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CompletedNCT01992536Updated Oct 25, 2016Results posted

Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)

A Phase 2 interventional study of MenABCWY+OMV and MenABCWY+¼OMV in Meningococcal Disease, sponsored by Novartis Vaccines. Completed at 13 sites in 2 countries. Open to participants aged 10 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-25.

Sponsored by Novartis Vaccines · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
10 Years to 25 Years
Sex
All
01

Study summary

The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the primary vaccination and 12 months after the booster dose will also be evaluated in these subjects.

In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV). These subjects will be followed for safety and immunogenicity for 12 months after vaccination in study V102_03E1.

02

Conditions studied

  • Meningococcal Disease

Keywords

  • Meningococcal
  • Booster
  • MenABCWY
  • Menveo
  • Vaccine Adolescents
  • Immune Response
  • N. Meningitidis
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 194 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03 (NCT01272180);
  2. Individuals or the individual's parents or legal guardian who have given written consent after the nature of the study has been explained according to local regulatory requirements;
  3. Individuals who have given written assent as required by local regulations after the nature of the study has been explained to them according to local regulatory requirements;
  4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
  5. Individuals and/or or the individual's parents or legal guardian who can comply with study procedures and are available for follow-up.

Exclusion criteria

Exclusion Criteria:

  1. History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180);
  2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
  3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
  4. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;

  5. All sexually active females that have not used an "acceptable contraceptive method(s)" for at least 2 months prior to study entry. Acceptable birth control methods are defined as one or more of the following:

    1. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
    2. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
    3. Intrauterine device (IUD)
    4. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry;
  6. Sexually active females that refuse to use to an "acceptable contraceptive method" through to 3 weeks following the study vaccination;
  7. Female subjects with a positive pregnancy test prior to the study vaccine being administered;
  8. Nursing (breastfeeding) mothers;
  9. Individuals with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study;
  10. Any serious, chronic, or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition);
  11. Subjects who required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥ 20mg/day. Inhaled and topical steroids are allowed).
  12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
  13. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
  14. Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days prior study vaccination, and up to 30 days after the vaccination (with the exception of any licensed influenza vaccine which may be administered >14 days preceding or >14 days following the study vaccination);
  15. Individuals who study personnel or immediate family members of study personnel including brother, sister, child, parent, or the spouse.
  16. Individuals who have experienced moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrolment.
  17. Who have received systemic antibiotic treatment within 7 days prior to enrollment.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
194 participants (actual)

Study arms

  • Experimental
    Ia: MenABCWY+OMV

    Investigational

    Biological: MenABCWY+OMV

  • Placebo comparator
    Ib: Placebo

    Saline

    Biological: Placebo

  • Experimental
    IIa: MenABCWY+¼OMV

    Investigational

    Biological: MenABCWY+¼OMV

  • Placebo comparator
    IIb: Placebo

    Saline

    Biological: Placebo

  • Experimental
    IIIa: MenABCWY+OMV

    Investigational

    Biological: MenABCWY+OMV

  • Experimental
    IIIb: MenABCWY+¼OMV

    Investigational

    Biological: MenABCWY+¼OMV

  • Experimental
    IVa: MenABCWY+OMV

    Investigational

    Biological: MenABCWY+OMV

  • Experimental
    IVb: MenABCWY+¼OMV

    Investigational

    Biological: MenABCWY+¼OMV

  • Placebo comparator
    IVc: Placebo

    Saline

    Biological: Placebo

Interventions

  • BiologicalMenABCWY+OMV

    Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine

  • BiologicalMenABCWY+¼OMV

    Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine

  • BiologicalPlacebo

    Saline solution for injection (0.5mL)

06

What researchers measure

Primary outcomes

  1. 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.

    Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.

    Time frame: Day 30

  2. 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.

    Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180).

    Time frame: Day 1 and Day 30

Secondary outcomes

  1. 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.

    Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

    Time frame: Day 1 (Pre vaccination)

  2. 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.

    Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

    Time frame: Day 1 (Pre vaccination)

  3. 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.

    The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

    Time frame: Day 1 (Pre-vaccination)

  4. 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.

    The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

    Time frame: Day 1 (Pre-vaccination)

  5. 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.

    The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.

    Time frame: Day 1 and Day 30

  6. 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.

    The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.

    Time frame: Day 1 and Day 30

  7. 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.

    Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer \< 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.

    Time frame: Day 1 and Day 30

  8. 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.

    Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.

    Time frame: Day 1 and Day 30

  9. 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.

    Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.

    Time frame: Day 1 and Day 30

  10. 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.

    Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.

    Time frame: Day 30

  11. 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.

    Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination.

    Time frame: Day 1 and Day 365

  12. 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B

    Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination.

    Time frame: Day 1, Day 30 and Day 365

  13. 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.

    Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer \< 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.

    Time frame: Day 1, Day 30 and Day 365

  14. 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.

    The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.

    Time frame: Day 1 and Day 365

  15. 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.

    The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.

    Time frame: Day 1 and Day 365

  16. 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.

    Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.

    Time frame: Day 1, Day 30 and Day 365

  17. 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.

    Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.

    Time frame: Day 1, Day 30 and Day 365

  18. 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.

    The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.

    Time frame: Day 1, Day 30 and Day 365

  19. 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.

    The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.

    Time frame: Day 1, Day 30 and Day 365

  20. 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.

    Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study.

    Time frame: Day 1, Day 30 and Day 365

  21. 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.

    Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever.

    Time frame: From day 1 (6 hours) through day 7 after any vaccination

  22. 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.

    Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30. Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.

    Time frame: Day 1 through Day 30

  23. 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.

    Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period.

    Time frame: Day 1 to Day 365

  24. 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.

    Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102_03 (NCT01272180) up to Day 1 visit in V102_03E1 study, is reported. (Any NOCD AEs: NOCD V102_03 (NCT01272180) vs. NOCD- Day 1, V102_03E1)

    Time frame: From primary parent study completion up to Day 1 in this study.

07

Results

Posted Oct 25, 2016

Participant flow

Subjects were recruited from 5 study sites in Poland and from 8 study sites in United States.

Participant flow — Overall Study
Milestone2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV2B_Pbo1M_OMV1M_qOMV1M_Pbo
Started2625172411217211919
Completed2222162211200211818
Not completed4312017011
Withdrew: Administrative reason0000007000
Withdrew: Lost to follow-up4210010011
Withdrew: Withdrawal by subject0102000000

Outcome measures

Primary1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.

Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.

Time frame:
Day 30
Reported as:
Number · Percentages of Subjects
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
Percentages of Subjects2OMV_OMV2qOMV_qOMV
Men A96 (79.6 to 99.9)94 (69.8 to 99.84)
Men C (N=20,10)85 (62.1 to 96.8)100 (69.2 to 100)
Men W (N=20,13)85 (62.1 to 96.8)85 (54.6 to 98.1)
Men Y (N=25,14)96 (79.6 to 99.9)100 (76.8 to 100)
Primary2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.

Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180).

Time frame:
Day 1 and Day 30
Reported as:
Number · Percentages of Subjects
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
Percentages of Subjects2OMV_OMV2qOMV_qOMV
5/99 (Day 1, N= 25,15)76 (54.9 to 90.6)87 (59.5 to 98.3)
5/99 (Day 30, N=25,17)100 (86.3 to 100.0)100 (80.5 to 100.0)
H44/76 (Day 1, N=25,16)16 (4.5 to 36.1)13 (1.6 to 38.3)
H44/76 (Day 30, N=25,17)96 (79.6 to 99.90)100 (80.5 to 100.0)
M01-0240364 (Day 1, N=24,15)25 (9.8 to 46.7)20 (4.3 to 48.1)
M01-0240364 (Day 30, N=25,17)100 (86.3 to 100.0)100 (80.5 to 100.0)
M07-0241084 (Day 1,N=25,15)36 (18.0 to 57.5)27 (7.8 to 55.1)
M07-0241084 (Day 30, N=25,17)100 (86.3 to 100.0)88 (63.6 to 98.5)
M14459 (Day 1, N=25,15)24 (9.4 to 45.1)7 (0.17 to 31.9)
M14459 (Day 30, N=25,17)92 (74.0 to 99.0)88 (63.6 to 98.5)
NZ98/254 (Day 1, N=25,15)16 (4.5 to 36.1)7 (0.17 to 31.9)
NZ98/254 (Day 30, N=25,17)92 (74.0 to 99.0)71 (44.0 to 89.7)
Secondary3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.

Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

Time frame:
Day 1 (Pre vaccination)
Reported as:
Number · Percentages of Subjects
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Percentages of SubjectsABCWY+OMVABCWY+qOMVrMenB+OMVMenveo
Men A (N=51,40,38,58)27 (15.9 to 41.7)28 (14.6 to 43.9)29 (15.4 to 45.9)31 (19.5 to 44.5)
Men C (N=48,38,38,58)67 (51.6 to 79.6)68 (51.3 to 82.5)45 (28.6 to 61.7)57 (43.2 to 69.8)
Men W (N=50,36,38,56)92 (80.8 to 97.8)75 (57.8 to 87.9)76 (59.8 to 88.6)68 (54 to 79.7)
Men Y (N=51,38,38,59)65 (50.1 to 77.6)50 (33.4 to 66.6)16 (6 to 31.3)46 (32.7 to 59.2)
Secondary4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.

Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

Time frame:
Day 1 (Pre vaccination)
Reported as:
Number · Percentages of Subjects
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Percentages of SubjectsABCWY+OMVABCWY+qOMVrMenB+OMVMenveo
5/99 (N=51,38,36,59)76 (62.5 to 87.2)87 (71.9 to 95.6)94 (81.3 to 99.3)19 (9.7 to 30.9)
H44/76 (N=51,39,38,59)22 (11.3 to 35.3)18 (7.5 to 33.5)34 (19.6 to 51.4)3 (0.41 to 11.7)
M01-0240364 (N=50,37,37,58)24 (13.1 to 38.2)16 (6.2 to 32.0)35 (20.2 to 52.5)7 (1.9 to 16.7)
M07-0241084 (N=51,38,38,59)37 (24.1 to 51.9)29 (15.4 to 45.9)50 (33.4 to 66.6)22 (12.3 to 34.7)
M14459 (N=51,39,38,59)29 (17.5 to 43.8)13 (4.3 to 27.4)26 (13.4 to 43.1)14 (6.0 to 25.0)
NZ98/254 (N=51,39,38,59)24 (12.8 to 37.5)8 (1.6 to 20.9)16 (6.0 to 31.3)3 (0.41 to 11.7)
Secondary5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.

