Who is sponsoring NCT00508261?

NCT00508261 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00508261?

Interventions in NCT00508261: Meningococcal vaccine GSK134612, Infanrix™ hexa, Meningitec™.

What condition does NCT00508261 study?

NCT00508261 studies Infections, Meningococcal.

Is NCT00508261 still recruiting?

NCT00508261 is currently completed. Last updated 24 January 2019.

Are results published for NCT00508261?

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

Last reviewed 2019-01-24 · How we verify

NCT00508261

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

Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine

Completed Phase 3 Results posted Last updated 24 January 2019

What this trial tests

Phase 3 trial testing Meningococcal vaccine GSK134612 in Infections, Meningococcal in 793 participants. Completed in 27 October 2008.

Timeline

1 August 2007

Primary endpoint
26 May 2008

27 October 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	793
Start date	1 August 2007
Primary completion	26 May 2008
Estimated completion	27 October 2008
Sites	89 locations across Austria, Greece, Germany

Drugs / interventions tested

Meningococcal vaccine GSK134612 — full drug profile →
Infanrix™ hexa
Meningitec™

Conditions studied

Infections, Meningococcal — all drugs for Infections, Meningococcal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 12 Months to 23 Months, 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 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off. Primary · 1 month after vaccination with Nimenrix vaccine (Month 1)

The cut-off for the assay was greater than or equal to (≥) 1:8. The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.

rSBA-MenA, M1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	193
Nimenrix Group	180

rSBA-MenC, M1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	191
Nimenrix Group	178

rSBA-MenW-135, M1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	193
Nimenrix Group	183

rSBA-MenY, M1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	192
Nimenrix Group	180

Anti-PT, Anti-FHA and Anti-PRN Concentrations Primary · 1 month after the first vaccination (Month 1)

The analysis was based only on subjects receiving Infanrix-hexa vaccination. The results were calculated as geometric mean expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Anti-PT, M1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	86	77 – 95
Infanrix-Hexa Group	85	75 – 96

Anti-FHA, M1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	542	492 – 597
Infanrix-Hexa Group	544	485 – 611

Anti-PRN, M1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	470	411 – 537
Infanrix-Hexa Group	450	387 – 522

Number of Subjects With Anti-HBs Concentrations ≥ the Cut-off Primary · 1 month after vaccination with Nimenrix vaccine (Month 1)

The cut-off for the assay was greater than or equal to (≥) 10 milli-interantional units per milliliter (mIU/mL).

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	180
Infanrix-Hexa Group	166

Number of Subjects With Anti-PRP Concentrations ≥ the Cut-off Primary · 1 month after vaccination with Nimenrix vaccine (Month 1)

The cut-off for the assay was ≥ 1μg/mL.

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	183
Infanrix-Hexa Group	170

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ the Cut-off Values Secondary · At month 0, month 1 and month 2

The cut-off values for the assay were ≥ 1:8 and ≥ 1:128

rSBA-MenA [M 0], ≥1:8

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	30
Nimenrix Group	32
Infanrix-Hexa Group	34
Meningitec Group	18

rSBA-MenA [M 1], ≥1:8

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	193
Nimenrix Group	180
Infanrix-Hexa Group	71
Meningitec Group	43

rSBA-MenA [M 2], ≥1:8

Group	Value	95% CI
Nimenrix Group	90
Infanrix-Hexa Group	178

rSBA-MenA [M 0], ≥1:128

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	18
Nimenrix Group	21
Infanrix-Hexa Group	24
Meningitec Group	11

rSBA-MenA [M 1], ≥1:128

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	193
Nimenrix Group	179
Infanrix-Hexa Group	57
Meningitec Group	30

rSBA-MenA [M 2], ≥1:128

Group	Value	95% CI
Nimenrix Group	90
Infanrix-Hexa Group	178

rSBA-MenC [M 0], ≥1:8

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	20
Nimenrix Group	25
Infanrix-Hexa Group	13
Meningitec Group	11

rSBA-MenC [M 1], ≥1:8

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	191
Nimenrix Group	178
Infanrix-Hexa Group	34
Meningitec Group	112

