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)
Official Title
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)
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Aug 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2013
Primary Completion Date
May 2014Actual
Completion Date
Apr 2015Actual
First Submitted Date
Nov 15, 2013
First Submission Date that Met QC Criteria
Nov 19, 2013
First Posted Date
Nov 25, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 14, 2016
Results First Submitted that Met QC Criteria
Aug 31, 2016
Results First Posted Date
Oct 25, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 17, 2015
Certification/Extension First Submitted that Passed QC Review
May 7, 2015
Certification/Extension First Posted Date
May 25, 2015Estimated
Last Update Submitted Date
Aug 31, 2016
Last Update Posted Date
Oct 25, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Meningococcal Disease
Keywords
Meningococcal
Booster
MenABCWY
Menveo
Vaccine Adolescents
Immune Response
N. Meningitidis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
194Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ia: MenABCWY+OMV
Experimental
Investigational
Biological: MenABCWY+OMV
Ib: Placebo
Placebo Comparator
Saline
Biological: Placebo
IIa: MenABCWY+¼OMV
Experimental
Investigational
Biological: MenABCWY+¼OMV
IIb: Placebo
Placebo Comparator
Saline
Biological: Placebo
IIIa: MenABCWY+OMV
Experimental
Investigational
Biological: MenABCWY+OMV
IIIb: MenABCWY+¼OMV
Experimental
Investigational
Biological: MenABCWY+¼OMV
IVa: MenABCWY+OMV
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MenABCWY+OMV
Biological
Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine
IIIa: MenABCWY+OMV
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Day 30
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).
Day 1 and Day 30
Secondary Outcomes
Measure
Description
Time Frame
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).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03 (NCT01272180);
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;
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;
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
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:
History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180);
Current or previous, confirmed or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
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:
Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
Intrauterine device (IUD)
Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry;
Sexually active females that refuse to use to an "acceptable contraceptive method" through to 3 weeks following the study vaccination;
Female subjects with a positive pregnancy test prior to the study vaccine being administered;
Nursing (breastfeeding) mothers;
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;
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);
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).
Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
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;
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);
Individuals who study personnel or immediate family members of study personnel including brother, sister, child, parent, or the spouse.
Individuals who have experienced moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrolment.
Who have received systemic antibiotic treatment within 7 days prior to enrollment.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
10 Years
Maximum Age
25 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Vaccines
Novartis Vaccines
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
Birmingham
Alabama
35205
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
All enrolled subjects were included in the study.
Recruitment Details
Subjects were recruited from 5 study sites in Poland and from 8 study sites in United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
FG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine
IIIb: MenABCWY+¼OMV
IIa: MenABCWY+¼OMV
IVb: MenABCWY+¼OMV
Placebo
Biological
Saline solution for injection (0.5mL)
IIb: Placebo
IVc: Placebo
Ib: Placebo
Day 1 (Pre vaccination)
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).
Day 1 (Pre vaccination)
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).
Day 1 (Pre-vaccination)
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).
Day 1 (Pre-vaccination)
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.
Day 1 and Day 30
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.
Day 1 and Day 30
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.
Day 1 and Day 30
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.
Day 1 and Day 30
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.
Day 1 and Day 30
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.
Day 30
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.
Day 1 and Day 365
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.
Day 1, Day 30 and Day 365
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.
Day 1, Day 30 and Day 365
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.
Day 1 and Day 365
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.
Day 1 and Day 365
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.
Day 1, Day 30 and Day 365
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.
Day 1, Day 30 and Day 365
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.
Day 1, Day 30 and Day 365
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.
Day 1, Day 30 and Day 365
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.
Day 1, Day 30 and Day 365
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.
From day 1 (6 hours) through day 7 after any vaccination
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.
Day 1 through Day 30
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.
Day 1 to Day 365
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)
From primary parent study completion up to Day 1 in this study.
