Exploratory Trial to Evaluate the Safety and Immunogenici... | NCT00874549

NCT00874549

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
Group 1: Menomune Day 0	Active Comparator	Participants received a single dose of Menomune® vaccine on Day 0.	Biological: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide
Group 2: Menactra® Day 0 x 2	Experimental	Participants received two single-dose injections of Menactra® vaccine on Day 0	Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
Group 3: Menactra® Day 0 and 14	Experimental	Participants received a single dose of Menactra® vaccine on Day 0 and on Day 14	Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
Group 4: Menactra® Day 0 and 28	Experimental	Participants received a single dose of Menactra® vaccine on Day 0 and on Day 28.	Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate

Name	Type	Description	Arm Group Labels	Other Names
Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide	Biological	0.5 mL, Subcutaneous	Group 1: Menomune Day 0

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.	Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.	0-7 days post-vaccination 1
Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2	Solicited injection site reactions: Pain, Erythema, and Swelling.	0-7 Days Post-vaccination 2
Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2	Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.	Day 0 to 7 Post-vaccination 2

Other Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.		Day 28 Post-vaccination 1
Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ambulatory and healthy, as determined by medical history.
56 years of age or older at the time of vaccination.
Signed Institutional Review Board (IRB)-approved informed consent form.
Able to attend all scheduled visits and to comply with all trial procedures.
For a woman, inability to become pregnant or a negative urine pregnancy test at the time of enrollment.

Exclusion Criteria:

Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc) that is unstable or that might 1) interfere with the ability to participate fully in the study or 2) interfere with evaluation of the vaccines.
Known or suspected impairment of immunologic function.
Febrile illness within the last 72 hours or an oral temperature ≥ 100.4ºF at the time of inclusion.
History of documented invasive meningococcal disease or previous meningococcal vaccination.
Known or suspected receipt of a diphtheria-containing vaccine within the preceding 2 years.
Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
Systemic antibiotic therapy within the 72 hours prior to collection of any blood samples.
Received any vaccine in the 28-day period prior to enrollment or scheduled to receive any vaccination through Visit 2 for Groups 1 and 2 and through Visit 3 for Groups 3 and 4. Influenza vaccines may be received 2 weeks before or after a study vaccination.
Suspected or known hypersensitivity to latex or to any of the components of either Menactra® vaccine or Menomune® vaccine.
Previous personal history of Guillain-Barré syndrome.
Not available for the entire study period or unable to attend the scheduled visits or to comply with the study procedures.
In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment.
A nursing mother.
Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial visits or procedures.
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Contacts/Locations Module

Name	Affiliation	Role
Medical Monitor	Sanofi Pasteur Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Scottsdale	Arizona	85251	United States

References Module

Label	URL
Related Info	View source

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	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
FG001	Group 2: Menactra® Day 0 x 2

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

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
BG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
BG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
BG003	Group 4: Menactra® Day 0 and 28	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00051 BG00156 BG00251 BG00358 BG004216

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00069.0± 7.2 BG00168.6± 7.0 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00029 BG00127 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00051 BG00156 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

Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.

Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.

Safety analysis post-vaccination 1 was on all enrolled and vaccinated participants, intent-to-treat population.

Posted

Number

Participants

0-7 days post-vaccination 1

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
OG003	Group 4: Menactra® Day 0 and 28	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.

Units	Counts
Participants	OG00051 OG00156 OG00251 OG003

Title

Denominators

Categories

Any Solicited Injection Site Reaction

Title	Measurements
	OG00026 OG00120 OG00228 OG003

Other Pre-specified

Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.

Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.

Posted

Number

Percentage of Participants

Day 28 Post-vaccination 1

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
OG003

Other Pre-specified

Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2

Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 2, were assessed in the per-protocol population. No data were collected for participants in Group 1.

