Immunogenicity and Safety Study of a Quadrivalent Meningo... | NCT03691610

NCT03691610

ID	Type	Description
U1111-1205-2836	Registry Identifier	ICTRP
MET61	Other Identifier	Sanofi Identifier
2019-004460-22	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
Group 1	Experimental	MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age	Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine Biological: Haemophilus b Conjugate Vaccine Biological: Pneumococcal 13-valent Conjugate Vaccine Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Hepatitis B Vaccine Biological: Measles, Mumps, and Rubella Virus Vaccine Live Biological: Varicella Virus Vaccine Live
Group 2	Active Comparator	MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age	Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine Biological: Haemophilus b Conjugate Vaccine Biological: Pneumococcal 13-valent Conjugate Vaccine Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Hepatitis B Vaccine Biological: Measles, Mumps, and Rubella Virus Vaccine Live Biological: Varicella Virus Vaccine Live
Group 3	Experimental	MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine	Biological	Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase from baseline for participant with pre-vaccination hSBA titer >= 1:8.	Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months

Secondary Outcomes

Measure	Description	Time Frame
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Seroprotection rate was defined as percentage of participants with hSBA titers >= 1:8.

Eligibility Module

Eligibility Criteria

Inclusion criteria :

Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the first visit
Informed consent form has been signed and dated by the parent(s) or other guardian and by an independent witness if required by local regulations
Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV), pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines
For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented history of having received all routine pediatric vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment

Exclusion criteria:

Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and / or following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of more than 2 doses of rotavirus vaccine (Rotateq), DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of more than 3 doses of hepatitis B vaccine)
For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the 2 doses of rotavirus vaccine at 2 and 4 months of age
Receipt of immune globulins, blood, or blood-derived products in the past 3 months
Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months
Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated
Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
Individuals with active tuberculosis
History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease
At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
History of intussusception
History of any neurologic disorders, including any seizures and progressive neurologic disorders
History of Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
History of Guillain-Barré syndrome
Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast
Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the investigator's opinion
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C [≥ 100.4 F]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts/Locations Module

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi Pasteur, a Sanofi Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Clinical Therapeutics Site Number : 8400036		Birmingham	Alabama	35205	United States
Southeastern Pediatric Associates Site Number : 8400009

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41792337	Derived	Duffy C, Lyabis O, Dhingra MS, Zambrano B, Chaix J, Syrkina O, B'Chir S, Gupta S, Rehm C. Meningococcal quadrivalent ACYW-TT conjugated vaccine at 6-23 months: phase III study (US/Puerto Rico). Pediatr Res. 2026 Mar 6. doi: 10.1038/s41390-026-04833-8. Online ahead of print.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Infants: Group 1	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 milliliter (mL) intramuscular (IM) injection at 6 to 7 month of age (MoA) and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
FG001

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	May 12, 2022	May 14, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

All randomized participants who received at least 1 dose of the study vaccine.

Arm/Group Information

ID	Title	Description
BG000	Infants: Group 1	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
BG001	Infants: Group 2	Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
BG002	Toddlers: Group 3	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
BG003	Toddlers: Group 4	Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
BG004	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

One participant in 'Infants: Group 1' reporting group had missing value of age.

Mean

Standard Deviation

Units: months

Title	Denominators	Categories
	ParticipantsBG000379 ParticipantsBG001370 ParticipantsBG00296 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000380 ParticipantsBG001370 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000380 ParticipantsBG001370 ParticipantsBG002

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

Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase from baseline for participant with pre-vaccination hSBA titer >= 1:8.

Per-protocol analysis set 2 (PPAS2) was a subset of the full analysis set 2 (FAS2). The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup are reported.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months

ID	Title	Description
OG000	Infants: Group 1	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
OG001	Infants: Group 2	Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

Units	Counts
Participants	OG000143 OG001128

Title

Denominators

Categories

Serogroup A

- ParticipantsOG000141
- ParticipantsOG001123

Title	Measurements
	OG00089.4(83.1 to 93.9)

Secondary

Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Seroprotection rate was defined as percentage of participants with hSBA titers >= 1:8.

The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup are reported.

Posted

Number

95% Confidence Interval

percentage of participants

At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO

ID	Title	Description
OG000	Infants: Group 1	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
OG001	Infants: Group 2	Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

Secondary

Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 and >= 1:8 were analyzed. PPAS1= Per-Protocol Analysis Set 1; FAS1= Full analysis set 1; PPAS3= Per-Protocol Analysis Set 3; and FAS3= Full analysis set 3.

