Safety and Immunogenicity Evaluation After One or Two Dos... | NCT00667602

NCT00667602

ID	Type	Description	Link
2007-004754-82

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MenACWY-CRM197 (2 doses) + Concomitant Vaccines	Experimental	Infants received two doses of MenACWY-CRM197 at 6 to 8 and 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months.	Biological: MenACWY-CRM197 (two doses) Biological: PCV7 Biological: DTPa-IPV-HepB-Hib
MenACWY-CRM197 (1 dose) + Concomitant Vaccines	Experimental	Infants received one dose of MenACWY-CRM197 at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age.	Biological: PCV7 Biological: DTPa-IPV-HepB-Hib Biological: MenACWY-CRM197 (one dose)
MenC (1 dose) + Concomitant Vaccines	Active Comparator	Infants received one dose of MenC vaccine at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age.	Biological: MenC Biological: PCV7 Biological: DTPa-IPV-HepB-Hib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MenACWY-CRM197 (two doses)	Biological	Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.	MenACWY-CRM197 (2 doses) + Concomitant Vaccines

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C	Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 against N.meningitidis serogroup C.	1 month postvaccination

Secondary Outcomes

Measure	Description	Time Frame
Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C	Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C.	1 month postvaccination

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Site 22		Bad Kreuznach		55543	Germany
Site 38

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33325757	Derived	Giuliani MM, Biolchi A, Keshavan P, Moriondo M, Tomei S, Santini L, Mori E, Brozzi A, Bodini M, Nieddu F, Ricci S, Mzolo T, Costantini M, Azzari C, Pellegrini M. Bactericidal antibodies against hypervirulent Neisseria meningitidis C field strains following MenC-CRM or MenACWY-CRM priming and MenACWY-CRM booster in children. Hum Vaccin Immunother. 2021 May 4;17(5):1442-1449. doi: 10.1080/21645515.2020.1833578. Epub 2020 Dec 16.

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	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
FG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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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

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No data is available for this block.

Masking Info

As one site has been excluded, the number of subjects included in the analysis are MenACWY-CRM197 (2dose) + Concomitant Vaccines N= 196, MenACWY-CRM197 (1dose) + Concomitant Vaccines N= 205 and MenC (1dose) + Concomitant Vaccines N= 193

Arm/Group Information

ID	Title	Description
BG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
BG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
BG002	MenC (1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

Days

Title

Denominators

Categories

Title	Measurements
	OG00083(77 to 89) OG00192(86 to 95)

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	The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥1:8 for serogroup C at 1 month following the 12 months vaccination was greater than -10% .	Miettinen and Nurminen	Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.			Percentage Difference	-8			2-Sided	95	-15	-1				Yes	Non-Inferiority or Equivalence

Secondary

Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C

Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers ≥ 1:4 against N. meningitidis serogroup C.

Analysis was done on PP set.

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month postvaccination

ID	Title	Description
OG000	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenC (1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Units	Counts
Participants	OG000

Secondary

Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y

Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup C.
Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8, ≥ 1:4 against N.meningitidis Serogroup A, W, Y.

Analysis was done on PP set.

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month postvaccination.

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenC (1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Units	Counts

Secondary

Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y

Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) ≥ 1:8 and titer ≥ 1:4 by serogroups A, W, Y.

Serogroup C is not shown here as it is shown in other outcome measures.

Analysis was done on PP set.

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month postvaccination.

ID	Title	Description
OG000	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Units	Counts
Participants	OG000

Secondary

Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C

Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C.

Analysis was done on PP set.

Posted

Mean

95% Confidence Interval

Titers

1 month postvaccination

ID	Title	Description
OG000	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenC (1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Units	Counts
Participants	OG000

Secondary

Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y

Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y.

Analysis was done on PP set.

Posted

Geometric Mean

95% Confidence Interval

Titers

1 month postvaccination

ID	Title	Description
OG000	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Units	Counts
Participants	OG000

Secondary

Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y

The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C.
The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y.

