Adults 6 Weeks to 12 Weeks, any sex, with Infections, Streptococcal. 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 Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)Primary· Within 4 day (Days 0-3) after each dose and across doses
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.
Fever > 39.0°C, post Dose 1
Group
Value
95% CI
Synflorix Pooled Group
31
Prevenar Pooled Group
6
Fever > 39.0°C, post Dose 2
Group
Value
95% CI
Synflorix Pooled Group
30
Prevenar Pooled Group
13
Fever > 39.0°C, post Dose 3
Group
Value
95% CI
Synflorix Pooled Group
42
Prevenar Pooled Group
8
Fever > 39.0°C, across doses
Group
Value
95% CI
Synflorix Pooled Group
88
Prevenar Pooled Group
23
Number of Subjects With Any and Any Grade 3 Solicited Local SymptomsSecondary· Within 4 day (Days 0-3) after each dose and across doses
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
Any Pain, Post Dose 1
Group
Value
95% CI
Synflorix 1 Group
240
Synflorix 2 Group
206
Prevenar 1 Group
76
Prevenar 2 Group
65
Grade 3 Pain, Post Dose 1
Group
Value
95% CI
Synflorix 1 Group
52
Synflorix 2 Group
59
Prevenar 1 Group
19
Prevenar 2 Group
17
Any Redness, Post Dose 1
Group
Value
95% CI
Synflorix 1 Group
126
Synflorix 2 Group
199
Prevenar 1 Group
35
Prevenar 2 Group
65
Grade 3 Redness, Post Dose 1
Group
Value
95% CI
Synflorix 1 Group
10
Synflorix 2 Group
30
Prevenar 1 Group
6
Prevenar 2 Group
8
Any Swelling, Post Dose 1
Group
Value
95% CI
Synflorix 1 Group
142
Synflorix 2 Group
153
Prevenar 1 Group
39
Prevenar 2 Group
56
Grade 3 Swelling, Post Dose 1
Group
Value
95% CI
Synflorix 1 Group
41
Synflorix 2 Group
43
Prevenar 1 Group
15
Prevenar 2 Group
9
Any Pain, Post Dose 2
Group
Value
95% CI
Synflorix 1 Group
191
Synflorix 2 Group
186
Prevenar 1 Group
55
Prevenar 2 Group
61
Grade 3 Pain, Post Dose 2
Group
Value
95% CI
Synflorix 1 Group
18
Synflorix 2 Group
31
Prevenar 1 Group
8
Prevenar 2 Group
12
Number of Subjects With Any, Grade 3 and Related Solicited General SymptomsSecondary· Within 4-day (Days 0-3) after each dose and across doses
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 (G3) drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 (G3) fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 (G3) irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 (G3) loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relati
Any Drowsiness, Dose 1
Group
Value
95% CI
Synflorix 1 Group
154
Synflorix 2 Group
223
Prevenar 1 Group
45
Prevenar 2 Group
75
G3 Drowsiness, Dose 1
Group
Value
95% CI
Synflorix 1 Group
6
Synflorix 2 Group
10
Prevenar 1 Group
3
Prevenar 2 Group
1
REL Drowsiness Dose 1
Group
Value
95% CI
Synflorix 1 Group
154
Synflorix 2 Group
222
Prevenar 1 Group
45
Prevenar 2 Group
75
Any Fever, Dose 1
Group
Value
95% CI
Synflorix 1 Group
214
Synflorix 2 Group
190
Prevenar 1 Group
74
Prevenar 2 Group
54
G3 Fever, Dose 1
Group
Value
95% CI
Synflorix 1 Group
0
Synflorix 2 Group
0
Prevenar 1 Group
0
Prevenar 2 Group
0
REL Fever, Dose 1
Group
Value
95% CI
Synflorix 1 Group
214
Synflorix 2 Group
190
Prevenar 1 Group
74
Prevenar 2 Group
54
Any Irritability, Dose 1
Group
Value