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Secondary · At month 0, month 1 and month 2

The results were tabulated as geometric mean expressed in titers.

rSBA-MenA [M 0]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	15	10 – 22.4
Nimenrix Group	19	12.2 – 29.5
Infanrix-Hexa Group	24	15 – 38.4
Meningitec Group	15.9	9.2 – 27.5

rSBA-MenA [M 1]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	3152.9	2752.5 – 3611.4
Nimenrix Group	3169.9	2577.2 – 3898.8
Infanrix-Hexa Group	24.2	17.4 – 33.7
Meningitec Group	21.5	14.5 – 32.1

rSBA-MenA [M 2]

Group	Value	95% CI
Nimenrix Group	2881.9	2292 – 3623.6
Infanrix-Hexa Group	1938.3	1699.1 – 2211.2

rSBA-MenC [M 0]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	7.4	5.7 – 9.6
Nimenrix Group	9.1	6.7 – 12.2
Infanrix-Hexa Group	6.1	4.9 – 7.7
Meningitec Group	7.6	5.2 – 11.2

rSBA-MenC [M 1]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	879.7	763.1 – 1014
Nimenrix Group	828.7	672.4 – 1021.4
Infanrix-Hexa Group	7.5	6.1 – 9.3
Meningitec Group	691.4	520.8 – 917.9

rSBA-MenC [M 2]

Group	Value	95% CI
Nimenrix Group	519.6	391.7 – 689.2
Infanrix-Hexa Group	386	333.9 – 446.2

rSBA-MenW-135 [M 0]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	19	13.1 – 27.6
Nimenrix Group	19.2	13.3 – 27.7
Infanrix-Hexa Group	24.8	16.7 – 36.8
Meningitec Group	15.6	9.8 – 25

rSBA-MenW-135 [M 1]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	4147	3670.1 – 4685.8
Nimenrix Group	4022.3	3269.2 – 4948.8
Infanrix-Hexa Group	25.2	18.6 – 34.2
Meningitec Group	14.2	10.2 – 19.7

Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Secondary · At month 0, month 1 and month 2

The cut-off for the assay were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL, respectively.

Anti-PSA [Month 0], ≥0.3

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	4
Nimenrix Group	1
Infanrix-Hexa Group	1
Meningitec Group	1

Anti-PSA [Month 1], ≥0.3

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	46
Nimenrix Group	45
Infanrix-Hexa Group	1
Meningitec Group	1

Anti-PSA [Month 2], ≥0.3

Group	Value	95% CI
Nimenrix Group	44
Infanrix-Hexa Group	42

Anti-PSA [Month 0], ≥2.0

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	0
Nimenrix Group	0
Infanrix-Hexa Group	0
Meningitec Group	0

Anti-PSA [Month 1], ≥2.0

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	46
Nimenrix Group	44
Infanrix-Hexa Group	1
Meningitec Group	0

Anti-PSA [Month 2], ≥2.0

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	0
Nimenrix Group	43
Infanrix-Hexa Group	40
Meningitec Group	0

Anti-PSC [Month 0], ≥0.3

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	1
Nimenrix Group	1
Infanrix-Hexa Group	2
Meningitec Group	0

Anti-PSC [Month 1], ≥0.3

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	51
Nimenrix Group	41
Infanrix-Hexa Group	2
Meningitec Group	28

Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations Secondary · At month 0, month 1 and month 2

The results for the assay were tabulated as geometric mean expressed in microgram per milliliter (μg/mL).