Posted

Number

Percentage of Participants

Day 28 Post-vaccination 2

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
OG003

Other Pre-specified

Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1

Geometric mean titers of serum bactericidal antibody using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0 and Day 28 Post-vaccination 1

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.

Post-Hoc

Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1

Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.

Posted

Number

Percentage of Participants

Day 28 Post-vaccination 1

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
OG003

Post-Hoc

Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2

Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 2 was determined in the per-protocol population. No data were collected for participants in Group 1.

Posted

Number

Percentage of Participants

28 Days post-vaccination 2

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
OG003

Post-Hoc

Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1

Geometric mean of serum bactericidal antibody titers using human complements (SBA-HC) pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0 and Day 28 Post-vaccination 1

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
OG003

Primary

Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2

Solicited injection site reactions: Pain, Erythema, and Swelling.

Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1.

Posted

Number

Participants

0-7 Days Post-vaccination 2

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.

Primary

Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2

Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.

Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1 and Group 2.

Posted

Number

Participants

Day 0 to 7 Post-vaccination 2

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.

Other Pre-specified

Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2

Geometric mean titers of serum bactericidal antibody using baby rabbit complement pre-vaccination 1 and post-vaccination 2 was determined in per-protocol population. No data were collected for participants in Group 1.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0 and 28 days Post-vaccination 2

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.

Other Pre-specified

Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1

Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.

Posted

Number

Percentage of Participants

Day 28 Post-vaccination 1

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.

Other Pre-specified

Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2

Serum bactericidal antibody using baby rabbit complement titer pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.

Posted

Number

Percentage of Participants

Day 0 and Day 28 Post-vaccination 2

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.

Post-Hoc

Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2

Geometric mean of serum bactericidal antibody titers using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0 and Day 28 Post-vaccination 2

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.

Post-Hoc

Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.

Serum bactericidal antibody using human complement (SBA-HC) titers pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.

Posted

Number

Percentage of Participants

Day 28 Post-vaccination 1

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.

Post-Hoc

Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2

Serum bactericidal antibody using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.

Posted

Number

Percentage of Participants

Day 0 and 28 days post-vaccination

ID	Title	Description
OG000	Group 1: Menomune® Day 0	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
OG001	Group 2: Menactra® Day 0 x 2	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
OG002	Group 3: Menactra® Day 0 and 14	Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.

Arm/Groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Menomune® Day 0	4	51	3	51
EG001	Menactra® Day 0 x 2	3	56	5	56
EG002	Menactra® Day 0 and Day 14	1	51	8	51
EG003	Menactra® Day 0 and Day 28	0	58	12	58

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Syncope	Cardiac disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected56 at risk EG0020 events0 affected51 at risk EG0030 events0 affected58 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected56 at risk EG0020 events0 affected51 at risk EG003
Transient ischaemic attack	Vascular disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected56 at risk EG0020 events0 affected51 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected56 at risk EG0020 events0 affected51 at risk EG003
Non-cardiac chest pain	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected56 at risk EG0021 events1 affected51 at risk EG003
Diabetes mellitus non-insulin-dependent	Endocrine disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected56 at risk EG0020 events0 affected51 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected56 at risk EG0020 events0 affected51 at risk EG003
Diverticulitis	Gastrointestinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected56 at risk EG0020 events0 affected51 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0011 events1 affected56 at risk EG0025 events5 affected51 at risk EG0035 events5 affected58 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Non-systematic Assessment	EG0002 events1 affected51 at risk EG0011 events1 affected56 at risk EG0022 events2 affected51 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0001 events1 affected51 at risk EG0014 events3 affected56 at risk EG0022 events2 affected51 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected56 at risk EG0020 events0 affected51 at risk EG003

ID	Term
D008589	Meningococcal Infections
D008585	Meningitis, Meningococcal

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
D008581	Meningitis
D000090862	Neuroinflammatory Diseases

ID	Term
D022401	Meningococcal Vaccines

ID	Term
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures