Immunogenicity and Safety Study of GSK Biologicals' Menin... | NCT01165242

NCT01165242

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

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 A	Experimental	Subjects were vaccinated with vaccine GSK134612 Lot A	Biological: Meningococcal vaccine GSK 134612
Group B	Experimental	Subjects were vaccinated with vaccine GSK134612 Lot B	Biological: Meningococcal vaccine GSK 134612
Group C	Active Comparator	Subjects were vaccinated with Menactra®	Biological: Menactra®

Name	Type	Description	Arm Group Labels	Other Names
Meningococcal vaccine GSK 134612	Biological	One intramuscular injection	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies	Vaccine response was defined as: for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.	One month after vaccination (Month 1)

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value	The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4.	Prior to (PRE) and one month after vaccination (Month 1)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subjects must satisfy ALL of the following criteria at study entry:

Subjects whom the investigator believes that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
A male or female between, and including, 10 and 25 years of age at the time of the vaccination.
Written informed consent obtained from the subject/from the parent or Legally Acceptable Representative(s) of the subject. Assent will be obtained from subjects who are still legally minors in line with local rules and regulations.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Previously completed routine childhood vaccinations to the best of subject's/Legally Acceptable Representative(s)'s knowledge.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception for 2 months after vaccination.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone <10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed.)
Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine.
Previous vaccination with meningococcal polysaccharide or conjugate vaccine.
Previous vaccination with vaccine components within the last month.
History of meningococcal disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection, based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
History of allergic reactions or disease likely to be exacerbated by any component of either vaccine, or by dry natural rubber latex.
History of any neurologic disorders, including Guillain-Barré Syndrome.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrollment.
Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Child in care.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Chandler	Arizona	85224	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24567843	Derived	Halperin SA, Baine Y, Domachowske JB, Aggarwal N, Simon M, Langley JM, McNeil SA, Friedland LR, Bianco V, Baccarini CI, Miller JM. Comparison of the Safety and Immunogenicity of a Novel Quadrivalent Meningococcal ACWY-Tetanus Toxoid Conjugate Vaccine and a Marketed Quadrivalent Meningococcal ACWY-Diphtheria Toxoid Conjugate Vaccine in Healthy Individuals 10-25 Years of Age. J Pediatric Infect Dis Soc. 2014 Mar;3(1):33-42. doi: 10.1093/jpids/pit058. Epub 2013 Oct 17.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
114249	Statistical Analysis Plan	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
FG001	Nimenrix Lot B 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

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	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
BG001	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
BG002	Menactra Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
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

Title	Measurements
	BG00016.4± 5.16 BG00116.3± 5.16 BG00216.2± 4.97 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000175 BG001169 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Geographic ancestry

Title	Measurements
African Heritage/ African American	BG00038 BG00129 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 Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies

Vaccine response was defined as:

for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination;
for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Posted

Count of Participants

Participants

One month after vaccination (Month 1)

ID	Title	Description
OG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Units	Counts
Participants	OG000310 OG001297

Title

Denominators

Categories

hSBA-MenA

- ParticipantsOG000310
- ParticipantsOG001297

Title	Measurements
	OG000218

Secondary

Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value

The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.

Posted

Count of Participants

Participants

Prior to (PRE) and one month after vaccination (Month 1)

ID	Title	Description
OG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Menactra Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value

The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:8.

Posted

Count of Participants

Participants

Prior to (PRE) and one month after vaccination (Month 1)

ID	Title	Description
OG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Menactra Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Secondary

hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers

Antibody titers are presented as geometric mean titers (GMTs).

Posted

Geometric Mean

95% Confidence Interval

Titers

Prior to (PRE) and one month after vaccination (Month 1)

ID	Title	Description
OG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Menactra Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies

Vaccine response was defined as: -for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; -for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.

