Safety, Tolerability and Immunogenicity of a Third Dose o... | NCT01367158

NCT01367158

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3ABCWY	Experimental	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study	Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine
2ABCWY	Experimental	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study	Biological: Tdap
3ABx2CWY	Experimental	two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study	Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine
2ABx2CWY	Experimental	two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine	Biological	The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo	Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).	At month 6 and month 7
Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo	Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)	At month 6 and month 7

Secondary Outcomes

Measure	Description	Time Frame
Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo	Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals eligible to be enrolled into this study were male or female who completed study V102_02 (primary study), and:

who were 11 to 18 years at the time of enrollment in primary study;
who had given their written consent at the time of enrollment;
who were available for all the visits scheduled in the study (ie, not planning to leave the area before the end of the study period);
who were in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

History of any meningococcal vaccine administration;
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;
Significant acute or chronic infection within the previous 7 days or fever (defined as temperature >38°C) within the previous 3 days;
Antibiotics within 7 days prior to enrollment or blood draw;
Pregnancy or nursing (breastfeeding) mothers;
Females of childbearing age who had not used or did not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide); intrauterine device or sexual abstinence was considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
Any serious chronic or progressive disease (eg, neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus infection or acquired immunodeficiency syndrome, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure or severe malnutrition).
Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids or immunostimulants within the previous 60 days. Use of topical corticosteroids administered during the study in limited areas (ie, eczema on knees or face or elbows) of the body was allowed;
Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
Individuals who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine within 4 weeks from the study vaccines.
Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or had intent to participate in another clinical study at any time during the conduct of this study.
Individuals who were part of study personnel or close family members conducting this study.
Individuals with medical history or any illness that, in the opinion of the investigator, might interfere with the results of the study or posed additional risk to the subjects due to participation in the study.

Contacts/Locations Module

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
CESFAM Gabriela Mistral:		Aurora de Chile 9872 - San Ramón	Saniago		Chile
Pontificia Universidad Catolica de Chile

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26135245	Derived	Saez-Llorens X, Aguilera Vaca DC, Abarca K, Maho E, Han L, Smolenov I, Dull P. Persistence of Meningococcal Antibodies and Response to a Third Dose After a Two-dose Vaccination Series with Investigational MenABCWY Vaccine Formulations in Adolescents. Pediatr Infect Dis J. 2015 Oct;34(10):e264-78. doi: 10.1097/INF.0000000000000822.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	3ABCWY	Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
FG001	2ABCWY	Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	3ABCWY	Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
BG001	2ABCWY	Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
BG002	3ABx2CWY	Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
BG003	2ABx2CWY	Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
BG004	3ABCWY+OMV	Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
BG005	2ABCWY+OMV	Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
BG006	3ABCWYqOMV	Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
BG007	2ABCWYqOMV	Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
BG008	3 B	Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
BG009	2 B	Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
BG010	1ACWY	One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
BG011	Total	Total of all reporting groups

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

Ser. A - month 6 (n=23,24,24,25,23,69)

Title	Measurements
	OG00052(31 to 73) OG00179(58 to 93) OG00275(53 to 90)

Primary

Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)

Analysis was done by MITT Month 7 Set.

Posted

Number

95% Confidence Interval

Percentages of subjects

At month 6 and month 7

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG002	3ABCWY+OMV	Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study

Secondary

Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)

Analysis was done by MITT Month 7 Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

At month 6 and month 7

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG002	3ABCWY+OMV	Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study

Secondary

Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Antibody response was measured as Geometric Mean Ratio (95% CI), against N meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination (month 7) With One of Four MenABCWY Formulations or rMenB

Analysis was done by MITT Month 7 Set.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At month 7

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG002	3ABCWY+OMV	Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study

Secondary

GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Analysis was done by MITT Month 7 Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

At month 6 and month 7

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG002	3ABCWY+OMV	Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study

Secondary

GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Antibody response was measured as Geometric Mean Ratio (95% CI), against Serogroup B Test Strains at One Month After the Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Analysis was done by MITT Month 7 Set.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At month 7

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG002	3ABCWY+OMV	Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study

Secondary

Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Antibody response was measured as the percentage of subjects with seroresponse Against N meningitidis Serogroups A, C, W and Y, after pre and post vaccination at month 6 and after the third vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo. Seroresponse to N meningitidis serogroups A, C, W and Y is defined as: For subjects with a prevaccination hSBA <1:4, a postvaccination hSBA ≥1:8;For subjects with a prevaccination hSBA ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.

