Immunogenicity and Safety of GlaxoSmithKline Biologicals'... | NCT00578175

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Subjects received refrigerator-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation A) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180	Biological: Priorix-Tetra™ (MMRV vaccine 208136) Biological: Havrix® Biological: Prevnar®
Group B	Experimental	Subjects received freezer-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation B) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180	Biological: Priorix-Tetra™ (MMRV vaccine 208136) Biological: Havrix® Biological: Prevnar®
Group C	Active Comparator	Subjects received ProQuad® co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180	Biological: ProQuad® Biological: Havrix® Biological: Prevnar®

Name	Type	Description	Arm Group Labels	Other Names
Priorix-Tetra™ (MMRV vaccine 208136)	Biological	One subcutaneous injection.	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)	Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.	At Day 42 after vaccination
Concentration of Antibodies to Varicella Virus (VZV)	Concentrations are given as Geometric Mean Concentrations (GMCs).	At Day 42 after vaccination
Number of Subjects With Seroresponse for Antibodies to Mumps Virus	Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.	At Day 42 after vaccination
Number of Subjects With Seroresponse for Antibodies to Measles Virus	Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.	At Day 42 after vaccination
Number of Subjects With Seroresponse for Antibodies to Rubella Virus	Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.

Secondary Outcomes

Measure	Description	Time Frame
Antibody Titers to Mumps Virus	Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.	At Day 42 after vaccination
Concentration of Antibodies to Measles Virus

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol.
Male or female between 12 and 14 months of age at the time of first vaccination.
Written informed consent obtained from the parent/guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Have previously received 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life.

Exclusion Criteria:

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
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.
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 from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine.
Previous vaccination against measles, mumps, rubella and/or varicella.
Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
History of measles, mumps, rubella and/or varicella/zoster diseases.
Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination, including human immunodeficiency virus infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures. Uncomplicated febrile convulsions are not an exclusion criterion.
Residence in the same household as the following persons:
- New-born infants (0-4 weeks of age).
- Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox.
- Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history.
- Persons with known immunodeficiency.
Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Contra-indications to commercially available vaccines used in this study (Havrix®, Prevnar®, ProQuad®).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35205	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
22622699	Background	Blatter MM, Klein NP, Shepard JS, Leonardi M, Shapiro S, Schear M, Mufson MA, Martin JM, Varman M, Grogg S, London A, Cambron P, Douha M, Nicholson O, da Costa C, Innis BL. Immunogenicity and safety of two tetravalent (measles, mumps, rubella, varicella) vaccines coadministered with hepatitis a and pneumococcal conjugate vaccines to children twelve to fourteen months of age. Pediatr Infect Dis J. 2012 Aug;31(8):e133-40. doi: 10.1097/INF.0b013e318259fc8a.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
110058	Annotated Case Report Form	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
BG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
BG002	Proquad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
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

Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)

Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Number

subjects

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	Proquad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Units	Counts
Participants	OG000622 OG001630 OG002347

Title

Denominators

Categories

Title	Measurements
	OG000355 OG001440 OG002301

Primary

Concentration of Antibodies to Varicella Virus (VZV)

Concentrations are given as Geometric Mean Concentrations (GMCs).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Geometric Mean

95% Confidence Interval

milli-international units per milliliter

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	Proquad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Primary

Number of Subjects With Seroresponse for Antibodies to Mumps Virus

Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Number

subjects

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	Proquad Group

Primary

Number of Subjects With Seroresponse for Antibodies to Measles Virus

Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Number

subjects

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh. .
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002

Primary

Number of Subjects With Seroresponse for Antibodies to Rubella Virus

Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Number

subjects

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	Proquad Group

Primary

Concentration of Antibodies to Hepatitis A Virus (HAV)

Concentrations are given as Geometric Mean Concentrations (GMCs).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Geometric Mean

95% Confidence Interval

milli-international units per milliliter

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	Proquad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Primary

Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F

Concentrations are given as Geometric Mean Concentrations (GMCs).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Geometric Mean

95% Confidence Interval

micrograms per milliliter (µg/mL)

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	Proquad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Antibody Titers to Mumps Virus

Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Geometric Mean

95% Confidence Interval

titer

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Concentration of Antibodies to Measles Virus

Concentrations are given as Geometric Mean Concentrations (GMCs).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Geometric Mean

95% Confidence Interval

milli-international units per milliliter

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Concentration of Antibodies to Rubella Virus

Concentrations are given as Geometric Mean Concentrations (GMCs).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Geometric Mean

95% Confidence Interval

International units per milliliter

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects With Vaccine Response to Havrix

Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies [concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Number

subjects

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.

Secondary

Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Number

subjects

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Number

subjects

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Number

subjects

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).

Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.

Posted

Number

subjects

At Day 42 after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling.

Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.

Posted

Number

subjects

During the 4 day follow up period following vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination

Fever was measured rectally.

Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.

Posted

Number

subjects

During the 15-day follow-up period following vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination

Fever was measured rectally.

Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.

Posted

Number

subjects

During the 43-day follow-up period following vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash

Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.

Posted

Number

subjects

During the 43-day follow-up period after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects Reporting Investigator-confirmed Varicella-like Rash

Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.

Posted

Number

subjects

During the 43-day follow-up period after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling

Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.

Posted

Number

subjects

During the 43-day follow-up period after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)

Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel.

Analysis was performed on the Total Vaccinated Cohort.

Posted

Number

subjects

During the 43-day follow-up period after vaccination

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.

Secondary

Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits

New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.

Analysis was performed on the Total Vaccinated Cohort.

Posted

Number

subjects

For approximately 6 months (Day 0-180)

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

Secondary

Number of Subjects Reporting Serious Adverse Events

Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Analysis was performed on the Total Vaccinated Cohort.

Posted

Number

subjects

For approximately 6 months (Day 0-180)

ID	Title	Description
OG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
OG002	ProQuad Group

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Refrigerator-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.	705	14	705	547	705
EG001	Freezer-stored Priorix-Tetra Group	Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.	689	20	689	541	689
EG002	Proquad Group	Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.	389	7	389	297	389

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastroenteritis	Infections and infestations	MedDRA (unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0012 affected689 at risk EG0020 affected389 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0012 affected689 at risk EG0020 affected389 at risk
Cellulitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Febrile convulsion	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0012 affected689 at risk EG0020 affected389 at risk
Groin abscess	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0012 affected689 at risk EG0020 affected389 at risk
Pneumonia	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0010 affected689 at risk EG0022 affected389 at risk
Staphylococcal infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Abscess	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Accidental drug intake by child	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Accidental exposure	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Acute sinusitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0010 affected689 at risk EG0021 affected389 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Autism spectrum disorder	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Bronchiolitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0010 affected689 at risk EG0021 affected389 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Convulsion	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Croup infectious	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Ear infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Foreign body trauma	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0010 affected689 at risk EG0021 affected389 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0010 affected689 at risk EG0021 affected389 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Hpoglycaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Otitis media	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Partial seizures	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Periorbital cellulitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0010 affected689 at risk EG0021 affected389 at risk
Perirectal abscess	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0010 affected689 at risk EG0021 affected389 at risk
Pneumonia viral	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Primitive neuroectodermal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Pyrexia	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 affected705 at risk EG0010 affected689 at risk EG0020 affected389 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Viral infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 affected705 at risk EG0011 affected689 at risk EG0020 affected389 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain	General disorders	MedDRA 12.0	Systematic Assessment	EG000136 affected673 at risk EG001114 affected666 at risk EG00265 affected378 at risk
Redness	General disorders	MedDRA 12.0	Systematic Assessment	EG000111 affected673 at risk EG001120 affected666 at risk EG00254 affected378 at risk
Swelling	General disorders	MedDRA 12.0	Systematic Assessment	EG00050 affected673 at risk EG00149 affected666 at risk EG00221 affected378 at risk
Fever	General disorders	MedDRA 12.0	Systematic Assessment	EG000312 affected676 at risk EG001302 affected668 at risk EG002163 affected379 at risk
Rash	General disorders	MedDRA 12.0	Systematic Assessment	EG000221 affected676 at risk EG001219 affected668 at risk EG002128 affected379 at risk
Otitis media	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG00071 affected705 at risk EG00162 affected689 at risk EG00234 affected389 at risk
Uper respiratory tract infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG00049 affected705 at risk EG00158 affected689 at risk EG00242 affected389 at risk
Teething	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00042 affected705 at risk EG00153 affected689 at risk EG00228 affected389 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00037 affected705 at risk EG00146 affected689 at risk EG00229 affected389 at risk
Irritability	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00025 affected705 at risk EG00135 affected689 at risk EG00220 affected389 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00029 affected705 at risk EG00121 affected689 at risk EG00224 affected389 at risk

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

ID	Term
C050102	measles, mumps, rubella, varicella vaccine
D022362	Hepatitis A Vaccines
D000069443	Heptavalent Pneumococcal Conjugate Vaccine

ID	Term
D014761	Viral Hepatitis Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D022242	Pneumococcal Vaccines
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D017778	Vaccines, Combined