Study to Assess the Safety and Immunogenicity of a Single... | NCT02986854

NCT02986854

ID	Type	Description	Link
V59_77	Other Identifier	Novartis
2016-003186-25	EudraCT Number

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
Menveo-Menveo Group	Experimental	Approximately 300 subjects, who were vaccinated with a single dose of Menveo 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.	Biological: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
Menactra-Menveo Group	Experimental	Approximately 300 subjects, who were vaccinated with a single dose of Menactra 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.	Biological: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
Naive Group	Active Comparator	Aproximately 100 subjects, of similar age to subjects enrolled in other primed groups, who have not received any meningococcal vaccination, will receive one dose of MenACWY-CRM at Day 1.	Biological: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)	Biological	One intramuscular injection of MenACWY at Day 1.	Menactra-Menveo Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.	Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W & Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo & Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives	At Day 29

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)	An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals of 15 through 55 years of age on the day of informed consent or assent.
Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who received Menactra 4 to 6 years prior to enrolment at an age of 11 years or older OR Individuals who have not received any previous meningococcal vaccine.
Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrolment, the parent(s)/legal guardian(s) of the subject should have voluntarily given written informed consent.
Individuals who can comply with study procedures including follow-up.
Males Or Females of non-childbearing potential Or
- Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.

Exclusion Criteria:

Each subject must not have:

History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before OR 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 prior to study vaccination.
Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
Clinical conditions representing a contraindication to intramuscular vaccination (IM) and blood draws.
Abnormal function of the immune system resulting from:
1. Clinical conditions.
2. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination.
3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
Received immunoglobulins or any blood products within 180 days prior to informed consent.
Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
Received an investigational or non-registered medicinal product within 30 days prior to study vaccination.
Study personnel as an immediate family or household member.
Individuals who have received any other vaccines within 7 days or 14 days prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccination.
Individuals who have experienced a moderate or severe acute infection and/or fever defined as a temperature ≥38°C (100.4°F) within 3 days prior to study vaccination.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35211	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31495595	Background	Tipton M, Daly W, Senders S, Block SL, Lattanzi M, Mzolo T, Barbi S, Pellegrini M, Keshavan P. MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. Vaccine. 2019 Sep 30;37(42):6171-6179. doi: 10.1016/j.vaccine.2019.08.065. Epub 2019 Sep 5.

Label	URL
Full CSR posting on GSK	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
FG001	Menactra-Menveo Group

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

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 24, 2016	Jul 4, 2018

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

Healthy subjects,15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
BG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
BG002	Naive Group	Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
BG003	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

American Indian or Alaska Native

Title	Measurements
	BG0002 BG0016 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

Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.

Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W & Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo & Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives

Analysis was performed on the per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis who received the study vaccination & provided evaluable serum samples at Day 29 with results available for atleast one serogroup

Posted

Number

95% Confidence Interval

Percentage of subjects

At Day 29

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)	Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups
OG003	Naive Group	Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.

Units	Counts
Participants	OG000290 OG001282 OG002571 OG003

Title	Denominators	Categories
hSBA-Men A, Pre < 4	ParticipantsOG000246 ParticipantsOG001234 ParticipantsOG002480 ParticipantsOG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	Serogroup A-day 29-Total seroresponse (Menveo-Menveo vs. Naive)	Miettinen & Nurminen score method				Difference in percentages	30.95			2-Sided	95	21.76	41.25					Other	Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method

Secondary

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)

An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.

Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.

Posted

Count of Participants

Participants

Within 30 minutes after vaccination

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

Secondary

Number of Subjects Reporting Solicited Local and Systemic AEs

Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever [defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)]. Threshold for Erythema and Induration: Grade 0 (<25 mm), Any (>= 25 mm)

Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.

Posted

Count of Participants

Participants

From Day 1 (6 hours) through Day 7 after vaccination

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002

Secondary

Number of Subjects Reporting Other Indicators of Reactogenicity

Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)

Posted

Count of Participants

Participants

From Day 1 (6 hours) through Day 7 after vaccination

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)

Secondary

Number of Subjects Reporting All Unsolicited AEs

An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.

Posted

Count of Participants

Participants

From Day 1 through Day 29 after vaccination

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

Secondary

Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)

Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.

SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed.

Posted

Count of Participants

Participants

From Day 1 through Day 181 (entire study period)

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

Secondary

Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup

Posted

Number

95% Confidence Interval

Percentages of subjects

At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)

Secondary

Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Posted

Number

95% Confidence Interval

Percentage of subjects

At day 1(pre-vaccination) , day 4, day 6 and day 29

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)

Secondary

Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Posted

Number

95% Confidence Interval

Percentage of subjects

At day 1(pre-vaccination), day 4, day 6 and day 29

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)

Secondary

Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Posted

Number

95% Confidence Interval

Percentage of subjects

At day 1(pre-vaccination), day 4, day 6 and day 29

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)

Secondary

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Posted

Number

95% Confidence Interval

Percentage of subjects

At day 1(pre-vaccination), day 4, day 6 and day 29

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)

Secondary

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C

Posted

Number

95% Confidence Interval

Percentage of subjects

At day 1(pre-vaccination) , day 4, day 6 and day 29

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.

Secondary

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Posted

Number

95% Confidence Interval

Percentage of subjects

At day 1(pre-vaccination), day 4, day 6 and day 29

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)

Secondary

Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Posted

Number

95% Confidence Interval

Percentage of subjects

At day 1(pre-vaccination) , day 4, day 6 and day 29

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)

Secondary

Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y

Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers <4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.

Posted

Number

95% Confidence Interval

Percentages of subjects

At Day 4 and Day 6

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)

Secondary

hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.

For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002	Pooled Group (Menveo-Menveo and Menactra-Menveo)

Secondary

Within Group hSBA Geometric Mean Ratios (GMRs)

Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.

Posted

Geometric Mean

95% Confidence Interval

Ratios

At Day 4, Day 6, Day 29 compared to Day 1

ID	Title	Description
OG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.
OG002

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Menveo-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	301	3	301	243	301
EG001	Menactra-Menveo Group	Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	300	2	300	211	300
EG002	Naive Group	Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.	100	3	100	60	100