Analysis was done by MITT month 7 Set.

Posted

Number

95% Confidence Interval

Percentages of subjects

At month 7

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study

Secondary

Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Antibody response was measured as the percentage of subjects with 4-fold Increase in human serum bactericidal assay (hSBA) titers and associated 95% CI, Against Serogroup B Test Strains at One Month After Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

Analysis was done by MITT month 7 Set.

Posted

Number

95% Confidence Interval

Percentages of subjects

At month 7

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG002	3ABCWY+OMV	Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study

Secondary

GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Antibody response was measured as Geometric Mean hSBA Titers Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.

Analysis was done by MITT Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

At month 1, 3, 6, 7 and 12

ID	Title	Description
OG000	2ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG001	2ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG002	2ABCWY+OMV

Secondary

GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Analysis was done by Per MITT Set.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At month 1, 3, 6, 7 and 12

ID	Title	Description
OG000	2ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG001	2ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG002	2ABCWY+OMV

Secondary

GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, After Third Vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Analysis was done by MITT Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

At month 1, 3, 6, 7 and 12

ID	Title	Description
OG000	2ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG001	2ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG002	2ABCWY+OMV	Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study

Secondary

GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (month 6) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Analysis was done by MITT Set.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At month 1, 3, 6, 7 and 12

ID	Title	Description
OG000	2ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG001	2ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG002	2ABCWY+OMV

Secondary

GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Analysis was done by MITT Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

At month 1, 3, 6, 7 and 12

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG002	3ABCWY+OMV

Secondary

GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Analysis was done by MITT Set.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At month 1, 3, 6, 7 and 12

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG002	3ABCWY+OMV

Secondary

GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Analysis was done by MITT Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

At month 1, 3, 6, 7 and 12

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG002	3ABCWY+OMV

Secondary

GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

Analysis was done by MITT Set.

Posted

Geometric Mean

95% Confidence Interval

Ratio

At month 1, 3, 6, 7 and 12

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG002	3ABCWY+OMV

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.

Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).

Posted

Number

Number of Subjects

From Day 1 to Day 7 after vaccination

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	2ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG002	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study

Secondary

Numbers of Subjects With Other Unsolicited AEs

Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.

Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).

Posted

Number

Number of Subjects

Day 8 After vaccination Through Study Termination, up to 6 months

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	2ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG002	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study

Secondary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination

Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.

Analysis was done on Safety Set (all subjects in the exposed set who provided post-vaccination solicited AE data).

Posted

Number

Number of Subjects

From Day 1 to Day 7 after vaccination

ID	Title	Description
OG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
OG001	2ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
OG002	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	3ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study	0	24	20	24
EG001	2ABCWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study	0	49	38	49
EG002	3ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study	1	24	20	24
EG003	2ABx2CWY	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study	1	49	36	49
EG004	3ABCWY+OMV	Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study	0	25	23	25
EG005	2ABCWY+OMV	Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study	0	48	37	48
EG006	3ABCWYqOMV	Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study	1	24	22	24
EG007	2ABCWYqOMV	Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study	1	50	38	50
EG008	3 B	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study	0	23	19	23
EG009	2 B	Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study	1	50	40	50
EG010	1ACWY	One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study	0	73	56	73

