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Clinical Trial Results:
Immunogenicity of GlaxoSmithKline Biologicals’ MMR vaccine (209762) vs. M-M-R® II, when co-administered with hepatitis A, varicella and pneumococcal conjugate vaccines to children 12-15 months of age

Summary
EudraCT number	2011-005860-31
Trial protocol	Outside EU/EEA
Global end of trial date	18 Jun 2012

Results information
Results version number	v1
This version publication date	11 May 2016
First version publication date	31 Jul 2015
Other versions	v2

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

111870

ISRCTN number

US NCT number

NCT00861744

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

14 Jun 2013

Is this the analysis of the primary completion data?

Yes

Primary completion date

21 Jul 2010

Global end of trial reached?

Yes

Global end of trial date

18 Jun 2012

Was the trial ended prematurely?

Main objective of the trial

To assess GSK’s candidate MMR vaccine formulated with a range of mumps virus potencies, co-administered with HAV, VV and PCV in contrast to MMRII co-administered with HAV, VV and PCV with respect to the seroresponse† rate for antibodies to measles virus, mumps virus and rubella virus at Day 42.

Protection of trial subjects

Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.

Background therapy

Evidence for comparator

Actual start date of recruitment

03 Jun 2009

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy

Long term follow-up duration

23 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 1259

Worldwide total number of subjects

1259

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

1259

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was divided in 3 phases: the active phase (up to Day 42), the extended safety follow-up (ESFU) phase (up to Day 180) and the antibody persistence phase (up to Day 730).

Screening details

The number of subjects enrolled was 1259. 39 subjects were enrolled in the study but did not receive a subject number and were never vaccinated.

Number of subjects started

1259

Number of subjects completed

1220

Reason: Number of subjects

Not allocated to a study group: 35

Reason: Number of subjects

No vaccine received: 4

Period 1 title

Overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind ^[1]

Roles blinded

Subject, Carer, Assessor

Blinding implementation details

The study was conducted in an observer blind manner in which the subject and the study personnel involved in the clinical evaluation of the subjects were blinded while other study personnel (investigator) were aware of the treatment allocation.

Are arms mutually exclusive

Yes

Priorix 1 Group

Arm description

Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

Arm type

Experimental

Investigational medicinal product name

Priorix™

Investigational medicinal product code

Other name

MMR

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injection, one dose, in the right upper arm.

Investigational medicinal product name

Varivax®

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injection, one dose, in the left upper arm.

Investigational medicinal product name

Havrix®

Investigational medicinal product code

Other name

HAV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, one dose, in the left tight.

Investigational medicinal product name

Prevnar®

Investigational medicinal product code

Other name

PCV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, one dose, in the right tight.

Priorix 2 Group

Arm description

Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

Arm type

Experimental

Investigational medicinal product name

Priorix™

Investigational medicinal product code

Other name

MMR

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injection, one dose, in the right upper arm.

Investigational medicinal product name

Varivax®

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injection, one dose, in the left upper arm.

Investigational medicinal product name

Havrix®

Investigational medicinal product code

Other name

HAV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, one dose, in the left tight.

Investigational medicinal product name

Prevnar®

Investigational medicinal product code

Other name

PCV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, one dose, in the right tight.

Priorix 3 Group

Arm description

Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

Arm type

Experimental

Investigational medicinal product name

Priorix™

Investigational medicinal product code

Other name

MMR

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injection, one dose, in the right upper arm.

Investigational medicinal product name

Varivax®

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injection, one dose, in the left upper arm.

Investigational medicinal product name

Prevnar®

Investigational medicinal product code

Other name

PCV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, one dose, in the right tight.

Investigational medicinal product name

Havrix®

Investigational medicinal product code

Other name

HAV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, one dose, in the left tight.

MMR-II Group

Arm description

Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

Arm type

Active comparator

Investigational medicinal product name

Prevnar®

Investigational medicinal product code

Other name

PCV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, one dose, in the right tight.

Investigational medicinal product name

Havrix®

Investigational medicinal product code

Other name

HAV

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Intramuscular injection, one dose, in the left tight.

Investigational medicinal product name

Varivax®

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injection, one dose, in the left upper arm.

Investigational medicinal product name

M-M-R® II

Investigational medicinal product code

Other name

MMR-II

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injection, one dose, in the right upper arm.

Notes
[1] - The roles blinded appear to be inconsistent with a double blind trial.
Justification: The study was conducted in an observer blind manner in which the subject and the study personnel involved in the clinical evaluation of the subjects were blinded while other study personnel (investigator) were aware of the treatment allocation.

