Who is sponsoring NCT00427908?

NCT00427908 is sponsored by GlaxoSmithKline.

What condition does NCT00427908 study?

NCT00427908 studies Infections, Meningococcal.

Is NCT00427908 still recruiting?

NCT00427908 is currently completed. Last updated 4 June 2018.

Are results published for NCT00427908?

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

Last reviewed 2018-06-04 · How we verify

NCT00427908

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

Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612

Completed Phase 2 Results posted Last updated 4 June 2018

What this trial tests

Phase 2 trial testing GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix) in Infections, Meningococcal in 613 participants. Completed in 3 December 2007.

Timeline

7 February 2007

Primary endpoint
3 December 2007

3 December 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	613
Start date	7 February 2007
Primary completion	3 December 2007
Estimated completion	3 December 2007
Sites	11 locations across Finland

Drugs / interventions tested

GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix) — full drug profile →
Mencevax™ ACWY
Meningitec™

Conditions studied

Infections, Meningococcal — all drugs for Infections, Meningococcal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 1 to 10, any sex, with Infections, Meningococcal. 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 Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response Primary · One Month after vaccination

Vaccine response was defined as: * for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32 * for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.

rSBA-MenA

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	182
Mencevax 2-11 Years of Age Primary Phase Group	57

rSBA-MenC

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	200
Mencevax 2-11 Years of Age Primary Phase Group	56

rSBA-MenW-135

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	199
Mencevax 2-11 Years of Age Primary Phase Group	65

rSBA-MenY

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	217
Mencevax 2-11 Years of Age Primary Phase Group	58

Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value Primary · Prior to (PRE) vaccination

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

rSBA-MenA

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	81
Meningitec 1-2 Years of Age Group	26

rSBA-MenC

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	80
Meningitec 1-2 Years of Age Group	19

rSBA-MenW-135

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	59
Meningitec 1-2 Years of Age Group	24

rSBA-MenY

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	115
Meningitec 1-2 Years of Age Group	41

Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value Primary · Prior to (PRE) to vaccination

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

rSBA-MenA

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	42.4	35.3 – 49.8
Meningitec 1-2 Years of Age Group	40.0	28.0 – 52.9

rSBA-MenC

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	39.4	32.6 – 46.5
Meningitec 1-2 Years of Age Group	31.1	19.9 – 44.3

rSBA-MenW-135

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	28.4	22.3 – 35
Meningitec 1-2 Years of Age Group	38.7	26.6 – 51.9

rSBA-MenY

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	55.3	48.3 – 62.2
Meningitec 1-2 Years of Age Group	61.2	48.5 – 72.9

Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value Primary · One month after vaccination [PI(M1)]

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

rSBA-MenA

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	222
Meningitec 1-2 Years of Age Group	22

rSBA-MenC

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	220
Meningitec 1-2 Years of Age Group	67

rSBA-MenW-135

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	222
Meningitec 1-2 Years of Age Group	27

rSBA-MenY

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	222
Meningitec 1-2 Years of Age Group	49

Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value Primary · One month after vaccination [PI(M1)]

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.

rSBA-MenA

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	100	98.4 – 100
Meningitec 1-2 Years of Age Group	34.9	23.3 – 48.0

rSBA-MenC

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	100	98.3 – 100
Meningitec 1-2 Years of Age Group	98.5	92.1 – 100

rSBA-MenW-135

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	100	98.4 – 100
Meningitec 1-2 Years of Age Group	42.9	30.5 – 56.0

rSBA-MenY

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	100	98.4 – 100
Meningitec 1-2 Years of Age Group	74.2	62.0 – 84.2

Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value Secondary · Prior to (PRE) and one month after vaccination [PI(M1)]

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. This analysis was performed by the GSK Biologicals' laboratory.

rSBA-MenA, PRE

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	59
Meningitec 1- 2 Years of Age Group	20

rSBA-MenA, PI(M1)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	222
Meningitec 1- 2 Years of Age Group	16

rSBA-MenC, PRE

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	29
Meningitec 1- 2 Years of Age Group	4

rSBA-MenC, PI(M1)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	218
Meningitec 1- 2 Years of Age Group	56

rSBA-MenW-135, PRE

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	38
Meningitec 1- 2 Years of Age Group	16

rSBA-MenW-135, PI(M1)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	222
Meningitec 1- 2 Years of Age Group	18

rSBA-MenY, PRE

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	77
Meningitec 1- 2 Years of Age Group	28

rSBA-MenY, PI(M1)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	221
Meningitec 1- 2 Years of Age Group	31

rSBA Antibody Titers Secondary · Prior to (PRE) and one month after vaccination [PI(M1)]