Posted

Count of Participants

Participants

One month after vaccination (Month 1)

ID	Title	Description
OG000	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, who had their symptom sheets filled in.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) post-vaccination period

ID	Title	Description
OG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Menactra Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, who had their symptom sheets filled in.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) post-vaccination period

ID	Title	Description
OG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Menactra Group

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

Within 31 days (Day 0-30) post-vaccination

ID	Title	Description
OG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Menactra Group

Secondary

Number of Subjects With New Onset of Chronic Illness(es) (NOCI)

NOCI included hypersensitivity, insulin resistance, asthma and bronchial hyperreactivity.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

From Month 0 through Month 6

ID	Title	Description
OG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Menactra Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With Any Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

From Month 0 through Month 6

ID	Title	Description
OG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Menactra Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nimenrix Lot A Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	337	1	337	232	337
EG001	Nimenrix Lot B Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	336	5	336	219	336
EG002	Menactra Group	Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.	338	2	338	234	338

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected337 at risk EG0010 affected336 at risk EG0021 affected338 at risk
Post-procedural haematoma	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected337 at risk EG0010 affected336 at risk EG0021 affected338 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected337 at risk EG0011 affected336 at risk EG0020 affected338 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected337 at risk EG0011 affected336 at risk EG0020 affected338 at risk
Appendicitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected337 at risk EG0012 affected336 at risk EG0020 affected338 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected337 at risk EG0012 affected336 at risk EG0020 affected338 at risk
Influenza	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected337 at risk EG0011 affected336 at risk EG0020 affected338 at risk
Tooth infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected337 at risk EG0011 affected336 at risk EG0020 affected338 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pain	General disorders	MedDRA 10.0	Systematic Assessment	This solicited local symptom was only collected from subjects with their symptom sheets completed.	EG000169 affected329 at risk EG001167 affected329 at risk EG002180 affected325 at risk
Redness	General disorders	MedDRA 10.0	Systematic Assessment	This solicited local symptom was only collected from subjects with their symptom sheets completed.	EG00085 affected329 at risk EG00160 affected329 at risk EG00266 affected325 at risk
Swelling	General disorders	MedDRA 10.0	Systematic Assessment	This solicited local symptom was only collected from subjects with their symptom sheets completed.	EG00063 affected329 at risk EG00140 affected329 at risk EG00244 affected325 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	This solicited general symptom was only collected from subjects with their symptom sheets completed.	EG00096 affected329 at risk EG00194 affected329 at risk EG00289 affected326 at risk
Gastrointestinal	General disorders	MedDRA 10.0	Systematic Assessment	This solicited general symptom was only collected from subjects with their symptom sheets completed.	EG00043 affected329 at risk EG00143 affected329 at risk EG00244 affected326 at risk
Headache	General disorders	MedDRA 10.0	Systematic Assessment	This solicited general symptom was only collected from subjects with their symptom sheets completed.	EG00086 affected329 at risk EG00187 affected329 at risk EG00283 affected326 at risk
Temperature (Orally)	General disorders	MedDRA 10.0	Systematic Assessment	This solicited general symptom was only collected from subjects with their symptom sheets completed.	EG00017 affected329 at risk EG00114 affected329 at risk EG00216 affected326 at risk

ID	Term
D008589	Meningococcal Infections

ID	Term
D022401	Meningococcal Vaccines

Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Units	Counts
Participants	OG000337 OG001336 OG002338

Units	Counts
Participants	OG000337 OG001336 OG002338

OG00149.6(39.6 to 62.1)

OG00241.3(32.3 to 52.9)

OG00116.0(12.8 to 20.0)

OG00218.0(14.4 to 22.6)

OG001755.8(557.3 to 1025.0)

OG002543.3(411.2 to 718.0)

OG0017.6(6.0 to 9.6)

OG0027.4(5.9 to 9.2)

OG001161.6(128.3 to 203.5)

OG002101.7(77.9 to 132.7)

OG00149.8(39.1 to 63.4)

OG00255.3(43.7 to 69.9)

OG001387.4(329.7 to 455.1)

OG002253.8(204.9 to 314.5)

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

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