Number of subjects in period 1 ^[2]	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Started	304	304	304	308
Completed	287	275	280	275
Not completed	17	29	24	33
Consent withdrawn by subject	10	6	6	19
Blodd draws	-	-	-	1
Adverse event, non-fatal	-	-	-	1
Lost to follow-up	7	19	17	12
Migration from study area	-	3	1	-
Protocol deviation	-	1	-	-

Notes
[2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: The number of subjects enrolled was 1259. 39 subjects were enrolled in the study but did not receive a subject number and were never vaccinated.

Baseline characteristics

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Reporting group title

Priorix 1 Group

Reporting group description

Reporting group title

Priorix 2 Group

Reporting group description

Reporting group title

Priorix 3 Group

Reporting group description

Reporting group title

MMR-II Group

Reporting group description

Reporting group values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group	Total
Number of subjects	304	304	304	308	1220
Age categorical
Units: Subjects
In utero					0
Preterm newborn infants (gestational age < 37 wks)					0
Newborns (0-27 days)					0
Infants and toddlers (28 days-23 months)					0
Children (2-11 years)					0
Adolescents (12-17 years)					0
Adults (18-64 years)					0
From 65-84 years					0
85 years and over					0
Age continuous
Units: months
arithmetic mean (standard deviation)	12.4 ( 0.75 )	12.4 ( 0.73 )	12.2 ( 0.56 )	12.4 ( 0.75 )	-
Gender categorical
Units: Subjects
Female	156	144	157	139	596
Male	148	160	147	169	624

End points

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Reporting group title

Priorix 1 Group

Reporting group description

Reporting group title

Priorix 2 Group

Reporting group description

Reporting group title

Priorix 3 Group

Reporting group description

Reporting group title

MMR-II Group

Reporting group description

Primary: Number of subjects with Anti-measles virus antibody concentration equal to or above the cut-off-value.

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End point title

Number of subjects with Anti-measles virus antibody concentration equal to or above the cut-off-value. ^[1]

End point description

Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

End point type

Primary

End point timeframe

At Day 42 after administration of a dose of Priorix vaccine.

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	247	240	240	249
Units: Subjects	245	236	236	248

No statistical analyses for this end point

Primary: Number of subjects with Anti-mumps virus antibody titer equal to or above the cut-off-value.

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End point title

Number of subjects with Anti-mumps virus antibody titer equal to or above the cut-off-value. ^[2]

End point description

Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.

End point type

Primary

End point timeframe

At Day 42 after administration of a dose of Priorix vaccine.

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	193	202	195	192
Units: Subjects	175	183	175	175

No statistical analyses for this end point

Primary: Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value.

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End point title

Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value. ^[3]

End point description

Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).

End point type

Primary

End point timeframe

At Day 42 after administration of a dose of Priorix vaccine.

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	247	238	239	249
Units: Subjects	244	235	233	249

No statistical analyses for this end point

Secondary: Number of subjects with Anti-varicella antibody concentration equal to or above the cut-off-value.

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End point title

Number of subjects with Anti-varicella antibody concentration equal to or above the cut-off-value.

End point description

Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).

End point type

Secondary

End point timeframe

At Day 42 after administration of a dose of Varivax vaccine.

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	245	238	240	246
Units: Subjects	240	230	230	241

No statistical analyses for this end point

Secondary: Anti-measles virus antibody concentrations

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End point title

Anti-measles virus antibody concentrations

End point description

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

End point type

Secondary

End point timeframe

At Day 42 after administration of a dose of Priorix vaccine.

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	247	240	240	249
Units: mIU/mL
geometric mean (confidence interval 95%)	2798.7 (2544.8 to 3077.9)	2878.2 (2607 to 3177.7)	2593.1 (2350.3 to 2861.1)	2949.5 (2698.4 to 3224)

No statistical analyses for this end point

Secondary: Anti-mumps virus antibody concentrations

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End point title

Anti-mumps virus antibody concentrations

End point description

Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.

End point type

Secondary

End point timeframe

At Day 42 after administration of a dose of Priorix vaccine.

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	193	202	195	192
Units: Titers
geometric mean (confidence interval 95%)	242 (204.5 to 286.5)	265 (221.8 to 316.5)	253.4 (213.4 to 300.9)	267.6 (224.2 to 319.5)

No statistical analyses for this end point

Secondary: Anti-rubella virus antibody concentrations

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End point title

Anti-rubella virus antibody concentrations

End point description

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.

End point type

Secondary

End point timeframe

At Day 42 after administration of a dose of Priorix vaccine.

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	247	238	239	249
Units: IU/mL
geometric mean (confidence interval 95%)	72.2 (65.6 to 79.6)	77.7 (70.4 to 85.7)	68.2 (61.8 to 75.3)	89.4 (81.4 to 98.2)

No statistical analyses for this end point

Secondary: Anti-S. pneumoniae antibody concentrations (by serotype).