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

rSBA-MenA, PRE

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	21.6	16.1 – 29
Meningitec 1- 2 Years of Age Group	20.2	12.1 – 33.8

rSBA-MenA, PI(M1)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	3706.5	3327.2 – 4128.9
Meningitec 1- 2 Years of Age Group	17.1	10.1 – 29

rSBA-MenC, PRE

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	13.9	11 – 17.5
Meningitec 1- 2 Years of Age Group	9.7	6.8 – 13.9

rSBA-MenC, PI(M1)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	878.7	779.4 – 990.7
Meningitec 1- 2 Years of Age Group	415	296.9 – 580

rSBA-MenW-135, PRE

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	11.3	8.9 – 14.3
Meningitec 1- 2 Years of Age Group	16.5	10.2 – 26.7

rSBA-MenW-135, PI(M1)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	5394.6	4869.9 – 5975.7
Meningitec 1- 2 Years of Age Group	20.3	12.5 – 33.2

rSBA-MenY, PRE

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	33.8	25.6 – 44.6
Meningitec 1- 2 Years of Age Group	45.3	27 – 75.8

rSBA-MenY, PI(M1)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	2823.8	2529 – 3153.1
Meningitec 1- 2 Years of Age Group	77.1	46.3 – 128.2

Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values Secondary · Prior to (PRE) and one month after vaccination [PI(M1)]

The cut-off value for the rSBA titers were greater than or equal to ≥ 1:8 and ≥ 1:128. These analyses were performed by the GSK Biologicals' laboratory.

rSBA-MenA (PRE) ≥ 1:8

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	124
Mencevax 2-11 Years of Age Primary Phase Group	40

rSBA-MenA (PRE) ≥ 1:128

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	96
Mencevax 2-11 Years of Age Primary Phase Group	32

rSBA-MenA (PI[M1]) ≥ 1:8

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	225
Mencevax 2-11 Years of Age Primary Phase Group	75

rSBA-MenA (PI[M1]) ≥ 1:128

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	224
Mencevax 2-11 Years of Age Primary Phase Group	75

rSBA-MenC (PRE) ≥ 1:8

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	133
Mencevax 2-11 Years of Age Primary Phase Group	36

rSBA-MenC (PRE) ≥ 1:128

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	59
Mencevax 2-11 Years of Age Primary Phase Group	19

rSBA-MenC (PI[M1]) ≥ 1:8

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	225
Mencevax 2-11 Years of Age Primary Phase Group	74

rSBA-MenC (PI[M1]) ≥ 1:128

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	224
Mencevax 2-11 Years of Age Primary Phase Group	70

rSBA Antibody Titers Secondary · Prior to (PRE) and one month post vaccination [PI(M1)]

Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

rSBA-MenA (PRE)

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	57.9	43.3 – 77.5
Mencevax 2-11 Years of Age Primary Phase Group	58.2	33.8 – 100.1

rSBA-MenA (PI[M1])

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	7300.9	6586 – 8093.4
Mencevax 2-11 Years of Age Primary Phase Group	2033.4	1667.1 – 2480.2

rSBA-MenC (PRE)

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	33.5	26 – 43.1
Mencevax 2-11 Years of Age Primary Phase Group	24.1	15.2 – 38.2

rSBA-MenC (PI[M1])

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	2435.3	2105.8 – 2816.3
Mencevax 2-11 Years of Age Primary Phase Group	750.2	555.2 – 1013.7

rSBA-MenW-135 (PRE)

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	43.1	32.4 – 57.4
Mencevax 2-11 Years of Age Primary Phase Group	40.1	23.9 – 67.3

rSBA-MenW-135 (PI[M1])

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	11777	10666.2 – 13003.5
Mencevax 2-11 Years of Age Primary Phase Group	2186.3	1723.1 – 2773.9

rSBA-MenY (PRE)

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	57.3	43.7 – 75.2
Mencevax 2-11 Years of Age Primary Phase Group	45.5	26.8 – 77

rSBA-MenY (PI[M1])

Group	Value	95% CI
Nimenrix 2-11 Years of Age Primary Phase Group	6641.4	6044.3 – 7297.4
Mencevax 2-11 Years of Age Primary Phase Group	1409.9	1085.9 – 1830.5

Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value Secondary · Prior to (PRE) and one month after vaccination [PI(M1)]

The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.