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendiceal Abscess	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected24 at risk EG0010 affected49 at risk EG0021 affected24 at risk EG0030 affected49 at risk EG0040 affected25 at risk EG0050 affected48 at risk EG0060 affected24 at risk EG0070 affected50 at risk EG0080 affected23 at risk EG0090 affected50 at risk EG0100 affected73 at risk
Gastroenteritis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected24 at risk EG0010 affected49 at risk EG0020 affected24 at risk EG003
Peritonsillar Abscess	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected24 at risk EG0010 affected49 at risk EG0020 affected24 at risk EG003
Burns Second Degree	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected24 at risk EG0010 affected49 at risk EG0020 affected24 at risk EG003
Vaccination Complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected24 at risk EG0010 affected49 at risk EG0020 affected24 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected24 at risk EG0016 affected49 at risk EG0022 affected24 at risk EG0033 affected49 at risk EG0044 affected25 at risk EG0057 affected48 at risk EG0066 affected24 at risk EG0073 affected50 at risk EG0082 affected23 at risk EG0094 affected50 at risk EG0106 affected73 at risk
Chills	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected24 at risk EG00110 affected49 at risk EG0024 affected24 at risk EG003
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected24 at risk EG0019 affected49 at risk EG0023 affected24 at risk EG003
Injection Site Erythema	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected24 at risk EG00116 affected49 at risk EG0027 affected24 at risk EG003
Injection Site Induration	General disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected24 at risk EG00116 affected49 at risk EG00211 affected24 at risk EG003
Injection Site Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG00018 affected24 at risk EG00133 affected49 at risk EG00215 affected24 at risk EG003
Injection Site Swelling	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected24 at risk EG00111 affected49 at risk EG0029 affected24 at risk EG003
Malaise	General disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected24 at risk EG00112 affected49 at risk EG0027 affected24 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected24 at risk EG0016 affected49 at risk EG0020 affected24 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected24 at risk EG0012 affected49 at risk EG0020 affected24 at risk EG003
Athralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected24 at risk EG0016 affected49 at risk EG0025 affected24 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected24 at risk EG00123 affected49 at risk EG0029 affected24 at risk EG003
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected24 at risk EG00120 affected49 at risk EG0026 affected24 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected24 at risk EG0012 affected49 at risk EG0022 affected24 at risk EG003

ID	Term
D008589	Meningococcal Infections
D008585	Meningitis, Meningococcal
D008581	Meningitis

Ancestor Terms

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D016920	Meningitis, Bacterial
D020806	Central Nervous System Bacterial Infections
D002494	Central Nervous System Infections
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000090862	Neuroinflammatory Diseases