The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

Time frame:
Day 1 (Pre-vaccination)
Reported as:
Geometric mean · Titers
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
TitersABCWY+OMVABCWY+qOMVrMenB+OMVMenveo
Men A (N=51,40,38,58)3.34 (2.19 to 5.08)3.3 (1.95 to 5.60)2.96 (1.70 to 5.17)4.14 (2.75 to 6.23)
Men C (N=48,38,38,58)18 (11 to 30)13 (8.00 to 20)6.05 (4.28 to 8.55)10 (6.36 to 17)
Men W (N=50,36,38,56)35 (24 to 52)23 (12 to 45)20 (11 to 34)17 (9.65 to 29)
Men Y (N=51,38,38,59)13 (7.01 to 23)8.85 (4.24 to 18)1.8 (1.25 to 2.60)6.49 (3.72 to 11)
Secondary6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.

The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180).

Time frame:
Day 1 (Pre-vaccination)
Reported as:
Geometric mean · Titers
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
TitersABCWY+OMVABCWY+qOMVrMenB+OMVMenveo
5/99 (N=51,38,36,59)16 (11 to 24)33 (19 to 54)39 (25 to 62)2.46 (1.73 to 3.51)
H44/76 (N=51,39,38,59)2.54 (1.69 to 3.82)1.78 (1.26 to 2.53)3.22 (2.18 to 4.76)1.32 (1.06 to 1.65)
M01-0240364 (N=50,37,37,58)2.67 (1.70 to 4.20)2.1 (1.21 to 3.65)4.72 (2.44 to 9.13)1.37 (1.06 to 1.78)
M07-0241084 (N=51,38,38,59)3.76 (2.55 to 5.56)2.42 (1.70 to 3.45)4.56 (2.97 to 7.01)2.35 (1.68 to 3.28)
M14459 (N=51,39,38,59)2.67 (1.92 to 3.70)1.94 (1.48 to 2.56)2.82 (2.00 to 3.96)1.87 (1.43 to 2.43)
NZ98/254 (N=51,39,38,59)2.03 (1.43 to 2.89)1.46 (1.15 to 1.85)1.75 (1.24 to 2.47)1.16 (1.00 to 1.34)
Secondary7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.

The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.

Time frame:
Day 1 and Day 30
Reported as:
Geometric mean · Titers
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Titers2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
Men A (Day 1, N=25,25,16,22,11,21,19,16,18)3.41 (1.87 to 6.22)2.92 (1.59 to 5.36)2.86 (1.23 to 6.63)2.73 (1.41 to 5.27)2.26 (0.96 to 5.31)3.94 (1.58 to 9.85)6.62 (2.85 to 15)2.09 (1.28 to 3.41)5.02 (2.06 to 12)
Men A (Day 30, N=25,25,16,22,11,21,19,17,18)259 (174 to 383)4.28 (2.03 to 9.03)333 (199 to 559)3.07 (1.51 to 6.25)438 (287 to 670)416 (198 to 871)138 (84 to 229)46 (24 to 87)4.91 (2.00 to 12)
Men C (Day 1, N=20,23,10,22,7,16,21,18,17)23 (9.45 to 57)16 (7.06 to 36)17 (5.98 to 51)11 (6.24 to 19)5.45 (2.41 to 12)9.02 (5.24 to 16)7.75 (4.19 to 14)7.53 (2.38 to 24)17 (6.60 to 44)
Men C (Day 30, N=21,24,11,23,7,16,21,18,18)660 (401 to 1084)17 (7.60 to 38)612 (245 to 1524)11 (5.51 to 22)292 (75 to 1142)135 (69 to 261)338 (205 to 558)304 (124 to 742)20 (7.20 to 56)
Men W (Day 1, N=20,24,13,21,11,19,18,17,15)34 (20 to 59)33 (17 to 65)30 (8.90 to 101)18 (7.30 to 46)25 (7.98 to 79)29 (13 to 64)28 (12 to 66)9.37 (2.85 to 31)9.42 (3.03 to 29)
Men W (Day 30, N=20,24,16,22,11,19,19,17,16)792 (516 to 1216)34 (16 to 71)880 (671 to 1154)26 (11 to 59)392 (252 to 610)363 (278 to 473)629 (384 to 1032)364 (180 to 736)16 (4.87 to 53)
Men Y (Day 1, N=25,25,14,22,11,21,21,18,18)10 (4.89 to 21)15 (5.50 to 43)15 (4.33 to 53)5.66 (2.25 to 14)2.4 (1.05 to 5.47)1.84 (1.07 to 3.14)6.43 (2.86 to 14)5.79 (1.77 to 19)5.32 (1.81 to 16)
Men Y (Day 30, N=25,25,16,23,11,21,21,18,18)464 (294 to 734)16 (5.65 to 48)697 (435 to 1116)5.17 (2.16 to 12)48 (14 to 157)39 (13 to 120)658 (431 to 1003)419 (217 to 809)6.36 (1.91 to 21)
Secondary8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.

The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.

Time frame:
Day 1 and Day 30
Reported as:
Geometric mean · Titers
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
Titers2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
5/99 (Day 1, N=25,25,15,22,9,21,21,19,18)17 (9.56 to 29)16 (8.32 to 30)35 (14 to 92)30 (15 to 60)27 (8.61 to 86)43 (24 to 77)2.97 (1.58 to 5.59)1.74 (1.01 to 3.03)2.81 (1.30 to 6.06)
5/99 (Day 30, N=25,25,17,23,11,21,21,19,18)1131 (716 to 1787)20 (10 to 42)1598 (900 to 2840)34 (20 to 59)2205 (1560 to 3117)2576 (1716 to 3867)28 (11 to 67)30 (11 to 78)3.41 (1.20 to 9.73)
H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18)2.92 (1.50 to 5.67)2.03 (1.23 to 3.34)1.46 (0.96 to 2.21)1.92 (1.11 to 3.32)3.45 (1.81 to 6.57)3.24 (1.76 to 5.94)1.09 (0.96 to 1.22)1.47 (0.92 to 2.36)1.18 (0.97 to 1.44)
H44/76 (Day 30, 25,25,17,23,11,21,19,19,18)97 (60 to 157)2.36 (1.39 to 4.01)56 (32 to 97)2.54 (1.42 to 4.53)132 (64 to 271)79 (42 to 149)5.27 (2.54 to 11)3.85 (1.85 to 8.02)1.63 (0.75 to 3.52)
M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18)2.28 (1.3 to 3.98)3.11 (1.44 to 6.68)2.67 (0.87 to 8.24)1.36 (0.83 to 2.23)2.46 (0.72 to 8.4)6.81 (2.47 to 19)1.34 (0.84 to 2.13)1.23 (0.88 to 1.71)1.63 (0.86 to 3.11)
M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18)685 (397 to 1182)3.21 (1.4 to 7.37)856 (454 to 1614)1.94 (1.02 to 3.69)1336 (810 to 2202)1275 (794 to 2048)3.5 (1.32 to 9.3)3.42 (1.19 to 9.8)1.76 (0.75 to 4.09)
M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18)3.53 (2.09 to 5.95)3.54 (1.98 to 6.31)2.16 (1.15 to 4.08)2.52 (1.58 to 4.03)4.10 (1.89 to 8.90)6.08 (3.18 to 12)2.08 (1.26 to 3.42)2.06 (1.13 to 3.77)3.01 (1.38 to 6.56)
M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18)50 (31 to 79)3.66 (2.02 to 6.64)29 (14 to 58)2.48 (1.55 to 3.96)68 (33 to 142)69 (36 to 129)3.26 (1.75 to 6.06)2.15 (1.13 to 4.07)3.86 (1.40 to 11)
M14459 (Day 1, N=25,25,15,23,11,21,20,19,18)2.57 (1.57 to 4.22)2.58 (1.62 to 4.12)1.6 (0.97 to 2.65)2.27 (1.61 to 3.2)3.11 (1.74 to 5.56)3.18 (1.87 to 5.41)1.91 (1.14 to 3.2)1.45 (1.03 to 2.05)2.37 (1.31 to 4.29)
M14459 (Day 30, N=25,25,17,23,11,21,20,19,18)31 (18 to 54)2.18 (1.39 to 3.42)20 (11 to 37)2.33 (1.62 to 3.35)56 (27 to 117)35 (21 to 58)3.44 (2.05 to 5.75)2.57 (1.51 to 4.37)2.93 (1.14 to 7.53)
NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18)1.65 (1.09 to 2.48)2.11 (1.28 to 3.49)1.32 (0.94 to 1.84)1.58 (1.11 to 2.27)1.72 (0.99 to 2.98)2.07 (1.17 to 3.66)1.18 (0.84 to 1.66)1.18 (0.90 to 1.54)1.12 (0.94 to 1.34)
NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18)29 (18 to 47)2.03 (1.21 to 3.40)12 (5.04 to 31)1.87 (1.11 to 3.16)17 (6.22 to 45)28 (17 to 44)2.48 (1.31 to 4.69)1.58 (0.96 to 2.59)1.71 (0.84 to 3.50)
Secondary9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.

Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer \< 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.