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End point title

Anti-S. pneumoniae antibody concentrations (by serotype).

End point description

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.

End point type

Secondary

End point timeframe

At Day 42 after vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	128	127	128	126
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-S.PNEU-4	3.57 (3.04 to 4.2)	3.72 (3.21 to 4.31)	3.4 (2.88 to 4)	3.8 (3.17 to 4.56)
Anti-S. PNEU-6B	5.68 (4.78 to 6.76)	5.87 (5.02 to 6.87)	5.41 (4.66 to 6.28)	7.22 (6.28 to 8.29)
Anti-S.PNEU 9V	6.56 (5.66 to 7.6)	7.3 (6.35 to 8.38)	5.81 (4.97 to 6.78)	7.8 (6.81 to 8.93)
Anti-S.PNEU-14	9.23 (8.03 to 10.61)	8.33 (7.3 to 9.51)	7.58 (6.55 to 8.76)	7.97 (6.95 to 9.14)
Anti-S.PNEU-18 C	6.2 (5.3 to 7.26)	6.62 (5.76 to 7.6)	6.15 (5.25 to 7.21)	6.73 (5.74 to 7.91)
Anti-S.PNEU-19 F	2.42 (2.05 to 2.85)	2.46 (2.11 to 2.88)	2.34 (2 to 2.73)	2.59 (2.23 to 3)
Anti-S.PNEU-23 F	9.34 (7.76 to 11.25)	9.27 (7.82 to 10.99)	8.33 (6.88 to 10.1)	11.49 (9.67 to 13.66)

No statistical analyses for this end point

Secondary: Anti-varicella antibody concentrations.

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End point title

Anti-varicella antibody concentrations.

End point description

Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.

End point type

Secondary

End point timeframe

At Day 42 after administration of a dose of Varivax vaccine.

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	245	238	240	246
Units: mIU/mL
geometric mean (confidence interval 95%)	245.5 (229 to 263.3)	235.2 (217.4 to 254.4)	236 (218 to 255.5)	255.9 (240.4 to 272.4)

No statistical analyses for this end point

Secondary: Anti-hepatitis A virus antibody concentrations.

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End point title

Anti-hepatitis A virus antibody concentrations.

End point description

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.

End point type

Secondary

End point timeframe

At Day 42 after administration of a dose of Havrix vaccine.

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	117	112	111	124
Units: mIU/mL
geometric mean (confidence interval 95%)	33.8 (28.8 to 39.6)	39.2 (33.1 to 46.5)	39.4 (32.7 to 47.5)	42.1 (35.8 to 49.6)

No statistical analyses for this end point

Secondary: Number of subjects with Anti-hepatitis A antibody concentrations equal to or above the cut-off-value.

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End point title

Number of subjects with Anti-hepatitis A antibody concentrations equal to or above the cut-off-value.

End point description

Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).

End point type

Secondary

End point timeframe

At Day 42 after administration of a dose of Havrix vaccine.

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	117	112	111	124
Units: Subjects	98	99	94	110

No statistical analyses for this end point

Secondary: Anti-S. pneumoniae antibody concentrations (by serotype).

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End point title

Anti-S. pneumoniae antibody concentrations (by serotype).

End point description

Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.

End point type

Secondary

End point timeframe

At Day 0 before vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	129	130	130	119
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-S.PNEU-4	0.54 (0.46 to 0.65)	0.61 (0.52 to 0.72)	0.67 (0.58 to 0.78)	0.67 (0.56 to 0.81)
Anti-S.PNEU-6B	0.53 (0.43 to 0.66)	0.57 (0.46 to 0.7)	0.52 (0.43 to 0.64)	0.67 (0.56 to 0.8)
Anti-S.PNEU-9V	1.01 (0.85 to 1.2)	1.13 (0.97 to 1.32)	1.04 (0.88 to 1.23)	1.26 (1.06 to 1.49)
Anti-S.PNEU-14	3.01 (2.6 to 3.47)	2.82 (2.42 to 3.28)	2.54 (2.21 to 2.92)	2.76 (2.38 to 3.2)
Anti-S.PNEU-18C	0.88 (0.74 to 1.03)	0.97 (0.83 to 1.13)	0.97 (0.83 to 1.14)	1 (0.86 to 1.15)
Anti-S.PNEU-19F	0.4 (0.32 to 0.5)	0.4 (0.33 to 0.5)	0.44 (0.36 to 0.53)	0.45 (0.37 to 0.56)
Anti-S.PNEU-23 F	0.64 (0.51 to 0.82)	0.63 (0.51 to 0.77)	0.65 (0.52 to 0.81)	0.85 (0.67 to 1.08)

No statistical analyses for this end point

Secondary: Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value

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End point title

Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value

End point description

Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).

