Immunogenicity and Safety Study of PriorixTetra™ When Co-... | NCT01506193

ID	Type	Description	Link
2011-001608-37	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).	Biological: PriorixTetra™ Biological: Meningitec
Group B	Experimental	Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).	Biological: PriorixTetra™ Biological: Meningitec
Group C	Active Comparator	Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).	Biological: PriorixTetra™ Biological: Meningitec

Name	Type	Description	Arm Group Labels	Other Names
PriorixTetra™	Biological	One dose administered subcutaneously	Group A Group B Group C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus	Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.	At 42 days after vaccination
Number of Seroprotected Subjects for rSBA-MenC Antibodies	Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.	At 42 days after vaccination

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol.
A male or female between, and including, 13 and 15 months of age at the time of the first vaccination.
Written informed consent obtained from the parent(s)/ LAR of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Child in care.
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C.
History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases.
Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
Major congenital defects or serious chronic illness.
Acute disease and/or fever at the time of enrollment.
Documented human immunodeficiency virus (HIV) positive subject.
Any contraindications as stated in the Summary of Product Characteristics.
Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Rome	Lazio	00165	Italy
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27423382	Derived	Durando P, Esposito S, Bona G, Cuccia M, Desole MG, Ferrera G, Gabutti G, Pellegrino A, Salvini F, Henry O, Povey M, Marchetti F. The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy. Vaccine. 2016 Aug 5;34(36):4278-84. doi: 10.1016/j.vaccine.2016.07.009. Epub 2016 Jul 14.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
BG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
BG002	Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000351 BG001183 BG002182 BG003716

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus

Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.

The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.

Posted

Count of Participants

Participants

At 42 days after vaccination

ID	Title	Description
OG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.

Units	Counts
Participants	OG000309 OG001164

Title

Denominators

Categories

Anti-measles ≥ 150 mIU/mL

- ParticipantsOG000307
- ParticipantsOG001163

Title	Measurements
	OG000305

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	Immune response for anti-measles antibodies Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-measles seroconversion rates (SCRs) at Day 42 after dose 1.					Difference in percentage	-0.04			2-Sided	95	-1.82	2.78					Non-Inferiority or Equivalence	Non-inferiority with respect to seroconversion rates for measles was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [-10%] or higher.

Primary

Number of Seroprotected Subjects for rSBA-MenC Antibodies

Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.

Posted

Count of Participants

Participants

At 42 days after vaccination

ID	Title	Description
OG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG001	Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.

Secondary

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.

The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) post-vaccination period

ID	Title	Description
OG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.

Secondary

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.

Posted

Count of Participants

Participants

During the 15-day (Days 0-14) post-vaccination period

ID	Title	Description
OG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.

Secondary

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were Parotid / salivary gland swelling and suspected signs of meningism / febrile convulsions. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.

Posted

Count of Participants

Participants

During the 43-day (Days 0-42) post-vaccination period

ID	Title	Description
OG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.

Secondary

Number of Subjects Reporting Fever Per Half Degree

Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever > 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination.

The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.

Posted

Count of Participants

Participants

During the 43-day (Days 0-42) post-vaccination period

ID	Title	Description
OG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG002	Meningitec Group

Secondary

Number of Subjects Reporting Any, Localised and Generalised Rashes

Rash/exanthem was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface. 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface or other types of rash (heat rash, diaper rash etc.). Any rash = no lesions and grade 3 = > 150 lesions.

The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets for rash completed.

Posted

Count of Participants

Participants

Within the 43-day (Days 0-42) post-vaccination period

ID	Title	Description
OG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.

Posted

Count of Participants

Participants

Within 43 days (Days 0-42) after each vaccination

ID	Title	Description
OG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.

Posted

Count of Participants

Participants

Throughout study period (from Day 0 to approximately Month 4)

ID	Title	Description
OG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG002	Meningitec Group

Secondary

Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses

Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively.