Time frame:
Day 1 and Day 30
Reported as:
Number · Percentages of Subjects
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Percentages of Subjects2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5)96 (78.9 to 99.89)100 (85.8 to 100.0)94 (69.8 to 99.84)100 (84.6 to 100.0)91 (58.7 to 99.77)95 (75.1 to 99.87)0 (0 to 45.9)0 (0.0 to 52.2)0 (0.0 to 52.2)
5/99 (Day 30, N=25,25,15,22,9,21,21,19,18)100 (86.3 to 100.0)4 (0.10 to 20.4)93 (68.1 to 99.83)0 (0.0 to 15.4)100 (66.4 to 100.0)95 (76.2 to 99.88)57 (34.0 to 78.2)79 (54.4 to 93.9)6 (0.14 to 27.3)
H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5)100 (85.8 to 100.0)96 (79.6 to 99.90)100 (79.4 to 100.0)96 (78.1 to 99.89)91 (58.7 to 99.77)90 (68.3 to 98.8)0 (0.0 to 45.9)0 (0.0 to 52.2)0 (0.0 to 52.2)
H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18)84 (63.9 to 95.5)4 (0.10 to 20.4)94 (69.8 to 99.84)0 (0.0 to 15.4)100 (71.5 to 100.0)76 (52.8 to 91.8)37 (16.3 to 61.6)26 (9.1 to 51.2)6 (0.14 to 27.3)
M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4)78 (56.3 to 92.5)74 (51.6 to 89.8)63 (35.4 to 84.8)75 (50.9 to 91.3)82 (48.2 to 97.7)85 (62.1 to 96.8)0 (0.0 to 45.9)0 (0.0 to 52.2)0 (0.0 to 60.2)
M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18)100 (85.8 to 100.0)4 (0.10 to 20.4)93 (68.1 to 99.83)5 (0.13 to 24.9)100 (69.2 to 100.0)90 (69.6 to 98.8)20 (5.7 to 43.7)22 (6.4 to 47.6)6 (0.14 to 27.3)
M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4)25 (9.8 to 46.7)17 (5.0 to 38.8)31 (11.0 to 58.7)19 (5.4 to 41.9)45 (16.7 to 76.6)55 (31.5 to 76.9)0 (0.0 to 45.9)0 (0.0 to 52.2)0 (0.0 to 60.2)
M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18)76 (54.9 to 90.6)0 (0.0 to 13.7)87 (59.5 to 98.3)0 (0.0 to 15.4)82 (48.2 to 97.7)62 (38.4 to 81.9)14 (3.0 to 36.3)0 (0.0 to 17.6)6 (0.14 to 27.3)
M14459 (Day 1, N=24,25,16,22,11,20,6,5,5)54 (32.8 to 74.4)48 (27.8 to 68.7)63 (35.4 to 84.8)59 (36.4 to 79.3)91 (58.7 to 99.77)60 (36.1 to 80.9)0 (0.0 to 45.9)0 (0.0 to 52.2)0 (0.0 to 52.2)
M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18)72 (50.6 to 87.9)0 (0.0 to 13.7)87 (59.5 to 98.3)0 (0.0 to 14.8)100 (71.5 to 100.0)76 (52.8 to 91.8)15 (3.2 to 37.9)5 (0.13 to 26.0)6 (0.14 to 27.3)
NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5)50 (29.1 to 70.9)46 (25.6 to 67.2)50 (24.7 to 75.3)59 (36.4 to 79.3)55 (23.4 to 83.3)70 (45.7 to 88.1)0 (0.0 to 45.9)0 (0.0 to 52.2)0 (0.0 to 52.2)
NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18)76 (54.9 to 90.6)0 (0.0 to 13.7)67 (38.4 to 88.2)4 (0.11 to 21.9)82 (48.2 to 97.7)67 (43.0 to 85.4)19 (5.4 to 41.9)5 (0.13 to 26.0)6 (0.14 to 27.3)
Secondary10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.

Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.

Time frame:
Day 1 and Day 30
Reported as:
Number · Percentages of Subjects
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Percentages of Subjects2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
Men A (Day 1, N=25,25,16,22,11,21,19,16,18)32 (14.9 to 53.5)20 (6.8 to 40.7)19 (4.0 to 45.6)27 (10.7 to 50.2)27 (6.0 to 61.0)33 (14.6 to 57.0)47 (24.4 to 71.1)6 (0.16 to 30.2)39 (17.3 to 64.3)
Men A (Day 30, N=25,25,16,22,11,21,19,17,18)100 (86.3 to 100)36 (18 to 57.5)100 (79.4 to 100)27 (10.7 to 50.2)100 (71.5 to 100)95 (76.2 to 99.88)100 (82.4 to 100)94 (71.3 to 99.85)39 (17.3 to 64.3)
Men C (Day 1, N=20,23,10,22,7,16,21,18,17)70 (45.7 to 88.1)65 (42.7 to 83.6)70 (34.8 to 93.3)68 (45.1 to 86.1)43 (9.9 to 81.6)63 (35.4 to 84.8)57 (34 to 78.2)44 (21.5 to 69.2)65 (38.3 to 85.8)
Men C (Day 30, N=21,24,11,23,7,16,21,18,18)100 (83.9 to 100)63 (40.6 to 81.2)100 (71.5 to 100)61 (38.5 to 80.3)100 (59 to 100)100 (79.4 to 100)100 (83.9 to 100)89 (65.3 to 98.6)61 (35.7 to 82.7)
Men W (Day 1, N=20,24,13,21,11,19,18,17,15)95 (75.1 to 99.87)88 (67.6 to 97.3)77 (46.2 to 95)71 (47.8 to 88.7)82 (48.2 to 97.7)79 (54.4 to 93.9)83 (58.6 to 96.4)53 (27.8 to 77)53 (26.6 to 78.7)
Men W (Day 30, N=20,24,16,22,11,19,19,17,16)100 (83.2 to 100)79 (57.8 to 92.9)100 (79.4 to 100)77 (54.6 to 92.9)100 (71.5 to 100)100 (82.4 to 100)100 (82.4 to 100)100 (80.5 to 100)63 (35.4 to 84.8)
Men Y (Day 1, N=25,25,14,22,11,21,21,18,18)64 (42.5 to 82)64 (42.5 to 82)64 (35.1 to 87.2)41 (20.7 to 63.6)36 (10.9 to 69.2)10 (1.2 to 30.4)52 (29.8 to 74.3)39 (17.3 to 64.3)39 (17.3 to 64.3)
Men Y (Day 30, N=25,25,16,23,11,21,21,18,18)100 (86.3 to 100)60 (38.7 to 78.9)100 (79.4 to 100)39 (19.7 to 61.5)82 (48.2 to 97.7)76 (52.8 to 91.8)100 (83.9 to 100)100 (81.5 to 100)39 (17.3 to 64.3)
Secondary11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.

Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.

Time frame:
Day 1 and Day 30
Reported as:
Number · Percentages of Subjects
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
Percentages of Subjects2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
5/99 (Day 1, N=25,25,15,22,9,21,21,19,18)76 (54.9 to 90.6)76 (54.9 to 90.6)87 (59.5 to 98.3)86 (65.1 to 97.1)89 (51.8 to 99.72)95 (76.2 to 99.88)19 (5.4 to 41.9)16 (3.4 to 39.6)22 (6.4 to 47.6)
5/99 (Day 30, N=25,25,17,23,11,21,21,19,18)100 (86.3 to 100)84 (63.9 to 95.5)100 (80.5 to 100)91 (72 to 98.6)100 (71.5 to 100)100 (83.9 to 100)76 (52.8 to 91.8)84 (60.4 to 96.6)22 (6.4 to 47.6)
H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18)16 (4.5 to 36.1)24 (9.4 to 45.1)13 (1.6 to 38.3)18 (5.2 to 40.3)45 (16.7 to 76.6)29 (11.3 to 52.2)0 (0 to 17.6)5 (0.13 to 26.0)0 (0 to 18.5)
H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18)96 (79.6 to 99.90)24 (9.4 to 45.1)100 (80.5 to 100)26 (10.2 to 48.4)100 (71.5 to 100)100 (83.9 to 100)58 (33.5 to 79.7)32 (12.6 to 56.6)6 (0.14 to 27.3)
M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18)25 (9.8 to 46.7)24 (9.4 to 45.1)20 (4.3 to 48.1)5 (0.13 to 24.9)20 (2.5 to 55.6)43 (21.8 to 66)5 (0.13 to 24.9)6 (0.14 to 27.3)11 (1.4 to 34.7)
M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18)100 (86.3 to 100)24 (9.4 to 45.1)100 (80.5 to 100)18 (5.2 to 40.3)100 (71.5 to 100)100 (83.9 to 100)25 (8.7 to 49.1)26 (9.1 to 51.2)11 (1.4 to 34.7)
M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18)36 (18.0 to 57.5)36 (18.0 to 57.5)27 (7.8 to 55.1)27 (10.7 to 50.2)64 (30.8 to 89.1)52 (29.8 to 74.3)19 (5.4 to 41.9)16 (3.4 to 39.6)33 (13.3 to 59.0)
M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18)100 (86.3 to 100)40 (21.1 to 61.3)88 (63.6 to 98.5)30 (13.2 to 52.9)91 (58.7 to 99.77)95 (76.2 to 99.88)33 (14.6 to 57.0)21 (6.1 to 45.6)33 (13.3 to 59.0)
M14459 (Day 1, N=25,25,15,23,11,21,20,19,18)24 (9.4 to 45.1)32 (14.9 to 53.5)7 (0.17 to 31.9)17 (5.0 to 38.8)36 (10.9 to 69.2)29 (11.3 to 52.2)10 (1.2 to 31.7)11 (1.3 to 33.1)22 (6.4 to 47.6)
M14459 (Day 30, N=25,25,17,23,11,21,20,19,18)92 (74 to 99)28 (12.1 to 49.4)88 (63.6 to 98.5)30 (13.2 to 52.9)100 (71.5 to 100)95 (76.2 to 99.88)35 (15.4 to 59.2)32 (12.6 to 56.6)22 (6.4 to 47.6)
NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18)16 (4.5 to 36.1)28 (12.1 to 49.4)7 (0.17 to 31.9)9 (1.1 to 28)9 (0.23 to 41.3)24 (8.2 to 47.2)5 (0.12 to 23.8)5 (0.13 to 26)0 (0 to 18.5)
NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18)92 (74 to 99)20 (6.8 to 40.7)71 (44 to 89.7)13 (2.8 to 33.6)82 (48.2 to 97.7)95 (76.2 to 99.88)19 (5.4 to 41.9)16 (3.4 to 39.6)6 (0.14 to 27.3)
Secondary12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.

Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.

Time frame:
Day 30
Reported as:
Number · Percentages of Subjects
12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
Percentages of Subjects2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
Men A Overall96 (79.6 to 99.90)12 (2.5 to 31.2)94 (69.8 to 99.84)0 (0 to 15.4)100 (71.5 to 100.0)86 (63.7 to 97)84 (60.4 to 96.6)94 (69.8 to 99.84)0 (0 to 18.5)
Men C Overall85 (62.1 to 96.8)4 (0.11 to 21.9)100 (69.2 to 100.0)0 (0 to 15.4)100 (59.0 to 100.0)81 (54.4 to 96.0)95 (76.2 to 99.88)78 (52.4 to 93.6)6 (0.15 to 28.7)
Men W Overall85 (62.1 to 96.8)4 (0.11 to 21.1)85 (54.6 to 98.1)5 (0.12 to 23.8)82 (48.2 to 97.7)68 (43.4 to 87.4)83 (58.6 to 96.4)76 (50.1 to 93.2)20 (4.3 to 48.1)
Men Y Overall96 (79.6 to 99.9)4 (0.1 to 20.4)100 (76.8 to 100.0)0 (0 to 15.4)73 (39 to 94)62 (38.4 to 81.9)95 (76.2 to 99.88)89 (65.3 to 98.6)6 (0.14 to 27.3)
Secondary13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.

Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination.

