Study of Menactra® in Children Aged 4 to 6 Years When Adm... | NCT00355121

NCT00355121

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	DAPTACEL® + IPOL on Day 0 and Menactra on Day 30	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Group 2	Experimental	DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Group 3	Experimental	Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Biological	0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination	Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.	Day 30 post-vaccination (Visit 1)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.	Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)	Day 30 post-vaccination (Visit 1)

Secondary Outcomes

Measure	Description	Time Frame
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1	Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).	Day 30 post-vaccination 1

Other Outcomes

Measure	Description	Time Frame
Geometric Mean Titers Against Poliovirus After IPOL Vaccination.	Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.	Day 30 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy, as determined by medical history and physical examination.
Aged 4 to < 7 years at the time of study vaccination on Day 0.
Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian.
Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.

Exclusion Criteria:

Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic)
Known or suspected impairment of immunologic function
Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment
History of documented invasive meningococcal disease or previous meningococcal vaccination
Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study.
Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment.
Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw.
Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances.
Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.
Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
Enrolled in another clinical trial.
Diagnosed with any condition, which, in the opinion of the physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study.
Personal or family history of Guillain-Barré Syndrome (GBS).

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Sanofi Pasteur Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Little Rock	Arkansas	72205	United States

References Module

Label	URL
Related Info	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Menactra®
DAPTACEL®
IPOL

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
BG001	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
BG002	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30	Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG000353 BG001353 BG002175 BG003

Age Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG0004.5± 0.48 BG0014.5± 0.51 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000172 BG001182 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000353 BG001353 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination

Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.

Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)

Posted

Number

Participants

Day 30 post-vaccination (Visit 1)

ID	Title	Description
OG000	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
OG001	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
OG002	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30	Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2

Units	Counts
Participants	OG000250 OG001238 OG0020

Title

Denominators

Categories

Diphtheria Antibody Concentration ≥ 1.0 IU/mL

Title	Measurements
	OG000249 OG001238

Tetanus Antibody Concentration ≥ 1.0 IU/mL

Title	Measurements
	OG000

Primary

Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.

Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)

Serum antibody titers were assessed in the per-protocol population. (Participants in Group 1 did not receive Menactra vaccine at Visit 1)

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 30 post-vaccination (Visit 1)

ID	Title	Description
OG000	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
OG001	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
OG002	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30

Secondary

Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1

Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).

Serum antibody titers were assessed in the per-protocol population. (Participants in Group 3 did not receive DAPTACEL vaccine at Visit 1)

Posted

Geometric Mean

95% Confidence Interval

EU/mL

Day 30 post-vaccination 1

ID	Title	Description
OG000	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
OG001	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
OG002	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30

Secondary

Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination

Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)

Serum antibody titers were assessed in the per protocol population. Participants in Group 1 received Menactra vaccine at Visit 2, Group 3 at Visit 1.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 30 post-vaccination

ID	Title	Description
OG000	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
OG001	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
OG002	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30

Secondary

Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine

Fever was defined as a maximum oral temperature of ≥ 100.4ºF.

Safety analysis was on enrolled and vaccinated participants with available reaction data, intent-to-treat population.

Posted

Number

Participants

Day 0 through Day 7 post-vaccination at Visit 1

ID	Title	Description
OG000	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
OG001	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
OG002	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30

Other Pre-specified

Geometric Mean Titers Against Poliovirus After IPOL Vaccination.

Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.

Serum antibody titers were assessed in the per-protocol population. (Participants received IPOL at Visit 1 in Group 1 and 3, and at Visit 2 for Group 2

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 30 post-vaccination

ID	Title	Description
OG000	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
OG001	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
OG002	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30	Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2

Other Pre-specified

Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1

Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.

Posted

Number

Participants

Day 0 through Day 7 post-vaccination

ID	Title	Description
OG000	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
OG001	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
OG002	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30

Other Pre-specified

Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2

Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.

