Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bexsero
rMenB+OMV NZ vaccine · 6 trials · 3 indications
The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 doses in MenB\_0\_2\_6 group and 1 month after the 2 dose schedule in MenB\_0\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.
The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 2 doses in MenB\_0\_2\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.
The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill \>=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.
The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill \>=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.
Immune response was measured in terms of hSBA GMTs directed against serogroups A, C, W and Y. As pre-specified in the protocol, the data reported in this outcome measures data were presented for individual lots to demonstrate the consistency of the immune response of 3 lots (ABCWY- 1 Group, ABCWY-2 Group, and ABCWY-3 Group) of the ACWY component of the MenABCWY vaccine.
Four-fold rise is defined as: If the pre-vaccination hSBA titer is \< 4, then post-vaccination hSBA titer should be \>= 16 . If the pre-vaccination hSBA titer is \>= limit of detection (LOD) but \< LL of quantification (LLOQ), then post-vaccination hSBA titer should be \>= 4 times the LLOQ. If the pre-vaccination hSBA titer is \>= LLOQ, then post-vaccination hSBA titer should be \>= 4 times the pre-vaccination hSBA titer. As pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group, ABCWY pooled group to evaluate the immunological non-inferiority of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
The effectiveness (test-based) of 2 doses of MenABCWY vaccine when compared to 1 dose of MenACWY vaccine, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
The effectiveness was measured in terms of percentage of samples with bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
The effectiveness (responder-based) of the MenABCWY vaccine is measured in terms of percentage of participants whose sera kill \>=70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method. Effectiveness is demonstrated Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains tested for MenABCWY is above 65%.
Assessed solicited local adverse events were injection or administration site = pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.
Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.
Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.
Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \[temperature \>= 38.0°C\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.
Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \[temperature \>= 38.0°C\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.
Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \[temperature \>= 38.0°C\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.
A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\_0\_2\_6 group, MenB\_0\_6 group, ACWY group, ABCWY pooled group.
Assessed solicited administration site events include injection site tenderness (administration site pain), erythema (redness), swelling and induration. Any solicited administration site events = occurrence of the event regardless of intensity grade. Rotarix was administered orally; therefore, no administration site events were analyzed.
Assessed systemic events include change in eating habits, sleepiness, vomiting, diarrhea, irritability, persistent crying, and fever, defined as body temperature greater than or equal to (≥)38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.
Rotarix was administered orally; therefore, no administration site events were analyzed.
Systemic events assessed included rash, parotid/salivary gland swelling, and fever. These systemic adverse events were recorded for 30 days following MMR and VV vaccine administration. Any solicited systemic events = occurrence of the event regardless of intensity grade.
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Any = occurrence of the event regardless of the intensity grade.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and that results in disability/incapacity. An AE leading to withdrawal includes any AEs/SAEs collected and recorded from the time of the 1st receipt of study vaccines until study end which are identified as reasons for withdrawal of the participant from the study. AESIs are pre-defined (serious or non-serious) AEs of scientific and medical concern specific to the product or program which might warrant further investigation in order to characterize and understand it. MAAEs includes any AEs that required hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 60% for each of the M14459, 96217, NZ98/254, M13520 test strain. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 50% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥75% for each of the M14459, 96217, NZ98/254, M13520 test strains. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥65% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
The immune response to PCV13 is evaluated by measuring IgG levels using electrochemiluminescence (ECL) assay. Adjusted GMCs are assessed for each of the 13 PCV13 antigens at 1 month after the third vaccination.
Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254.
Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713.
Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713
Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713
Bactericidal activity was measured against each of the N. meningitidis group B Indicator strains H44/76,5/99,NZ98/254 and M10713
Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99, NZ98/254 a nd M10713.
The GMRs of GMTs at Day 1 versus one month after the last dose of rMenB+OMV NZ vaccination in the parent study were calculated. Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713.
Solicited adverse events are signs and symptoms derived from organized data collection systems, such as Subject Diaries or interview. The percentage and frequencies of subjects reporting solicited local and systemic AEs were tabulated. Threshold for any Erythema, Swelling and Induration: \>= 25 mm Note:Vaccination 2 was performed only on group B\_0\_1 subjects. Threshold for any Erythema, Swelling and Induration: \>= 25 mm
An unsolicited adverse event is an adverse event that was not solicited using a subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Note : Vaccination 2 was performed only on group B\_0\_1 subjects.