Time frame:
Day 1 and Day 365
Reported as:
Number · Percentages of Subjects
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Percentages of Subjects2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
Men A (Day 1, N= 21,22,15,20,10,20,20,17,17)38 (18.1 to 61.6)18 (5.2 to 40.3)20 (4.3 to 48.1)30 (11.9 to 54.3)30 (6.7 to 65.2)35 (15.4 to 59.2)45 (23.1 to 68.5)12 (1.5 to 36.4)41 (18.4 to 67.1)
Men A (Day 365, N= 21,22,16,20,10,20,20,18,17)67 (43.0 to 85.4)23 (7.8 to 45.4)88 (61.7 to 98.4)25 (8.7 to 49.1)90 (55.5 to 99.75)85 (62.1 to 96.8)85 (62.1 to 96.8)50 (26.0 to 74.0)35 (14.2 to 61.7)
Men C (Day 1, N= 20,19,14,20,11,19,19,18,16)65 (40.8 to 84.6)68 (43.4 to 87.4)71 (41.9 to 91.6)65 (40.8 to 84.6)36 (10.9 to 69.2)58 (33.5 to 79.7)58 (33.5 to 79.7)50 (26 to 74)75 (47.6 to 92.7)
Men C (Day 365, N= 21,21,16,20,11,19,19,18,17)100 (83.9 to 100)62 (38.4 to 81.9)100 (79.4 to 100)50 (27.2 to 72.8)82 (48.2 to 97.7)95 (74 to 99.87)100 (82.4 to 100)89 (65.3 to 98.6)65 (38.3 to 85.8)
Men W (Day 1, N= 20,22,12,20,11,20,17,18,16)95 (75.1 to 99.87)95 (77.2 to 99.88)75 (42.8 to 94.5)70 (45.7 to 88.1)82 (48.2 to 97.7)75 (50.9 to 91.3)82 (56.6 to 96.2)61 (35.7 to 82.7)56 (29.9 to 80.2)
Men W (Day 365, N= 21,22,16,20,11,20,19,18,17)100 (83.9 to 100)82 (59.7 to 94.8)100 (79.4 to 100)65 (40.8 to 84.6)91 (58.7 to 99.77)100 (83.2 to 100)100 (82.4 to 100)100 (81.5 to 100)65 (38.3 to 85.8)
Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17)62 (38.4 to 81.9)62 (38.4 to 81.9)71 (41.9 to 91.6)40 (19.1 to 63.9)36 (10.9 to 69.2)11 (1.4 to 34.7)55 (31.5 to 76.9)44 (21.5 to 69.2)41 (18.4 to 67.1)
Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17)95 (76.2 to 99.88)52 (29.8 to 74.3)100 (79.4 to 100)40 (19.1 to 63.9)45 (16.7 to 76.6)72 (46.5 to 90.3)100 (83.2 to 100)89 (65.3 to 98.6)47 (23 to 72.2)
Secondary14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B

Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination.

Time frame:
Day 1, Day 30 and Day 365
Reported as:
Number · Percentages of Subjects
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
Percentages of Subjects2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
5/99 (Day 1, N=21,22,14,20,9,19,21,18,17)76 (52.8 to 91.8)82 (59.7 to 94.8)86 (57.2 to 98.2)85 (62.1 to 96.8)89 (51.8 to 99.72)95 (74.0 to 99.87)19 (5.4 to 41.9)17 (3.6 to 41.4)24 (6.8 to 49.9)
5/99 (Day 30, N=21,22,16,20,11,19,21,18,16)100 (83.9 to 100.0)86 (65.1 to 97.1)100 (79.4 to 100.0)90 (68.3 to 98.8)100 (71.5 to 100.0)100 (82.4 to 100.0)76 (52.8 to 91.8)83 (58.6 to 96.4)25 (7.3 to 52.4)
5/99 (Day 365, N=21,22,16,20,11,19,21,18,17)95 (76.2 to 99.88)77 (54.6 to 92.2)100 (79.4 to 100.0)80 (56.3 to 94.3)100 (71.5 to 100.0)100 (82.4 to 100.0)43 (21.8 to 66.0)33 (13.3 to 59.0)18 (3.8 to 43.4)
H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17)19 (5.4 to 41.9)27 (10.7 to 50.2)13 (1.7 to 40.5)15 (3.2 to 37.9)45 (16.7 to 76.6)30 (11.9 to 54.3)5 (0.12 to 23.8)6 (0.14 to 27.3)0 (0.0 to 19.5)
H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16)95 (76.2 to 99.88)27 (10.7 to 50.2)100 (79.4 to 100.0)15 (3.2 to 37.9)100 (71.5 to 100.0)100 (83.2 to 100.0)58 (33.5 to 79.7)33 (13.3 to 59.0)6 (0.16 to 30.2)
H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17)76 (52.8 to 91.8)18 (5.2 to 40.3)44 (19.8 to 70.1)10 (1.2 to 31.7)82 (48.2 to 97.7)65 (40.8 to 84.6)19 (5.4 to 41.9)11 (1.4 to 34.7)6 (0.15 to 28.7)
M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17)24 (8.2 to 47.2)27 (10.7 to 50.2)21 (4.7 to 50.8)6 (0.14 to 27.3)20 (2.5 to 55.6)42 (20.3 to 66.5)5 (0.13 to 24.9)6 (0.15 to 28.7)12 (1.5 to 36.4)
M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16)100 (83.9 to 100.0)27 (10.7 to 50.2)100 (79.4 to 100.0)6 (0.15 to 28.7)100 (71.5 to 100.0)100 (82.4 to 100.0)21 (6.1 to 45.6)28 (9.7 to 53.5)13 (1.6 to 38.3)
M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17)71 (47.8 to 88.7)32 (13.9 to 54.9)75 (47.6 to 92.7)6 (0.14 to 27.3)100 (71.5 to 100.0)95 (74.0 to 99.87)15 (3.2 to 37.9)11 (1.4 to 34.7)18 (3.8 to 43.4)
M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17)38 (18.1 to 61.6)41 (20.7 to 63.6)29 (8.4 to 58.1)25 (8.7 to 49.1)64 (30.8 to 89.1)58 (33.5 to 79.7)19 (5.4 to 41.9)17 (3.6 to 41.4)35 (14.2 to 61.7)
M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16)100 (83.9 to 100.0)45 (24.4 to 67.8)94 (69.8 to 99.84)25 (8.7 to 49.1)91 (58.7 to 99.77)95 (74.0 to 99.87)33 (14.6 to 57.0)22 (6.4 to 47.6)38 (15.2 to 64.6)
M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17)62 (38.4 to 81.9)32 (13.9 to 54.9)50 (24.7 to 75.3)20 (5.7 to 43.7)82 (48.2 to 97.7)74 (48.8 to 90.9)29 (11.3 to 52.2)17 (3.6 to 41.4)35 (14.2 to 61.7)
M14459 (Day 1, N=21,22,14,20,11,20,21,18,17)24 (8.2 to 47.2)36 (17.2 to 59.3)7 (0.18 to 33.9)15 (3.2 to 37.9)36 (10.9 to 69.2)30 (11.9 to 54.3)10 (1.2 to 30.4)11 (1.4 to 34.7)24 (6.8 to 49.9)
M14459 (Day 30, N=21,22,16,20,11,20,20,18,16)95 (76.2 to 99.88)32 (13.9 to 54.9)88 (61.7 to 98.4)20 (5.7 to 43.7)100 (71.5 to 100.0)95 (75.1 to 99.87)35 (15.4 to 59.2)33 (13.3 to 59.0)25 (7.3 to 52.4)
M14459 (Day 365, N=21,22,16,20,11,20,21,18,17)57 (34.0 to 78.2)18 (5.2 to 40.3)38 (15.2 to 64.6)5 (0.13 to 24.9)82 (48.2 to 97.7)60 (36.1 to 80.9)14 (3.0 to 36.3)11 (1.4 to 34.7)24 (6.8 to 49.9)
NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17)19 (5.4 to 41.9)32 (13.9 to 54.9)7 (0.18 to 33.9)5 (0.13 to 24.9)9 (0.23 to 41.3)26 (9.1 to 51.2)5 (0.12 to 23.8)6 (0.14 to 27.3)0 (0.0 to 19.5)
NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16)95 (76.2 to 99.88)23 (7.8 to 45.4)75 (47.6 to 92.7)10 (1.2 to 31.7)82 (48.2 to 97.7)95 (74.0 to 99.87)19 (5.4 to 41.9)17 (3.6 to 41.4)6 (0.16 to 30.2)
NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17)29 (11.3 to 52.2)14 (2.9 to 34.9)31 (11.0 to 58.7)5 (0.13 to 24.9)45 (16.7 to 76.6)42 (20.3 to 66.5)19 (5.4 to 41.9)6 (0.14 to 27.3)6 (0.15 to 28.7)
Secondary15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.

Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer \< 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.

Time frame:
Day 1, Day 30 and Day 365
Reported as:
Number · Percentages of Subjects
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Percentages of Subjects2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5)95 (75.1 to 99.87)100 (83.9 to 100.0)100 (78.2 to 100.0)100 (82.4 to 100.0)91 (58.7 to 99.77)94 (72.7 to 99.86)0 (0.0 to 45.9)0 (0.0 to 60.2)0 (0.0 to 52.2)
5/99 (Day 30, N=21,22,14,20,9,19,21,18,16)100 (83.9 to 100.0)5 (0.12 to 22.8)93 (66.1 to 99.82)0 (0.0 to 16.8)100 (66.4 to 100.0)100 (82.4 to 100.0)57 (34.0 to 78.2)78 (52.4 to 93.6)6 (0.16 to 30.2)
5/99 (Day 365, N=21,22,14,20,9,19,21,18,17)67 (43.0 to 85.4)5 (0.12 to 22.8)86 (57.2 to 98.2)0 (0.0 to 16.8)89 (51.8 to 99.72)74 (48.8 to 90.9)29 (11.3 to 52.2)28 (9.7 to 53.5)6 (0.15 to 28.7)
H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5)100 (83.2 to 100.0)95 (77.2 to 99.88)100 (78.2 to 100.0)95 (75.1 to 99.87)91 (58.7 to 99.77)89 (66.9 to 98.7)0 (0.0 to 45.9)0 (0.0 to 60.2)0 (0.0 to 52.2)
H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16)81 (58.1 to 94.6)5 (0.12 to 22.8)93 (68.1 to 99.83)0 (0.0 to 16.8)100 (71.5 to 100.0)75 (50.9 to 91.3)37 (16.3 to 61.6)28 (9.7 to 53.5)6 (0.16 to 30.2)
H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17)38 (18.1 to 61.6)0 (0.0 to 15.4)20 (4.3 to 48.1)0 (0.0 to 16.8)64 (30.8 to 89.1)30 (11.9 to 54.3)10 (1.2 to 30.4)0 (0.0 to 18.5)6 (0.15 to 28.7)
M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4)79 (54.4 to 93.9)76 (52.8 to 91.8)67 (38.4 to 88.2)67 (38.4 to 88.2)82 (48.2 to 97.7)89 (65.3 to 98.6)0 (0.0 to 45.9)0 (0.0 to 60.2)0 (0.0 to 60.2)
M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16)100 (83.9 to 100.0)5 (0.12 to 22.8)93 (66.1 to 99.82)6 (0.15 to 28.7)100 (69.2 to 100.0)89 (66.9 to 98.7)16 (3.4 to 39.6)24 (6.8 to 49.9)6 (0.16 to 30.2)
M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17)62 (38.4 to 81.9)5 (0.12 to 22.8)64 (35.1 to 87.2)6 (0.14 to 27.3)90 (55.5 to 99.75)79 (54.4 to 93.9)15 (3.2 to 37.9)6 (0.15 to 28.7)6 (0.15 to 28.7)
M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4)30 (11.9 to 54.3)20 (5.7 to 43.7)33 (11.8 to 61.6)17 (3.6 to 41.4)45 (16.7 to 76.6)56 (30.8 to 78.5)0 (0.0 to 45.9)0 (0.0 to 60.2)0 (0.0 to 60.2)
M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16)81 (58.1 to 94.6)0 (0.0 to 15.4)93 (66.1 to 99.82)0 (0.0 to 16.8)82 (48.2 to 97.7)58 (33.5 to 79.7)14 (3.0 to 36.3)0 (0.0 to 18.5)6 (0.16 to 30.2)
M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17)19 (5.4 to 41.9)0 (0.0 to 15.4)0 (0.0 to 23.2)0 (0.0 to 16.8)27 (6.0 to 61.0)5 (0.13 to 26.0)0 (0.0 to 16.1)0 (0.0 to 18.5)6 (0.15 to 28.7)
M14459 (Day 1, N=20,22,15,19,11,19,6,4,5)55 (31.5 to 76.9)55 (32.2 to 75.6)67 (38.4 to 88.2)58 (33.5 to 79.7)91 (58.7 to 99.77)63 (38.4 to 83.7)0 (0.0 to 45.9)0 (0.0 to 60.2)0 (0.0 to 52.2)
M14459 (Day 30, N=21,22,14,20,11,20,20,18,16)76 (52.8 to 91.8)0 (0.0 to 15.4)86 (57.2 to 98.2)0 (0.0 to 16.8)100 (71.5 to 100.0)75 (50.9 to 91.3)15 (3.2 to 37.9)6 (0.14 to 27.3)6 (0.16 to 30.2)
M14459 (Day 365, N=21,22,14,20,11,20,21,18,17)24 (8.2 to 47.2)0 (0.0 to 15.4)0 (0.0 to 23.2)0 (0.0 to 16.8)36 (10.9 to 69.2)25 (8.7 to 49.1)10 (1.2 to 30.4)0 (0.0 to 18.5)6 (0.15 to 28.7)
NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5)60 (36.1 to 80.9)52 (29.8 to 74.3)53 (26.6 to 78.7)58 (33.5 to 79.7)55 (23.4 to 83.3)67 (41.0 to 86.7)0 (0.0 to 45.9)0 (0.0 to 60.2)0 (0.0 to 52.2)
NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16)81 (58.1 to 94.6)0 (0.0 to 15.4)71 (41.9 to 91.6)5 (0.13 to 24.9)82 (48.2 to 97.7)63 (38.4 to 83.7)19 (5.4 to 41.9)6 (0.14 to 27.3)6 (0.16 to 30.2)
NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17)10 (1.2 to 30.4)0 (0.0 to 15.4)14 (1.8 to 42.8)0 (0.0 to 16.8)9 (0.23 to 41.3)5 (0.13 to 26.0)10 (1.2 to 30.4)0 (0.0 to 18.5)6 (0.15 to 28.7)
Secondary16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.

The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.

Time frame:
Day 1 and Day 365
Reported as:
Geometric mean · Titers
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
Titers2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
Men A (Day 1, N=21,22,15,20,10,20,20,17,17)3.98 (1.98 to 8)2.73 (1.44 to 5.15)3.07 (1.26 to 7.47)2.98 (1.38 to 6.42)2.27 (0.87 to 5.94)4.22 (1.63 to 11)6.31 (2.82 to 14)2.49 (1.52 to 4.09)5.48 (2.18 to 14)
Men A (Day 365, N=21,22,16,20,10,20,20,18,17)25 (11 to 59)2.62 (1.39 to 4.94)44 (18 to 105)3.03 (1.30 to 7.06)54 (17 to 174)53 (22 to 130)34 (16 to 69)6.52 (2.71 to 16)3.54 (1.40 to 8.92)
Men C (Day 1, N=20,19,14,20,11,19,19,18,16)18 (8.21 to 39)19 (7.54 to 49)19 (8.13 to 44)10 (5.52 to 19)5.20 (2.80 to 9.65)7.83 (4.51 to 14)7.89 (4.26 to 15)8.45 (2.64 to 27)24 (9.34 to 61)
Men C (Day 365, N=21,21,16,20,11,19,19,18,17)128 (75 to 217)15 (5.82 to 39)177 (102 to 305)9.14 (4.07 to 21)29 (10 to 82)32 (16 to 67)81 (46 to 141)72 (27 to 191)24 (8.98 to 66)
Men W (Day 1, N=20,22,12,20,11,20,17,18,16)36 (21 to 62)43 (24 to 79)30 (7.82 to 112)17 (6.88 to 43)25 (7.98 to 79)23 (9.81 to 52)28 (11 to 70)15 (4.54 to 47)10 (3.53 to 30)
Men W (Day 365, N=21,22,16,20,11,20,19,18,17)190 (133 to 272)28 (13 to 59)213 (135 to 337)16 (5.58 to 47)80 (26 to 246)96 (72 to 127)172 (97 to 306)104 (49 to 221)16 (5.27 to 49)
Men Y (Day 1, N=21,21,14,20,11,18,20,18,17)10 (4.39 to 24)16 (4.85 to 54)24 (6.62 to 90)5.39 (2.06 to 14)2.40 (1.05 to 5.47)1.90 (1.02 to 3.55)7.05 (3.08 to 16)6.83 (2.11 to 22)7.03 (1.99 to 25)
Men Y (Day 365, N=21,21,16,20,11,18,20,18,17)116 (58 to 231)18 (5.05 to 62)235 (147 to 376)5.93 (1.97 to 18)7.17 (1.91 to 27)20 (6.92 to 58)193 (123 to 301)101 (36 to 280)9.56 (2.44 to 37)
Secondary17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.

The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.

Time frame:
Day 1 and Day 365
Reported as:
Geometric mean · Titers
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
Titers2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17)18 (9.47 to 34)18 (9.50 to 34)31 (12 to 85)31 (15 to 65)27 (8.61 to 86)39 (21 to 74)2.97 (1.58 to 5.59)1.80 (1.01 to 3.22)3.20 (1.44 to 7.09)
5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17)175 (79 to 385)13 (6.07 to 29)305 (149 to 625)23 (11 to 47)587 (351 to 983)491 (258 to 936)6.05 (3.10 to 12)4.23 (1.48 to 12)2.45 (1 to 5.99)
H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17)3.58 (1.66 to 7.71)2.23 (1.28 to 3.90)1.49 (0.96 to 2.33)1.73 (0.97 to 3.10)3.45 (1.81 to 6.57)3.43 (1.83 to 6.43)1.34 (0.85 to 2.13)1.51 (0.91 to 2.48)1.19 (0.97 to 1.47)
H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17)12 (5.18 to 26)1.93 (1.20 to 3.10)4.19 (1.93 to 9.11)1.83 (1.07 to 3.15)21 (6.00 to 71)11 (4.68 to 25)1.96 (1.21 to 3.19)1.92 (1.17 to 3.17)1.49 (0.90 to 2.48)
M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17)2.33 (1.25 to 4.36)3.39 (1.43 to 8.05)2.87 (0.86 to 9.59)1.26 (0.89 to 1.80)2.46 (0.72 to 8.40)6.29 (2.22 to 18)1.24 (0.79 to 1.94)1.24 (0.88 to 1.77)1.68 (0.85 to 3.33)
M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17)30 (9.54 to 93)3.55 (1.56 to 8.07)74 (18 to 300)1.23 (0.91 to 1.68)303 (174 to 527)155 (69 to 350)1.61 (0.99 to 2.63)1.71 (0.86 to 3.42)2.03 (0.90 to 4.58)
M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17)3.68 (2.07 to 6.54)4.20 (2.25 to 7.85)2.28 (1.16 to 4.48)2.36 (1.51 to 3.70)4.10 (1.89 to 8.90)7.35 (3.82 to 14)2.08 (1.26 to 3.42)2.15 (1.14 to 4.05)3.50 (1.57 to 7.80)
M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17)7.96 (4.60 to 14)3.28 (2.16 to 4.97)4.09 (2.30 to 7.25)2.04 (1.43 to 2.92)10 (4.51 to 24)11 (6.35 to 18)2.45 (1.59 to 3.79)1.91 (1.14 to 3.23)3.92 (1.90 to 8.07)
M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16)2.69 (1.51 to 4.78)2.94 (1.77 to 4.89)1.54 (0.90 to 2.63)2.01 (1.40 to 2.88)3.11 (1.74 to 5.56)3.37 (1.95 to 5.81)1.85 (1.13 to 3.04)1.48 (1.03 to 2.13)2.55 (1.37 to 4.77)
M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17)7.19 (3.89 to 13)1.67 (1.07 to 2.60)2.94 (1.49 to 5.80)1.47 (1.07 to 2.03)11 (4.41 to 28)7.12 (3.59 to 14)2.09 (1.33 to 3.29)1.38 (0.98 to 1.93)2.17 (1.07 to 4.41)
NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17)1.73 (1.06 to 2.81)2.34 (1.33 to 4.10)1.34 (0.94 to 1.93)1.48 (1.01 to 2.17)1.72 (0.99 to 2.98)2.24 (1.20 to 4.17)1.18 (0.84 to 1.66)1.19 (0.90 to 1.58)1.13 (0.94 to 1.37)
NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17)3.49 (2.12 to 5.74)1.71 (1.41 to 2.57)2.67 (1.27 to 5.61)1.23 (0.90 to 1.69)3.28 (1.66 to 6.49)3.77 (1.98 to 7.18)1.65 (1.04 to 2.61)1.19 (0.91 to 1.54)1.28 (0.85 to 1.92)
Secondary18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.

Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.

Time frame:
Day 1, Day 30 and Day 365
Reported as:
Number · Percentages of Subjects
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Percentages of Subjects2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
Men A (Day 1,N=21,22,15,20,10,20,20,17,17)38 (18.1 to 61.6)18 (5.2 to 40.3)20 (4.3 to 48.1)30 (11.9 to 54.3)30 (6.7 to 65.2)35 (15.4 to 59.2)45 (23.1 to 68.5)12 (1.5 to 36.4)41 (18.4 to 67.1)
Men A (Day 30, N=21,22,15,19,10,20,18,16,16)100 (83.9 to 100.0)32 (13.9 to 54.9)100 (78.2 to 100.0)26 (9.1 to 51.2)100 (69.2 to 100.0)95 (75.1 to 99.87)100 (81.5 to 100.0)94 (69.8 to 99.84)44 (19.8 to 70.1)
Men A (Day 365, N=21,22,16,20,10,20,20,18,17)67 (43.0 to 85.4)23 (7.8 to 45.4)88 (61.7 to 98.4)25 (8.7 to 49.1)90 (55.5 to 99.75)85 (62.1 to 96.8)85 (62.1 to 96.8)50 (26.0 to 74.0)35 (14.2 to 61.7)
Men C (Day 1, N=20,19,14,20,11,19,19,18,16)65 (40.8 to 84.6)68 (43.4 to 87.4)71 (41.9 to 91.6)65 (40.8 to 84.6)36 (10.9 to 69.2)58 (33.5 to 79.7)58 (33.5 to 79.7)50 (26.0 to 74.0)75 (47.6 to 92.7)
Men C (Day 30, N=17,20,10,20,7,14,19,17,16)100 (80.5 to 100.0)65 (40.8 to 84.6)100 (69.2 to 100.0)55 (31.5 to 76.9)100 (59.0 to 100.0)100 (76.8 to 100.0)100 (82.4 to 100.0)88 (63.6 to 98.5)69 (41.3 to 89.0)
Men C (Day 365, N=21,21,16,20,11,19,19,18,17)100 (83.9 to 100.0)62 (38.4 to 81.9)100 (79.4 to 100.0)50 (27.2 to 72.8)82 (48.2 to 97.7)95 (74.0 to 99.87)100 (82.4 to 100.0)89 (65.3 to 98.6)65 (38.3 to 85.8)
Men W (Day 1,N=20,22,12,20,11,20,17,18,16)95 (75.1 to 99.87)95 (77.2 to 99.88)75 (42.8 to 94.5)70 (45.7 to 88.1)82 (48.2 to 97.7)75 (50.9 to 91.3)82 (56.6 to 96.2)61 (35.7 to 82.7)56 (29.9 to 80.2)
Men W (Day 30, N=18,22,15,19,11,18,17,16,14)100 (81.5 to 100.0)86 (65.1 to 97.1)100 (78.2 to 100.0)74 (48.8 to 90.9)100 (71.5 to 100.0)100 (81.5 to 100.0)100 (80.5 to 100.0)100 (79.4 to 100.0)57 (28.9 to 82.3)
Men W (Day 365, N=21,22,16,20,11,20,19,18,17)100 (83.9 to 100.0)82 (59.7 to 94.8)100 (79.4 to 100.0)65 (40.8 to 84.6)91 (58.7 to 99.77)100 (83.2 to 100.0)100 (82.4 to 100.0)100 (81.5 to 100.0)65 (38.3 to 85.8)
Men Y (Day 1, N=21,21,14,20,11,18,20,18,17)62 (38.4 to 81.9)62 (38.4 to 81.9)71 (41.9 to 91.6)40 (19.1 to 63.9)36 (10.9 to 69.2)11 (1.4 to 34.7)55 (31.5 to 76.9)44 (21.5 to 69.2)41 (18.4 to 67.1)
Men Y (Day 30, N=21,21,15,20,11,18,20,17,16)100 (83.9 to 100.0)57 (34.0 to 78.2)100 (78.2 to 100.0)40 (19.1 to 63.9)82 (48.2 to 97.7)83 (58.6 to 96.4)100 (83.2 to 100.0)100 (80.5 to 100.0)38 (15.2 to 64.6)
Men Y (Day 365, N=21,21,16,20,11,18,20,18,17)95 (76.2 to 99.88)52 (29.8 to 74.3)100 (79.4 to 100.0)40 (19.1 to 63.9)45 (16.7 to 76.6)72 (46.5 to 90.3)100 (83.2 to 100.0)89 (65.3 to 98.6)47 (23.0 to 72.2)
Secondary19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.

Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.

Time frame:
Day 1, Day 30 and Day 365
Reported as:
Number · Percentages of Subjects
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Percentages of Subjects2OMV_OMV2qOMV_qOMV2B_OMV2B_qOMV1M_OMV1M_qOMV
5/99 (Day 1,N= 21,14,9,19,21,18)76 (52.8 to 91.8)86 (57.2 to 98.2)89 (51.8 to 99.72)95 (74 to 99.87)19 (5.4 to 41.9)17 (3.6 to 41.4)
5/99 (Day 30, N= 21,16,11,19,21,18)100 (83.9 to 100)100 (79.4 to 100)100 (71.5 to 100)100 (82.4 to 100)76 (52.8 to 91.8)83 (58.6 to 96.4)
5/99 (Day 365, 21,16,11,19,21,18)95 (76.2 to 99.88)100 (79.4 to 100)100 (71.5 to 100)100 (82.4 to 100)43 (21.8 to 66)33 (13.3 to 59)
H44/76 (Day 1, N= 21,15,11,20,21,18)19 (5.4 to 41.9)13 (1.7 to 40.5)45 (16.7 to 76.6)30 (11.9 to 54.3)5 (0.12 to 23.8)6 (0.14 to 27.3)
H44/76 (Day 30, N= 21,16,11,20,19,18)95 (76.2 to 99.88)100 (79.4 to 100)100 (71.5 to 100)100 (83.2 to 100)58 (33.5 to 79.7)33 (13.3 to 59)
H44/76 (Day 365, N= 21,16,11,20,21,18)76 (52.8 to 91.8)44 (19.8 to 70.1)82 (48.2 to 97.7)65 (40.8 to 84.6)19 (5.4 to 41.9)11 (1.4 to 34.7)
M01-0240364 (Day 1, N= 21,14,10,19,20,17)24 (8.2 to 47.2)21 (4.7 to 50.8)20 (2.5 to 55.6)42 (20.3 to 66.5)5 (0.13 to 24.9)6 (0.15 to 28.7)
M01-0240364(Day 30, N= 21,16,11,19,19,18)100 (83.9 to 100)100 (79.4 to 100)100 (71.5 to 100)100 (82.4 to 100)21 (6.1 to 45.6)28 (9.7 to 53.5)
M01-0240364 (Day 365, N= 21,16,11,19,20,18)71 (47.8 to 88.7)75 (47.6 to 92.7)100 (71.5 to 100)95 (74 to 99.87)15 (3.2 to 37.9)11 (1.4 to 34.7)
M07-0241084 (Day 1, N= 21,14,11,19,21,18)38 (18.1 to 61.6)29 (8.4 to 58.1)64 (30.8 to 89.1)58 (33.5 to 79.7)19 (5.4 to 41.9)17 (3.6 to 41.4)
M07-0241084 (Day 30, N= 21,16,11,19,21,18)100 (83.9 to 100)94 (69.8 to 99.84)91 (58.7 to 99.77)95 (74 to 99.87)33 (14.6 to 57)22 (6.4 to 47.6)
M07-0241084(Day 365, N=21,16,11,19,21,18)62 (38.4 to 81.9)50 (24.7 to 75.3)82 (48.2 to 97.7)74 (48.8 to 90.9)29 (11.3 to 52.2)17 (3.6 to 41.4)
M14459 (Day 1, N= 21,14,11,20,21,18)24 (8.2 to 47.2)7 (0.18 to 33.9)36 (10.9 to 69.2)30 (11.9 to 54.3)10 (1.2 to 30.4)11 (1.4 to 34.7)
M14459 (Day 30, N= 21,16,11,20,20,18)95 (76.2 to 99.88)88 (61.7 to 98.4)100 (71.5 to 100)95 (75.1 to 99.87)35 (15.4 to 59.2)33 (13.3 to 59)
M14459 (Day 365, N= 21,16,11,20,21,18)57 (34 to 78.2)38 (15.2 to 64.6)82 (48.2 to 97.7)60 (36.1 to 80.9)14 (3 to 36.3)11 (1.4 to 34.7)
NZ98/254 (Day 1,N= 21,14,11,19,21,18)19 (5.4 to 41.9)7 (0.18 to 33.9)9 (0.23 to 41.3)26 (9.1 to 51.2)5 (0.12 to 23.8)6 (0.14 to 27.3)
NZ98/254 (Day 30, N= 21,16,11,19,21,18)95 (76.2 to 99.88)75 (47.6 to 92.7)82 (48.2 to 97.7)95 (74 to 99.87)19 (5.4 to 41.9)17 (3.6 to 41.4)
NZ98/254 (Day 365, N= 21,16,11,19,21,18)29 (11.3 to 52.2)31 (11 to 58.7)45 (16.7 to 76.6)42 (20.3 to 66.5)19 (5.4 to 41.9)6 (0.14 to 27.3)
Secondary20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.

The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.

Time frame:
Day 1, Day 30 and Day 365
Reported as:
Geometric mean · Titers
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
Titers2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
Men A (Day 1, N= 21,22,15,20,10,20,20,17,17)3.98 (1.98 to 8)2.73 (1.44 to 5.15)3.07 (1.26 to 7.47)2.98 (1.38 to 6.42)2.27 (0.87 to 5.94)4.22 (1.63 to 11)6.31 (2.82 to 14)2.49 (1.52 to 4.09)5.48 (2.18 to 14)
Men A (Day 30, N= 21,22,15,19,10,20,18,16,16)275 (174 to 435)3.88 (1.74 to 8.66)348 (202 to 601)2.95 (1.41 to 6.17)445 (277 to 715)428 (196 to 931)140 (82 to 239)46 (23 to 91)5.99 (2.27 to 16)
Men A (Day 365, N= 21,22,16,20,10,20,20,18,17)25 (11 to 59)2.62 (1.39 to 4.94)44 (18 to 105)3.03 (1.30 to 7.06)54 (17 to 174)53 (22 to 130)34 (16 to 69)6.52 (2.71 to 16)3.54 (1.40 to 8.92)
Men C (Day 1, N= 20,19,14,20,11,19,19,18,16)18 (8.21 to 39)19 (7.54 to 49)19 (8.13 to 44)10 (5.52 to 19)5.20 (2.80 to 9.65)7.83 (4.51 to 14)7.89 (4.26 to 15)8.45 (2.64 to 27)24 (9.34 to 61)
Men C (Day 30, N= 17,20,10,20,7,14,19,17,16)737 (459 to 1183)21 (8.38 to 52)766 (325 to 1804)8.43 (4.37 to 16)292 (75 to 1142)102 (57 to 181)322 (186 to 556)307 (118 to 795)27 (9.15 to 78)
Men C (Day 365, N= 21,21,16,20,11,19,19,18,17)128 (75 to 217)15 (5.82 to 39)177 (102 to 305)9.14 (4.07 to 21)29 (10 to 82)32 (16 to 67)81 (46 to 141)72 (27 to 191)24 (8.98 to 66)
Men W (Day 1, N= 20,22,12,20,11,20,17,18,16)36 (21 to 62)43 (24 to 79)30 (7.82 to 112)17 (6.88 to 43)25 (7.98 to 79)23 (9.81 to 52)28 (11 to 70)15 (4.54 to 47)10 (3.53 to 30)
Men W (Day 30, N= 18,22,15,19,11,18,17,16,14)844 (535 to 1333)46 (23 to 89)890 (665 to 1190)22 (8.89 to 52)392 (252 to 610)395 (321 to 487)620 (354 to 1085)360 (169 to 765)13 (3.50 to 52)
Men W (Day 365, N= 21,22,16,20,11,20,19,18,17)190 (133 to 272)28 (13 to 59)213 (135 to 337)16 (5.58 to 47)80 (26 to 246)96 (72 to 127)172 (97 to 306)104 (49 to 221)16 (5.27 to 49)
Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17)10 (4.39 to 24)16 (4.85 to 54)24 (6.62 to 90)5.39 (2.06 to 14)2.40 (1.05 to 5.47)1.90 (1.02 to 3.55)7.05 (3.08 to 16)6.83 (2.11 to 22)7.03 (1.99 to 25)
Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16)444 (257 to 768)17 (4.77 to 57)748 (463 to 1208)4.86 (1.86 to 13)48 (14 to 157)54 (17 to 171)662 (424 to 1032)404 (201 to 811)6.84 (1.78 to 26)
Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17)116 (58 to 231)18 (5.05 to 62)235 (147 to 376)5.93 (1.97 to 18)7.17 (1.91 to 27)20 (6.92 to 58)193 (123 to 301)101 (36 to 280)9.56 (2.44 to 37)
Secondary21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.

The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.

Time frame:
Day 1, Day 30 and Day 365
Reported as:
Geometric mean · Titers
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
Titers2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
5/99 (Day 1, N=21,22,14,20,9,19,21,18,17)18 (9.47 to 34)18 (9.50 to 34)31 (12 to 85)31 (15 to 65)27 (8.61 to 86)39 (21 to 74)2.97 (1.58 to 5.59)1.8 (1.01 to 3.22)3.2 (1.44 to 7.09)
5/99 (Day 30, N=21,22,16,20,11,19,21,18,16)1147 (665 to 1980)23 (11 to 48)1598 (864 to 2956)35 (19 to 65)2205 (1560 to 3117)2816 (1856 to 4273)28 (11 to 67)29 (10 to 80)3.98 (1.24 to 13)
5/99 (Day 365, N=21,22,16,20,11,19,21,18,17)175 (79 to 385)13 (6.07 to 29)305 (149 to 625)23 (11 to 47)587 (351 to 983)491 (258 to 936)6.05 (3.10 to 12)4.23 (1.48 to 12)2.45 (1 to 5.99)
H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17)3.58 (1.66 to 7.71)2.23 (1.28 to 3.90)1.49 (0.96 to 2.33)1.73 (0.97 to 3.10)3.45 (1.81 to 6.57)3.43 (1.83 to 6.43)1.34 (0.85 to 2.13)1.51 (0.91 to 2.48)1.19 (0.97 to 1.47)
H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16)104 (59 to 184)2.65 (1.48 to 4.78)57 (32 to 102)2.03 (1.11 to 3.73)132 (64 to 271)79 (40 to 153)5.27 (2.54 to 11)3.89 (1.79 to 8.47)1.6 (0.67 to 3.83)
H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17)12 (5.18 to 26)1.93 (1.20 to 3.10)4.19 (1.93 to 9.11)1.83 (1.07 to 3.15)21 (6 to 71)11 (4.68 to 25)1.96 (1.21 to 3.19)1.92 (1.17 to 3.17)1.49 (0.90 to 2.48)
M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17)2.33 (1.25 to 4.36)3.39 (1.43 to 8.05)2.87 (0.86 to 9.59)1.26 (0.89 to 1.80)2.46 (0.72 to 8.40)6.29 (2.22 to 18)1.24 (0.79 to 1.94)1.24 (0.88 to 1.77)1.68 (0.85 to 3.33)
M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16)679 (352 to 1310)3.57 (1.39 to 9.14)903 (463 to 1761)1.23 (0.89 to 1.70)1336 (810 to 2202)1261 (746 to 2131)2.68 (1.15 to 6.25)3.66 (1.21 to 11)1.89 (0.72 to 4.91)
M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17)30 (9.54 to 93)3.55 (1.56 to 8.07)74 (18 to 300)1.23 (0.91 to 1.68)303 (174 to 527)155 (69 to 350)1.61 (0.99 to 2.63)1.71 (0.86 to 3.42)2.03 (0.90 to 4.58)
M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17)3.68 (2.07 to 6.54)4.2 (2.25 to 7.85)2.28 (1.16 to 4.48)2.36 (1.51 to 3.70)4.1 (1.89 to 8.90)7.35 (3.82 to 14)2.08 (1.26 to 3.42)2.15 (1.14 to 4.05)3.5 (1.57 to 7.80)
M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16)59 (36 to 98)4.37 (2.29 to 8.31)36 (20 to 64)2.2 (1.38 to 3.49)68 (33 to 142)66 (35 to 124)3.26 (1.75 to 6.06)2.24 (1.14 to 4.38)4.57 (1.48 to 14)
M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17)7.96 (4.60 to 14)3.28 (2.16 to 4.97)4.09 (2.30 to 7.25)2.04 (1.43 to 2.92)10 (4.51 to 24)11 (6.35 to 18)2.45 (1.59 to 3.79)1.91 (1.14 to 3.23)3.92 (1.90 to 8.07)
M14459 (Day 1, N=21,22,14,20,11,20,21,18,17)2.69 (1.51 to 4.78)2.94 (1.77 to 4.89)1.54 (0.90 to 2.63)2.01 (1.40 to 2.88)3.11 (1.74 to 5.56)3.37 (1.95 to 5.81)1.85 (1.13 to 3.04)1.48 (1.03 to 2.13)2.55 (1.37 to 4.77)
M14459 (Day 30, N=21,22,16,20,11,20,20,18,16)39 (21 to 70)2.31 (1.39 to 3.82)20 (10 to 39)2.03 (1.38 to 2.98)56 (27 to 117)35 (21 to 60)3.44 (2.05 to 5.75)2.71 (1.56 to 4.70)3.05 (1.05 to 8.83)
M14459 (Day 365, N=21,22,16,20,11,20,21,18,17)7.19 (3.89 to 13)1.67 (1.07 to 2.60)2.94 (1.49 to 5.80)1.47 (1.07 to 2.03)11 (4.41 to 28)7.12 (3.59 to 14)2.09 (1.33 to 3.29)1.38 (0.98 to 1.93)2.17 (1.07 to 4.41)
NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17)1.73 (1.06 to 2.81)2.34 (1.33 to 4.10)1.34 (0.94 to 1.93)1.48 (1.01 to 2.17)1.72 (0.99 to 2.98)2.24 (1.20 to 4.17)1.18 (0.84 to 1.66)1.19 (0.90 to 1.58)1.13 (0.94 to 1.37)
NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16)32 (19 to 52)2.23 (1.25 to 3.99)15 (5.93 to 36)1.75 (0.98 to 3.14)17 (6.22 to 45)28 (17 to 47)2.48 (1.31 to 4.69)1.62 (0.96 to 2.74)1.73 (0.77 to 3.90)
NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17)3.49 (2.12 to 5.74)1.71 (1.14 to 2.57)2.67 (1.27 to 5.61)1.23 (0.90 to 1.69)3.28 (1.66 to 6.49)3.77 (1.98 to 7.18)1.65 (1.04 to 2.61)1.19 (0.91 to 1.54)1.28 (0.85 to 1.92)
Secondary22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.

Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study.

