Safety and Immune Response of Novartis MenACWY-CRM Conjug... | NCT00626327

ID	Type	Description	Link
BB-IND 11278

Status Module

Label	Type	Intervention Names
MenACWY-CRM+ MMRV	Experimental	Biological: MenACWY-CRM + MMRV
MMRV	Active Comparator	Biological: MMRV
MenACWY-CRM	Experimental	Biological: MenACWY-CRM

Name	Type	Description	Arm Group Labels	Other Names
MenACWY-CRM + MMRV	Biological	One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine	Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported. Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5 gp ELISA units/mL) for varicella. Immunogenicity to measles, mumps, rubella and varicella at 6 weeks after vaccination with one dose of MMRV given concomitantly with MenACWY-CRM was considered non-inferior to immunogenicity of MMRV administered alone if the lower limit of two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles, mumps, and rubella, and seroprotection for varicella was greater than -5% (measles, mumps and rubella) and -10% (varicella).	6 weeks post vaccination
Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.	Percentages of subjects with hSBA ≥1:8, against N.meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) when concomitantly administered with MMRV vaccine (12 months) compared to when MenACWY-CRM vaccine was given alone, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups A, C, W-135, and Y, were measured by human complement Serum Bactericidal Assay (hSBA). The immune response of MenACWY-CRM given concomitantly with MMRV was considered non-inferior to the immunogenicity of MenACWY-CRM administered alone if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12-month old toddlers {P MMRV+MenACWY minus P MenACWY} was greater than -10% for each serogroup.	6 weeks post second dose
Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine

Secondary Outcomes

Measure	Description	Time Frame
Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine	The percentages of subjects with hSBA ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 and 12 months of age) when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.	6 weeks post vaccine dose 2

Eligibility Module

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive		Birmingham	Alabama	35205	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MenACWY-CRM+ MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
FG001	MMRV	Subjects in this group received 1 injection of MMRV vaccine at 12 months of age

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	MenACWY-CRM+ MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
BG001	MMRV	Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
BG002	MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
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

Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine

Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.

Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5 gp ELISA units/mL) for varicella.

Immunogenicity to measles, mumps, rubella and varicella at 6 weeks after vaccination with one dose of MMRV given concomitantly with MenACWY-CRM was considered non-inferior to immunogenicity of MMRV administered alone if the lower limit of two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles, mumps, and rubella, and seroprotection for varicella was greater than -5% (measles, mumps and rubella) and -10% (varicella).

The analysis was performed on the MMRV per-protocol population

Posted

Number

95% Confidence Interval

Percentages of subjects

6 weeks post vaccination

ID	Title	Description
OG000	MenACWY-CRM+ MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
OG001	MMRV	Subjects in this group received 1 injection of MMRV vaccine at 12 months of age

Units	Counts
Participants	OG000370 OG001515

Title

Denominators

Categories

Measles (N=350,467)

Title	Measurements
	OG00098(96 to 99) OG00199(98 to 100)

Mumps (N=365,499)

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	Non-inferiority of immune response to measles following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV given alone.					Difference % (MenACWY-CRM+MMRV-MMRV)	-1			2-Sided	95	-3.4	0.5				Yes	Non-Inferiority or Equivalence	The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles was greater than -5%, at 6 weeks after MMRV vaccination.

Primary

Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.

Percentages of subjects with hSBA ≥1:8, against N.meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) when concomitantly administered with MMRV vaccine (12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.

The serum bactericidal antibodies directed against N.meningitidis serogroups A, C, W-135, and Y, were measured by human complement Serum Bactericidal Assay (hSBA).

The immune response of MenACWY-CRM given concomitantly with MMRV was considered non-inferior to the immunogenicity of MenACWY-CRM administered alone if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12-month old toddlers {P MMRV+MenACWY minus P MenACWY} was greater than -10% for each serogroup.

The analysis was performed on the MenACWY per-protocol population

Posted

Number

95% Confidence Interval

Percentages of subjects

6 weeks post second dose

ID	Title	Description
OG000	MenACWY-CRM+ MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
OG001	MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months

Primary

Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine

The antibody response following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) was considered adequate if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA ≥1:8, at 6 weeks following the second dose of MenACWY-CRM, was greater than 85% for serogroups C, W-135, or Y and greater than 65% for serogroup A.

The analysis was performed on the MenACWY per-protocol population

Posted

Number

95% Confidence Interval

Percentages of subjects

6 weeks post vaccine dose 2

ID	Title	Description
OG000	MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months

Units	Counts
Participants	OG000

Secondary

Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine

The percentages of subjects with hSBA ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 and 12 months of age) when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.

The analysis was performed on the MenACWY per-protocol population

Posted

Number

95% Confidence Interval

Percentages of subjects

6 weeks post vaccine dose 2

ID	Title	Description
OG000	MenACWY-CRM+MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
OG001	MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine

The geometric mean titers (GMTs) directed against N.meningitidis serogroups A, C, W-135 and Y, following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months of age), when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.

The analysis was performed on the MenACWY per-protocol population

Posted

Geometric Mean

95% Confidence Interval

Titers

6 weeks post vaccine dose 2

ID	Title	Description
OG000	MenACWY-CRM + MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
OG001	MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.

Units	Counts
Participants

Secondary

Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.

The GMTs directed against measles, mumps, rubella and varicella, following one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.

The analysis was performed on the MMRV per-protocol population.

Only subjects with a baseline titer below the specified cut-off for that antigen were included in the immunogenicity analysis for the same antigen.

Posted

Geometric Mean

95% Confidence Interval

Titers

6 weeks post vaccination

ID	Title	Description
OG000	MenACWY-CRM+ MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
OG001	MMRV	Subjects in this group received 1 injection of MMRV vaccine at 12 months of age

Units	Counts
Participants

Secondary

Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.

The percentages of subjects showing seroconversion response to varicella after concomitant administration of MMRV vaccine (at 12 months) with MenACWY-CRM vaccine compared to when MMRV vaccine is given alone, is reported .

Seroconversion for varicella is defined as percentage of subjects who show pre-vaccination antibody titer <1.25 gp ELISA units/mL to a post-vaccination antibody titer ≥1.25 gp ELISA units/mL.

The analysis was performed on the MMRV per-protocol population

Posted

Number

95% Confidence Interval

Percentages of subjects

6 weeks post vaccination

ID	Title	Description
OG000	MenACWY-CRM +MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
OG001	MMRV	Subjects in this group received 1 injection of MMRV vaccine at 12 months of age

Units	Counts
Participants

Secondary

Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine

The percentages of subjects with hSBA ≥1:4 and hSBA ≥1:8 after one dose of MenACWY-CRM vaccine (at 7-9 months), are reported

The analysis was performed on the MenACWY per-protocol population

Posted

Number

95% Confidence Interval

Percentages of subjects

1 month post vaccine dose 1

ID	Title	Description
OG000	MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine

The immunogenicity of one dose of MenACWY-CRM vaccine given at 7 to 9 months of age was assessed in terms of GMTs directed against N.meningitidis serogroups A, C, W-135, and Y.

The analysis was performed on the MenACWY per-protocol population

Posted

Geometric Mean

95% Confidence Interval

Titers

1 month post vaccine dose 1

ID	Title	Description
OG000	MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months.

Units	Counts
Participants	OG000

Secondary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination

Safety and tolerability of MenACWY-CRM and MMRV vaccines when given concomitantly compared to when either MenACWY-CRM or MMRV vaccine was administered alone is reported in terms of the number of subjects with local and systemic adverse events after vaccination.

Systemic reactions including axillary temperature reported during 28 days after vaccination at 12 months of age. These included the following systemic reactions: Measles-like rash, Rubella-like rash, Varicellalike rash, injection site rash, Mumps-like symptoms and axillary temperature.

The analysis was performed on the safety set population

Posted

Number

Participants

upto 7 days after any vaccination

ID	Title	Description
OG000	MenACWY-CRM+MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
OG001	MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months
OG002	MMRV	Subjects in this group received 1 injection of MMRV vaccine at 12 months of age

Secondary

Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

The safety profile of MenACWY-CRM and MMRV vaccines when given concomitantly as compared to when MenACWY-CRM or MMRV was given alone is reported in terms of number of subjects reporting unsolicited adverse events (AEs), medically significant adverse events and serious adverse events (SAEs) after vaccination.