End point type

Secondary

End point timeframe

At 1 year post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	213	215	218	210
Units: Subjects	211	211	218	209

No statistical analyses for this end point

Secondary: Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value

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End point title

Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value

End point description

Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).

End point type

Secondary

End point timeframe

At 2 years post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	171	159	169	166
Units: Subjects	171	159	168	166

No statistical analyses for this end point

Secondary: Anti-measles virus antibody concentrations

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End point title

Anti-measles virus antibody concentrations

End point description

End point type

Secondary

End point timeframe

At 2 years post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	171	159	169	166
Units: mIU/mL
geometric mean (confidence interval 95%)	3361.1 (2922.3 to 3865.6)	3963.8 (3479.3 to 4515.7)	3360.3 (2923.3 to 3862.7)	4022.1 (3507.7 to 4611.9)

No statistical analyses for this end point

Secondary: Anti-measles virus antibody concentrations

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End point title

Anti-measles virus antibody concentrations

End point description

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.

End point type

Secondary

End point timeframe

At 1 year post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	213	215	218	210
Units: mIU/mL
geometric mean (confidence interval 95%)	3224.3 (2840.1 to 3660.5)	3708.2 (3226.2 to 4262.2)	3534.7 (3139.9 to 3979.1)	3828.1 (3371.3 to 4346.7)

No statistical analyses for this end point

Secondary: Number of subjects reporting investigator-confirmed measles/rubella-like rash and varicella-like rash.

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End point title

Number of subjects reporting investigator-confirmed measles/rubella-like rash and varicella-like rash.

End point description

End point type

Secondary

End point timeframe

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

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	283	275	283	277
Units: Subjects
Varicella like	0	4	0	0
Measles/Rubella like	6	7	5	5

No statistical analyses for this end point

Secondary: Number of subjects reporting febrile convulsions

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End point title

Number of subjects reporting febrile convulsions

End point description

Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.

End point type

Secondary

End point timeframe

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

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	283	275	283	277
Units: Subjects	0	1	0	1

No statistical analyses for this end point

Secondary: Anti-mumps virus antibody titers (enhanced Plaque Reduction Neutralization (PRN))

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End point title

Anti-mumps virus antibody titers (enhanced Plaque Reduction Neutralization (PRN))

End point description

Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.

End point type

Secondary

End point timeframe

At 1 year post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	189	186	189	183
Units: Titers
geometric mean (confidence interval 95%)	162.8 (141.8 to 186.9)	188.3 (162.4 to 218.3)	176.2 (152.6 to 203.3)	185.5 (163.5 to 210.6)

No statistical analyses for this end point

Secondary: Number of subjects reporting other rash.

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End point title

Number of subjects reporting other rash.

End point description

Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature

End point type

Secondary

End point timeframe

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

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	283	275	283	277
Units: Subjects
Localized or generalized	72	74	60	60
With fever	26	29	23	23
Grade 3	11	10	6	6
Related	9	14	6	6

No statistical analyses for this end point

Secondary: Number of subjects with anti-mumps virus antibody titers above the cut-off value (enhanced PRN)

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End point title

Number of subjects with anti-mumps virus antibody titers above the cut-off value (enhanced PRN)

End point description

Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.

End point type

Secondary

End point timeframe

At 1 year post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	189	186	189	183
Units: Subjects	169	170	171	170

No statistical analyses for this end point

Secondary: Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value.

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End point title

Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value.

End point description

Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.

End point type

Secondary

End point timeframe

At 1 year post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	213	214	218	210
Units: Subjects	212	213	217	210

No statistical analyses for this end point

Secondary: Number of subjects with anti-rubella virus antibody concentrations equal to or above the cut-off-value.

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End point title

Number of subjects with anti-rubella virus antibody concentrations equal to or above the cut-off-value.

End point description

Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).

End point type

Secondary

End point timeframe

At 2 years post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	171	158	168	166
Units: Subjects	171	158	168	166

No statistical analyses for this end point

Secondary: Anti-rubella virus antibody concentrations

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End point title

Anti-rubella virus antibody concentrations

End point description

End point type

Secondary

End point timeframe

At 1 year post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	213	214	218	210
Units: IU/mL
geometric mean (confidence interval 95%)	138.1 (125.3 to 152.2)	145.4 (132 to 160.1)	136.5 (123.5 to 150.9)	166.8 (151.5 to 183.6)

No statistical analyses for this end point

Secondary: Anti-rubella virus antibody concentrations

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End point title

Anti-rubella virus antibody concentrations

End point description

End point type

Secondary

End point timeframe

At 2 years post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	171	158	168	166
Units: IU/mL
geometric mean (confidence interval 95%)	78 (69.7 to 87.2)	79.5 (71.7 to 88.2)	81.7 (73.8 to 90.4)	93.1 (83.6 to 103.6)

No statistical analyses for this end point

Secondary: Number of subjects reporting fever.