Time frame:
Day 1, Day 30 and Day 365
Reported as:
Number · Percentages of Subjects
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Percentages of Subjects2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV1M_OMV1M_qOMV1M_Pbo
Men A (Day 1, N= 21,22,15,20,10,20,20,17,17)38 (18.1 to 61.6)18 (5.2 to 40.3)20 (4.3 to 48.1)30 (11.9 to 54.3)30 (6.7 to 65.2)35 (15.4 to 59.2)45 (23.1 to 68.5)12 (1.5 to 36.4)41 (18.4 to 67.1)
Men A (Day 30, N= 21,22,15,19,10,20,18,16,16)100 (83.9 to 100)32 (13.9 to 54.9)100 (78.2 to 100)26 (9.1 to 51.2)100 (69.2 to 100)95 (75.1 to 99.87)100 (81.5 to 100)94 (69.8 to 99.84)44 (19.8 to 70.1)
Men A (Day 365, N= 21,22,16,20,10,20,20,18,17)67 (43 to 85.4)23 (7.8 to 45.4)88 (61.7 to 98.4)25 (8.7 to 49.1)90 (55.5 to 99.75)85 (62.1 to 96.8)85 (62.1 to 96.8)50 (26 to 74)35 (14.2 to 61.7)
Men C (Day 1, N= 20,19,14,20,11,19,19,18,16)65 (40.8 to 84.6)68 (43.4 to 87.4)71 (41.9 to 91.6)65 (40.8 to 84.6)36 (10.9 to 69.2)58 (33.5 to 79.7)58 (33.5 to 79.7)50 (26 to 74)75 (47.6 to 92.7)
Men C (Day 30, N= 17,20,10,20,7,14,19,17,16)100 (80.5 to 100)65 (40.8 to 84.6)100 (69.2 to 100)55 (31.5 to 76.9)100 (59 to 100)100 (76.8 to 100)100 (82.4 to 100)88 (63.6 to 98.5)69 (41.3 to 89)
Men C (Day 365, N= 21,21,16,20,11,19,19,18,17)100 (83.9 to 100)62 (38.4 to 81.9)100 (79.4 to 100)50 (27.2 to 72.8)82 (48.2 to 97.7)95 (74 to 99.87)100 (82.4 to 100)89 (65.3 to 98.6)65 (38.3 to 85.8)
Men W (Day 1, 20,22,12,20,11,20,17,18,16)95 (75.1 to 99.87)95 (77.2 to 99.88)75 (42.8 to 94.5)70 (45.7 to 88.1)82 (48.2 to 97.7)75 (50.9 to 91.3)82 (56.6 to 96.2)61 (35.7 to 82.7)56 (29.9 to 80.2)
Men W (Day 30, N= 18,22,15,19,11,18,17,16,14)100 (81.5 to 100)86 (65.1 to 97.1)100 (78.2 to 100)74 (48.8 to 90.9)100 (71.5 to 100)100 (81.5 to 100)100 (80.5 to 100)100 (79.4 to 100)57 (28.9 to 82.3)
Men W (Day 365, N= 21,22,16,20,11,20,19,18,17)100 (83.9 to 100)82 (59.7 to 94.8)100 (79.4 to 100)65 (40.8 to 84.6)91 (58.7 to 99.77)100 (83.2 to 100)100 (82.4 to 100)100 (81.5 to 100)65 (38.3 to 85.8)
Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17)62 (38.4 to 81.9)62 (38.4 to 81.9)71 (41.9 to 91.6)40 (19.1 to 63.9)36 (10.9 to 69.2)11 (1.4 to 34.7)55 (31.5 to 76.9)44 (21.5 to 69.2)41 (18.4 to 67.1)
Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16)100 (83.9 to 100)57 (34 to 78.2)100 (78.2 to 100)40 (19.1 to 63.9)82 (48.2 to 97.7)83 (58.6 to 96.4)100 (83.2 to 100)100 (80.5 to 100)38 (15.2 to 64.6)
Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17)95 (76.2 to 99.88)52 (29.8 to 74.3)100 (79.4 to 100)40 (19.1 to 63.9)45 (16.7 to 76.6)72 (46.5 to 90.3)100 (83.2 to 100)89 (65.3 to 98.6)47 (23 to 72.2)
Secondary23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.

Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever.

Time frame:
From day 1 (6 hours) through day 7 after any vaccination
Reported as:
Number · Participants
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Participants2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV2B_Pbo1M_OMV1M_qOMV1M_PboTotal
Any AEs (N=26,24,17,23,11,21,6,21,19,19,187)231015131118220178137
Any Local (N=26,24,17,23,11,21,6,21,19,19,187)2371581118119175124
Erythema (N=26,23,17,23,11,21,6,21,19,19,186)1127367069253
Induration (N=26,23,17,23,11,21,6,21,19,18,185)7252960119152
Pain (N=26,24,17,23,11,21,6,21,19,19,187)2061471117119174116
Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187)12912661011510586
Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184)323102042320
Chills(N=26,23,17,23,11,21,6,21,19,19,186)310012051114
Fatigue(N=26,23,17,23,11,21,6,21,19,19,186)9682580116560
Headache(N=26,23,17,23,11,21,6,21,19,19,186)7683541125253
Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186214213083226
Myalgia(N=26,23,17,23,10,21,6,21,19,19,185)625014084131
Nausea(N=26,23,17,23,11,21,6,21,19,19,186)023135045124
Rash (N=26,23,17,23,11,21,6,21,18,19,185)00100101205
Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185)20010000003
Prevention (N=25,23,17,23,11,21,6,21,19,19,185)20100000003
Treatment (N=25,23,17,23,11,21,6,21,19,19,185)213215062022
Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1)00100000001
Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1)00100000001
Secondary24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.

Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30. Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.

Time frame:
Day 1 through Day 30
Reported as:
Number · Participants
24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.
Participants2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV2B_Pbo1M_OMV1M_qOMV1M_Pbo
Any AEs6452371654
At least possibly related3130230230
Secondary25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.

Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period.

Time frame:
Day 1 to Day 365
Reported as:
Number · Participants
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
Participants2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV2B_Pbo1M_OMV1M_qOMV1M_Pbo
Any SAEs0011010011
At Least Possibly related SAEs0000000000
NOCD0320010111
Medically attended AEs1210129691131111
AEs leading to withdrawal0000000000
Deaths0000000000
Secondary26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.

Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102_03 (NCT01272180) up to Day 1 visit in V102_03E1 study, is reported. (Any NOCD AEs: NOCD V102_03 (NCT01272180) vs. NOCD- Day 1, V102_03E1)

Time frame:
From primary parent study completion up to Day 1 in this study.
Reported as:
Number · Participants
26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.
Participants2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV2B_Pbo1M_OMV1M_qOMV1M_Pbo
26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.2401021221

Adverse events

Collected over Solicited adverse events (AEs) between Day 1 (from 30 minutes) to Day 7; any unsolicited AE from Day 1 (from 30 minutes) to Day 30 and serious AE, medically attended AE, AE leading to withdrawal, death and NOCD from Day 1 to Day 365.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
2OMV_OMV—0/26 (0%)25/26 (96.2%)
2OMV_Pbo—0/24 (0%)16/24 (66.7%)
2qOMV_qOMV—1/17 (5.9%)16/17 (94.1%)
2qOMV_Pbo—1/23 (4.3%)15/23 (65.2%)
2B_OMV—0/11 (0%)11/11 (100%)
2B_qOMV—1/21 (4.8%)19/21 (90.5%)
2B_Pbo—0/6 (0%)4/6 (66.7%)
1M_OMV—0/21 (0%)20/21 (95.2%)
1M_qOMV—1/19 (5.3%)17/19 (89.5%)
1M_Pbo—1/19 (5.3%)15/19 (78.9%)
Total—5/188 (2.7%)158/188 (84%)
Most frequent serious events
Most frequent serious events
Event2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV2B_Pbo1M_OMV1M_qOMV1M_PboTotal
SyncopeNervous system disorders0/260/241/170/230/110/210/60/210/190/191/188
Limb injuryInjury, poisoning and procedural complications0/260/240/170/230/110/210/60/211/190/191/188
AsthmaRespiratory, thoracic and mediastinal disorders0/260/240/170/230/110/210/60/210/191/191/188
AppendicitisInfections and infestations0/260/240/170/230/111/210/60/210/190/191/188
Facial bones fractureInjury, poisoning and procedural complications0/260/240/171/230/110/210/60/210/190/191/188
Most frequent other events
Showing 10 of 76
Most frequent other events
Event2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV2B_Pbo1M_OMV1M_qOMV1M_PboTotal
Injection site painGeneral disorders21/267/2414/177/2311/1118/211/619/2117/196/19121/188
Injection site indurationGeneral disorders7/262/246/173/2310/117/210/611/219/191/1956/188
HeadacheNervous system disorders8/266/248/173/235/114/211/614/215/192/1956/188
Injection site erythemaGeneral disorders11/262/247/173/237/117/210/67/219/192/1955/188
FatigueGeneral disorders9/268/248/172/235/118/210/611/216/195/1962/188
Decreased appetiteMetabolism and nutrition disorders2/261/244/172/231/113/211/68/214/192/1928/188
MyalgiaMusculoskeletal and connective tissue disorders6/262/245/170/231/114/210/68/214/191/1931/188
ChillsGeneral disorders3/261/240/170/231/112/210/66/211/191/1915/188
NauseaGastrointestinal disorders1/262/243/171/233/115/210/64/215/191/1925/188
ArthralgiaMusculoskeletal and connective tissue disorders4/262/243/171/230/112/210/64/212/193/1921/188

Baseline characteristics

Age, Continuous
Age, Continuous(Years)2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV2B_Pbo1M_OMV1M_qOMV1M_PboTotal
Mean18.8 ± 5.1917.1 ± 4.3118 ± 5.0519 ± 5.420.9 ± 3.9919.7 ± 5.3617.9 ± 4.6716.8 ± 4.6519.2 ± 6.117.6 ± 5.1918.4 ± 5.08
Sex/Gender, Customized
Sex/Gender, Customized(Participants)2OMV_OMV2OMV_Pbo2qOMV_qOMV2qOMV_Pbo2B_OMV2B_qOMV2B_Pbo1M_OMV1M_qOMV1M_PboTotal
Female813914215312121199
Male181281096497891
08

Study locations

13 sites
  • Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
    Birmingham, Alabama 35205, United States
  • Site 24, Madera Family Medical Group 1111 West 4th Street
    Madera, California 93637, United States
  • Site 25, Center for Clinical Trials LLC 16660 Paramount Blvd, Suite 301
    Paramount, California 90723, United States
  • Site 28, Kentucky Pediatric/Adult Research 201 South 5th Street
    Bardstown, Kentucky 40004, United States
  • Site 21, Bluegrass Clinical Research Inc. 5512 Bardstown Road, Suite 2
    Louisville, Kentucky 40291, United States
  • Site 26, Ohio Pediatric Research Association 7200 Poe Ave, Suite 200
    Dayton, Ohio 45414, United States
  • Site 27, Ohio Pediatric Research Association 1775 Delco Park Drive
    Kettering, Ohio 45420, United States
  • Site 22, Focus Research Group 201 Signature Place
    Lebanon, Tennessee 37087, United States
  • Site 15, Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna, Juniperus" s.c.
    ul.Kościuszki 41, Izabelin 05-080, Poland
  • Site 13, Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
    ul. Braci Kiemliczów 14, Kraków 31-223, Poland
  • Site 12, NZOZ PRAKTIMED Sp.zo.o
    ul.Strzelców 15, Kraków 31-422, Poland
  • Site 14, Klinika Pediatrii Centrum Medycznego Kształcenia Podyplomowego,Szpital Bielański
    ul. Cegłowska 80, Warszawa 01-809, Poland
  • Site 11, Katedra i Klinika Pediatrii i Chorób Infekcyjnych
    ul.O.Bujwida 44, Wrocław 50-354, Poland
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01992536
Lead sponsor
Novartis Vaccines
Responsible party
Sponsor
First posted
Nov 25, 2013
Start date
Dec 2013
Primary completion
May 2014
Completion
Apr 2015
Results posted
Oct 25, 2016
Last update
Oct 25, 2016

Study contacts

Novartis Vaccines
study chair · Novartis Vaccines

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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