A Clinical Trial to Study the Safety, Tolerance and Immun... | NCT01461980

ID	Type	Description	Link
6108A1-2005	Other Identifier	Alias Study Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MCV4 + Tdap+ rLP2086	Active Comparator	Group 1 - MCV4 + Tdap + rLP2086	Biological: rLP2086 + MCV4 + Tdap
MCV4 + Tdap + saline	Active Comparator	Group 2, MCV4 + Tdap+ saline	Biological: MCV4 + Tdap + saline
Saline + saline + rLP2086	Placebo Comparator	Group 3- rLP2086 + saline	Biological: rLP2086 + saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rLP2086 + MCV4 + Tdap	Biological	At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens	Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.	1 Month after Vaccination 1
Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens	Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.	1 Month after Vaccination 1
Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens	Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.	1 Month after Vaccination 1
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3	Antibody hSBA GMTs of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.	1 Month after Vaccination 3

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens	Seroconversion rate for Tdap antigens was defined as greater than or equal to (>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (<=), greater than (>) cutoff value, respectively. For MCV4 antigens >=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value >= lower limit of quantitation (LLOQ), postdose rSBA titers >=2×LLOQ if baseline value was less than (<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.

Other Outcomes

Measure	Description	Time Frame
Immunogloblulin G (IgG) Measured by GMC	IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.	Before Vaccination 1, 1 Month after Vaccination 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study.
Parent /legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
Male or female subject aged greater than or equal to 10 and <13 years at the time of enrollment.
Available for the entire study period and can be reached by telephone.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Has received full series (5-dose series is preferred, 4-dose catch up series is allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per country specific recommendations applicable at the time of receipt.
Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study.

Exclusion Criteria:

Previous vaccination with any meningococcal serogroup B vaccine.
Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the first study vaccination.
Previous vaccination with any MCV4 vaccine.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with MCV4 and/or Tdap vaccine.
Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may not be included.
History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
Current chronic use of systemic antibiotics.
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Radiant Research, Inc.		Birmingham	Alabama	35209	United States
Costal Clinical Research, Inc.

PubMed Identifier	Type	Citation	Retractions
35164991	Derived	Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
32681472	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
BG001	MCV4+Tdap+Saline	Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
BG002	Saline+Saline+rLP2086	Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
BG003	Total	Total of all reporting groups

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

Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens

Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.

Post vaccination 1 evaluable immunogenicity population: eligible participants randomized to Group 1 or 2, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

1 Month after Vaccination 1

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	MCV4+Tdap+Saline	Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.

Units	Counts
Participants	OG000778 OG001780

Title

Denominators

Categories

Diphtheria

Title	Measurements
	OG0009.3(8.67 to 9.92) OG0019.8(9.23 to 10.51)

Tetanus

Title	Measurements
	OG000

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 OG001	Diphtheria: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Diphtheria antigens).					GMC Ratio	0.94			2-Sided	95	0.86	1.03					Non-Inferiority or Equivalence	The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.

Primary

Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens

Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.

Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

1 Month after Vaccination 1

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	MCV4+Tdap+Saline	Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.

Units	Counts
Participants

Primary

Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens

Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.

Post vaccination 1 evaluable immunogenicity population. Here, 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.

Posted

Geometric Mean

95% Confidence Interval

titer

1 Month after Vaccination 1

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	MCV4+Tdap+Saline	Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.

Units	Counts
Participants

Primary

Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3

Antibody hSBA GMTs of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.

Post vaccination 3 evaluable immunogenicity population: eligible participants randomized to Group 1 or 3, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.

Posted

Geometric Mean

95% Confidence Interval

titer

1 Month after Vaccination 3

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	Saline+Saline+rLP2086	Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.

Secondary

Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens

Seroconversion rate for Tdap antigens was defined as greater than or equal to (>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (<=), greater than (>) cutoff value, respectively. For MCV4 antigens >=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value >= lower limit of quantitation (LLOQ), postdose rSBA titers >=2×LLOQ if baseline value was less than (<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.

Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid, determinate assay results for given antigen at specified time point and baseline. 'N' signifies number of participants with seroresponse.

Posted

Number

95% Confidence Interval

percentage of participants

1 Month after Vaccination 1

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	MCV4+Tdap+Saline

Secondary

Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens

Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.

Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid, determinate assay results for given antigen.

Posted

Number

95% Confidence Interval

percentage of participants

1 Month after Vaccination 1

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	MCV4+Tdap+Saline	Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.

Units	Counts
Participants

Secondary

Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2

Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.

Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.

Posted

Geometric Mean

95% Confidence Interval

titer

Before Vaccination 1, 1 Month after Vaccination (Vac) 2

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	Saline+Saline+rLP2086	Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.

Secondary

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)

Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 [A22] and 1:8 for PMB2948 [B24].

Posted

Number

95% Confidence Interval

percentage of participants

Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	Saline+Saline+rLP2086	Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.

Units

Secondary

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level

Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] with hSBA titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 were computed along with corresponding 2-sided 95% CIs.

Posted

Number

95% Confidence Interval

percentage of participants

Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	Saline+Saline+rLP2086	Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.

Units

Other Pre-specified

Immunogloblulin G (IgG) Measured by GMC

IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.

Post vaccination 1 evaluable immunogenicity population.

Posted

Geometric Mean

95% Confidence Interval

microgram per milliliter (mcg/mL)

Before Vaccination 1, 1 Month after Vaccination 1

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	MCV4+Tdap+Saline	Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.

Units	Counts
Participants

Other Pre-specified

Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level

Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point and baseline.

Posted

Number

95% Confidence Interval

percentage of participants

1 Month after Vaccination (Vac) 2, 3

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	Saline+Saline+rLP2086	Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.

Units	Counts
Participants

Other Pre-specified

Percentage of Participants With at Least One Adverse Event (AE)

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.

Safety population included all participants who received at least 1 dose of the investigational product and had safety information available. 'N' signifies participants evaluable for this measure during specified time period.

Posted

Number

percentage of participants

Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)

ID	Title	Description
OG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
OG001	MCV4+Tdap+Saline	Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
OG002	Saline+Saline+rLP2086	Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MCV4+Tdap+rLP2086	Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	15	883	277	883
EG001	MCV4+Tdap+Saline	Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	9	870	260	870
EG002	Saline+Saline+rLP2086	Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.	11	875	292	875