Anti-PSA (PRE) ≥ 0.3 μg/mL

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	10
Meningitec 1-2 Years of Age Group	4

Anti-PSA (PRE) ≥ 2.0 μg/mL

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	2
Meningitec 1-2 Years of Age Group	1

Anti-PSA [PI(M1)] ≥ 0.3 μg/mL

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	162
Meningitec 1-2 Years of Age Group	2

Anti-PSA [PI(M1)] ≥ 2.0 μg/mL

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	162
Meningitec 1-2 Years of Age Group	1

Anti-PSC (PRE) ≥ 0.3 μg/mL

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	3
Meningitec 1-2 Years of Age Group	1

Anti-PSC (PRE) ≥ 2.0 μg/mL

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	1
Meningitec 1-2 Years of Age Group	1

Anti-PSC [PI(M1)] ≥ 0.3 μg/mL

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	168
Meningitec 1-2 Years of Age Group	51

Anti-PSC [PI(M1)] ≥ 2.0 μg/mL

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	166
Meningitec 1-2 Years of Age Group	50

Anti-PS Antibody Concentrations Secondary · Prior to (PRE) and one month after vaccination [PI(M1)]

Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

Anti-PSA (PRE)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	0.17	0.15 – 0.18
Meningitec 1-2 Years of Age Group	0.18	0.14 – 0.23

Anti-PSA [PI(M1)]

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	33.36	29.07 – 38.27
Meningitec 1-2 Years of Age Group	0.17	0.14 – 0.2

Anti-PSC (PRE)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	0.16	0.15 – 0.17
Meningitec 1-2 Years of Age Group	0.16	0.14 – 0.18

Anti-PSC [PI(M1)]

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	13.47	12 – 15.12
Meningitec 1-2 Years of Age Group	8.29	6.8 – 10.1

Anti-PSW-135 (PRE)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	0.15	0.15 – 0.16
Meningitec 1-2 Years of Age Group	0.15	0.15 – 0.15

Anti-PSW-135 [PI(M1)]

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	6.86	5.87 – 8.02
Meningitec 1-2 Years of Age Group	0.15	0.15 – 0.15

Anti-PSY (PRE)

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	0.15	0.15 – 0.15
Meningitec 1-2 Years of Age Group	0.16	0.14 – 0.17

Anti-PSY [PI(M1)]

Group	Value	95% CI
Nimenrix 1-2 Years of Age Group	10.35	9.12 – 11.74
Meningitec 1-2 Years of Age Group	0.15	0.15 – 0.15

Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value Secondary · Prior to (PRE) and one month after vaccination [PI(M1)]

The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and (≥) 2.0 μg/mL.

Anti-PSA ≥0.3μg/mL, PRE

Group	Value	95% CI
Nimenrix 2- 11 Years of Age Primary Phase Group	29
Mencevax 2- 11 Years of Age Primary Phase Group	12

Anti-PSA ≥0.3μg/mL, PI(M1)

Group	Value	95% CI
Nimenrix 2- 11 Years of Age Primary Phase Group	224
Mencevax 2- 11 Years of Age Primary Phase Group	73

Anti-PSA ≥2.0μg/mL, PRE

Group	Value	95% CI
Nimenrix 2- 11 Years of Age Primary Phase Group	9
Mencevax 2- 11 Years of Age Primary Phase Group	2

Anti-PSA ≥2.0μg/mL, PI(M1)

Group	Value	95% CI
Nimenrix 2- 11 Years of Age Primary Phase Group	224
Mencevax 2- 11 Years of Age Primary Phase Group	68

Anti-PSC ≥0.3μg/mL , PRE

Group	Value	95% CI
Nimenrix 2- 11 Years of Age Primary Phase Group	28
Mencevax 2- 11 Years of Age Primary Phase Group	6

Anti-PSC ≥0.3μg/mL, PI(M1)

Group	Value	95% CI
Nimenrix 2- 11 Years of Age Primary Phase Group	224
Mencevax 2- 11 Years of Age Primary Phase Group	74

Anti-PSC ≥2.0μg/mL, PRE

Group	Value	95% CI
Nimenrix 2- 11 Years of Age Primary Phase Group	9
Mencevax 2- 11 Years of Age Primary Phase Group	2

Anti-PSC ≥2.0μg/mL, PI(M1)

