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NCT00985751

Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

Completed Phase 2 Results posted Last updated 5 November 2020
What this trial tests

Phase 2 trial testing Pneumococcal vaccine GSK2189242A (formulation 1) in Infections, Streptococcal in 257 participants. Completed in 2 March 2011.

Timeline
24 November 2009
Primary endpoint
12 October 2010
2 March 2011

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment257
Start date24 November 2009
Primary completion12 October 2010
Estimated completion2 March 2011
Sites10 locations across Czechia

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 12 Months to 23 Months, 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 With Fever > 40.0°C (Rectal Temperature) Primary · Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination

The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.

GroupValue95% CI
Synflorix Group0
Synflorix/GSK 2189242A Group1
Number of Subjects With Fever > 40.0°C (Rectal Temperature) Primary · Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination

The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.

GroupValue95% CI
Synflorix Group0
GSK 2189242A Group1
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Secondary · During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)

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 Dose 1
GroupValue95% CI
GSK 2189242A-LD Group18
GSK 2189242A-HD Group15
Synflorix/GSK 2189242A-LD Group31
Synflorix/GSK 2189242A-HD Group23
Synflorix Group26
Grade 3 Pain Dose 1
GroupValue95% CI
GSK 2189242A-LD Group0
GSK 2189242A-HD Group0
Synflorix/GSK 2189242A-LD Group1
Synflorix/GSK 2189242A-HD Group2
Synflorix Group4
Any Redness Dose 1
GroupValue95% CI
GSK 2189242A-LD Group17
GSK 2189242A-HD Group20
Synflorix/GSK 2189242A-LD Group32
Synflorix/GSK 2189242A-HD Group28
Synflorix Group25
Grade 3 Redness Dose 1
GroupValue95% CI
GSK 2189242A-LD Group1
GSK 2189242A-HD Group0
Synflorix/GSK 2189242A-LD Group5
Synflorix/GSK 2189242A-HD Group4
Synflorix Group2
Any Swelling Dose 1
GroupValue95% CI
GSK 2189242A-LD Group8
GSK 2189242A-HD Group5
Synflorix/GSK 2189242A-LD Group19
Synflorix/GSK 2189242A-HD Group17
Synflorix Group19
Grade 3 Swelling Dose 1
GroupValue95% CI
GSK 2189242A-LD Group0
GSK 2189242A-HD Group0
Synflorix/GSK 2189242A-LD Group2
Synflorix/GSK 2189242A-HD Group2
Synflorix Group1
Any Pain Dose 2
GroupValue95% CI
GSK 2189242A-LD Group15
GSK 2189242A-HD Group22
Synflorix/GSK 2189242A-LD Group24
Synflorix/GSK 2189242A-HD Group27
Synflorix Group27
Grade 3 Pain Dose 2
GroupValue95% CI
GSK 2189242A-LD Group0
GSK 2189242A-HD Group0
Synflorix/GSK 2189242A-LD Group2
Synflorix/GSK 2189242A-HD Group2
Synflorix Group3
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Secondary · During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)

Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

Any Drowsiness Dose 1
GroupValue95% CI
GSK 2189242A-LD Group16
GSK 2189242A-HD Group13
Synflorix/GSK 2189242A-LD Group24
Synflorix/GSK 2189242A-HD Group20
Synflorix Group26
Grade 3 Drowsiness Dose 1
GroupValue95% CI
GSK 2189242A-LD Group0
GSK 2189242A-HD Group0
Synflorix/GSK 2189242A-LD Group0
Synflorix/GSK 2189242A-HD Group0
Synflorix Group0
Related Drowsiness Dose 1
GroupValue95% CI
GSK 2189242A-LD Group6
GSK 2189242A-HD Group6
Synflorix/GSK 2189242A-LD Group13
Synflorix/GSK 2189242A-HD Group10
Synflorix Group16
Any Irritability Dose 1
GroupValue95% CI
GSK 2189242A-LD Group21
GSK 2189242A-HD Group16
Synflorix/GSK 2189242A-LD Group31
Synflorix/GSK 2189242A-HD Group27
Synflorix Group23
Grade 3 Irritability Dose 1
GroupValue95% CI
GSK 2189242A-LD Group0
GSK 2189242A-HD Group0
Synflorix/GSK 2189242A-LD Group0
Synflorix/GSK 2189242A-HD Group0
Synflorix Group0
Related Irritability Dose 1
GroupValue95% CI
GSK 2189242A-LD Group6
GSK 2189242A-HD Group9
Synflorix/GSK 2189242A-LD Group17
Synflorix/GSK 2189242A-HD Group16
Synflorix Group14
Any Loss of appetite Dose 1
GroupValue95% CI
GSK 2189242A-LD Group15
GSK 2189242A-HD Group7
Synflorix/GSK 2189242A-LD Group14
Synflorix/GSK 2189242A-HD Group12
Synflorix Group14
Grade 3 Loss of appetite Dose 1
GroupValue95% CI
GSK 2189242A-LD Group2
GSK 2189242A-HD Group0
Synflorix/GSK 2189242A-LD Group1
Synflorix/GSK 2189242A-HD Group0
Synflorix Group0
Number of Subjects With Unsolicited Adverse Events (AEs) Secondary · During the 31-day (Days 0-30) follow-up period after each primary dose

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.

GroupValue95% CI
GSK 2189242A-LD Group25
GSK 2189242A-HD Group24
Synflorix/GSK 2189242A-LD Group31
Synflorix/GSK 2189242A-HD Group24
Synflorix Group22
Number of Subjects With Unsolicited Adverse Events (AEs) Secondary · During the 31-day (Days 0-30) follow-up period after the booster dose

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.

GroupValue95% CI
GSK 2189242A-LD Group14
GSK 2189242A-HD Group12
Synflorix/GSK 2189242A-LD Group13
Synflorix/GSK 2189242A-HD Group4
Synflorix Group9
Number of Subjects With Serious Adverse Events (SAEs) Secondary · During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)

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

GroupValue95% CI
GSK 2189242A-LD Group5
GSK 2189242A-HD Group3
Synflorix/GSK 2189242A-LD Group5
Synflorix/GSK 2189242A-HD Group0
Synflorix Group4
Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations Secondary · One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.

Anti-dPly, Post-dose 2
GroupValue95% CI
GSK 2189242A-LD Group135703.595376.62 – 193081.3
GSK 2189242A-HD Group148447.5101599.9 – 216896.7
Synflorix/GSK 2189242A-LD Group32436.0725523.77 – 41220.35
Synflorix/GSK 2189242A-HD Group57149.8344908.69 – 72727.64
Synflorix Group3759.822376.77 – 5947.68
Anti-dPly, Pre-booster
GroupValue95% CI
GSK 2189242A-LD Group100811.474005.55 – 137326.8
GSK 2189242A-HD Group96552.5273753.5 – 126399.3
Synflorix/GSK 2189242A-LD Group19573.5514948.37 – 25629.82
Synflorix/GSK 2189242A-HD Group29592.9122065.25 – 39688.66
Synflorix Group4654.162879.42 – 7522.78
Anti-dPly, Post-booster
GroupValue95% CI
GSK 2189242A-LD Group224726.2178187.6 – 283419.8
GSK 2189242A-HD Group305912.3248087.9 – 377214.4
Synflorix/GSK 2189242A-LD Group44123.4334299.98 – 56760.29
Synflorix/GSK 2189242A-HD Group85805.0267740.53 – 108686.8
Synflorix Group4553.432878.04 – 7204.12
Anti-PhtD, Post-dose 2
GroupValue95% CI
GSK 2189242A-LD Group30402.8420723.61 – 44602.88
GSK 2189242A-HD Group35043.9124164.16 – 50822.19
Synflorix/GSK 2189242A-LD Group23438.0616617.86 – 33057.36
Synflorix/GSK 2189242A-HD Group22141.1815065.44 – 32540.15
Synflorix Group3795.682268.23 – 6351.73
Anti-PhtD, Pre-booster
GroupValue95% CI
GSK 2189242A-LD Group24350.5817056.09 – 34764.74
GSK 2189242A-HD Group23918.7717724.59 – 32277.63
Synflorix/GSK 2189242A-LD Group14375.599338.31 – 22130.1
Synflorix/GSK 2189242A-HD Group12721.018498 – 19042.62
Synflorix Group4814.972881.25 – 8046.46
Anti-PhtD, Post-booster
GroupValue95% CI
GSK 2189242A-LD Group65584.2450985.27 – 84363.43
GSK 2189242A-HD Group77312.0758589.49 – 102017.6
Synflorix/GSK 2189242A-LD Group32609.1923615.58 – 45027.88
Synflorix/GSK 2189242A-HD Group36098.1826620.97 – 48949.34
Synflorix Group5072.433023.97 – 8508.53
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations Secondary · One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).

