Who is sponsoring NCT00985465?

NCT00985465 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00985465?

Interventions in NCT00985465: Pneumococcal vaccine GSK1024850A.

What condition does NCT00985465 study?

NCT00985465 studies Infections, Streptococcal.

Is NCT00985465 still recruiting?

NCT00985465 is currently completed. Last updated 14 December 2018.

Are results published for NCT00985465?

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

Last reviewed 2018-12-14 · How we verify

NCT00985465

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

Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali

Completed Phase 3 Results posted Last updated 14 December 2018

What this trial tests

Phase 3 trial testing Pneumococcal vaccine GSK1024850A in Infections, Streptococcal in 218 participants. Completed in 26 July 2010.

Timeline

12 November 2009

Primary endpoint
26 June 2010

26 July 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	218
Start date	12 November 2009
Primary completion	26 June 2010
Estimated completion	26 July 2010
Sites	1 location across Mali

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 15 Months to 21 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 Grade 3 Adverse Events (Solicited and Unsolicited) Primary · Within 31 days (Day 0-Day 30) after booster vaccination

The incidence and nature of Grade 3 symptoms (solicited and unsolicited), reported during the 31-day (Days 0-30) post-vaccination are presented.

Any symptom

Group	Value	95% CI
Synflorix Primed Group	3

General symptoms

Group	Value	95% CI
Synflorix Primed Group	1

Local symptoms

Group	Value	95% CI
Synflorix Primed Group	2

Number of Subjects With Any and Grade 3 Solicited Local Symptoms Secondary · Within 4 days (Day 0-Day 3) after the booster dose

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

Any Pain

Group	Value	95% CI
Synflorix Primed Group	40

Grade 3 Pain

Group	Value	95% CI
Synflorix Primed Group	0

Any Redness

Group	Value	95% CI
Synflorix Primed Group	17

Grade 3 Redness

Group	Value	95% CI
Synflorix Primed Group	2

Any Swelling

Group	Value	95% CI
Synflorix Primed Group	67

Grade 3 Swelling

Group	Value	95% CI
Synflorix Primed Group	0

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Secondary · Within 4 days (Day 0-Day 3) after the booster dose

Assessed solicited general symptoms were drowsiness, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness and Irritability = symptom that prevented normal activity. Grade 3 Loss of appetite = not eating at all. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Any Drowsiness

Group	Value	95% CI
Synflorix Primed Group	0

Grade 3 Drowsiness

Group	Value	95% CI
Synflorix Primed Group	0

Related Drowsiness

Group	Value	95% CI
Synflorix Primed Group	0

Any Fever

Group	Value	95% CI
Synflorix Primed Group	34

Grade 3 Fever

Group	Value	95% CI
Synflorix Primed Group	0

Related Fever

Group	Value	95% CI
Synflorix Primed Group	31

Any Irritability

Group	Value	95% CI
Synflorix Primed Group	8

Grade 3 Irritability

Group	Value	95% CI
Synflorix Primed Group	0

Number of Subjects With Any and Grade 3 Solicited Local Symptoms Secondary · Within 4 days (Day 0-Day 3) after each vaccine dose

Any Pain, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	22

Grade 3 Pain, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	0

Any Redness, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	6

Grade 3 Redness, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	0

Any Swelling, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	46

Grade 3 Swelling, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	1

Any Pain, Dose 2

Group	Value	95% CI
Synflorix Unprimed Group	7

Grade 3 Pain, Dose 2

Group	Value	95% CI
Synflorix Unprimed Group	0

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Secondary · Within 4 days (Day 0-Day 3) after each vaccine dose

Any Drowsiness, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	1

Grade 3 Drowsiness, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	0

Related Drowsiness, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	1

Any Fever, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	21

Grade 3 Fever, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	0

Related Fever, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	19

Any Irritability, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	3

Grade 3 Irritability, Dose 1

Group	Value	95% CI
Synflorix Unprimed Group	0

Number of Subjects With Any Unsolicited Adverse Events (AEs) Secondary · Within 31 days (Day 0-Day 30) after each vaccine dose

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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Group	Value	95% CI
Synflorix Primed Group	95
Synflorix Unprimed Group	57

Number of Subjects With Serious Adverse Events (SAEs) Secondary · From the first vaccination up to one month (31 days) after the last vaccination for each subject

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 Primed Group	0
Synflorix Unprimed Group	0

Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Secondary · Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group

Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). Pneumococcal serotype specific total immunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥ 0.05 μg/mL.

Anti-1, PRE

Group	Value	95% CI
Synflorix Primed Group	0.28	0.23 – 0.35
Synflorix Unprimed Group	0.04	0.03 – 0.05

Anti-1, POST

Group	Value	95% CI
Synflorix Primed Group	5.85	5.07 – 6.76
Synflorix Unprimed Group	3.2	2.68 – 3.84

Anti-4, PRE

Group	Value	95% CI
Synflorix Primed Group	0.32	0.26 – 0.38
Synflorix Unprimed Group	0.06	0.04 – 0.09

Anti-4, POST

Group	Value	95% CI
Synflorix Primed Group	10.44	9.31 – 11.71
Synflorix Unprimed Group	6.54	5.47 – 7.82

Anti-5, PRE

Group	Value	95% CI
Synflorix Primed Group	0.37	0.32 – 0.43
Synflorix Unprimed Group	0.04	0.03 – 0.05

Anti-5, POST

Group	Value	95% CI
Synflorix Primed Group	6.07	5.2 – 7.1
Synflorix Unprimed Group	3.05	2.4 – 3.87

Anti-6B, PRE

Group	Value	95% CI
Synflorix Primed Group	0.66	0.55 – 0.8
Synflorix Unprimed Group	0.03	0.03 – 0.04

Anti-6B, POST

Group	Value	95% CI
Synflorix Primed Group	4.44	3.69 – 5.33
Synflorix Unprimed Group	0.78	0.57 – 1.08

Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Secondary · Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group

OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.