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End point title

Number of subjects reporting fever.

End point description

fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.

End point type

Secondary

End point timeframe

During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	283	275	283	277
Units: Subjects
Day 15 (N= 283; 275; 283; 277) ≥38.0°C	65	79	64	56
Day 15 (N= 283; 275; 283; 277) >39.5°C	10	7	9	8
Day 43 (N= 283; 275; 283; 277) ≥38.0°C	103	104	104	85
Day 43 (N= 283; 275; 283; 277) >39.5°C	20	14	18	13

No statistical analyses for this end point

Secondary: Number of subjects with solicited local symptoms.

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End point title

Number of subjects with solicited local symptoms.

End point description

Solicited local symptoms assessed were pain, redness and swelling.

End point type

Secondary

End point timeframe

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

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	282	274	282	274
Units: Subjects
Pain	70	70	79	67
Redness	45	47	41	47
Swelling	20	26	19	15

No statistical analyses for this end point

Secondary: Number of subjects reporting Medically attended visit (MAEs)

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End point title

Number of subjects reporting Medically attended visit (MAEs)

End point description

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

End point type

Secondary

End point timeframe

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

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	304	304	304	308
Units: Subjects
Any MAE(s)	99	99	97	107

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited adverse events (AEs).

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End point title

Number of subjects with unsolicited adverse events (AEs).

End point description

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 and 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. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

End point type

Secondary

End point timeframe

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

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	304	304	304	308
Units: Subjects
Any AEs	170	153	164	169

No statistical analyses for this end point

Secondary: Number of subjects reporting investigator-confirmed parotid/salivary gland swelling.

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End point title

Number of subjects reporting investigator-confirmed parotid/salivary gland swelling.

End point description

Swelling with accompanying general symptoms

End point type

Secondary

End point timeframe

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

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	283	275	283	277
Units: Subjects
Subjects with parotid gland swelling	3	3	5	2

No statistical analyses for this end point

Secondary: Number of subjects with solicited general symptoms.

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End point title

Number of subjects with solicited general symptoms.

End point description

Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.

End point type

Secondary

End point timeframe

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

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	283	275	283	277
Units: Subjects
Any drowsiness	133	106	113	109
Any irritability	180	141	150	153
Any loss of appetite	111	77	110	94

No statistical analyses for this end point

Secondary: Number of subjects reporting new onset chronic illnesses (NOCIs).

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End point title

Number of subjects reporting new onset chronic illnesses (NOCIs).

End point description

NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.

End point type

Secondary

End point timeframe

From Day 0 to Day 180 after vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	304	304	304	308
Units: Subjects
NOCIs	5	2	4	2

No statistical analyses for this end point

Secondary: Number of subjects reporting serious adverse events (SAEs)

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End point title

Number of subjects reporting serious adverse events (SAEs)

End point description

SAEs assessed include medical occurrences that result in death, are 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.

End point type

Secondary

End point timeframe

From Day 0 to Day 180 after vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	304	304	304	308
Units: Subjects
SAEs	1	6	7	9

No statistical analyses for this end point

Secondary: Number of subjects reporting serious adverse events (SAEs).

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End point title

Number of subjects reporting serious adverse events (SAEs).

End point description

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

End point type

Secondary

End point timeframe

From Day 180 to Day 730 after vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	304	304	304	308
Units: Subjects
SAEs	0	0	0	1

No statistical analyses for this end point

Secondary: Number of subjects reporting conditions prompting emergency room (ER) visits.

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End point title

Number of subjects reporting conditions prompting emergency room (ER) visits.

End point description

End point type

Secondary

End point timeframe

From Day 0 to Day 180 after vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	304	304	304	308
Units: Subjects
AE prompting ER visits	27	28	22	26

No statistical analyses for this end point

Secondary: Anti-mumps virus antibody titers (unenhanced PRN)

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End point title

Anti-mumps virus antibody titers (unenhanced PRN)

End point description

Antibody titers were expressed as Geometric Mean Titer (GMT).

End point type

Secondary

End point timeframe

At 1 year post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	196	205	211	195
Units: Titer
geometric mean (confidence interval 95%)	31 (24.1 to 39.9)	46.1 (36.2 to 58.7)	39.3 (31 to 50)	46.6 (36.6 to 59.3)

No statistical analyses for this end point

Secondary: Number of subjects with anti-mumps virus antibody titers above the cut-off value (unenhanced PRN)

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End point title

Number of subjects with anti-mumps virus antibody titers above the cut-off value (unenhanced PRN)

End point description

Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).