Anti-1, Post-Dose 2
GroupValue95% CI
GSK 2189242A-LD Group0.040.03 – 0.05
GSK 2189242A-HD Group0.050.04 – 0.06
Synflorix/GSK 2189242A-LD Group2.52.01 – 3.11
Synflorix/GSK 2189242A-HD Group2.081.56 – 2.77
Synflorix Group2.131.62 – 2.79
Anti-1, Pre-booster
GroupValue95% CI
GSK 2189242A-LD Group0.050.03 – 0.06
GSK 2189242A-HD Group0.050.04 – 0.07
Synflorix/GSK 2189242A-LD Group0.870.68 – 1.12
Synflorix/GSK 2189242A-HD Group0.750.57 – 0.99
Synflorix Group0.730.55 – 0.97
Anti-1, Post-booster
GroupValue95% CI
GSK 2189242A-LD Group0.040.03 – 0.06
GSK 2189242A-HD Group0.050.04 – 0.08
Synflorix/GSK 2189242A-LD Group2.692.13 – 3.39
Synflorix/GSK 2189242A-HD Group2.472.03 – 3
Synflorix Group2.41.85 – 3.12
Anti-4, Post-Dose 2
GroupValue95% CI
GSK 2189242A-LD Group0.050.03 – 0.08
GSK 2189242A-HD Group0.030.02 – 0.03
Synflorix/GSK 2189242A-LD Group6.425.23 – 7.87
Synflorix/GSK 2189242A-HD Group6.65.12 – 8.52
Synflorix Group5.674.56 – 7.06
Anti-4, Pre-booster
GroupValue95% CI
GSK 2189242A-LD Group0.050.03 – 0.07
GSK 2189242A-HD Group0.030.03 – 0.03
Synflorix/GSK 2189242A-LD Group2.31.82 – 2.91
Synflorix/GSK 2189242A-HD Group2.361.79 – 3.11
Synflorix Group2.111.68 – 2.64
Anti-4, Post-booster
GroupValue95% CI
GSK 2189242A-LD Group0.050.03 – 0.07
GSK 2189242A-HD Group0.040.03 – 0.05
Synflorix/GSK 2189242A-LD Group5.264.14 – 6.69
Synflorix/GSK 2189242A-HD Group5.614.46 – 7.07
Synflorix Group5.184.05 – 6.63
Anti-5, Post-Dose 2
GroupValue95% CI
GSK 2189242A-LD Group0.060.04 – 0.08
GSK 2189242A-HD Group0.060.05 – 0.08
Synflorix/GSK 2189242A-LD Group2.421.85 – 3.17
Synflorix/GSK 2189242A-HD Group2.411.85 – 3.13
Synflorix Group2.361.88 – 2.97
Anti-5, Pre-booster
GroupValue95% CI
GSK 2189242A-LD Group0.070.05 – 0.1
GSK 2189242A-HD Group0.060.05 – 0.08
Synflorix/GSK 2189242A-LD Group1.080.83 – 1.41
Synflorix/GSK 2189242A-HD Group1.050.81 – 1.36
Synflorix Group1.180.94 – 1.48
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes Secondary · One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.

OPSONO-1, Post-Dose 2
GroupValue95% CI
GSK 2189242A-LD Group44 – 4
GSK 2189242A-HD Group5.43.8 – 7.8
Synflorix/GSK 2189242A-LD Group71.840.9 – 126.1
Synflorix/GSK 2189242A-HD Group48.226.5 – 87.6
Synflorix Group9052.9 – 153
OPSONO-1, Pre-booster
GroupValue95% CI
GSK 2189242A-LD Group44 – 4
GSK 2189242A-HD Group4.33.7 – 5
Synflorix/GSK 2189242A-LD Group2313.1 – 40.3
Synflorix/GSK 2189242A-HD Group12.47.6 – 20.3
Synflorix Group19.311.1 – 33.6
OPSONO-1, Post-booster
GroupValue95% CI
GSK 2189242A-LD Group5.24 – 6.9
GSK 2189242A-HD Group8.14.8 – 13.7
Synflorix/GSK 2189242A-LD Group169.596.1 – 298.8
Synflorix/GSK 2189242A-HD Group200138.2 – 289.4
Synflorix Group206.9123.1 – 347.5
OPSONO-4, Post-Dose 2
GroupValue95% CI
GSK 2189242A-LD Group73.1 – 15.6
GSK 2189242A-HD Group8.94.5 – 17.6
Synflorix/GSK 2189242A-LD Group1260.2856.1 – 1855.2
Synflorix/GSK 2189242A-HD Group1197.9784.1 – 1830.2
Synflorix Group1220.4913.8 – 1629.9
OPSONO-4, Pre-booster
GroupValue95% CI
GSK 2189242A-LD Group12.65.6 – 28.4
GSK 2189242A-HD Group16.27 – 37.2
Synflorix/GSK 2189242A-LD Group247.9117.4 – 523.2
Synflorix/GSK 2189242A-HD Group259.9120.6 – 560
Synflorix Group478.9309.3 – 741.3
OPSONO-4, Post-booster
GroupValue95% CI
GSK 2189242A-LD Group15.56.1 – 39.5
GSK 2189242A-HD Group17.87.3 – 43.4
Synflorix/GSK 2189242A-LD Group1206.2888.9 – 1636.8
Synflorix/GSK 2189242A-HD Group1385974.5 – 1968.4
Synflorix Group14761076 – 2024.6
OPSONO-5, Post-Dose 2
GroupValue95% CI
GSK 2189242A-LD Group44 – 4
GSK 2189242A-HD Group4.73.4 – 6.5
Synflorix/GSK 2189242A-LD Group43.827.1 – 70.8
Synflorix/GSK 2189242A-HD Group37.321.7 – 64
Synflorix Group4226.6 – 66.4
OPSONO-5, Pre-booster
GroupValue95% CI
GSK 2189242A-LD Group4.53.5 – 5.8
GSK 2189242A-HD Group44 – 4
Synflorix/GSK 2189242A-LD Group12.88.2 – 19.9
Synflorix/GSK 2189242A-HD Group14.89.6 – 23
Synflorix Group1710.9 – 26.4
Antibody Concentrations to Protein D (Anti-PD) Secondary · One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).

Anti-PD, Post-Dose 2
GroupValue95% CI
GSK 2189242A-LD Group90.971.1 – 116.3
GSK 2189242A-HD Group100.476.3 – 132.1
Synflorix/GSK 2189242A-LD Group1105.4833.7 – 1465.7
Synflorix/GSK 2189242A-HD Group600.2426.5 – 844.7
Synflorix Group860659.2 – 1121.9
Anti-PD, Pre-booster
GroupValue95% CI
GSK 2189242A-LD Group89.171.8 – 110.7
GSK 2189242A-HD Group118.289.6 – 155.9
Synflorix/GSK 2189242A-LD Group734.6523.9 – 1030.1
Synflorix/GSK 2189242A-HD Group463330.2 – 649.3
Synflorix Group691.8527.6 – 907.1
Anti-PD, Post-booster
GroupValue95% CI
GSK 2189242A-LD Group97.978 – 122.9
GSK 2189242A-HD Group130.693.1 – 183.3
Synflorix/GSK 2189242A-LD Group1882.61407.4 – 2518.1
Synflorix/GSK 2189242A-HD Group1474.61103.7 – 1970.3
Synflorix Group1963.81560.1 – 2472
Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity Secondary · One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.

Anti-Hem-dPly, Post-Dose 2
GroupValue95% CI
GSK 2189242A-LD Group30802555.3 – 3712.5
GSK 2189242A-HD Group2988.72410.1 – 3706.2
Synflorix/GSK 2189242A-LD Group1278.91048.2 – 1560.3
Synflorix/GSK 2189242A-HD Group18141495.3 – 2200.8
Synflorix Group913.2699.1 – 1192.8
Anti-Hem-dPly, Pre-booster
GroupValue95% CI
GSK 2189242A-LD Group2441.11867.1 – 3191.7
GSK 2189242A-HD Group2193.71737.3 – 2770
Synflorix/GSK 2189242A-LD Group1141.5950.6 – 1370.6
Synflorix/GSK 2189242A-HD Group1344.21087.6 – 1661.3
Synflorix Group995.9788.3 – 1258.2
Anti-Hem-dPly, Post-booster
GroupValue95% CI
GSK 2189242A-LD Group4332.43327.6 – 5640.4
GSK 2189242A-HD Group5931.94744.5 – 7416.4
Synflorix/GSK 2189242A-LD Group1346.21068.2 – 1696.5
Synflorix/GSK 2189242A-HD Group2388.31830.6 – 3115.9
Synflorix Group818.6662.5 – 1011.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK 2189242A-LD Group
Serious: 5/51 (10%)
Deaths: 0/51
GSK 2189242A-HD Group
Serious: 3/52 (6%)
Deaths: 0/52
Synflorix/GSK 2189242A-LD Group
Serious: 5/52 (10%)
Deaths: 0/52
Synflorix/GSK 2189242A-HD Group
Serious: 0/51 (0%)
Deaths: 0/51
Synflorix Group
Serious: 4/51 (8%)
Deaths: 0/51