Posted

Number

Participants

Day 0 through Day 7 post-vaccination

ID	Title	Description
OG000	Group 1: Menactra on Day 30 (Visit 2)	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
OG001	Group 2: IPOL on Day 30 (Visit 2)	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
OG002	Group 3: DAPTACEL on Day 30 (Visit 2)	Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2	0	341	236	341
EG001	Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30	Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2	2	344	229	344
EG002	Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30	Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2	1	169	98	169

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pancytopenia	Blood and lymphatic system disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected344 at risk EG0020 events0 affected169 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected341 at risk EG0010 events0 affected344 at risk EG0021 events1 affected169 at risk
Rhabdomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Non-systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected344 at risk EG0020 events0 affected169 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection Site Pain	General disorders	MedDRA 9.0	Systematic Assessment	EG000236 events236 affected329 at risk EG001229 events229 affected330 at risk EG00298 events98 affected166 at risk
Injection Site Erythema	General disorders	MedDRA 9.0	Systematic Assessment	EG000161 events161 affected330 at risk EG001161 events161 affected330 at risk EG00242 events42 affected163 at risk
Injection Site Swelling	General disorders	MedDRA 9.0	Systematic Assessment	EG000113 events113 affected330 at risk EG001109 events109 affected329 at risk EG00232 events32 affected162 at risk
Fever	General disorders	MedDRA 9.0	Systematic Assessment	EG00027 events27 affected328 at risk EG00118 events18 affected325 at risk EG00213 events13 affected163 at risk
Malaise	General disorders	MedDRA 9.0	Systematic Assessment	EG00086 events86 affected331 at risk EG00181 events81 affected330 at risk EG00244 events44 affected165 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG000153 events153 affected331 at risk EG001123 events123 affected330 at risk EG00244 events44 affected165 at risk
Headache	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG00048 events48 affected331 at risk EG00142 events42 affected330 at risk EG00222 events22 affected165 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.0	Non-systematic Assessment	EG00014 events14 affected341 at risk EG00118 events18 affected344 at risk EG00210 events10 affected169 at risk
Injection Site Induration	General disorders	MedDRA 9.0	Non-systematic Assessment	EG00022 events22 affected341 at risk EG00116 events16 affected344 at risk EG00212 events12 affected169 at risk
Injection Site Pruritus	General disorders	MedDRA 9.0	Non-systematic Assessment	EG00018 events18 affected341 at risk EG00115 events15 affected344 at risk EG0020 events0 affected169 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG00038 events38 affected341 at risk EG00139 events39 affected343 at risk EG00223 events23 affected169 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Non-systematic Assessment	EG00015 events15 affected341 at risk EG00122 events22 affected343 at risk EG0029 events9 affected169 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 9.0	Non-systematic Assessment	EG0009 events9 affected341 at risk EG00112 events12 affected343 at risk EG00211 events11 affected169 at risk

ID	Term
D008585	Meningitis, Meningococcal
D013742	Tetanus
D004165	Diphtheria
D014917	Whooping Cough
D011051	Poliomyelitis

Ancestor Terms

ID	Term
D016920	Meningitis, Bacterial
D020806	Central Nervous System Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D008589	Meningococcal Infections
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D002494	Central Nervous System Infections
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D008581	Meningitis
D000090862	Neuroinflammatory Diseases
D003015	Clostridium Infections
D016908	Gram-Positive Bacterial Infections
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D001885	Bordetella Infections
D012141	Respiratory Tract Infections
D012140	Respiratory Tract Diseases
D009187	Myelitis
D004769	Enterovirus Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D013118	Spinal Cord Diseases
D009468	Neuromuscular Diseases

ID	Term
C052180	Haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid conjugate
D022401	Meningococcal Vaccines
D022681	Diphtheria-Tetanus-acellular Pertussis Vaccines

Ancestor Terms

ID	Term
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D010567	Pertussis Vaccine
D004168	Diphtheria Toxoid
D014121	Toxoids
D013745	Tetanus Toxoid
D017778	Vaccines, Combined
D022282	Vaccines, Acellular
D022223	Vaccines, Subunit

Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2