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
FG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
FG003
2qOMV_Pbo
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
FG004
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
FG005
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
FG006
2B_Pbo
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
FG007
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
FG008
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
FG009
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
FG00026 subjects
FG00125 subjects
FG00217 subjects
FG00324 subjects
FG00411 subjects
FG00521 subjects
FG0067 subjects
FG00721 subjects
FG00819 subjects
FG00919 subjects
COMPLETED
FG00022 subjects
FG00122 subjects
FG00216 subjects
FG00322 subjects
FG00411 subjects
FG00520 subjects
FG0060 subjects
FG00721 subjects
FG00818 subjects
FG00918 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0067 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
Type
Comment
Reasons
Administrative Reason
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0067 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Lost to Follow-up
FG0004 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
BG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
BG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
BG003
2qOMV_Pbo
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
BG004
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
BG005
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
BG006
2B_Pbo
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
BG007
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
BG008
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
BG009
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00026
BG00125
BG00217
BG00324
BG00411
BG00521
BG0067
BG00721
BG00819
BG00919
BG010190
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00018.8± 5.19
BG00117.1± 4.31
BG00218± 5.05
BG003
Sex/Gender, Customized
Number
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG0008
BG00113
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 30
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Units
Counts
Participants
OG00025
OG00116
Title
Denominators
Categories
Men A
Title
Measurements
OG00096(79.6 to 99.9)
OG00194(69.8 to 99.84)
Men C (N=20,10)
Title
Measurements
OG000
Primary
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).
Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1 and Day 30
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Units
Counts
Secondary
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).
Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1 (Pre vaccination)
ID
Title
Description
OG000
ABCWY+OMV
Subjects received two doses of MenABCWY + OMV administered two months apart.
OG001
ABCWY+qOMV
Subjects received two doses of MenABCWY + qOMV administered two months apart.
OG002
rMenB+OMV
Subjects received two doses of rMenB + OMV, administered two months apart.
OG003
Menveo
Secondary
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).
Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1 (Pre vaccination)
ID
Title
Description
OG000
ABCWY+OMV
Subjects received two doses of MenABCWY + OMV administered two months apart.
OG001
ABCWY+qOMV
Subjects received two doses of MenABCWY + qOMV administered two months apart.
OG002
rMenB+OMV
Subjects received two doses of rMenB + OMV, administered two months apart.
OG003
Menveo
Secondary
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).
Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1 (Pre-vaccination)
ID
Title
Description
OG000
ABCWY+OMV
Subjects received two doses of MenABCWY + OMV administered two months apart.
OG001
ABCWY+qOMV
Subjects received two doses of MenABCWY + qOMV administered two months apart.
OG002
rMenB+OMV
Subjects received two doses of rMenB + OMV, administered two months apart.
OG003
Menveo
Secondary
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).
Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1 (Pre-vaccination)
ID
Title
Description
OG000
ABCWY+OMV
Subjects received two doses of MenABCWY + OMV administered two months apart.
OG001
ABCWY+qOMV
Subjects received two doses of MenABCWY + qOMV administered two months apart.
OG002
rMenB+OMV
Subjects received two doses of rMenB + OMV, administered two months apart.
OG003
Menveo
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
Secondary
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.
Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1 and Day 30
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
OG003
Secondary
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.
Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1 and Day 30
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
OG003
Secondary
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.
Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1 and Day 30
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Secondary
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.
Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1 and Day 30
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Secondary
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.
Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1 and Day 30
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Secondary
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.
Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 30
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Secondary
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.
Analysis was done on the FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1 and Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
OG003
Secondary
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.
Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1, Day 30 and Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
OG003
Secondary
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.
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1, Day 30 and Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Secondary
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.
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1 and Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
OG003
2qOMV_Pbo
Secondary
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.
Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1 and Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
OG003
2qOMV_Pbo
Secondary
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.
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1, Day 30 and Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Secondary
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.
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1, Day 30 and Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
OG002
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
Secondary
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.
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1, Day 30 and Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Secondary
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.
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 1, Day 30 and Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
OG003
Secondary
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.
Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1, Day 30 and Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Secondary
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.
Analysis was done on the Solicited Safety Set, i.e. all exposed subjects who provide post vaccination solicited adverse event data.