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Adrenogenital syndrome	Congenital, familial and genetic disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Congenital spinal cord anomaly	Congenital, familial and genetic disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0010 affected870 at risk EG0021 affected875 at risk
Appendicitis	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0021 affected875 at risk
Bone abscess	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Gastroenteritis	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Influenza	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0011 affected870 at risk EG0020 affected875 at risk
Pneumonia	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0011 affected870 at risk EG0020 affected875 at risk
Pneumonia viral	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Tooth abscess	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0010 affected870 at risk EG0021 affected875 at risk
Epiphyseal fracture	Injury, poisoning and procedural complications	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0010 affected870 at risk EG0021 affected875 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0011 affected870 at risk EG0020 affected875 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0011 affected870 at risk EG0020 affected875 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0011 affected870 at risk EG0021 affected875 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0010 affected870 at risk EG0021 affected875 at risk
Bone cyst	Musculoskeletal and connective tissue disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0011 affected870 at risk EG0020 affected875 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Convulsion	Nervous system disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0011 affected870 at risk EG0021 affected875 at risk
Dural arteriovenous fistula	Nervous system disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Hemiplegic migraine	Nervous system disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0010 affected870 at risk EG0021 affected875 at risk
Migraine	Nervous system disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0011 affected870 at risk EG0020 affected875 at risk
Syncope	Nervous system disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Affective disorder	Psychiatric disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0011 affected870 at risk EG0020 affected875 at risk
Depression suicidal	Psychiatric disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0011 affected870 at risk EG0020 affected875 at risk
Disorientation	Psychiatric disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0010 affected870 at risk EG0021 affected875 at risk
Encopresis	Psychiatric disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Psychogenic seizure	Psychiatric disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0010 affected870 at risk EG0021 affected875 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0010 affected870 at risk EG0021 affected875 at risk
Haemorrhage	Vascular disorders	MedDRA v 17.1	Non-systematic Assessment	EG0001 affected883 at risk EG0010 affected870 at risk EG0020 affected875 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v 17.1	Non-systematic Assessment	EG0000 affected883 at risk EG0010 affected870 at risk EG0021 affected875 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG00018 affected883 at risk EG00121 affected870 at risk EG00219 affected875 at risk
Nausea	Gastrointestinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG00010 affected883 at risk EG0019 affected870 at risk EG00214 affected875 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG0002 affected883 at risk EG0017 affected870 at risk EG00210 affected875 at risk
Injection site pain	General disorders	MedDRA v 17.1	Non-systematic Assessment	EG00019 affected883 at risk EG00121 affected870 at risk EG00215 affected875 at risk
Pyrexia	General disorders	MedDRA v 17.1	Non-systematic Assessment	EG00020 affected883 at risk EG00114 affected870 at risk EG00217 affected875 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG00047 affected883 at risk EG00161 affected870 at risk EG00270 affected875 at risk
Pharyngitis	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG00038 affected883 at risk EG00127 affected870 at risk EG00228 affected875 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG00023 affected883 at risk EG00120 affected870 at risk EG00230 affected875 at risk
Nasopharyngitis	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG00022 affected883 at risk EG00119 affected870 at risk EG00216 affected875 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG00015 affected883 at risk EG00115 affected870 at risk EG00225 affected875 at risk
Gastroenteritis	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG00015 affected883 at risk EG00120 affected870 at risk EG00216 affected875 at risk
Sinusitis	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG00018 affected883 at risk EG00113 affected870 at risk EG00217 affected875 at risk
Otitis media	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG00017 affected883 at risk EG00111 affected870 at risk EG00214 affected875 at risk
Bronchitis	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG0005 affected883 at risk EG0016 affected870 at risk EG00215 affected875 at risk
Viral infection	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG0004 affected883 at risk EG0017 affected870 at risk EG00212 affected875 at risk
Conjunctivitis	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG0009 affected883 at risk EG0016 affected870 at risk EG0023 affected875 at risk
Otitis externa	Infections and infestations	MedDRA v 17.1	Non-systematic Assessment	EG00017 affected883 at risk EG00111 affected870 at risk EG00214 affected875 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v 17.1	Non-systematic Assessment	EG00012 affected883 at risk EG00113 affected870 at risk EG00216 affected875 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA v 17.1	Non-systematic Assessment	EG00012 affected883 at risk EG00112 affected870 at risk EG00213 affected875 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v 17.1	Non-systematic Assessment	EG0009 affected883 at risk EG0014 affected870 at risk EG0028 affected875 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v 17.1	Non-systematic Assessment	EG0009 affected883 at risk EG0012 affected870 at risk EG0023 affected875 at risk
Headache	Nervous system disorders	MedDRA v 17.1	Non-systematic Assessment	EG00024 affected883 at risk EG00129 affected870 at risk EG00226 affected875 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG00026 affected883 at risk EG00120 affected870 at risk EG00231 affected875 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG00017 affected883 at risk EG00113 affected870 at risk EG00223 affected875 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG0004 affected883 at risk EG0015 affected870 at risk EG00211 affected875 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG0006 affected883 at risk EG0014 affected870 at risk EG00210 affected875 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v 17.1	Non-systematic Assessment	EG0006 affected883 at risk EG0014 affected870 at risk EG0029 affected875 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA v 17.1	Non-systematic Assessment	EG00011 affected883 at risk EG0011 affected870 at risk EG0025 affected875 at risk

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds