Who is sponsoring NCT00950833?

NCT00950833 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00950833?

Interventions in NCT00950833: Pneumococcal vaccine GSK1024850A.

What condition does NCT00950833 study?

NCT00950833 studies Infections, Streptococcal.

Is NCT00950833 still recruiting?

NCT00950833 is currently completed. Last updated 20 September 2018.

Are results published for NCT00950833?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-09-20 · How we verify

NCT00950833

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Long-term Follow-up Study of Children Previously Primed With GSK Pneumococcal Vaccine (GSK1024850A) and of Unprimed Children

Completed Phase 3 Results posted Last updated 20 September 2018

What this trial tests

Phase 3 trial testing Pneumococcal vaccine GSK1024850A in Infections, Streptococcal in 466 participants. Completed in 27 October 2010.

Timeline

10 August 2009

Primary endpoint
16 September 2010

27 October 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	466
Start date	10 August 2009
Primary completion	16 September 2010
Estimated completion	27 October 2010
Sites	10 locations across Czechia

Drugs / interventions tested

Pneumococcal vaccine GSK1024850A — full drug profile →

Conditions studied

Infections, Streptococcal — all drugs for Infections, Streptococcal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 31 Months to 44 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.

Antibody Concentrations Against Vaccine Pneumococcal Serotypes Primary · At 7-10 days after the first vaccine dose

Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.

Anti-1

Group	Value	95% CI
Synflorix III Group	1.24	1.07 – 1.42
Pooled Synflorix I+II Group	7.63	6.57 – 8.86

Anti-4

Group	Value	95% CI
Synflorix III Group	4.52	3.96 – 5.17
Pooled Synflorix I+II Group	12.95	11.37 – 14.75

Anti-5

Group	Value	95% CI
Synflorix III Group	0.72	0.63 – 0.84
Pooled Synflorix I+II Group	9.76	8.44 – 11.29

Anti-6B

Group	Value	95% CI
Synflorix III Group	0.27	0.22 – 0.33
Pooled Synflorix I+II Group	7.67	6.7 – 8.78

Anti-7F

Group	Value	95% CI
Synflorix III Group	1.37	1.19 – 1.58
Pooled Synflorix I+II Group	6.51	5.69 – 7.46

Anti-9V

Group	Value	95% CI
Synflorix III Group	0.69	0.58 – 0.83
Pooled Synflorix I+II Group	9.75	8.46 – 11.24

Anti-14

Group	Value	95% CI
Synflorix III Group	1.01	0.8 – 1.27
Pooled Synflorix I+II Group	23.07	20.03 – 26.57

Anti-18C

Group	Value	95% CI
Synflorix III Group	3.25	2.71 – 3.9
Pooled Synflorix I+II Group	32.54	28.15 – 37.61

Antibody Concentrations Against Vaccine Pneumococcal Serotypes Secondary · Prior to the first study vaccine dose (At Day 0)

Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition ELISA, presented as GMCs and expressed in μg/mL. The seropositivity cut-off value of the assay was an antibody concentration ≥ 0.05 μg/mL.

Anti-1

Group	Value	95% CI
Synflorix III Group	0.09	0.08 – 0.11
Pooled Synflorix I+II Group	0.27	0.23 – 0.33

Anti-4

Group	Value	95% CI
Synflorix III Group	0.05	0.04 – 0.06
Pooled Synflorix I+II Group	0.2	0.17 – 0.23

Anti-5

Group	Value	95% CI
Synflorix III Group	0.1	0.09 – 0.11
Pooled Synflorix I+II Group	0.41	0.36 – 0.47

Anti-6B

Group	Value	95% CI
Synflorix III Group	0.1	0.08 – 0.12
Pooled Synflorix I+II Group	0.8	0.61 – 1.05

Anti-7F

Group	Value	95% CI
Synflorix III Group	0.06	0.05 – 0.07
Pooled Synflorix I+II Group	0.48	0.41 – 0.56

Anti-9V

Group	Value	95% CI
Synflorix III Group	0.07	0.06 – 0.09
Pooled Synflorix I+II Group	0.5	0.41 – 0.61

Anti-14

Group	Value	95% CI
Synflorix III Group	0.28	0.22 – 0.36
Pooled Synflorix I+II Group	1.21	0.97 – 1.5

Anti-18C

Group	Value	95% CI
Synflorix III Group	0.09	0.07 – 0.11
Pooled Synflorix I+II Group	0.65	0.54 – 0.79

Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes Secondary · Prior to (Day 0) and 7-10 days after the first vaccine dose

Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).