The analysis was performed on the ATP cohort for immunogenicity post-dose 1 which included all eligible subjects with post-dose 1 serology results available for at least one antigen, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood drawn.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Day 42 after vaccination

ID	Title	Description
OG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
OG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Priorix-Tetra + Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.	6	351	327	351
EG001	Priorix-Tetra Group	Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.	4	183	158	183
EG002	Meningitec Group	Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.	2	182	146	182

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected351 at risk EG0010 events0 affected183 at risk EG0020 events0 affected182 at risk
Febrile convulsion	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected351 at risk EG0010 events0 affected183 at risk EG0020 events0 affected182 at risk
Loss of consciousness	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected351 at risk EG0010 events0 affected183 at risk EG0020 events0 affected182 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected351 at risk EG0010 events0 affected183 at risk EG0020 events0 affected182 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected351 at risk EG0010 events0 affected183 at risk EG0020 events0 affected182 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected351 at risk EG0010 events0 affected183 at risk EG0020 events0 affected182 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected351 at risk EG0011 events1 affected183 at risk EG0020 events0 affected182 at risk
Growth retardation	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected351 at risk EG0010 events0 affected183 at risk EG0020 events0 affected182 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected351 at risk EG0011 events1 affected183 at risk EG0020 events0 affected182 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected351 at risk EG0011 events1 affected183 at risk EG0021 events1 affected182 at risk
Cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected351 at risk EG0011 events1 affected183 at risk EG0020 events0 affected182 at risk
Cellulitis orbital	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected351 at risk EG0010 events0 affected183 at risk EG0021 events1 affected182 at risk
Gastroenteritis adenovirus	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 events1 affected351 at risk EG0010 events0 affected183 at risk EG0020 events0 affected182 at risk
Staphylococcal infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 events0 affected351 at risk EG0011 events1 affected183 at risk EG0020 events0 affected182 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00011 events11 affected351 at risk EG00110 events10 affected183 at risk EG0025 events5 affected182 at risk
Somnolence	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG000148 events148 affected351 at risk EG00189 events89 affected183 at risk EG00256 events56 affected182 at risk
Injection site pain	General disorders	MedDRA 17.0	Systematic Assessment	EG00092 events92 affected351 at risk EG00131 events31 affected183 at risk EG0020 events0 affected182 at risk
Injection site swelling	General disorders	MedDRA 17.0	Systematic Assessment	EG00079 events79 affected351 at risk EG00120 events20 affected183 at risk EG0021 events1 affected182 at risk
Injection site erythema	General disorders	MedDRA 17.0	Systematic Assessment	EG000121 events121 affected351 at risk EG00141 events41 affected183 at risk EG0020 events0 affected182 at risk
Decreased appetite	General disorders	MedDRA 17.0	Systematic Assessment	EG000178 events178 affected351 at risk EG00199 events99 affected183 at risk EG00260 events60 affected182 at risk
Irritability postvaccinal	General disorders	MedDRA 17.0	Systematic Assessment	EG000187 events187 affected351 at risk EG001104 events104 affected183 at risk EG00284 events84 affected182 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG000220 events220 affected351 at risk EG001114 events114 affected183 at risk EG00264 events64 affected182 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00011 events11 affected351 at risk EG00110 events10 affected183 at risk EG0024 events4 affected182 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG00091 events91 affected351 at risk EG00141 events41 affected183 at risk EG00215 events15 affected182 at risk
Pharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00016 events16 affected351 at risk EG00110 events10 affected183 at risk EG0029 events9 affected182 at risk

ID	Term
D018355	Rubivirus Infections
D014036	Togaviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D018185	Morbillivirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D019351	Rubulavirus Infections
D010309	Parotitis
D010305	Parotid Diseases
D012466	Salivary Gland Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

ID	Term
C050102	measles, mumps, rubella, varicella vaccine
C000625559	MenC-CRM vaccine