Analysis was done on PP set.

Posted

Geometric Mean

95% Confidence Interval

Titers

1 month postvaccination

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenC (1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Units	Counts
Participants

Secondary

Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine)

The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed.

For Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration < LLQ) is defined as post-vaccination antibody concentration >= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration >=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration.

Diptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.

Polio type 1, 2 and 3: bNT (neutralization test) with >=1:8.

HepB (HBV): primary endpoint ELISA >=10mU/mL.

PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.

Analysis was done on PP set.

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month postvaccination

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and concomitant dose of PCV7 and DTPa-IPV-HepBHib at 12 months.

Secondary

Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine)

To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age.

Seroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA ≥ 0.35 mcg/mL and secondary endpoint ELISA ≥ 1.0 mcg/mL.

Analysis was done on PP set.

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month postvaccination

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG002	MenC (1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Secondary

Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C

Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers ≥ 1:8, and titers ≥ 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).

Analysis was done on PP set (persistence subgroup).

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month postvaccination and 6-18 months postvaccination.

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG002	MenC (1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Secondary

Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y

Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer ≥ 1:8 and titer ≥ 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia).

Analysis was done on PP set (persistence subset).

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month postvaccination 6-18 months postvaccination

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Units	Counts
Participants

Secondary

Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C

Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia).

Analysis was done on PP set (subjects enrolled in Australia).

Posted

Geometric Mean

95% Confidence Interval

Titers

1 month postvaccination and 6-18 months postvaccination.

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG002	MenC(1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Secondary

Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y

Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia).

Analysis was done on PP set (only for subjects enrolled in Australia).

Posted

Geometric Mean

95% Confidence Interval

Titers

6-18 months postvaccination.

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Units	Counts
Participants	OG000

Secondary

Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C

Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.
Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup C.

Analysis was done on PP set.

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month postvaccination.

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG002	MenC (1dose) + Concomitant Vaccines

Secondary

Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y

Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.
Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) ≥ 1:8, ≥ 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.

Analysis was done on PP set.

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month postvaccination.

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Secondary

Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C

Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.
Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.

Analysis was done on PP set.

Posted

Geometric Mean

95% Confidence Interval

Titers

1 month postvaccination.

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG002	MenC (1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Secondary

Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y

Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y.
Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y.

Analysis was done on PP set.

Posted

Geometric Mean

95% Confidence Interval

Titers

1 month postvaccination.

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Units	Counts
Participants

Secondary

Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination

Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups.

safety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups

Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.

Posted

Number

Number of subjects

From day 1 to day 7 postvaccination

ID	Title	Description
OG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.
OG002	MenC (1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MenACWY-CRM197 (2dose) + Concomitant Vaccines	Infants received two doses of MenACWY-CRM197 at 6-8 months and 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	13	195	192	195
EG001	MenACWY-CRM197 (1dose) + Concomitant Vaccines	Infants received one dose of MenACWY-CRM197 at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	19	192	184	192
EG002	MenC (1dose) + Concomitant Vaccines	Infants received one dose of MenC vaccine at 12 months and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.	12	179	170	179