Opsono-1, D0

Group	Value	95% CI
Synflorix III Group	5.4	4.7 – 6.2
Pooled Synflorix I+II Group	10.2	8 – 12.9

Opsono-1, D7-10

Group	Value	95% CI
Synflorix III Group	632	524.4 – 761.7
Pooled Synflorix I+II Group	3106.5	2670 – 3614.5

Opsono-4, D0

Group	Value	95% CI
Synflorix III Group	9.1	6.8 – 12.1
Pooled Synflorix I+II Group	18.1	13.1 – 24.9

Opsono-4, D7-10

Group	Value	95% CI
Synflorix III Group	13109.9	11080.6 – 15510.7
Pooled Synflorix I+II Group	27273.3	22682.9 – 32792.6

Opsono-5, D0

Group	Value	95% CI
Synflorix III Group	4	4 – 4.1
Pooled Synflorix I+II Group	8.9	7.6 – 10.5

Opsono-5, D7-10

Group	Value	95% CI
Synflorix III Group	145.8	111.7 – 190.3
Pooled Synflorix I+II Group	1020	874 – 1190.2

Opsono-6B, D0

Group	Value	95% CI
Synflorix III Group	46.7	29.8 – 73.3
Pooled Synflorix I+II Group	163.5	108.5 – 246.4

Opsono-6B, D7-10

Group	Value	95% CI
Synflorix III Group	1472.2	1053.2 – 2057.8
Pooled Synflorix I+II Group	5789.5	4637.3 – 7227.9

Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A Secondary · Prior to (Day 0) and 7-10 days after the first vaccine dose

The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Anti-6A, D0

Group	Value	95% CI
Synflorix III Group	0.11	0.09 – 0.13
Pooled Synflorix I+II Group	0.39	0.3 – 0.5

Anti-6A, D7-10

Group	Value	95% CI
Synflorix III Group	0.2	0.17 – 0.25
Pooled Synflorix I+II Group	2.4	2.01 – 2.85

Anti-19A, D0

Group	Value	95% CI
Synflorix III Group	0.22	0.18 – 0.28
Pooled Synflorix I+II Group	0.52	0.41 – 0.67

Anti-19A, D7-10

Group	Value	95% CI
Synflorix III Group	0.65	0.52 – 0.82
Pooled Synflorix I+II Group	6.75	5.41 – 8.41

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A Secondary · Prior to (Day 0) and 7-10 days after the first vaccine dose

Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (Opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).

Opsono-6A, D0

Group	Value	95% CI
Synflorix III Group	49	32.4 – 74
Pooled Synflorix I+II Group	95.2	65.3 – 138.7

Opsono-6A, D7-10

Group	Value	95% CI
Synflorix III Group	863.3	619.3 – 1203.4
Pooled Synflorix I+II Group	2408.4	1815.7 – 3194.5

Opsono-19A, D0

Group	Value	95% CI
Synflorix III Group	10.3	7.9 – 13.4
Pooled Synflorix I+II Group	15.9	11.7 – 21.6

Opsono-19A, D7-10

Group	Value	95% CI
Synflorix III Group	880.5	622.7 – 1245
Pooled Synflorix I+II Group	2104.9	1560.9 – 2838.7

Antibody Concentrations Against Protein D (Anti-PD) Secondary · Prior to (Day 0) and 7-10 days after the first vaccine dose

Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.

Anti-PD, D0

Group	Value	95% CI
Synflorix III Group	105.6	93.8 – 119
Pooled Synflorix I+II Group	464.2	401.6 – 536.5

Anti-PD, D7-10

Group	Value	95% CI
Synflorix III Group	374.3	315.1 – 444.6
Pooled Synflorix I+II Group	2673.7	2359.1 – 3030.2

Memory B-cell Detection for Vaccine Polysaccharides (PS) Secondary · Prior to (Day 0) and 7-10 days after the first vaccine dose

B-cell detection for the pneumococcal serotype specific polysaccharides (1, 5, 6B, 18C, 19F, 23F and C) was tabulated for a subset of subjects from each group. The results are expressed as the frequencies of antigen-specific memory B-cells within the total memory B-cell population.

1 PS, D0

Group	Value	95% CI
Synflorix I Group	288.6	± 352.5
Synflorix II Group	269.5	± 432.2
Synflorix III Group	254.8	± 368.4

1 PS, D7-10

Group	Value	95% CI
Synflorix I Group	1488.8	± 1584.2
Synflorix II Group	1017.4	± 1309.9
Synflorix III Group	755.9	± 1017.4

5 PS, D0

Group	Value	95% CI
Synflorix I Group	139.4	± 214.7
Synflorix II Group	141.9	± 232.4
Synflorix III Group	81.5	± 109.2

5 PS, D7-10

Group	Value	95% CI
Synflorix I Group	233.5	± 235.7
Synflorix II Group	406.6	± 447.8
Synflorix III Group	152.6	± 231

6B PS, D0

Group	Value	95% CI
Synflorix I Group	372	± 545.5
Synflorix II Group	327.2	± 554.4
Synflorix III Group	639.9	± 846.5

6B PS, D7-10

Group	Value	95% CI
Synflorix I Group	629.1	± 773.2
Synflorix II Group	1265.8	± 1738.6
Synflorix III Group	526	± 648.6

18C PS, D0

Group	Value	95% CI
Synflorix I Group	537.7	± 641.8
Synflorix II Group	530.9	± 693.8
Synflorix III Group	135.2	± 200.6

18C PS, D7-10

Group	Value	95% CI
Synflorix I Group	3839	± 5960.5
Synflorix II Group	8308.4	± 7166.9
Synflorix III Group	2053.8	± 2122.2

Antibody Concentrations Against Vaccine Pneumococcal Serotypes Secondary · At Month 12, one month after the second vaccine dose

The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs), expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.