End point type

Secondary

End point timeframe

At 1 year post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	196	205	211	195
Units: Subjects	173	186	184	173

No statistical analyses for this end point

Secondary: Anti-mumps virus antibody titers (unenhanced PRN)

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End point title

Anti-mumps virus antibody titers (unenhanced PRN)

End point description

Antibody concentrations are expressed as Geometric Mean Titer (GMT).

End point type

Secondary

End point timeframe

At 2 years post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	157	144	157	152
Units: Titer
geometric mean (confidence interval 95%)	43.4 (33.4 to 56.3)	48.9 (37.7 to 63.5)	57.4 (45.7 to 72.2)	60.7 (47.6 to 77.5)

No statistical analyses for this end point

Secondary: Number of subjects with anti-mumps virus antibody titers above the cut-off value (unenhanced PRN)

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End point title

Number of subjects with anti-mumps virus antibody titers above the cut-off value (unenhanced PRN)

End point description

Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).

End point type

Secondary

End point timeframe

At 2 years post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	157	144	157	152
Units: Subjects	144	134	152	144

No statistical analyses for this end point

Secondary: Anti-mumps virus antibody concentrations (Pharmaceutical Product Development (PPD) ELISA)

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End point title

Anti-mumps virus antibody concentrations (Pharmaceutical Product Development (PPD) ELISA)

End point description

Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.

End point type

Secondary

End point timeframe

At 1 year post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	170	173	179	170
Units: EU/mL
geometric mean (confidence interval 95%)	47.3 (39.2 to 57.1)	42.9 (36.4 to 50.6)	42.5 (35.9 to 50.3)	58.6 (50.6 to 67.8)

No statistical analyses for this end point

Secondary: Number of subjects with anti-mumps virus antibody concentrations above the cut-off value (PPD ELISA)

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End point title

Number of subjects with anti-mumps virus antibody concentrations above the cut-off value (PPD ELISA)

End point description

Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)

End point type

Secondary

End point timeframe

At 1 year post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	170	173	179	170
Units: Subjects	155	159	162	164

No statistical analyses for this end point

Secondary: Anti-mumps virus antibody concentrations (PPD ELISA)

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End point title

Anti-mumps virus antibody concentrations (PPD ELISA)

End point description

End point type

Secondary

End point timeframe

At 2 years post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	136	130	141	140
Units: EU/mL
geometric mean (confidence interval 95%)	47.8 (40.2 to 56.9)	50.2 (42.1 to 59.9)	54 (46.1 to 63.3)	59.2 (50.1 to 70)

No statistical analyses for this end point

Secondary: Number of subjects with anti-mumps virus antibody concentrations above the cut-off value (PPD ELISA)

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End point title

Number of subjects with anti-mumps virus antibody concentrations above the cut-off value (PPD ELISA)

End point description

Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)

End point type

Secondary

End point timeframe

At 2 years post-vaccination

End point values	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Number of subjects analysed	136	130	141	140
Units: Subjects	128	125	136	134

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730).

Adverse event reporting additional description

The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences. Solicited symptoms were only assessed on subjects returning the symptom sheet.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

