Adults 12 Months to 15 Months, any sex, with Rubella or Mumps. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.Primary· At Day 42 after administration of a dose of Priorix vaccine.
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.
Group
Value
95% CI
Priorix 1 Group
245
Priorix 2 Group
236
Priorix 3 Group
236
MMR-II Group
248
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.Primary· At Day 42 after administration of a dose of Priorix vaccine.
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.
Group
Value
95% CI
Priorix 1 Group
175
Priorix 2 Group
183
Priorix 3 Group
175
MMR-II Group
175
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.Primary· At Day 42 after administration of a dose of Priorix vaccine.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Group
Value
95% CI
Priorix 1 Group
244
Priorix 2 Group
235
Priorix 3 Group
233
MMR-II Group
249
Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.Secondary· At Day 42 after administration of a dose of Varivax vaccine.
Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).
Group
Value
95% CI
Priorix 1 Group
240
Priorix 2 Group
230
Priorix 3 Group
230
MMR-II Group
241
Anti-measles Virus Antibody ConcentrationsSecondary· At Day 42 after administration of a dose of Priorix vaccine.
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.
Group
Value
95% CI
Priorix 1 Group
2798.7
2544.8 – 3077.9
Priorix 2 Group
2878.2
2607.0 – 3177.7
Priorix 3 Group
2593.1
2350.3 – 2861.1
MMR-II Group
2949.5
2698.4 – 3224.0
Anti-mumps Virus Antibody ConcentrationsSecondary· At Day 42 after administration of a dose of Priorix vaccine.
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.
Group
Value
95% CI
Priorix 1 Group
242.0
204.5 – 286.5
Priorix 2 Group
265.0
221.8 – 316.5
Priorix 3 Group
253.4
213.4 – 300.9
MMR-II Group
267.6
224.2 – 319.5
Anti-rubella Virus Antibody ConcentrationsSecondary· At Day 42 after administration of a dose of Priorix vaccine.
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.
Group
Value
95% CI
Priorix 1 Group
72.2
65.6 – 79.6
Priorix 2 Group
77.7
70.4 – 85.7
Priorix 3 Group
68.2
61.8 – 75.3
MMR-II Group
89.4
81.4 – 98.2
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).Secondary· At Day 42 after vaccination
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Anti-S.PNEU-4
Group
Value
95% CI
Priorix 1 Group
3.57
3.04 – 4.20
Priorix 2 Group
3.72
3.21 – 4.31
Priorix 3 Group
3.40
2.88 – 4.00
MMR-II Group
3.80
3.17 – 4.56
Anti-S. PNEU-6B
Group
Value
95% CI
Priorix 1 Group
5.68
4.78 – 6.76
Priorix 2 Group
5.87
5.02 – 6.87
Priorix 3 Group
5.41
4.66 – 6.28
MMR-II Group
7.22
6.28 – 8.29
Anti-S.PNEU 9V
Group
Value
95% CI
Priorix 1 Group
6.56
5.66 – 7.60
Priorix 2 Group
7.30
6.35 – 8.38
Priorix 3 Group
5.81
4.97 – 6.78
MMR-II Group
7.80
6.81 – 8.93
Anti-S.PNEU-14
Group
Value
95% CI
Priorix 1 Group
9.23
8.03 – 10.61
Priorix 2 Group
8.33
7.30 – 9.51
Priorix 3 Group
7.58
6.55 – 8.76
MMR-II Group
7.97
6.95 – 9.14
Anti-S.PNEU-18 C
Group
Value
95% CI
Priorix 1 Group
6.20
5.30 – 7.26
Priorix 2 Group
6.62
5.76 – 7.60
Priorix 3 Group
6.15
5.25 – 7.21
MMR-II Group
6.73
5.74 – 7.91
Anti-S.PNEU-19 F
Group
Value
95% CI
Priorix 1 Group
2.42
2.05 – 2.85
Priorix 2 Group
2.46
2.11 – 2.88
Priorix 3 Group
2.34
2.00 – 2.73
MMR-II Group
2.59
2.23 – 3.00
Anti-S.PNEU-23 F
Group
Value
95% CI
Priorix 1 Group
9.34
7.76 – 11.25
Priorix 2 Group
9.27
7.82 – 10.99
Priorix 3 Group
8.33
6.88 – 10.10
MMR-II Group
11.49
9.67 – 13.66
Anti-varicella Antibody Concentrations.Secondary· At Day 42 after administration of a dose of Varivax vaccine.
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.
Group
Value
95% CI
Priorix 1 Group
245.5
229.0 – 263.3
Priorix 2 Group
235.2
217.4 – 254.4
Priorix 3 Group
236.0
218.0 – 255.5
MMR-II Group
255.9
240.4 – 272.4
Anti-hepatitis A Virus Antibody Concentrations.Secondary· At Day 42 after administration of a dose of Havrix vaccine.