A serious adverse event is any untoward medical occurrence that at any dose results in death or is life threatening or requires prolonged hospitalization, leads to Persistent or significant disability/incapacity.
Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).
Percentage of subjects with hSBA titer ≥ 1:4 at 1 month after third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).
The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero) vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N.meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, is reported. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated in the rMenB\_0\_2 and ABCWY\_ 0\_2 Groups.
| Arm | Type | Description |
|---|---|---|
| Primed group | EXPERIMENTAL | Participants who were primed with rMenB+OMV NZ in a 2+1 or 3+1 schedule during the first 2 years of life will receive 1 dose of rMenB+OMV NZ at Day 1. |
| Naive group | ACTIVE_COMPARATOR | Participants who are group B-meningococcal-vaccine-naive within the same age range as the primed group receive 2 doses of rMenB+OMV NZ at Day 1 and Day 31. |
| MenB_0_2_6 Group | EXPERIMENTAL | Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care. |
| MenB_0_6 Group | EXPERIMENTAL | Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding. |
| ABCWY-1 Group | EXPERIMENTAL | Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211. |
| ABCWY-2 Group | EXPERIMENTAL | Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211. |
| ABCWY-3 Group | EXPERIMENTAL | Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211. |
| ACWY Group | ACTIVE_COMPARATOR | Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care. |
| ABCWY_Pooled | EXPERIMENTAL | Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding. To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group. |
| MenB+PCV Group | EXPERIMENTAL | Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301. |
| Placebo+PCV Group | PLACEBO_COMPARATOR | Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301. |
| Group 3B | EXPERIMENTAL | Subjects who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during studies V72P10 (NCT00661713) or V72\_41(NCT0142384), and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster. |
| Group B_0_1 | ACTIVE_COMPARATOR | Subjects who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose. |
| Bexsero + Routine Group | EXPERIMENTAL | Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age. |
| Routine Group | ACTIVE_COMPARATOR | Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age. |
| rMenB_0_2 Group | EXPERIMENTAL | Subjects received two injections of Bexsero vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1. |
| ABCWY_ 0_2 Group | EXPERIMENTAL | Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 2, Havrix vaccine at Visit Month 6 and Visit Month 12 and saline placebo at Visit Month 1. |
| ABCWY_0_1 Group | EXPERIMENTAL | Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 1, Havrix vaccine at Visit Month 2 and Visit Month 12 and saline placebo at Visit Month 6. |
| ABCWY_0_6 Group | EXPERIMENTAL | Subjects received MenABCWY vaccine at Visit Month 0 and Visit Month 6, Havrix vaccine at Visit Month 1 and Visit Month 12 and saline placebo at Visit Month 2. |
| ABCWY_0_11 Group | EXPERIMENTAL | Subjects received MenABCWY vaccine at Visit Month 1 and Visit Month 12, Havrix vaccine at Visit Month 0 and Visit Month 6 and saline placebo at Visit Month 2. |
| ABCWY_0_2_6 Group | EXPERIMENTAL | Subjects received MenABCWY vaccine at Visit Month 0, Visit Month 2 and Visit Month 6 and Havrix vaccine at Visit Month 1 and Visit Month 12. |
| Name | Type | Description |
|---|---|---|
| rMenB+OMV NZ vaccine | BIOLOGICAL | 1 dose in the Primed group or 2 doses in the Naive group. |
| Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) | BIOLOGICAL | MenACWY vaccine was administered intramuscularly. |
| Placebo | COMBINATION_PRODUCT | Placebo was administered intramuscularly. |
| MenABCWY-1 | COMBINATION_PRODUCT | Lot 1 of the MenABCWY vaccine was administered intramuscularly. |
| MenABCWY-2 | COMBINATION_PRODUCT | Lot 2 of the MenABCWY vaccine was administered intramuscularly. |
| MenABCWY-3 | COMBINATION_PRODUCT | Lot 3 of the MenABCWY vaccine was administered intramuscularly. |
| Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ) | BIOLOGICAL | Bexsero was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301. |
| Prevnar13 | BIOLOGICAL | Prevnar13 (PCV13) was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301. |
| Pediarix | BIOLOGICAL | Pediarix (DTPa-HBV-IPV) was administered intramuscularly on Day 1, Day 61, and Day 121. |
| Hiberix | BIOLOGICAL | Hiberix (Hib) was administered intramuscularly on Day 1, Day 61, and Day 121. |
| Rotarix | BIOLOGICAL | Rotarix (HRV) was administered intramuscularly on Day 1 and Day 61. |
| M-M-R II | BIOLOGICAL | M-M-R II (MMR) was administered intramuscularly on Day 301. |
| Varivax | BIOLOGICAL | Varivax (VV) was administered intramuscularly on Day 301. |
| Placebo (saline water) | BIOLOGICAL | Placebo was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301. |
| Prevnar 20 | BIOLOGICAL | Prevnar 20 (PCV13) was administered intramuscularly as a booster dose on Day 301 group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose. |
| rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine) | BIOLOGICAL | One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm. |
| Bexsero® | BIOLOGICAL | Four doses administered in the anterolateral area of the right or left thigh. |
| Routine vaccines | BIOLOGICAL | Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh. |
| Bexsero | BIOLOGICAL | Two doses administered intramuscularly into the deltoid area at Months 0 and 2 in rMenB\_0\_2 Group. |
| Saline Placebo | OTHER | One dose administered intramusculary in the deltoid muscle at Month 1 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group, Month 2 in ABCWY\_0\_6 Group and ABCWY\_0\_11 Group and Month 6 in ABCWY\_0\_1 Group. |
| Havrix | BIOLOGICAL | Two doses administered in the deltoid muscle at Month 2 and 12 in ABCWY\_0\_1 Group, Month 1 and 12 in Group ABCWY\_0\_6 Group and ABCWY\_0\_2\_6 Group , Month 0 and 6 in ABCWY\_0\_11 Group and Month 6 and 12 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group. |
| MenABCWY | BIOLOGICAL | Two to three doses administered in the deltoid muscle at Month 0 and 1 in ABCWY\_0\_1 Group, Month 0 and 6 in ABCWY\_0\_6 Group, Month 1 and 12 in ABCWY\_0\_11 Group, Month 0, 2 and 6 in ABCWY\_0\_2\_6 Group, Month 0 and 2 in ABCWY\_ 0\_2 Group and rMenB\_0\_2 Group. |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: For primed group only: • Participated who were primed with rMenB + OMV NZ in only either 3+1 or 2+1 schedule during the first 2 years of life as confirmed by electronic or paper ...
rMenB+OMV NZ is a vaccine developed by GSK plc for the prevention of meningococcal group B infections and meningitis. It is a multi component recombinant adsorbed vaccine that combines recombinant meningococcal proteins with outer membrane vesicles from the New Zealand strain. It is given to healthy adolescents and young adults.
rMenB+OMV NZ vaccine is used to prevent infections caused by meningococcal group B bacteria, including meningitis. Its clinical program has studied healthy participants from 10 years of age and older, including adolescents and young adults, in countries across Europe, North America, Australia, and South America.
rMenB+OMV NZ vaccine is developed by GSK plc, which trades under the ticker GSK. The vaccine is also known as Bexsero, and its full descriptive name is the Meningococcal (Group B) multi component recombinant adsorbed vaccine.
rMenB+OMV NZ vaccine has been studied in Phase 3 clinical development. The completed Phase 3 trials enrolled a total of 4,188 participants and included randomized, double blind, active controlled designs. It is an investigational vaccine asset in GSK's infectious disease portfolio.
Three completed Phase 3 trials are registered for rMenB+OMV NZ vaccine: NCT06995430 in primed healthy participants aged 10 to 20 years, NCT04502693 evaluating meningococcal group B and combined ABCWY vaccines in adolescents and young adults, and NCT02446743 on long term persistence in adolescents.
Yes, rMenB+OMV NZ vaccine is also known as Bexsero. The same asset is referred to as rMenB+OMV NZ (Bexsero) vaccine and by its full descriptive name, the Meningococcal (Group B) multi component recombinant adsorbed vaccine. These names all refer to the same GSK meningococcal group B vaccine.