Titers |
| 68_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (Day 61) | 34 Titers |
| 68_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | NZ98/254 (baseline) | 1.2 Titers |
| 68_11 | The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination. | M10713 (Day 61) | 14 Titers |