16.0

Reporting group title

Priorix 1 Group

Reporting group description

Reporting group title

Priorix 2 Group

Reporting group description

Reporting group title

Priorix 3 Group

Reporting group description

Reporting group title

MMR-II Group

Reporting group description

Serious adverse events	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 304 (0.33%)	7 / 304 (2.30%)	8 / 304 (2.63%)	10 / 308 (3.25%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nephroblastoma (Persistence Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Thermal burn (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Febrile convulsion (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ataxia (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Febrile convulsion (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Leukocytosis (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lymphadenitis (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Idiopathic thrombocytopenic purpura (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Leukocytosis (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lymphadenitis (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Hypoxia (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	2 / 308 (0.65%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Inflenza like illness (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza like illness (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngotonsillitis (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Intussusception (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intussusception (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nasal congestion (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchial hyperreactivity (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchial hyperreactivity (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoxia (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	2 / 308 (0.65%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nasal congestion (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Petechiae (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Petechiae (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rash (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Extremity necrosis (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Extremity necrosis (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Ataxia (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchiolitis (Active Phase)
subjects affected / exposed	1 / 304 (0.33%)	1 / 304 (0.33%)	0 / 304 (0.00%)	2 / 308 (0.65%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Coxsackie viral infection (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Croup infectious (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis viral (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
H1N1 influenza (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Otitis media acute (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia respiratory syncytial viral (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rash (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncitial virus infection (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal infection (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection (Active Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchiolitis (ESFU Phase)
subjects affected / exposed	1 / 304 (0.33%)	1 / 304 (0.33%)	0 / 304 (0.00%)	2 / 308 (0.65%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Coxsackie viral infection (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis viral (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
H1N1 influenza (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngotonsillitis (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia respiratory syncytial viral (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus infection (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal infection (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	1 / 304 (0.33%)	0 / 304 (0.00%)	0 / 308 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection (ESFU Phase)
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	0 / 304 (0.00%)	1 / 308 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Priorix 1 Group	Priorix 2 Group	Priorix 3 Group	MMR-II Group
Total subjects affected by non serious adverse events
subjects affected / exposed	180 / 304 (59.21%)	141 / 304 (46.38%)	150 / 304 (49.34%)	153 / 308 (49.68%)
General disorders and administration site conditions
Pain
alternative assessment type: Systematic
subjects affected / exposed	70 / 304 (23.03%)	70 / 304 (23.03%)	79 / 304 (25.99%)	67 / 308 (21.75%)
occurrences all number	70	70	79	67
Redness
alternative assessment type: Systematic
subjects affected / exposed	45 / 304 (14.80%)	47 / 304 (15.46%)	41 / 304 (13.49%)	47 / 308 (15.26%)
occurrences all number	45	47	41	47
Swelling
alternative assessment type: Systematic
subjects affected / exposed	20 / 304 (6.58%)	26 / 304 (8.55%)	19 / 304 (6.25%)	15 / 308 (4.87%)
occurrences all number	20	26	19	15
Drowsiness
alternative assessment type: Systematic
subjects affected / exposed	133 / 304 (43.75%)	106 / 304 (34.87%)	113 / 304 (37.17%)	109 / 308 (35.39%)
occurrences all number	133	106	113	109
Irritability
alternative assessment type: Systematic
subjects affected / exposed	180 / 304 (59.21%)	141 / 304 (46.38%)	150 / 304 (49.34%)	153 / 308 (49.68%)
occurrences all number	180	141	150	153
Loss of appetite
alternative assessment type: Systematic
subjects affected / exposed	111 / 304 (36.51%)	77 / 304 (25.33%)	110 / 304 (36.18%)	94 / 308 (30.52%)
occurrences all number	111	77	110	94
Gastrointestinal disorders
Teething
subjects affected / exposed	35 / 304 (11.51%)	35 / 304 (11.51%)	37 / 304 (12.17%)	35 / 308 (11.36%)
occurrences all number	35	35	37	35
Diarrhoea
subjects affected / exposed	25 / 304 (8.22%)	24 / 304 (7.89%)	19 / 304 (6.25%)	21 / 308 (6.82%)
occurrences all number	25	24	19	21
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	25 / 304 (8.22%)	21 / 304 (6.91%)	0 / 304 (0.00%)	19 / 308 (6.17%)
occurrences all number	25	21	0	19
Rhinorrhoea
subjects affected / exposed	0 / 304 (0.00%)	0 / 304 (0.00%)	21 / 304 (6.91%)	0 / 308 (0.00%)
occurrences all number	0	0	21	0
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	40 / 304 (13.16%)	22 / 304 (7.24%)	39 / 304 (12.83%)	43 / 308 (13.96%)
occurrences all number	40	22	39	43
Otitis media
subjects affected / exposed	25 / 304 (8.22%)	25 / 304 (8.22%)	29 / 304 (9.54%)	24 / 308 (7.79%)
occurrences all number	25	25	29	24

More information

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Were there any global substantial amendments to the protocol? Yes

29 Jun 2010

•Update Sponsor contact details for reporting SAEs and for emergency unblinding. •Clarify the timeframe to which medications, treatments and/or vaccinations are to be recorded in the eCRF. •Clarify the that the second dose of Havrix® is not a part of the study procedures, but is recorded in the eCRF

29 Apr 2011

Clarify/require the collection of any subsequent MMR vaccinations through visit 5. Change/update the interim analysis from a yearly persistence analysis to a 2 year analysis.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: Immunogenicity of GlaxoSmithKline Biologicals’ MMR vaccine (209762) vs. M-M-R® II, when co-administered with hepatitis A, varicella and pneumococcal conjugate vaccines to children 12-15 months of age

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of subjects with Anti-measles virus antibody concentration equal to or above the cut-off-value.

Primary: Number of subjects with Anti-measles virus antibody concentration equal to or above the cut-off-value.

Primary: Number of subjects with Anti-mumps virus antibody titer equal to or above the cut-off-value.