95% CI
Synflorix 1 Group
236
Synflorix 2 Group
269
Prevenar 1 Group
78
Prevenar 2 Group
83
G3 Irritability, Dose 1
Group
Value
95% CI
Synflorix 1 Group
11
Synflorix 2 Group
60
Prevenar 1 Group
3
Prevenar 2 Group
17
Number of Subjects With Unsolicited Adverse Events (AEs)Secondary· Within 31 days (Days 0-30) after each vaccination
An AE is 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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Group
Value
95% CI
Synflorix 1 Group
168
Synflorix 2 Group
166
Prevenar 1 Group
46
Prevenar 2 Group
61
Number of Subjects With Serious Adverse Events (SAEs)Secondary· During the Active Phase: From Month 0 to Month 3 for Synflorix 1 Group and Prevenar 1 Group and from Month 0 to Month 5 for the Synflorix 2 Group and Prevenar 2 Group
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Group
Value
95% CI
Synflorix 1 Group
6
Synflorix 2 Group
34
Prevenar 1 Group
1
Prevenar 2 Group
9
Number of Subjects With Serious Adverse (SAEs)Secondary· During the Extended Safety Follow-Up Phase: At Month 8 for Synflorix 1 Group and Prevenar 1 Group and at Month 10 for the Synflorix 2 Group and Prevenar 2 Group
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Group
Value
95% CI
Synflorix 1 Group
16
Synflorix 2 Group
52
Prevenar 1 Group
4
Prevenar 2 Group
19
Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23FSecondary· One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Seropositivity status, defined as Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).
Anti-1 POST
Group
Value
95% CI
Synflorix 1 Group
3.23
2.94 – 3.54
Synflorix 2 Group
1.04
0.94 – 1.15
Prevenar 1 Group
0.03
0.03 – 0.4
Prevenar 2 Group
0.03
0.03 – 0.03
Anti-4 POST
Group
Value
95% CI
Synflorix 1 Group
4.96
4.46 – 5.51
Synflorix 2 Group
1.64
1.49 – 1.8
Prevenar 1 Group
5.68
4.94 – 6.53
Prevenar 2 Group
2.14
1.88 – 2.44
Anti-5 POST
Group
Value
95% CI
Synflorix 1 Group
4.87
4.5 – 5.26
Synflorix 2 Group
1.62
1.48 – 1.78
Prevenar 1 Group
0.03
0.03 – 0.04
Prevenar 2 Group
0.03
0.03 – 0.03
Anti-6B POST
Group
Value
95% CI
Synflorix 1 Group
1.19
1.02 – 1.38
Synflorix 2 Group
0.73
0.64 – 0.84
Prevenar 1 Group
1.06
0.8 – 1.4
Prevenar 2 Group
1.23
0.96 – 1.58
Anti-7F POST
Group
Value
95% CI
Synflorix 1 Group
4.84
4.45 – 5.27
Synflorix 2 Group
2.25
2.07 – 2.45
Prevenar 1 Group
0.05
0.04 – 0.06
Prevenar 2 Group
0.04
0.03 – 0.04
Anti-9V POST
Group
Value
95% CI
Synflorix 1 Group
4.04
3.66 – 4.46
Synflorix 2 Group
1.51
1.37 – 1.66
Prevenar 1 Group
5.07
4.32 – 5.96
Prevenar 2 Group
2.7
2.32 – 3.14
Anti-14 POST
Group
Value
95% CI
Synflorix 1 Group
6.45
5.65 – 7.38
Synflorix 2 Group
3.31
2.98 – 3.68
Prevenar 1 Group
5.88
4.71 – 7.34
Prevenar 2 Group
5.23
4.39 – 6.24
Anti-18C POST
Group
Value
95% CI
Synflorix 1 Group
11.56
10.22 – 13.08
Synflorix 2 Group
3.74
3.28 – 4.28
Prevenar 1 Group
3.71
3.14 – 4.38
Prevenar 2 Group
2.64
2.25 – 3.11
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL)Secondary· One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Cut-off values assessed were greater than or equal to 0.2 microgram per milliliter (µg/mL) in the sera of subjects.