PPAS1 was a subset of FAS1. FAS1 included all randomized participants who received at least 1 dose of study vaccine in infancy (< 12 MOA) and had a valid post vaccination serology result in infancy. PPAS2 analysis set. PPAS3 was a subset of FAS3. FAS3 included all randomized participants who received at least 1 dose of study vaccine in infancy and had a valid pre-vaccination serology result at visit 3. Only participants with data collected for each serogroup at specific timepoint are reported.

Posted

Number

95% Confidence Interval

percentage of participants

PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO

ID	Title	Description
OG000	Infants: Group 1	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
OG001	Infants: Group 2

Secondary

Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.

Posted

Geometric Mean

95% Confidence Interval

titer

ID	Title	Description
OG000	Infants: Group 1	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
OG001	Infants: Group 2	Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

Secondary

Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128

Posted

Number

percentage of participants

ID	Title	Description
OG000	Infants: Group 1	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
OG001	Infants: Group 2	Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

Secondary

Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed.

PPAS1 was a subset of FAS1. FAS1 included all randomized participants who received at least 1 dose of study vaccine in infancy (<12 MOA) and had a valid post vaccination serology result in infancy. PPAS2 was a subset of FAS2. FAS2 included all randomized participants who received at least 1 dose of study vaccine in second year of life (>=12 MOA) and had a valid post vaccination serology result in second year of life. Only participants with data collected for each specific serogroup are reported.

Posted

Number

95% Confidence Interval

percentage of participants

PPAS1: At 30 days post first dose (6 to 7 MoA); and PPAS2: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO

ID	Title	Description
OG000	Infants: Group 1	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
OG001	Infants: Group 2	Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

Secondary

Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as >= 4-fold increase from baseline (pre-vaccination) were analyzed.

The PPAS1 was a subset of the FAS1. The FAS1 included all randomized participants who received at least 1 dose of the study vaccine in infancy (< 12 MOA) and had a valid post vaccination serology result in infancy. Only participants with data collected for each specific serogroup are reported.

Posted

Number

95% Confidence Interval

percentage of participants

At 30 days post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO

ID	Title	Description
OG000	Infants: Group 1	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.
OG001	Infants: Group 2	Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.

Secondary

Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8

Posted

Number

95% Confidence Interval

percentage of participants

Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

ID	Title	Description
OG000	Toddlers: Group 3	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
OG001	Toddlers: Group 4	Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

Units	Counts

Secondary

Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y

Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.

Posted

Geometric Mean

95% Confidence Interval

titer

Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

ID	Title	Description
OG000	Toddlers: Group 3	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
OG001	Toddlers: Group 4	Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

Units	Counts

Secondary

Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128

Posted

Number

percentage of participants

Baseline (Day 0) and at 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

ID	Title	Description
OG000	Toddlers: Group 3	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
OG001	Toddlers: Group 4	Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

Units	Counts

Secondary

Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination

Posted

Number

95% Confidence Interval

percentage of participants

At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

ID	Title	Description
OG000	Toddlers: Group 3	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
OG001	Toddlers: Group 4	Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

Units

Secondary

Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra

Posted

Number

95% Confidence Interval

percentage of participants

At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra

ID	Title	Description
OG000	Toddlers: Group 3	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.
OG001	Toddlers: Group 4	Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Infants: Group 1	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	370	6	370	288	370
EG001	Infants: Group 2	Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age.	361	12	361	257	361
EG002	Toddlers: Group 3	Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W [MenACYW conjugate vaccine]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.	96	1	96	68	96
EG003	Toddlers: Group 4	Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA.	103	4	103	74	103