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Diverticulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Septic shock	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Tonsillitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Diabetic ketoacidotic hyperglycaemic coma	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Suicide attempt	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Major depression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Middle ear effusion	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Oculogyric crisis	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Retinal tear	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Eye disorder	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Vision blurred	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Erythema of eyelid	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00065 events51 affected301 at risk EG00155 events44 affected300 at risk EG00217 events15 affected100 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 events5 affected301 at risk EG0011 events1 affected300 at risk EG0021 events1 affected100 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0013 events3 affected300 at risk EG0020 events0 affected100 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0012 events2 affected300 at risk EG0023 events3 affected100 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Anal skin tags	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Eosinophilic oesophagitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Salivary gland mucocoele	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Injection site pain	General disorders	MedDRA 20.1	Systematic Assessment	EG000124 events119 affected301 at risk EG001113 events106 affected300 at risk EG00241 events41 affected100 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG000146 events116 affected301 at risk EG001159 events111 affected300 at risk EG00221 events19 affected100 at risk
Chills	General disorders	MedDRA 20.1	Systematic Assessment	EG00036 events34 affected301 at risk EG00150 events37 affected300 at risk EG00210 events10 affected100 at risk
Injection site induration	General disorders	MedDRA 20.1	Systematic Assessment	EG00017 events17 affected301 at risk EG00111 events10 affected300 at risk EG0029 events8 affected100 at risk
Injection site erythema	General disorders	MedDRA 20.1	Systematic Assessment	EG00016 events14 affected301 at risk EG00110 events10 affected300 at risk EG00214 events11 affected100 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 events3 affected301 at risk EG0018 events7 affected300 at risk EG0021 events1 affected100 at risk
Injection site pruritus	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0012 events2 affected300 at risk EG0023 events3 affected100 at risk
Influenza like illness	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Medical device site erythema	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Medical device site swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Injection site swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Peripheral swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Vaccination site pruritus	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Axillary pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Injection site bruising	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Seasonal allergy	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Hypersensitivity	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Allergy to animal	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00016 events13 affected301 at risk EG0015 events5 affected300 at risk EG0022 events2 affected100 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00012 events12 affected301 at risk EG0019 events9 affected300 at risk EG0023 events3 affected100 at risk
Acute sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00013 events11 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Otitis media	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected301 at risk EG0014 events4 affected300 at risk EG0020 events0 affected100 at risk
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected301 at risk EG0013 events3 affected300 at risk EG0021 events1 affected100 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected301 at risk EG0017 events7 affected300 at risk EG0023 events3 affected100 at risk
Pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected301 at risk EG0015 events5 affected300 at risk EG0021 events1 affected100 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected301 at risk EG0013 events3 affected300 at risk EG0020 events0 affected100 at risk
Viral pharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 events3 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Otitis media acute	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0017 events6 affected300 at risk EG0021 events1 affected100 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0013 events3 affected300 at risk EG0024 events2 affected100 at risk
Conjunctivitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Otitis externa	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0016 events6 affected300 at risk EG0020 events0 affected100 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Tooth abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected300 at risk EG0021 events1 affected100 at risk
Folliculitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Bronchitis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Croup infectious	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Cystitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Hordeolum	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Laryngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Viral rash	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0013 events2 affected300 at risk EG0020 events0 affected100 at risk
Bacterial vaginosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0021 events1 affected100 at risk
Bartholin's abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Chlamydial infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Fungal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Infectious mononucleosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Oral herpes	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Rhinitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Diverticulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Kidney infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Vaginal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected301 at risk EG0013 events3 affected300 at risk EG0020 events0 affected100 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0011 events1 affected300 at risk EG0021 events1 affected100 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Conjunctival abrasion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Cardiac murmur	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG00050 events37 affected301 at risk EG00163 events48 affected300 at risk EG0026 events6 affected100 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG00063 events57 affected301 at risk EG00172 events55 affected300 at risk EG00215 events15 affected100 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG00060 events46 affected301 at risk EG00150 events41 affected300 at risk EG00213 events13 affected100 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected301 at risk EG0011 events1 affected300 at risk EG0022 events1 affected100 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Myalgia intercostal	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Benign bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG000135 events103 affected301 at risk EG001118 events84 affected300 at risk EG00227 events23 affected100 at risk
Syncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0013 events3 affected300 at risk EG0020 events0 affected100 at risk
Migraine	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Loss of consciousness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Migraine with aura	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Tension headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0014 events4 affected300 at risk EG0020 events0 affected100 at risk
Presyncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Anxiety	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0005 events5 affected301 at risk EG0013 events3 affected300 at risk EG0020 events0 affected100 at risk
Depression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Major depression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Sleep disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Disruptive mood dysregulation disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Dysuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Polyuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Proteinuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Pelvic congestion	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0007 events7 affected301 at risk EG0015 events5 affected300 at risk EG0021 events1 affected100 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0007 events7 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0016 events6 affected300 at risk EG0021 events1 affected100 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0016 events6 affected300 at risk EG0020 events0 affected100 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0012 events2 affected300 at risk EG0021 events1 affected100 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0012 events2 affected300 at risk EG0020 events0 affected100 at risk
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0004 events4 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0003 events3 affected301 at risk EG0015 events5 affected300 at risk EG0020 events0 affected100 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0012 events1 affected300 at risk EG0020 events0 affected100 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Lymphangiopathy	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected300 at risk EG0020 events0 affected100 at risk
Hot flush	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected300 at risk EG0020 events0 affected100 at risk
Essential hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected301 at risk EG0010 events0 affected300 at risk EG0021 events1 affected100 at risk

ID	Term
D008589	Meningococcal Infections
D008581	Meningitis

Ancestor Terms

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000090862	Neuroinflammatory Diseases
D009422	Nervous System Diseases

ID	Term
D022401	Meningococcal Vaccines

Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups

Title	Measurements
	OG000162 OG001148 OG002310 OG00335

Title	Measurements
	OG00015 OG0019 OG00224 OG0038

Title	Measurements
	OG00012 OG0018 OG00220 OG00310

Title	Measurements
	OG000114 OG00196 OG002210 OG00340

Title	Measurements
	OG00048 OG00144 OG00292 OG00313

Title	Measurements
	OG000113 OG001110 OG002223 OG00319

Title	Measurements
	OG00055 OG00154 OG002109 OG00315

Title	Measurements
	OG00044 OG00138 OG00282 OG00313

Title	Measurements
	OG000100 OG00182 OG002182 OG00321

Title	Measurements
	OG00037 OG00146 OG00283 OG0036

Title	Measurements
	OG00034 OG00135 OG00269 OG00310

Title	Measurements
	OG0002 OG0015 OG0027 OG0030

Title	Measurements
	OG00011.11(6.49 to 17.42) OG00113.04(7.92 to 19.83) OG00212.06(8.5 to 16.44) OG0034.17(0.51 to 14.25)

Title	Measurements
	OG00053.42(44.99 to 61.71) OG00147.14(38.66 to 55.75) OG00250.35(44.4 to 56.29) OG0039.09(2.53 to 21.67)

Title	Measurements
	OG00098.62(96.51 to 99.62) OG00198.94(96.92 to 99.78) OG00298.78(97.49 to 99.51) OG00370.97(60.64 to 79.92)

Title	Measurements
	OG00070.83(62.68 to 78.1) OG00160.14(51.47 to 68.38) OG00265.6(59.74 to 71.13) OG00343.75(29.48 to 58.82)

Title	Measurements
	OG00087.59(81.09 to 92.47) OG00192.09(86.28 to 95.98) OG00289.79(85.66 to 93.05) OG00343.18(28.35 to 58.97)

Title	Measurements
	OG000100(98.74 to 100) OG00199.64(98.03 to 99.99) OG00299.82(99.03 to 100) OG00387.1(78.55 to 93.15)

Title	Measurements
	OG00081.94(74.67 to 87.85) OG00182.61(75.24 to 88.53) OG00282.27(77.3 to 86.54) OG00362.5(47.35 to 76.05)

Title	Measurements
	OG00093.84(88.62 to 97.14) OG00197.86(93.87 to 99.56) OG00295.8(92.79 to 97.81) OG00363.64(47.77 to 77.59)

Title	Measurements
	OG000100(98.74 to 100) OG001100(98.7 to 100) OG002100(99.36 to 100) OG00384.78(75.79 to 91.42)

Title	Measurements
	OG00055.24(46.71 to 63.56) OG00155.8(47.1 to 64.24) OG00255.52(49.5 to 61.42) OG00333.33(20.4 to 48.41)

Title	Measurements
	OG00085.52(78.72 to 90.81) OG00187.86(81.27 to 92.76) OG00286.67(82.16 to 90.39) OG00345.45(30.39 to 61.15)

Title	Measurements
	OG000100(98.74 to 100) OG00199.64(98.03 to 99.99) OG00299.82(99.03 to 100) OG00377.42(67.58 to 85.45)

Title	Measurements
	OG0008.33(4.38 to 14.1) OG0018.7(4.57 to 14.7) OG0028.51(5.53 to 12.4) OG0032.08(0.05 to 11.07)

Title	Measurements
	OG00045.89(37.62 to 54.33) OG00141.43(33.17 to 50.05) OG00243.71(37.87 to 49.67) OG0034.55(0.56 to 15.47)

Title	Measurements
	OG00098.28(96.02 to 99.44) OG00197.52(94.95 to 99) OG00297.9(96.36 to 98.91) OG00366.67(56.13 to 76.11)

Title	Measurements
	OG00054.17(45.67 to 62.49) OG00144.93(36.46 to 53.62) OG00249.65(43.66 to 55.64) OG00329.17(16.95 to 44.06)

Title	Measurements
	OG00082.07(74.84 to 87.94) OG00181.29(73.81 to 87.4) OG00281.69(76.69 to 86.01) OG00331.82(18.61 to 47.58)

Title	Measurements
	OG00099.66(98.09 to 99.99) OG00199.64(98.03 to 99.99) OG00299.65(98.74 to 99.96) OG00369.89(59.5 to 78.97)

Title	Measurements
	OG00068.75(60.5 to 76.21) OG00176.81(68.87 to 83.57) OG00272.7(67.1 to 77.81) OG00354.17(39.17 to 68.63)

Title	Measurements
	OG00089.04(82.81 to 93.6) OG00192.14(86.38 to 96.01) OG00290.56(86.56 to 93.69) OG00350(34.56 to 65.44)

Title	Measurements
	OG000100(98.74 to 100) OG001100(98.7 to 100) OG002100(99.36 to 100) OG00380.43(70.85 to 87.97)

Title	Measurements
	OG00039.16(31.11 to 47.67) OG00139.13(30.94 to 47.8) OG00239.15(33.4 to 45.12) OG00320.83(10.47 to 34.99)

Title	Measurements
	OG00080.69(73.31 to 86.77) OG00180(72.41 to 86.28) OG00280.35(75.26 to 84.8) OG00331.82(18.61 to 47.58)

Title	Measurements
	OG000100(98.74 to 100) OG00198.58(96.4 to 99.61) OG00299.3(98.22 to 99.81) OG00364.52(53.91 to 74.17)

Title	Measurements
	OG0004.76(0.12 to 23.82) OG0010(0 to 16.11) OG0022.38(0.06 to 12.57) OG0030(0 to 70.76)

Title	Measurements
	OG00036.36(17.2 to 59.34) OG00122.22(8.62 to 42.26) OG00228.57(16.58 to 43.26) OG00320(0.51 to 71.64)

Title	Measurements
	OG0000(0 to 9.74) OG0019.8(3.26 to 21.41) OG0025.75(1.89 to 12.9) OG0035(0.13 to 24.87)

Title	Measurements
	OG00065.31(50.36 to 78.33) OG00164.71(50.07 to 77.57) OG00265(54.82 to 74.27) OG00313.04(2.78 to 33.59)

Title	Measurements
	OG0009.52(1.17 to 30.38) OG00130(14.73 to 49.4) OG00221.57(11.29 to 35.32) OG00311.76(1.46 to 36.44)

Title	Measurements
	OG00064.52(45.37 to 80.77) OG00175(55.13 to 89.31) OG00269.49(56.13 to 80.81) OG00325(7.27 to 52.38)

Title	Measurements
	OG0002.83(2.43 to 3.29) OG0013(2.57 to 3.51) OG0022.91(2.61 to 3.25) OG0032.25(1.73 to 2.93)

Title	Measurements
	OG00012.87(9.63 to 17.19) OG00110.17(7.57 to 13.66) OG00211.47(9.32 to 14.1) OG0032.48(1.46 to 4.2)

Title	Measurements
	OG000210.1(181.07 to 243.78) OG001236.69(203.56 to 275.2) OG002222.81(200.43 to 247.7) OG00332.11(24.7 to 41.76)

Title	Measurements
	OG00016.11(13.28 to 19.54) OG00110.72(8.82 to 13.03) OG00213.17(11.48 to 15.12) OG0035.06(3.6 to 7.1)

Title	Measurements
	OG00022.96(17.31 to 30.45) OG00114.29(10.71 to 19.07) OG00218.21(14.86 to 22.31) OG0036.69(4.1 to 10.9)

Title	Measurements
	OG00092.27(68.91 to 123.56) OG00190.06(66.84 to 121.35) OG00291.18(74.04 to 112.3) OG0036.71(3.95 to 11.4)

Title	Measurements
	OG0001159.93(977.33 to 1376.63) OG0011057.66(888.74 to 1258.68) OG0021108.42(981.09 to 1252.27) OG00359.7(44.12 to 80.78)

Title	Measurements
	OG00022.07(18.54 to 26.29) OG00123.46(19.66 to 28) OG00222.75(20.09 to 25.76) OG00312.21(8.98 to 16.62)

Title	Measurements
	OG00025.9(20.13 to 33.32) OG00133.87(26.18 to 43.82) OG00229.53(24.66 to 35.37) OG00313.8(8.92 to 21.35)

Title	Measurements
	OG000112.49(86.26 to 146.71) OG001143.75(109.61 to 188.54) OG002126.84(104.9 to 153.37) OG00315.98(9.85 to 25.93)

Title	Measurements
	OG0001394.65(1176.59 to 1653.11) OG0011883.96(1585.12 to 2239.15) OG0021617.11(1431.93 to 1826.23) OG00355.31(40.9 to 74.8)

Title	Measurements
	OG0009.24(7.81 to 10.94) OG0018.22(6.93 to 9.75) OG0028.72(7.74 to 9.83) OG0034.56(3.39 to 6.13)

Title	Measurements
	OG00010.87(8.26 to 14.32) OG00112.12(9.16 to 16.04) OG00211.47(9.43 to 13.95) OG0034.63(2.88 to 7.44)

Title	Measurements
	OG00063.3(47.73 to 83.95) OG00161.56(46.18 to 82.05) OG00262.44(51.06 to 76.34) OG0036.44(3.86 to 10.76)

Title	Measurements
	OG0001066.66(900.67 to 1263.25) OG0011007.62(848.53 to 1196.54) OG0021037.19(919.46 to 1169.98) OG00337.4(27.75 to 50.42)

Title	Measurements
	OG0004.58(3.49 to 6) OG0013.25(2.46 to 4.28) OG0023.87(3.19 to 4.7) OG0031.09(0.66 to 1.78)

Title	Measurements
	OG00075.02(63.87 to 88.12) OG00180.13(68.09 to 94.3) OG00277.5(69.12 to 86.9) OG00314.14(10.65 to 18.77)

Title	Measurements
	OG0001.12(0.99 to 1.28) OG0011.35(1.19 to 1.54) OG0021.23(1.12 to 1.35) OG0031.21(0.97 to 1.51)

Title	Measurements
	OG0007.25(5.39 to 9.75) OG0017.94(5.87 to 10.73) OG0027.58(6.14 to 9.36) OG0031.45(0.85 to 2.48)

Title	Measurements
	OG00071.72(58.88 to 87.37) OG00197.13(79.51 to 118.65) OG00283.29(72.34 to 95.89) OG00311.81(8.34 to 16.71)

Title	Measurements
	OG0001.05(0.91 to 1.23) OG0011.4(1.2 to 1.63) OG0021.21(1.09 to 1.35) OG0031.14(0.88 to 1.48)

Title	Measurements
	OG0005.71(4.37 to 7.45) OG0016.27(4.78 to 8.23) OG0025.98(4.95 to 7.23) OG0031.32(0.81 to 2.15)

Title	Measurements
	OG00063.63(51.37 to 78.81) OG00180.61(64.88 to 100.14) OG00271.5(61.38 to 83.27) OG0034.57(3.13 to 6.68)

Title	Measurements
	OG0001.35(1.15 to 1.59) OG0011.31(1.11 to 1.54) OG0021.33(1.19 to 1.49) OG0030.99(0.75 to 1.31)

Title	Measurements
	OG0006.09(4.53 to 8.19) OG0018.59(6.37 to 11.59) OG0027.22(5.85 to 8.92) OG0031.48(0.87 to 2.52)

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