Anti-1

Group	Value	95% CI
Synflorix III Group	2.33	2.13 – 2.54

Anti-4

Group	Value	95% CI
Synflorix III Group	6.26	5.73 – 6.84

Anti-5

Group	Value	95% CI
Synflorix III Group	2.69	2.44 – 2.96

Anti-6B

Group	Value	95% CI
Synflorix III Group	0.84	0.73 – 0.97

Anti-7F

Group	Value	95% CI
Synflorix III Group	3.63	3.33 – 3.95

Anti-9V

Group	Value	95% CI
Synflorix III Group	1.73	1.56 – 1.93

Anti-14

Group	Value	95% CI
Synflorix III Group	5.21	4.6 – 5.89

Anti-18C

Group	Value	95% CI
Synflorix III Group	13.59	11.91 – 15.51

Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes Secondary · At Month 12, one month after the second vaccine dose

Opsono-1

Group	Value	95% CI
Synflorix III Group	125.6	105 – 150.1

Opsono-4

Group	Value	95% CI
Synflorix III Group	2451.2	2203.6 – 2726.8

Opsono-5

Group	Value	95% CI
Synflorix III Group	57.2	47.3 – 69.1

Opsono-6B

Group	Value	95% CI
Synflorix III Group	1345	1066.8 – 1695.7

Opsono-7F

Group	Value	95% CI
Synflorix III Group	6527.2	5836.5 – 7299.6

Opsono-9V

Group	Value	95% CI
Synflorix III Group	6091.6	5328.7 – 6963.8

Opsono-14

Group	Value	95% CI
Synflorix III Group	4544.9	4030.2 – 5125.4

Opsono-18C

Group	Value	95% CI
Synflorix III Group	3827.5	3367.5 – 4350.4

Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A Secondary · At Month 12, one month after the second vaccine dose

Anti-6A

Group	Value	95% CI
Synflorix III Group	0.51	0.43 – 0.6

Anti-19A

Group	Value	95% CI
Synflorix III Group	1.99	1.68 – 2.36

Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A Secondary · At Month 12, one month after the second vaccine dose

Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).

Opsono-6A

Group	Value	95% CI
Synflorix III Group	918.6	742.7 – 1136.1

Opsono-19A

Group	Value	95% CI
Synflorix III Group	597.6	467.2 – 764.4

Antibody Concentrations Against Protein D (Anti-PD) Secondary · At Month 12, one month after the second vaccine dose

Group	Value	95% CI
Synflorix III Group	785.9	695.7 – 887.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited symptoms: during the 4-day (Days 0-3) follow-up periods after vaccination. Unsolicited AEs: within the 31-day (Days 0-30) follow-up periods after vaccination. SAEs: during the entire study period (from Day 0 up to Month 10/12).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Synflorix I Group

Serious: 0/112 (0%)

Deaths: 0/112

Synflorix II Group

Serious: 0/108 (0%)

Deaths: 0/108

Synflorix III Group

Serious: 0/223 (0%)

Deaths: 0/223

Other adverse events (7 terms — click to expand)

Reaction	System	Synflorix I Group	Synflorix II Group	Synflorix III Group
Pain	General disorders	—	—	—
Redness	General disorders	—	—	—
Drowsiness	General disorders	—	—	—
Swelling	General disorders	—	—	—
Irritability	General disorders	—	—	—
Loss of appetite	General disorders	—	—	—
Fever/(Axillary)	General disorders	—	—	—

Data from ClinicalTrials.gov NCT00950833 adverse events section.

Sponsor's own description

The objective of this study is to evaluate the immune memory through the administration of an additional dose of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A, the antibody persistence and long-term effect on nasopharyngeal carriage of S. pneumoniae and H. influenzae in subjects primed and boosted with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A in previous primary and booster studies. For subjects that did not receive the investigational vaccine during the primary and booster study, the objective is to evaluate immunogenicity, safety and reactogenicity of a 2-dose catch-up vaccination with GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A. This protocol posting deals with objectives \& outcome measures of the extension phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00370318). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT00496015).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Pneumococcal vaccine GSK1024850A

Trials testing the same drug.

NCT01153893 — Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria · Phase 3 · completed
NCT01119625 — Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose · Phase 3 · completed
NCT01030822 — Booster and Catch-up Vaccination With Vaccine GSK1024850A · Phase 3 · completed
NCT01027845 — Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children · Phase 3 · completed
NCT00985751 — Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination · Phase 2 · completed

Other GlaxoSmithKline trials

Trials by the same sponsor.

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NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · 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

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00950833 (US National Library of Medicine, public domain)
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: 20 September 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/NCT00950833.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00950833

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Pneumococcal vaccine GSK1024850A

Other GlaxoSmithKline trials

Verify against primary sources