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.
Group
Value
95% CI
Priorix 1 Group
33.8
28.8 – 39.6
Priorix 2 Group
39.2
33.1 – 46.5
Priorix 3 Group
39.4
32.7 – 47.5
MMR-II Group
42.1
35.8 – 49.6
Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.Secondary· At Day 42 after administration of a dose of Havrix vaccine.
Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).
Group
Value
95% CI
Priorix 1 Group
98
Priorix 2 Group
99
Priorix 3 Group
94
MMR-II Group
110
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).Secondary· At Day 0 before vaccination
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Anti-S.PNEU-4
Group
Value
95% CI
Priorix 1 Group
0.54
0.46 – 0.65
Priorix 2 Group
0.61
0.52 – 0.72
Priorix 3 Group
0.67
0.58 – 0.78
MMR-II Group
0.67
0.56 – 0.81
Anti-S.PNEU-6B
Group
Value
95% CI
Priorix 1 Group
0.53
0.43 – 0.66
Priorix 2 Group
0.57
0.46 – 0.70
Priorix 3 Group
0.52
0.43 – 0.64
MMR-II Group
0.67
0.56 – 0.80
Anti-S.PNEU-9V
Group
Value
95% CI
Priorix 1 Group
1.01
0.85 – 1.20
Priorix 2 Group
1.13
0.97 – 1.32
Priorix 3 Group
1.04
0.88 – 1.23
MMR-II Group
1.26
1.06 – 1.49
Anti-S.PNEU-14
Group
Value
95% CI
Priorix 1 Group
3.01
2.60 – 3.47
Priorix 2 Group
2.82
2.42 – 3.28
Priorix 3 Group
2.54
2.21 – 2.92
MMR-II Group
2.76
2.38 – 3.20
Anti-S.PNEU-18C
Group
Value
95% CI
Priorix 1 Group
0.88
0.74 – 1.03
Priorix 2 Group
0.97
0.83 – 1.13
Priorix 3 Group
0.97
0.83 – 1.14
MMR-II Group
1.00
0.86 – 1.15
Anti-S.PNEU-19F
Group
Value
95% CI
Priorix 1 Group
0.40
0.32 – 0.50
Priorix 2 Group
0.40
0.33 – 0.50
Priorix 3 Group
0.44
0.36 – 0.53
MMR-II Group
0.45
0.37 – 0.56
Anti-S.PNEU-23 F
Group
Value
95% CI
Priorix 1 Group
0.64
0.51 – 0.82
Priorix 2 Group
0.63
0.51 – 0.77
Priorix 3 Group
0.65
0.52 – 0.81
MMR-II Group
0.85
0.67 – 1.08
Adverse events — posted to ClinicalTrials.gov
Time frame: 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)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Priorix 1 Group
Serious: 1/304 (0%)
Deaths: 0/304
Priorix 2 Group
Serious: 7/304 (2%)
Deaths: 0/304
Priorix 3 Group
Serious: 8/304 (3%)
Deaths: 0/304
MMR-II Group
Serious: 10/308 (3%)
Deaths: 0/308
Serious adverse events (61 terms)
Reaction
System
Priorix 1 Group
Priorix 2 Group
Priorix 3 Group
MMR-II Group
Bronchiolitis
Infections and infestations
—
—
—
—
Hypoxia
General disorders
—
—
—
—
Bronchiolitis
Infections and infestations
—
—
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Bronchitis
Infections and infestations
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
Asthma
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
Coxsackie viral infection
Infections and infestations
—
—
—
—
Croup infectious
Infections and infestations
—
—
—
—
Extremity necrosis
Vascular disorders
—
—
—
—
Febrile convulsion
Nervous system disorders
—
—
—
—
Gastroenteritis viral
Infections and infestations
—
—
—
—
H1N1 influenza
Infections and infestations
—
—
—
—
Idiopathic thrombocytopenic purpura
Blood and lymphatic system disorders
—
—
—
—
Influenza
Infections and infestations
—
—
—
—
Inflenza like illness
General disorders
—
—
—
—
Intussusception
Gastrointestinal disorders
—
—
—
—
Leukocytosis
Blood and lymphatic system disorders
—
—
—
—
Lymphadenitis
Blood and lymphatic system disorders
—
—
—
—
Nasal congestion
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Otitis media acute
Infections and infestations
—
—
—
—
Petechiae
Skin and subcutaneous tissue disorders
—
—
—
—
Pharyngotonsillitis
Infections and infestations
—
—
—
—
Pneumonia respiratory syncytial viral
Infections and infestations
—
—
—
—
Other adverse events (185 terms — click to expand)
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine.
The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 3 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00861744.