Anti-1 POST
Group
Value
95% CI
Synflorix 1 Group
285
Synflorix 2 Group
280
Prevenar 1 Group
3
Prevenar 2 Group
3
Anti-4 POST
Group
Value
95% CI
Synflorix 1 Group
283
Synflorix 2 Group
282
Prevenar 1 Group
95
Prevenar 2 Group
96
Anti-5 POST
Group
Value
95% CI
Synflorix 1 Group
285
Synflorix 2 Group
282
Prevenar 1 Group
3
Prevenar 2 Group
2
Anti-6B POST
Group
Value
95% CI
Synflorix 1 Group
260
Synflorix 2 Group
244
Prevenar 1 Group
82
Prevenar 2 Group
91
Anti-7F POST
Group
Value
95% CI
Synflorix 1 Group
284
Synflorix 2 Group
285
Prevenar 1 Group
9
Prevenar 2 Group
5
Anti-9V POST
Group
Value
95% CI
Synflorix 1 Group
284
Synflorix 2 Group
285
Prevenar 1 Group
95
Prevenar 2 Group
96
Anti-14 POST
Group
Value
95% CI
Synflorix 1 Group
285
Synflorix 2 Group
285
Prevenar 1 Group
95
Prevenar 2 Group
96
Anti-18C POST
Group
Value
95% CI
Synflorix 1 Group
284
Synflorix 2 Group
281
Prevenar 1 Group
95
Prevenar 2 Group
95
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL)Secondary· One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Cut-off values assessed were greater than or equal to 0.05 microgram per liter (µg/mL) in the sera of subjects.
Anti-1 POST
Group
Value
95% CI
Synflorix 1 Group
285
Synflorix 2 Group
285
Prevenar 1 Group
20
Prevenar 2 Group
13
Anti-4 POST
Group
Value
95% CI
Synflorix 1 Group
285
Synflorix 2 Group
285
Prevenar 1 Group
95
Prevenar 2 Group
96
Anti-5 POST
Group
Value
95% CI
Synflorix 1 Group
285
Synflorix 2 Group
285
Prevenar 1 Group
19
Prevenar 2 Group
13
Anti-6B POST
Group
Value
95% CI
Synflorix 1 Group
279
Synflorix 2 Group
274
Prevenar 1 Group
92
Prevenar 2 Group
91
Anti-7F POST
Group
Value
95% CI
Synflorix 1 Group
285
Synflorix 2 Group
285
Prevenar 1 Group
37
Prevenar 2 Group
22
Anti-9V POST
Group
Value
95% CI
Synflorix 1 Group
285
Synflorix 2 Group
285
Prevenar 1 Group
95
Prevenar 2 Group
96
Anti-14 POST
Group
Value
95% CI
Synflorix 1 Group
285
Synflorix 2 Group
285
Prevenar 1 Group
95
Prevenar 2 Group
96
Anti-18C POST
Group
Value
95% CI
Synflorix 1 Group
284
Synflorix 2 Group
285
Prevenar 1 Group
95
Prevenar 2 Group
95
Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23FSecondary· One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8
OPA Anti-1
Group
Value
95% CI
Synflorix 1 Group
93.7
68.2 – 128.7
Synflorix 2 Group
14.8
11.2 – 19.6
Prevenar 1 Group
4.2
3.8 – 4.5
Prevenar 2 Group
4
4 – 4
OPA Anti-4
Group
Value
95% CI
Synflorix 1 Group
1008.7
849.1 – 1198.4
Synflorix 2 Group
602.9
494.8 – 734.6
Prevenar 1 Group
1229.9
975.5 – 1550.7
Prevenar 2 Group
513
388.2 – 677.9
OPA Anti-5
Group
Value
95% CI
Synflorix 1 Group
209.3
176.6 – 248
Synflorix 2 Group
67.2
52.2 – 86.6
Prevenar 1 Group
4
4 – 4
Prevenar 2 Group
4
4 – 4
OPA Anti-6B
Group
Value
95% CI
Synflorix 1 Group
963.5
714.7 – 1299
Synflorix 2 Group
361.9
255 – 513.7
Prevenar 1 Group
1762.2
975.3 – 3184
Prevenar 2 Group
805
436.9 – 1483.4
OPA Anti-7F
Group
Value
95% CI
Synflorix 1 Group
5196.4
4349.2 – 6208.6
Synflorix 2 Group
2002.2
1543.1 – 2597.9
Prevenar 1 Group
14.2
6.9 – 29.4
Prevenar 2 Group
6.9
4.3 – 11.1
OPA Anti-9V
Group
Value
95% CI
Synflorix 1 Group
1631.9
1343.8 – 1981.9
Synflorix 2 Group
1171.7
966.1 – 1421.1
Prevenar 1 Group
1713.3
1294.6 – 2267.5
Prevenar 2 Group
1166
782.6 – 1737.2
OPA Anti-14
Group
Value
95% CI
Synflorix 1 Group
1669.1
1267.7 – 2197.6
Synflorix 2 Group
640
520.2 – 787.5
Prevenar 1 Group
2117.4
1210.9 – 3702.6
Prevenar 2 Group
947.6
658.6 – 1363.4
OPA Anti-18C
Group
Value
95% CI
Synflorix 1 Group
673.3
569.7 – 795.8
Synflorix 2 Group
174.9
137.1 – 223.1
Prevenar 1 Group
283.7
209.6 – 384.1
Prevenar 2 Group
127
86.4 – 186.5
Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8Secondary· One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F ≥ 8.
OPA Anti-1
Group
Value
95% CI
Synflorix 1 Group
117
Synflorix 2 Group
62
Prevenar 1 Group
1
Prevenar 2 Group
0
OPA Anti-4
Group
Value
95% CI
Synflorix 1 Group
137
Synflorix 2 Group
143
Prevenar 1 Group
43
Prevenar 2 Group
49
OPA Anti-5
Group
Value
95% CI
Synflorix 1 Group
139
Synflorix 2 Group
127
Prevenar 1 Group
0
Prevenar 2 Group
0
OPA Anti-6B
Group
Value
95% CI
Synflorix 1 Group
132
Synflorix 2 Group
122
Prevenar 1 Group
40
Prevenar 2 Group
44
OPA Anti-7F
Group
Value
95% CI
Synflorix 1 Group
137
Synflorix 2 Group
141
Prevenar 1 Group
10
Prevenar 2 Group
5
OPA Anti-9V
Group
Value
95% CI
Synflorix 1 Group
130
Synflorix 2 Group
144
Prevenar 1 Group
43
Prevenar 2 Group
49
OPA Anti-14
Group
Value
95% CI
Synflorix 1 Group
138
Synflorix 2 Group
142
Prevenar 1 Group
43
Prevenar 2 Group
48
OPA Anti-18C
Group
Value
95% CI
Synflorix 1 Group
138
Synflorix 2 Group
137
Prevenar 1 Group
45
Prevenar 2 Group
48
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19ASecondary· One month after the administration of the 3rd vaccine dose of Synflorix™ and Prevenar™
Seropositivity status, defined as Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).
Anti-6A
Group
Value
95% CI
Synflorix 1 Group
0.3
0.26 – 0.35
Synflorix 2 Group
0.17
0.15 – 0.2
Prevenar 1 Group
0.23
0.18 – 0.3
Prevenar 2 Group
0.26
0.2 – 0.33
Anti-19A
Group
Value
95% CI
Synflorix 1 Group
0.36
0.31 – 0.41
Synflorix 2 Group
0.29
0.25 – 0.34
Prevenar 1 Group
0.18
0.15 – 0.22
Prevenar 2 Group
0.12
0.1 – 0.15
Adverse events — posted to ClinicalTrials.gov
Time frame: Solicited AEs: Within 4 day (Days 0-3) after each dose and across doses; Unsolicited AEs: Within 31 days (Days 0-30) after each vaccination. SAEs: From study Day 0 until the 6-month extended safety follow-up.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age.
The study has 2 groups.
* One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated).
* The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.
All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives \& outcome measures of the primary study. The objectives \& outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Pneumococcal conjugate vaccine GSK1024850A
Trials testing the same drug.
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· Phase 3
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NCT00861380 — Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
· Phase 3
· completed
NCT00814710 — Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
· Phase 3
· completed
NCT00792909 — Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A
· Phase 3
· completed
NCT00466947 — COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococc
· Phase 3
· completed
Other GlaxoSmithKline trials
Trials by the same sponsor.
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· Phase 1
· not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH
· Phase 3
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
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: 7 December 2018
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/NCT00344318.