Posted
Number
Participants
From day 1 (6 hours) through day 7 after any vaccination
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Secondary
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.
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.
Posted
Number
Participants
Day 1 through Day 30
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Secondary
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.
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.
Posted
Number
Participants
Day 1 to Day 365
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
OG003
Secondary
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)
Analysis was done on the all enrolled set population. All screened subjects who have been enrolled (ie, attended the first clinic visit and received a subject ID).
Posted
Number
Participants
From primary parent study completion up to Day 1 in this study.
ID
Title
Description
OG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
OG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
OG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
Time Frame
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.
Description
Safety analysis was conducted on the solicited and unsolicited safety set cohorts that included only the exposed subjects who provided solicited adverse event data and post-vaccination AE data, respectively.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
2OMV_OMV
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
0
26
25
26
EG001
2OMV_Pbo
Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
0
24
16
24
EG002
2qOMV_qOMV
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
1
17
16
17
EG003
2qOMV_Pbo
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
1
23
15
23
EG004
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
0
11
11
11
EG005
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
1
21
19
21
EG006
2B_Pbo
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
0
6
4
6
EG007
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
0
21
20
21
EG008
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
1
19
17
19
EG009
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
1
19
15
19
EG010
Total
Total
5
188
158
188
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG0030 affected23 at risk
EG0040 affected11 at risk
EG0051 affected21 at risk
EG0060 affected6 at risk
EG0070 affected21 at risk
EG0080 affected19 at risk
EG0090 affected19 at risk
EG0101 affected188 at risk
Facial bones fracture
Injury, poisoning and procedural complications
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Syncope
Nervous system disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ear pain
Ear and labyrinth disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG0030 affected23 at risk
EG0040 affected11 at risk
EG0050 affected21 at risk
EG0060 affected6 at risk
EG0070 affected21 at risk
EG0080 affected19 at risk
EG0091 affected19 at risk
EG0101 affected188 at risk
Myopia
Eye disorders
18.1
Non-systematic Assessment
EG0001 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Photophobia
Eye disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Abdominal pain
Gastrointestinal disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Diarrhoea
Gastrointestinal disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0012 affected24 at risk
EG0020 affected17 at risk
EG003
Nausea
Gastrointestinal disorders
18.1
Systematic Assessment
EG0001 affected26 at risk
EG0012 affected24 at risk
EG0023 affected17 at risk
EG003
Tooth impacted
Gastrointestinal disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Chills
General disorders
18.1
Systematic Assessment
EG0003 affected26 at risk
EG0011 affected24 at risk
EG0020 affected17 at risk
EG003
Fatigue
General disorders
18.1
Systematic Assessment
EG0009 affected26 at risk
EG0018 affected24 at risk
EG0028 affected17 at risk
EG003
Induration
General disorders
18.1
Systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Injection site erythema
General disorders
18.1
Systematic Assessment
EG00011 affected26 at risk
EG0012 affected24 at risk