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Accidental Exposure To Product	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0010 events0 affected361 at risk EG0021 events1 affected96 at risk EG0030 events0 affected103 at risk
Burns First Degree	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0011 events1 affected361 at risk EG0020 events0 affected96 at risk EG003
Febrile Convulsion	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected370 at risk EG0012 events2 affected361 at risk EG0020 events0 affected96 at risk EG003
Abscess Limb	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected370 at risk EG0010 events0 affected361 at risk EG0020 events0 affected96 at risk EG003
Arthritis Bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected370 at risk EG0010 events0 affected361 at risk EG0020 events0 affected96 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected370 at risk EG0012 events2 affected361 at risk EG0020 events0 affected96 at risk EG003
Croup Infectious	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0010 events0 affected361 at risk EG0020 events0 affected96 at risk EG003
Gastroenteritis Escherichia Coli	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0011 events1 affected361 at risk EG0020 events0 affected96 at risk EG003
Gastroenteritis Salmonella	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0011 events1 affected361 at risk EG0020 events0 affected96 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0010 events0 affected361 at risk EG0020 events0 affected96 at risk EG003
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected370 at risk EG0010 events0 affected361 at risk EG0020 events0 affected96 at risk EG003
Pneumonia Parainfluenzae Viral	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0011 events1 affected361 at risk EG0020 events0 affected96 at risk EG003
Respiratory Syncytial Virus Bronchiolitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0012 events2 affected361 at risk EG0020 events0 affected96 at risk EG003
Staphylococcal Scalded Skin Syndrome	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected370 at risk EG0010 events0 affected361 at risk EG0020 events0 affected96 at risk EG003
Viral Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0011 events1 affected361 at risk EG0020 events0 affected96 at risk EG003
Acute Myeloid Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0011 events1 affected361 at risk EG0020 events0 affected96 at risk EG003
Respiratory Depression	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected370 at risk EG0011 events1 affected361 at risk EG0020 events0 affected96 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Somnolence	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG000208 events160 affected370 at risk EG001218 events157 affected361 at risk EG00241 events28 affected96 at risk EG00336 events30 affected103 at risk
Teething	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00044 events29 affected370 at risk EG00142 events25 affected361 at risk EG0021 events1 affected96 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00050 events44 affected370 at risk EG00141 events39 affected361 at risk EG0029 events8 affected96 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG000104 events83 affected370 at risk EG001102 events83 affected361 at risk EG00236 events28 affected96 at risk EG003
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected370 at risk EG0010 events0 affected361 at risk EG0025 events5 affected96 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00022 events20 affected370 at risk EG00116 events11 affected361 at risk EG0021 events1 affected96 at risk EG003
Otitis Media	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00017 events15 affected370 at risk EG00117 events14 affected361 at risk EG0025 events5 affected96 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00045 events41 affected370 at risk EG00144 events40 affected361 at risk EG0024 events3 affected96 at risk EG003
Crying	General disorders	MedDRA 26.0	Systematic Assessment	EG000200 events160 affected370 at risk EG001179 events138 affected361 at risk EG00245 events35 affected96 at risk EG003
Injection Site Bruising	General disorders	MedDRA 26.0	Systematic Assessment	EG00035 events19 affected370 at risk EG00117 events13 affected361 at risk EG0023 events3 affected96 at risk EG003
Injection Site Erythema	General disorders	MedDRA 26.0	Systematic Assessment	EG000479 events151 affected370 at risk EG001460 events138 affected361 at risk EG00241 events29 affected96 at risk EG003
Injection Site Pain	General disorders	MedDRA 26.0	Systematic Assessment	EG000782 events202 affected370 at risk EG001691 events180 affected361 at risk EG00265 events43 affected96 at risk EG003
Injection Site Swelling	General disorders	MedDRA 26.0	Systematic Assessment	EG000361 events125 affected370 at risk EG001331 events105 affected361 at risk EG00234 events23 affected96 at risk EG003
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00083 events68 affected370 at risk EG00181 events71 affected361 at risk EG00228 events18 affected96 at risk EG003
Irritability	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG000289 events202 affected370 at risk EG001264 events186 affected361 at risk EG00265 events44 affected96 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00011 events11 affected370 at risk EG0018 events6 affected361 at risk EG0027 events6 affected96 at risk EG003

First MCP Posted Date

ID	Term
D008589	Meningococcal Infections

ID	Term
D013745	Tetanus Toxoid
C061963	HibTITER protein, Haemophilus influenzae
D017325	Hepatitis B Vaccines
D011054	Poliovirus Vaccine, Inactivated
C538862	13-valent pneumococcal vaccine
D022243	Rotavirus Vaccines
D022542	Measles-Mumps-Rubella Vaccine
D053061	Herpes Zoster Vaccine

Ancestor Terms

ID	Term
D014121	Toxoids
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D014761	Viral Hepatitis Vaccines
D014765	Viral Vaccines
D015164	Vaccines, Inactivated
D023321	Poliovirus Vaccines
D017778	Vaccines, Combined
D008458	Measles Vaccine
D009108	Mumps Vaccine
D012411	Rubella Vaccine
D019433	Chickenpox Vaccine
D022283	Herpesvirus Vaccines

ParticipantsBG004949

ParticipantsBG003104

ParticipantsBG004950

ParticipantsBG003104

ParticipantsBG004950

OG00182.9(75.1 to 89.1)

Units	Counts
Participants	OG000171 OG001160

Units	Counts
Participants	OG000108 OG001112

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