Primary: Number of subjects with Anti-mumps virus antibody titer equal to or above the cut-off-value.

Primary: Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value.

Primary: Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value.

Secondary: Number of subjects with Anti-varicella antibody concentration equal to or above the cut-off-value.

Secondary: Number of subjects with Anti-varicella antibody concentration equal to or above the cut-off-value.

Secondary: Anti-measles virus antibody concentrations

Secondary: Anti-measles virus antibody concentrations

Secondary: Anti-mumps virus antibody concentrations

Secondary: Anti-mumps virus antibody concentrations

Secondary: Anti-rubella virus antibody concentrations

Secondary: Anti-rubella virus antibody concentrations

Secondary: Anti-S. pneumoniae antibody concentrations (by serotype).

Secondary: Anti-S. pneumoniae antibody concentrations (by serotype).

Secondary: Anti-varicella antibody concentrations.

Secondary: Anti-varicella antibody concentrations.

Secondary: Anti-hepatitis A virus antibody concentrations.

Secondary: Anti-hepatitis A virus antibody concentrations.

Secondary: Number of subjects with Anti-hepatitis A antibody concentrations equal to or above the cut-off-value.

Secondary: Number of subjects with Anti-hepatitis A antibody concentrations equal to or above the cut-off-value.

Secondary: Anti-S. pneumoniae antibody concentrations (by serotype).

Secondary: Anti-S. pneumoniae antibody concentrations (by serotype).

Secondary: Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value

Secondary: Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value

Secondary: Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value

Secondary: Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value

Secondary: Anti-measles virus antibody concentrations

Secondary: Anti-measles virus antibody concentrations

Secondary: Anti-measles virus antibody concentrations

Secondary: Anti-measles virus antibody concentrations

Secondary: Number of subjects reporting investigator-confirmed measles/rubella-like rash and varicella-like rash.

Secondary: Number of subjects reporting investigator-confirmed measles/rubella-like rash and varicella-like rash.

Secondary: Number of subjects reporting febrile convulsions

Secondary: Number of subjects reporting febrile convulsions

Secondary: Anti-mumps virus antibody titers (enhanced Plaque Reduction Neutralization (PRN))

Secondary: Anti-mumps virus antibody titers (enhanced Plaque Reduction Neutralization (PRN))

Secondary: Number of subjects reporting other rash.

Secondary: Number of subjects reporting other rash.

Secondary: Number of subjects with anti-mumps virus antibody titers above the cut-off value (enhanced PRN)

Secondary: Number of subjects with anti-mumps virus antibody titers above the cut-off value (enhanced PRN)

Secondary: Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value.

Secondary: Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value.

Secondary: Number of subjects with anti-rubella virus antibody concentrations equal to or above the cut-off-value.

Secondary: Number of subjects with anti-rubella virus antibody concentrations equal to or above the cut-off-value.

Secondary: Anti-rubella virus antibody concentrations

Secondary: Anti-rubella virus antibody concentrations

Secondary: Anti-rubella virus antibody concentrations

Secondary: Anti-rubella virus antibody concentrations

Secondary: Number of subjects reporting fever.

Secondary: Number of subjects reporting fever.

Secondary: Number of subjects with solicited local symptoms.

Secondary: Number of subjects with solicited local symptoms.

Secondary: Number of subjects reporting Medically attended visit (MAEs)

Secondary: Number of subjects reporting Medically attended visit (MAEs)

Secondary: Number of subjects with unsolicited adverse events (AEs).

Secondary: Number of subjects with unsolicited adverse events (AEs).

Secondary: Number of subjects reporting investigator-confirmed parotid/salivary gland swelling.

Secondary: Number of subjects reporting investigator-confirmed parotid/salivary gland swelling.

Secondary: Number of subjects with solicited general symptoms.

Secondary: Number of subjects with solicited general symptoms.

Secondary: Number of subjects reporting new onset chronic illnesses (NOCIs).

Secondary: Number of subjects reporting new onset chronic illnesses (NOCIs).

Secondary: Number of subjects reporting serious adverse events (SAEs)

Secondary: Number of subjects reporting serious adverse events (SAEs)

Secondary: Number of subjects reporting serious adverse events (SAEs).

Secondary: Number of subjects reporting serious adverse events (SAEs).

Secondary: Number of subjects reporting conditions prompting emergency room (ER) visits.

Secondary: Number of subjects reporting conditions prompting emergency room (ER) visits.

Clinical Trial Results:
Immunogenicity of GlaxoSmithKline Biologicals’ MMR vaccine (209762) vs. M-M-R® II, when co-administered with hepatitis A, varicella and pneumococcal conjugate vaccines to children 12-15 months of age