EG0027 affected17 at risk
EG003
Injection site induration
General disorders
18.1
Systematic Assessment
EG0007 affected26 at risk
EG0012 affected24 at risk
EG0026 affected17 at risk
EG003
Injection site pain
General disorders
18.1
Systematic Assessment
EG00021 affected26 at risk
EG0017 affected24 at risk
EG00214 affected17 at risk
EG003
Injection site pruritus
General disorders
18.1
Non-systematic Assessment
EG0001 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Pyrexia
General disorders
18.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0011 affected24 at risk
EG0020 affected17 at risk
EG003
Vaccination site erythema
General disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Vaccination site pain
General disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Hypersensitivity
Immune system disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Acute sinusitis
Infections and infestations
18.1
Non-systematic Assessment
EG0001 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Bronchitis
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0012 affected24 at risk
EG0022 affected17 at risk
EG003
Conjunctivitis
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Croup infectious
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Herpes virus infection
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Influenza
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Laryngitis
Infections and infestations
18.1
Non-systematic Assessment
EG0001 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Lice infestation
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Nasopharyngitis
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0012 affected24 at risk
EG0020 affected17 at risk
EG003
Onychomycosis
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Otitis media
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Pharyngitis
Infections and infestations
18.1
Non-systematic Assessment
EG0001 affected26 at risk
EG0012 affected24 at risk
EG0022 affected17 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
18.1
Non-systematic Assessment
EG0001 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Pneumonia
Infections and infestations
18.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
18.1
Non-systematic Assessment
EG0001 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Respiratory tract infection
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Sinusitis
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Tonsillitis
Infections and infestations
18.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Tooth abscess
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Upper respiratory tract infection
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0022 affected17 at risk
EG003
Viral infection
Infections and infestations
18.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Viral pharyngitis
Infections and infestations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Concussion
Injury, poisoning and procedural complications
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Head injury
Injury, poisoning and procedural complications
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
18.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0011 affected24 at risk
EG0020 affected17 at risk
EG003
Post vaccination syndrome
Injury, poisoning and procedural complications
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Blood iron decreased
Investigations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Body temperature increased
Investigations
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Abnormal weight gain
Metabolism and nutrition disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
18.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0011 affected24 at risk
EG0024 affected17 at risk
EG003
Obesity
Metabolism and nutrition disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0012 affected24 at risk
EG0020 affected17 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
18.1
Non-systematic Assessment
EG0004 affected26 at risk
EG0012 affected24 at risk