Opsono-1, PRE

Group	Value	95% CI
Synflorix Primed Group	9.3	7.3 – 11.8
Synflorix Unprimed Group	5.8	4.3 – 7.8

Opsono-1, POST

Group	Value	95% CI
Synflorix Primed Group	661.7	513.5 – 852.6
Synflorix Unprimed Group	108.7	79.5 – 148.6

Opsono-4, PRE

Group	Value	95% CI
Synflorix Primed Group	24	16.7 – 34.6
Synflorix Unprimed Group	11.8	6.3 – 22.1

Opsono-4, POST

Group	Value	95% CI
Synflorix Primed Group	6541.7	5468.5 – 7825.6
Synflorix Unprimed Group	2716.7	2149 – 3434.2

Opsono-5, PRE

Group	Value	95% CI
Synflorix Primed Group	9	7.4 – 10.9
Synflorix Unprimed Group	4.3	3.7 – 5

Opsono-5, POST

Group	Value	95% CI
Synflorix Primed Group	340.5	272.2 – 426
Synflorix Unprimed Group	71.9	51.8 – 99.7

Opsono-6B, PRE

Group	Value	95% CI
Synflorix Primed Group	82.6	50.5 – 135.1
Synflorix Unprimed Group	38.7	16.2 – 92

Opsono-6B, POST

Group	Value	95% CI
Synflorix Primed Group	1729	1361.9 – 2194.9
Synflorix Unprimed Group	1202.9	701.3 – 2063

Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Secondary · Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group

Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥ 0.05 μg/mL.

Anti-6A, PRE

Group	Value	95% CI
Synflorix Primed Group	0.13	0.11 – 0.17
Synflorix Unprimed Group	0.04	0.03 – 0.05

Anti-6A, POST

Group	Value	95% CI
Synflorix Primed Group	0.55	0.42 – 0.73
Synflorix Unprimed Group	0.1	0.07 – 0.14

Anti-19A, PRE

Group	Value	95% CI
Synflorix Primed Group	0.16	0.13 – 0.22
Synflorix Unprimed Group	0.06	0.04 – 0.09

Anti-19A, POST

Group	Value	95% CI
Synflorix Primed Group	1.13	0.83 – 1.53
Synflorix Unprimed Group	1.36	0.91 – 2.03

Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A Secondary · Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group

OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and Opsono-19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.

Opsono-6A, PRE

Group	Value	95% CI
Synflorix Primed Group	18.7	12.2 – 28.6
Synflorix Unprimed Group	24	12.5 – 46.3

Opsono-6A, POST

Group	Value	95% CI
Synflorix Primed Group	100.7	60.4 – 168
Synflorix Unprimed Group	106.3	46.3 – 244

Opsono-19A, PRE

Group	Value	95% CI
Synflorix Primed Group	6.2	5.1 – 7.6
Synflorix Unprimed Group	5.9	4.2 – 8.3

Opsono-19A, POST

Group	Value	95% CI
Synflorix Primed Group	91.5	60.4 – 138.5
Synflorix Unprimed Group	171.2	94.2 – 311.3

Concentrations of Antibodies Against Protein D (PD) Secondary · Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group

Concentrations of antibodies against protein D (PD) were determined by ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is ≥ 100 ELISA units per milliliter (EL.U/mL).

Anti-PD, PRE

Group	Value	95% CI
Synflorix Primed Group	301.1	257.7 – 351.8
Synflorix Unprimed Group	62.1	54.9 – 70.3

Anti-PD, POST

Group	Value	95% CI
Synflorix Primed Group	3710.1	3109 – 4427.4
Synflorix Unprimed Group	839.3	643.5 – 1094.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited AEs: within 4 days (Day 0-Day 3) after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-Day 30) after each vaccine dose; SAEs: from the first vaccination up to one month (31 days) after the last vaccination for each subject.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Synflorix Primed Group

Serious: 0/141 (0%)

Deaths: —

Synflorix Unprimed Group

Serious: 0/69 (0%)

Deaths: —

Other adverse events (13 terms — click to expand)

Reaction	System	Synflorix Primed Group	Synflorix Unprimed Group
Swelling	General disorders	—	—
Pain	General disorders	—	—
Allergic bronchitis	Respiratory, thoracic and mediastinal disorders	—	—
Pyrexia	General disorders	—	—
Rhinitis	Infections and infestations	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Injection site induration	General disorders	—	—
Skin infection	Infections and infestations	—	—
Enteritis	Gastrointestinal disorders	—	—
Irritability	Psychiatric disorders	—	—
Wound	Injury, poisoning and procedural complications	—	—
Circumcision	Surgical and medical procedures	—	—

Data from ClinicalTrials.gov NCT00985465 adverse events section.

Sponsor's own description

The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).

Publications & conference data

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

Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children.
Dicko A, Santara G, Mahamar A, Sidibe Y, et al · · 2013 · cited 8× · PMID 23291945 · DOI 10.4161/hv.22692
Safety and immunogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian children: Booster dose and 2-dose catch-up regimens in the second year of life.
Odusanya OO, Kuyinu YA, Kehinde OA, Shafi F, et al · · 2014 · cited 7× · PMID 24356787 · DOI 10.4161/hv.27276
Safety, reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children in the second year of life: Results from an open study.
Dicko A, Dicko Y, Barry A, Sidibe Y, et al · · 2015 · cited 1× · PMID 26020101 · DOI 10.1080/21645515.2015.1016679

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.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
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 NCT00985465 (US National Library of Medicine, public domain)
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: 14 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/NCT00985465.

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