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Amphthous stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected192 at risk EG0020 affected179 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Intussusception	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected192 at risk EG0020 affected179 at risk
Stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0010 affected192 at risk EG0021 affected179 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0012 affected192 at risk EG0020 affected179 at risk
Hyperpyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Food Allergy	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0010 affected192 at risk EG0021 affected179 at risk
Appendicitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected195 at risk EG0013 affected192 at risk EG0020 affected179 at risk
Croup infectious	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0010 affected192 at risk EG0021 affected179 at risk
Febrile infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0010 affected192 at risk EG0021 affected179 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0003 affected195 at risk EG0014 affected192 at risk EG0024 affected179 at risk
Influenza	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Malaria	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected195 at risk EG0010 affected192 at risk EG0020 affected179 at risk
Otitis media	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected192 at risk EG0023 affected179 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0010 affected192 at risk EG0021 affected179 at risk
Tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Viral infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0010 affected192 at risk EG0021 affected179 at risk
Accidental exposure	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected195 at risk EG0012 affected192 at risk EG0020 affected179 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0010 affected192 at risk EG0021 affected179 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected192 at risk EG0021 affected179 at risk
Neuroblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected192 at risk EG0020 affected179 at risk
Febrile convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected195 at risk EG0011 affected192 at risk EG0021 affected179 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected195 at risk EG0010 affected192 at risk EG0020 affected179 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Conjunctivitis	Eye disorders	MedDRA	Non-systematic Assessment	EG00036 affected195 at risk EG00115 affected192 at risk EG00218 affected179 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00054 affected195 at risk EG00144 affected192 at risk EG00244 affected179 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00013 affected195 at risk EG0014 affected192 at risk EG0025 affected179 at risk
Teething	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00021 affected195 at risk EG0016 affected192 at risk EG0027 affected179 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00038 affected195 at risk EG00124 affected192 at risk EG00219 affected179 at risk
Injection site erythema	General disorders	MedDRA	Systematic Assessment	EG000110 affected195 at risk EG001102 affected192 at risk EG002110 affected179 at risk
Injection site induration	General disorders	MedDRA	Systematic Assessment	EG00086 affected195 at risk EG00182 affected192 at risk EG002104 affected179 at risk
Injection site pain	General disorders	MedDRA	Systematic Assessment	EG00090 affected195 at risk EG00197 affected192 at risk EG00284 affected179 at risk
Irritability	General disorders	MedDRA	Systematic Assessment	EG00085 affected195 at risk EG00168 affected192 at risk EG00273 affected179 at risk
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG000127 affected195 at risk EG001111 affected192 at risk EG002102 affected179 at risk
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00047 affected195 at risk EG00129 affected192 at risk EG00229 affected179 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00022 affected195 at risk EG00114 affected192 at risk EG00212 affected179 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00019 affected195 at risk EG00114 affected192 at risk EG00214 affected179 at risk
Otitis media	Infections and infestations	MedDRA	Non-systematic Assessment	EG00033 affected195 at risk EG00122 affected192 at risk EG00221 affected179 at risk
Rhinitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00024 affected195 at risk EG0017 affected192 at risk EG0028 affected179 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG00067 affected195 at risk EG00131 affected192 at risk EG00229 affected179 at risk
Viral infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG00038 affected195 at risk EG00126 affected192 at risk EG00226 affected179 at risk
Crying	Nervous system disorders	MedDRA	Systematic Assessment	EG000100 affected195 at risk EG00193 affected192 at risk EG00276 affected179 at risk
Somnolence	Nervous system disorders	MedDRA	Non-systematic Assessment	EG000126 affected195 at risk EG00199 affected192 at risk EG00294 affected179 at risk
Eating disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG00087 affected195 at risk EG00166 affected192 at risk EG00249 affected179 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00025 affected195 at risk EG00111 affected192 at risk EG00210 affected179 at risk
Dermatitis Diaper	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG00024 affected195 at risk EG00120 affected192 at risk EG0029 affected179 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00028 affected195 at risk EG00124 affected192 at risk EG0027 affected179 at risk

GCP compliance issues were identified at one site, data collected for this site were not used in this data posting.

Certain Agreements

ID	Term
D008585	Meningitis, Meningococcal
D008581	Meningitis

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
D000090862	Neuroinflammatory Diseases

(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)

Units	Counts
Participants	OG000163 OG001168 OG002150

Units	Counts
Participants	OG00017 OG00114 OG00213

Infants received one dose of MenC vaccine and Concomitant dose of PCV7 and DTPa-IPV-HepB-Hib at 12 months.