EG0023 affected17 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
18.1
Non-systematic Assessment
EG0001 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
18.1
Non-systematic Assessment
EG0006 affected26 at risk
EG0012 affected24 at risk
EG0025 affected17 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0022 affected17 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Dizziness postural
Nervous system disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Headache
Nervous system disorders
18.1
Systematic Assessment
EG0008 affected26 at risk
EG0016 affected24 at risk
EG0028 affected17 at risk
EG003
Syncope
Nervous system disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Proteinuria
Renal and urinary disorders
18.1
Non-systematic Assessment
EG0001 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Breast mass
Reproductive system and breast disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
18.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
18.1
Non-systematic Assessment
EG0002 affected26 at risk
EG0011 affected24 at risk
EG0020 affected17 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0021 affected17 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Essential hypertension
Vascular disorders
18.1
Non-systematic Assessment
EG0000 affected26 at risk
EG0010 affected24 at risk
EG0020 affected17 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com
ID
Term
D008589
Meningococcal Infections
Ancestor Terms
ID
Term
D016870
Neisseriaceae Infections
D016905
Gram-Negative Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
19
± 5.4
BG00420.9± 3.99
BG00519.7± 5.36
BG00617.9± 4.67
BG00716.8± 4.65
BG00819.2± 6.1
BG00917.6± 5.19
BG01018.4± 5.08
9
BG00314
BG0042
BG00515
BG0063
BG00712
BG00812
BG00911
BG01099
Male
Title
Measurements
BG00018
BG00112
BG0028
BG00310
BG0049
BG0056
BG0064
BG0079
BG0087
BG0098
BG01091
85
(62.1 to 96.8)
OG001100(69.2 to 100)
Men W (N=20,13)
Title
Measurements
OG00085(62.1 to 96.8)
OG00185(54.6 to 98.1)
Men Y (N=25,14)
Title
Measurements
OG00096(79.6 to 99.9)
OG001100(76.8 to 100)
Participants
OG00025
OG00117
Title
Denominators
Categories
5/99 (Day 1, N= 25,15)
Title
Measurements
OG00076(54.9 to 90.6)
OG00187(59.5 to 98.3)
5/99 (Day 30, N=25,17)
Title
Measurements
OG000100(86.3 to 100.0)
OG001100(80.5 to 100.0)
H44/76 (Day 1, N=25,16)
Title
Measurements
OG00016(4.5 to 36.1)
OG00113(1.6 to 38.3)
H44/76 (Day 30, N=25,17)
Title
Measurements
OG00096(79.6 to 99.90)
OG001100(80.5 to 100.0)
M01-0240364 (Day 1, N=24,15)
Title
Measurements
OG00025(9.8 to 46.7)
OG00120(4.3 to 48.1)
M01-0240364 (Day 30, N=25,17)
Title
Measurements
OG000100(86.3 to 100.0)
OG001100(80.5 to 100.0)
M07-0241084 (Day 1,N=25,15)
Title
Measurements
OG00036(18.0 to 57.5)
OG00127(7.8 to 55.1)
M07-0241084 (Day 30, N=25,17)
Title
Measurements
OG000100(86.3 to 100.0)
OG00188(63.6 to 98.5)
M14459 (Day 1, N=25,15)
Title
Measurements
OG00024(9.4 to 45.1)
OG0017(0.17 to 31.9)
M14459 (Day 30, N=25,17)
Title
Measurements
OG00092(74.0 to 99.0)
OG00188(63.6 to 98.5)
NZ98/254 (Day 1, N=25,15)
Title
Measurements
OG00016(4.5 to 36.1)
OG0017(0.17 to 31.9)
NZ98/254 (Day 30, N=25,17)
Title
Measurements
OG00092(74.0 to 99.0)
OG00171(44.0 to 89.7)
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
Units
Counts
Participants
OG00051
OG00140
OG00238
OG00359
Title
Denominators
Categories
Men A (N=51,40,38,58)
Title
Measurements
OG00027(15.9 to 41.7)
OG00128(14.6 to 43.9)
OG00229(15.4 to 45.9)
OG00331(19.5 to 44.5)
Men C (N=48,38,38,58)
Title
Measurements
OG00067(51.6 to 79.6)
OG00168(51.3 to 82.5)
OG00245(28.6 to 61.7)
OG003
Men W (N=50,36,38,56)
Title
Measurements
OG00092(80.8 to 97.8)
OG00175(57.8 to 87.9)
OG00276(59.8 to 88.6)
OG003
Men Y (N=51,38,38,59)
Title
Measurements
OG00065(50.1 to 77.6)
OG00150(33.4 to 66.6)
OG00216(6 to 31.3)
OG003
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
Units
Counts
Participants
OG00051
OG00139
OG00238
OG00359
Title
Denominators
Categories
5/99 (N=51,38,36,59)
Title
Measurements
OG00076(62.5 to 87.2)
OG00187(71.9 to 95.6)
OG00294(81.3 to 99.3)
OG00319(9.7 to 30.9)
H44/76 (N=51,39,38,59)
Title
Measurements
OG00022(11.3 to 35.3)
OG00118(7.5 to 33.5)
OG00234(19.6 to 51.4)
OG003
M01-0240364 (N=50,37,37,58)
Title
Measurements
OG00024(13.1 to 38.2)
OG00116(6.2 to 32.0)
OG00235(20.2 to 52.5)
OG003
M07-0241084 (N=51,38,38,59)
Title
Measurements
OG00037(24.1 to 51.9)
OG00129(15.4 to 45.9)
OG00250(33.4 to 66.6)
OG003
M14459 (N=51,39,38,59)
Title
Measurements
OG00029(17.5 to 43.8)
OG00113(4.3 to 27.4)
OG00226(13.4 to 43.1)
OG003
NZ98/254 (N=51,39,38,59)
Title
Measurements
OG00024(12.8 to 37.5)
OG0018(1.6 to 20.9)
OG00216(6.0 to 31.3)
OG003
Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
Units
Counts
Participants
OG00051
OG00140
OG00238
OG00359
Title
Denominators
Categories
Men A (N=51,40,38,58)
Title
Measurements
OG0003.34(2.19 to 5.08)
OG0013.3(1.95 to 5.60)
OG0022.96(1.70 to 5.17)
OG0034.14(2.75 to 6.23)
Men C (N=48,38,38,58)
Title
Measurements
OG00018(11 to 30)
OG00113(8.00 to 20)
OG0026.05(4.28 to 8.55)
OG003
Men W (N=50,36,38,56)
Title
Measurements
OG00035(24 to 52)
OG00123(12 to 45)
OG00220(11 to 34)
OG003
Men Y (N=51,38,38,59)
Title
Measurements
OG00013(7.01 to 23)
OG0018.85(4.24 to 18)
OG0021.8(1.25 to 2.60)
OG003
Units
Counts
Participants
OG00050
OG00138
OG00236
OG00317
Title
Denominators
Categories
5/99 (N=51,38,36,59)
Title
Measurements
OG00016(11 to 24)
OG00133(19 to 54)
OG00239(25 to 62)
OG0032.46(1.73 to 3.51)
H44/76 (N=51,39,38,59)
Title
Measurements
OG0002.54(1.69 to 3.82)
OG0011.78(1.26 to 2.53)
OG0023.22(2.18 to 4.76)
OG003
M01-0240364 (N=50,37,37,58)
Title
Measurements
OG0002.67(1.70 to 4.20)
OG0012.1(1.21 to 3.65)
OG0024.72(2.44 to 9.13)
OG003
M07-0241084 (N=51,38,38,59)
Title
Measurements
OG0003.76(2.55 to 5.56)
OG0012.42(1.70 to 3.45)
OG0024.56(2.97 to 7.01)
OG003
M14459 (N=51,39,38,59)
Title
Measurements
OG0002.67(1.92 to 3.70)
OG0011.94(1.48 to 2.56)
OG0022.82(2.00 to 3.96)
OG003
NZ98/254 (N=51,39,38,59)
Title
Measurements
OG0002.03(1.43 to 2.89)
OG0011.46(1.15 to 1.85)
OG0021.75(1.24 to 2.47)
OG003
2qOMV_Pbo
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
OG004
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
OG005
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
OG006
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
OG007
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
OG008
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
Units
Counts
Participants
OG00025
OG00125
OG00216
OG00323
OG00411
OG00521
OG00621
OG00718
OG00818
Title
Denominators
Categories
Men A (Day 1, N=25,25,16,22,11,21,19,16,18)
Title
Measurements
OG0003.41(1.87 to 6.22)
OG0012.92(1.59 to 5.36)
OG0022.86(1.23 to 6.63)
OG0032.73(1.41 to 5.27)
OG0042.26(0.96 to 5.31)
OG0053.94(1.58 to 9.85)
OG0066.62(2.85 to 15)
OG0072.09(1.28 to 3.41)
OG0085.02(2.06 to 12)
Men A (Day 30, N=25,25,16,22,11,21,19,17,18)
Title
Measurements
OG000259(174 to 383)
OG0014.28(2.03 to 9.03)
OG002333(199 to 559)
OG003
Men C (Day 1, N=20,23,10,22,7,16,21,18,17)
Title
Measurements
OG00023(9.45 to 57)
OG00116(7.06 to 36)
OG00217(5.98 to 51)
OG003
Men C (Day 30, N=21,24,11,23,7,16,21,18,18)
Title
Measurements
OG000660(401 to 1084)
OG00117(7.60 to 38)
OG002612(245 to 1524)
OG003
Men W (Day 1, N=20,24,13,21,11,19,18,17,15)
Title
Measurements
OG00034(20 to 59)
OG00133(17 to 65)
OG00230(8.90 to 101)
OG003
Men W (Day 30, N=20,24,16,22,11,19,19,17,16)
Title
Measurements
OG000792(516 to 1216)
OG00134(16 to 71)
OG002880(671 to 1154)
OG003
Men Y (Day 1, N=25,25,14,22,11,21,21,18,18)
Title
Measurements
OG00010(4.89 to 21)
OG00115(5.50 to 43)
OG00215(4.33 to 53)
OG003
Men Y (Day 30, N=25,25,16,23,11,21,21,18,18)
Title
Measurements
OG000464(294 to 734)
OG00116(5.65 to 48)
OG002697(435 to 1116)
OG003
2qOMV_Pbo
Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
OG004
2B_OMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
OG005
2B_qOMV
Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
OG006
1M_OMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
OG007
1M_qOMV
Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
OG008
1M_Pbo
Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.