Serious adverse events (20 terms)

ReactionSystemGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD …Synflorix/GSK 2189242A-HD …Synflorix Group
HaematomaVascular disorders—————
ConcussionInjury, poisoning and procedural complications—————
Accidental exposureInjury, poisoning and procedural complications—————
Foreign bodyInjury, poisoning and procedural complications—————
Open woundInjury, poisoning and procedural complications—————
Adenoidal hypertrophyRespiratory, thoracic and mediastinal disorders—————
Febrile convulsionNervous system disorders—————
PyrexiaGeneral disorders—————
Ear haemorrhageEar and labyrinth disorders—————
EnterocolitisGastrointestinal disorders—————
Affective disorderPsychiatric disorders—————
Type 1 diabetes mellitusMetabolism and nutrition disorders—————
Gastroenteritis salmonellaInfections and infestations—————
BronchitisInfections and infestations—————
BronchopneumoniaInfections and infestations—————
GastroenteritisInfections and infestations—————
LaryngitisInfections and infestations—————
Oral herpesInfections and infestations—————
Pharyngo-tonsillitisInfections and infestations—————
Viral infectionInfections and infestations—————
Other adverse events (25 terms — click to expand)

ReactionSystemGSK 2189242A-LD GroupGSK 2189242A-HD GroupSynflorix/GSK 2189242A-LD …Synflorix/GSK 2189242A-HD …Synflorix Group
Redness PrimaryGeneral disorders—————
Irritability PrimaryGeneral disorders—————
Drowsiness PrimaryGeneral disorders—————
Pain PrimaryGeneral disorders—————
Pain BoosterGeneral disorders—————
Redness BoosterGeneral disorders—————
Swelling PrimaryGeneral disorders—————
Irritability BoosterGeneral disorders—————
Loss of appetite PrimaryGeneral disorders—————
Swelling BoosterGeneral disorders—————
Temperature/Rectally PrimaryGeneral disorders—————
Drowsiness BoosterGeneral disorders—————
Loss of appetite BoosterGeneral disorders—————
Temperature/Rectally BoosterGeneral disorders—————
Nasopharyngitis PrimaryInfections and infestations—————
CoughRespiratory, thoracic and mediastinal disorders—————
Rhinitis PrimaryInfections and infestations—————
Rhinitis BoosterInfections and infestations—————
BronchitisInfections and infestations—————
Viral infectionInfections and infestations—————
LaryngitisInfections and infestations—————
ConjunctivitisEye disorders—————
Nasopharyngitis BoosterInfections and infestations—————
GastroenteritisInfections and infestations—————
VaricellaInfections and infestations—————

Most-reported serious reactions: Haematoma, Concussion, Accidental exposure, Foreign body, Open wound, Adenoidal hypertrophy, Febrile convulsion, Pyrexia.

Data from ClinicalTrials.gov NCT00985751 adverse events section.

Sponsor's own description

This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature \>40.0°C).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Development of Next Generation <i>Streptococcus pneumoniae</i> Vaccines Conferring Broad Protection.
    Masomian M, Ahmad Z, Gew LT, Poh CL. · · 2020 · cited 102× · PMID 32192117 · DOI 10.3390/vaccines8010132
  2. Pneumococcal whole-cell and protein-based vaccines: changing the paradigm.
    Pichichero ME. · · 2017 · cited 50× · PMID 29130395 · DOI 10.1080/14760584.2017.1393335
  3. Safety and immunogenicity of an investigational vaccine containing two common pneumococcal proteins in toddlers: a phase II randomized clinical trial.
    Prymula R, Pazdiora P, Traskine M, Rüggeberg JU, et al · · 2014 · cited 43× · PMID 24699466 · DOI 10.1016/j.vaccine.2014.03.066
  4. &lt;i&gt;Streptococcus pneumoniae&lt;/i&gt; serotype distribution in low- and middle-income countries of South Asia: Do we need to revisit the pneumococcal vaccine strategy?
    Dhawale P, Shah S, Sharma K, Sikriwal D, et al · · 2025 · cited 3× · PMID 39999432 · DOI 10.1080/21645515.2025.2461844
  5. Vaccination for the control of childhood bacterial pneumonia - <i>Haemophilus influenzae</i> type b and pneumococcal vaccines.
    Otczyk DC, Cripps AW. · · 2013 · cited 3× · PMID 31463182 · DOI 10.15172/pneu.2013.2/229

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