This analysis was done on the safety set population

Posted

Number

Participants

Day 1- Day 180 (Through out the study)

ID	Title	Description
OG000	MenACWY-CRM+ MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV
OG001	MMRV	Subjects in this group received 1 injection of MMRV vaccine at 12 months of age
OG002	MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MenACWY-CRM+ MMRV	Subjects in this group received 2 injections of MenACWY-CRM at 7-9 and 12 months; second injection administered concomitantly with MMRV	18	500	433	500
EG001	MMRV	Subjects in this group received 1 injection of MMRV vaccine at 12 months of age	9	597	482	597
EG002	MenACWY-CRM	Subjects in this group received 2 injections of the MenACWY-CRM vaccine at 7-9 and 12 months of age followed by 1 injection of MMRV at 13.5 months	19	500	442	500

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Systemic inflamatory response syndrome	General disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Arthritis bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
CROUP infectious	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0012 events2 affected597 at risk EG0020 events0 affected500 at risk
Empyema	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 events2 affected500 at risk EG0010 events0 affected597 at risk EG0023 events3 affected500 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Impetigo	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Pneumonia viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Postoperative wound infections	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0012 events2 affected597 at risk EG0021 events1 affected500 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0021 events1 affected500 at risk
Sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0022 events2 affected500 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Toxic shock syndrome	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Viral infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0003 events3 affected500 at risk EG0011 events1 affected597 at risk EG0023 events3 affected500 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Feeding disorder	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Febrile convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0022 events2 affected500 at risk
Grand mal convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Tethered cord syndrome	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0021 events1 affected500 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected500 at risk EG0010 events0 affected597 at risk EG0020 events0 affected500 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected500 at risk EG0011 events1 affected597 at risk EG0020 events0 affected500 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000125 events125 affected500 at risk EG001114 events114 affected597 at risk EG002128 events128 affected500 at risk
Teething	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00041 events41 affected500 at risk EG00141 events41 affected597 at risk EG00260 events60 affected500 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00068 events68 affected500 at risk EG00143 events43 affected597 at risk EG00279 events79 affected500 at risk
Injection site erythema	General disorders	MedDRA	Systematic Assessment	EG000219 events219 affected500 at risk EG001224 events224 affected597 at risk EG002230 events230 affected500 at risk
Injection site induration	General disorders	MedDRA	Systematic Assessment	EG000128 events128 affected500 at risk EG001102 events102 affected597 at risk EG002115 events115 affected500 at risk
Injection site pain	General disorders	MedDRA	Systematic Assessment	EG000163 events163 affected500 at risk EG001180 events180 affected597 at risk EG002188 events188 affected500 at risk
Irritability	General disorders	MedDRA	Systematic Assessment	EG000273 events273 affected500 at risk EG001299 events299 affected597 at risk EG002299 events299 affected500 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00090 events90 affected500 at risk EG00170 events70 affected597 at risk EG002114 events114 affected500 at risk
Otitis media	Infections and infestations	MedDRA	Non-systematic Assessment	EG00092 events92 affected500 at risk EG00140 events40 affected597 at risk EG002120 events120 affected500 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG00071 events71 affected500 at risk EG00120 events20 affected597 at risk EG00292 events92 affected500 at risk
Crying	Nervous system disorders		Systematic Assessment	EG000135 events135 affected500 at risk EG001109 events109 affected597 at risk EG002152 events152 affected500 at risk
Somnolence	Nervous system disorders	MedDRA	Systematic Assessment	EG000219 events219 affected500 at risk EG001197 events197 affected597 at risk EG002199 events199 affected500 at risk
Eating disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG000132 events132 affected500 at risk EG001105 events105 affected597 at risk EG002136 events136 affected500 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG00026 events26 affected500 at risk EG00129 events29 affected597 at risk EG00230 events30 affected500 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00076 events76 affected500 at risk EG00187 events87 affected597 at risk EG00252 events52 affected500 at risk

Ancestor Terms

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000090862	Neuroinflammatory Diseases
D009422	Nervous System Diseases
D018185	Morbillivirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D019351	Rubulavirus Infections
D010309	Parotitis
D010305	Parotid Diseases
D012466	Salivary Gland Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D018355	Rubivirus Infections
D014036	Togaviridae Infections
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections

ID	Term
D008589	Meningococcal Infections
D008581	Meningitis
D008457	Measles
D009107	Mumps
D012409	Rubella
D002644	Chickenpox

ID	Term
C050102	measles, mumps, rubella, varicella vaccine
C556088	MenACWY-CRM vaccine