EG0040 affected25 at risk

EG0050 affected48 at risk

EG0060 affected24 at risk

EG0071 affected50 at risk

EG0080 affected23 at risk

EG0090 affected50 at risk

EG0100 affected73 at risk

EG0040 affected25 at risk

EG0050 affected48 at risk

EG0060 affected24 at risk

EG0070 affected50 at risk

EG0080 affected23 at risk

EG0090 affected50 at risk

EG0100 affected73 at risk

EG0040 affected25 at risk

EG0050 affected48 at risk

EG0060 affected24 at risk

EG0070 affected50 at risk

EG0080 affected23 at risk

EG0091 affected50 at risk

EG0100 affected73 at risk

EG0040 affected25 at risk

EG0050 affected48 at risk

EG0061 affected24 at risk

EG0070 affected50 at risk

EG0080 affected23 at risk

EG0090 affected50 at risk

EG0100 affected73 at risk

EG0047 affected25 at risk

EG0058 affected48 at risk

EG0064 affected24 at risk

EG0075 affected50 at risk

EG0085 affected23 at risk

EG0095 affected50 at risk

EG0108 affected73 at risk

EG0045 affected25 at risk

EG00511 affected48 at risk

EG0064 affected24 at risk

EG0077 affected50 at risk

EG0083 affected23 at risk

EG00910 affected50 at risk

EG0109 affected73 at risk

EG00413 affected25 at risk

EG00512 affected48 at risk

EG00616 affected24 at risk

EG0075 affected50 at risk

EG00810 affected23 at risk

EG00914 affected50 at risk

EG01020 affected73 at risk

EG00412 affected25 at risk

EG00517 affected48 at risk

EG00613 affected24 at risk

EG0078 affected50 at risk

EG0088 affected23 at risk

EG00915 affected50 at risk

EG01019 affected73 at risk

EG00423 affected25 at risk

EG00535 affected48 at risk

EG00619 affected24 at risk

EG00731 affected50 at risk

EG00817 affected23 at risk

EG00936 affected50 at risk

EG01052 affected73 at risk

EG00411 affected25 at risk

EG00514 affected48 at risk

EG00614 affected24 at risk

EG0076 affected50 at risk

EG0088 affected23 at risk

EG00914 affected50 at risk

EG01016 affected73 at risk

EG0048 affected25 at risk

EG0059 affected48 at risk

EG0068 affected24 at risk

EG0078 affected50 at risk

EG0085 affected23 at risk

EG00913 affected50 at risk

EG01013 affected73 at risk

EG0043 affected25 at risk

EG0050 affected48 at risk

EG0065 affected24 at risk

EG0071 affected50 at risk

EG0082 affected23 at risk

EG0093 affected50 at risk

EG0104 affected73 at risk

EG0041 affected25 at risk

EG0051 affected48 at risk

EG0061 affected24 at risk

EG0072 affected50 at risk

EG0081 affected23 at risk

EG0093 affected50 at risk

EG0104 affected73 at risk

EG0046 affected25 at risk

EG0055 affected48 at risk

EG0068 affected24 at risk

EG0073 affected50 at risk

EG0082 affected23 at risk

EG0098 affected50 at risk

EG0109 affected73 at risk

EG00415 affected25 at risk

EG00518 affected48 at risk

EG00614 affected24 at risk

EG00719 affected50 at risk

EG0089 affected23 at risk

EG00921 affected50 at risk

EG01032 affected73 at risk

EG0049 affected25 at risk

EG00511 affected48 at risk

EG00610 affected24 at risk

EG00715 affected50 at risk

EG0087 affected23 at risk

EG00918 affected50 at risk

EG01027 affected73 at risk

EG0040 affected25 at risk

EG0051 affected48 at risk

EG0060 affected24 at risk

EG0070 affected50 at risk

EG0080 affected23 at risk

EG0090 affected50 at risk

EG0100 affected73 at risk

OG0044.54(2.66 to 7.75)

OG0041.72(0.93 to 3.18)

OG0042.64(1.41 to 4.96)

OG0048.41(6.31 to 11)

OG0050.75(0.64 to 0.89)

OG0051.01(0.82 to 1.24)

OG0041.46(1 to 2.14)

OG0050.81(0.65 to 1.02)

OG0051.21(1.04 to 1.4)

OG0051.74(1.36 to 2.22)

OG004832(548 to 1263)

OG0051.93(1.5 to 2.48)

OG0041.81(1.17 to 2.81)

OG0051.15(1.05 to 1.25)

OG0042.64(1.65 to 4.23)

OG0051.2(1.07 to 1.33)

OG0042.48(1.55 to 3.97)

OG0051.28(1.11 to 1.49)

OG0051.28(1.1 to 1.49)

OG0043.32(1.91 to 5.75)

OG0052.99(2.16 to 4.14)

OG0049.73(5.33 to 18)

OG0053.03(2.22 to 4.15)

OG0047.21(3.15 to 17)

OG0051.18(1 to 1.39)

OG004474(229 to 980)

OG0051.18(1 to 1.39)

OG0045.47(4 to 7.48)

OG0051.12(0.93 to 1.36)

OG0041.45(1.04 to 2.04)

OG0051.05(0.95 to 1.15)

OG0044.37(2.93 to 6.53)

OG0051.01(0.91 to 1.11)

OG0042.75(1.89 to 4.01)

OG0051.01(0.91 to 1.12)