Group	Value	95% CI
Nimenrix 2- 11 Years of Age Primary Phase Group	223
Mencevax 2- 11 Years of Age Primary Phase Group	71

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nimenrix 1-2 Years of Age Group

Serious: 5/229 (2%)

Deaths: 0/229

Nimenrix 2-11 Years of Age Group

Serious: 2/231 (1%)

Deaths: 0/231

Meningitec 1-2 Years of Age Group

Serious: 7/75 (9%)

Deaths: 0/75

Mencevax 2-11 Years of Age Group

Serious: 1/78 (1%)

Deaths: 0/78

Serious adverse events (10 terms)

Reaction	System	Nimenrix 1-2 Years of Age …	Nimenrix 2-11 Years of Age…	Meningitec 1-2 Years of Ag…	Mencevax 2-11 Years of Age…
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Gastroenteritis rotavirus	Infections and infestations	—	—	—	—
Lower limb fracture	Injury, poisoning and procedural complications	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—
Testicular torsion	Reproductive system and breast disorders	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Laryngitis	Infections and infestations	—	—	—	—

Other adverse events (18 terms — click to expand)

Reaction	System	Nimenrix 1-2 Years of Age …	Nimenrix 2-11 Years of Age…	Meningitec 1-2 Years of Ag…	Mencevax 2-11 Years of Age…
Pain	General disorders	—	—	—	—
Redness	General disorders	—	—	—	—
Irritability	General disorders	—	—	—	—
Swelling	General disorders	—	—	—	—
Drowsiness	General disorders	—	—	—	—
Loss of appetite	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Fever (Rectally)	General disorders	—	—	—	—
Headache	General disorders	—	—	—	—
Gastrointestinal	General disorders	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Teething	Gastrointestinal disorders	—	—	—	—

Most-reported serious reactions: Bronchitis chronic, Gastroenteritis rotavirus, Lower limb fracture, Stomatitis, Testicular torsion, Hyperglycemia, Pneumonia, Bronchitis.

Data from ClinicalTrials.gov NCT00427908 adverse events section.

Sponsor's own description

This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination. Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.

Publications & conference data

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

Epidemiologic Trends, Global Shifts in Meningococcal Vaccination Guidelines, and Data Supporting the Use of MenACWY-TT Vaccine: A Review.
Presa J, Findlow J, Vojicic J, Williams S, et al · · 2019 · cited 34× · PMID 31347097 · DOI 10.1007/s40121-019-0254-1
Randomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers.
Vesikari T, Forstén A, Boutriau D, Bianco V, et al · · 2012 · cited 32× · PMID 23032159 · DOI 10.4161/hv.22166
Meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine: a new conjugate vaccine against invasive meningococcal disease.
Hedari CP, Khinkarly RW, Dbaibo GS. · · 2014 · cited 27× · PMID 24729718 · DOI 10.2147/idr.s36243
Antibody persistence up to 5 years after vaccination of toddlers and children between 12 months and 10 years of age with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine.
Vesikari T, Forsten A, Bianco V, Van der Wielen M, et al · · 2016 · cited 21× · PMID 26575983 · DOI 10.1080/21645515.2015.1058457
A randomized study to assess the immunogenicity, antibody persistence and safety of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in children aged 2-10 years.
Vesikari T, Forstén A, Boutriau D, Bianco V, et al · · 2012 · cited 21× · PMID 23032168 · DOI 10.4161/hv.22165
Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age.
Vesikari T, Peyrani P, Webber C, Van Der Wielen M, et al · · 2020 · cited 15× · PMID 32598244 · DOI 10.1080/21645515.2020.1746110
Review of clinical studies comparing meningococcal serogroup C immune responses induced by MenACWY-TT and monovalent serogroup C vaccines.
Serra L, Knuf M, Martinón-Torres F, Yi K, et al · · 2021 · cited 10× · PMID 33606596 · DOI 10.1080/21645515.2020.1855952
Modeling antibody persistence after MenACYW-TT vaccination and comparative analysis with other quadrivalent meningococcal vaccines.
Coudeville L, Bertrand-Gerentes I, Zocchetti C, Langevin E, et al · · 2025 · PMID 40640249 · DOI 10.1038/s41598-025-08112-0

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Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00427908 (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: 4 June 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/NCT00427908.

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NCT00427908

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (10 terms)

Sponsor's own description

Publications & conference data

Related trials

Other GlaxoSmithKline trials

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