Anti-PSA [M 0]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	0.17	0.15 – 0.19
Nimenrix Group	0.15	0.15 – 0.16
Infanrix-Hexa Group	0.16	0.14 – 0.18
Meningitec Group	0.16	0.14 – 0.18

Anti-PSA [M 1]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	31.01	23.73 – 40.52
Nimenrix Group	33.15	21.89 – 50.18
Infanrix-Hexa Group	0.17	0.13 – 0.22
Meningitec Group	0.16	0.14 – 0.18

Anti-PSA [M 2]

Group	Value	95% CI
Nimenrix Group	16.93	12.39 – 23.13
Infanrix-Hexa Group	12.28	9.38 – 16.06

Anti-PSC [M 0]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	0.16	0.14 – 0.2
Nimenrix Group	0.16	0.14 – 0.17
Infanrix-Hexa Group	0.16	0.15 – 0.17
Meningitec Group	0.15	0.15 – 0.15

Anti-PSC [M 1]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	13.74	10.68 – 17.67
Nimenrix Group	23.52	18.91 – 29.25
Infanrix-Hexa Group	0.16	0.15 – 0.17
Meningitec Group	7.99	5.57 – 11.46

Anti-PSC [M 2]

Group	Value	95% CI
Nimenrix Group	9.73	7.82 – 12.12
Infanrix-Hexa Group	5.84	4.66 – 7.32

Anti-PSW-135 [M 0]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	0.16	0.14 – 0.17
Nimenrix Group	0.15	0.15 – 0.16
Infanrix-Hexa Group	0.17	0.14 – 0.22
Meningitec Group	0.15	0.15 – 0.15

Anti-PSW-135 [M 1]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	6.43	4.92 – 8.4
Nimenrix Group	4.15	2.82 – 6.11
Infanrix-Hexa Group	0.18	0.14 – 0.22
Meningitec Group	0.15	0.15 – 0.15

Number of Seroprotected Subjects for Anti-tetanus Toxoid (Anti-TT) Secondary · At month 0, month 1 and month 2

The cut-off for the assay was ≥ 0.1

anti-TT [M 0], ≥0.1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	177
Nimenrix Group	161
Infanrix-Hexa Group	155
Meningitec Group	99

anti-TT [M 1], ≥0.1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	184
Nimenrix Group	177
Infanrix-Hexa Group	173
Meningitec Group	99

anti-TT [M 2], ≥0.1

Group	Value	95% CI
Nimenrix Group	177
Infanrix-Hexa Group	176

Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Secondary · At month 0, month 1 and month 2

The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).

anti-TT [M 0]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	0.481	0.417 – 0.554
Nimenrix Group	0.39	0.332 – 0.457
Infanrix-Hexa Group	0.416	0.354 – 0.489
Meningitec Group	0.393	0.325 – 0.475

anti-TT [M 1]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	10.47	9.131 – 12.007
Nimenrix Group	7.941	6.517 – 9.677
Infanrix-Hexa Group	6.189	5.404 – 7.089
Meningitec Group	0.374	0.306 – 0.457

anti-TT [M 2]

Group	Value	95% CI
Nimenrix Group	13.966	12.199 – 15.987
Infanrix-Hexa Group	8.236	7.348 – 9.231

Number of Subjects Seroprotected for Anti-diphtheria (Anti-D) ≥ the Cut-off Secondary · At month 0, month 1 and month 2

The cut-off for the assay was ≥ 0.1

anti-D [M 0], ≥0.1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	169
Nimenrix Group	157
Infanrix-Hexa Group	154
Meningitec Group	94

anti-D [M 1], ≥0.1

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	184
Nimenrix Group	156
Infanrix-Hexa Group	173
Meningitec Group	109

anti-D [M 2], ≥0.1

Group	Value	95% CI
Nimenrix Group	176
Infanrix-Hexa Group	176

Anti-diphtheria (Anti-D) Antibody Concentrations Secondary · At month 0, month 1 and month 2

The results for the assay were tabulated as geometric mean expressed in internationl units per milliliter (IU/mL).

anti-D [M 0]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	0.477	0.407 – 0.559
Nimenrix Group	0.476	0.397 – 0.57
Infanrix-Hexa Group	0.437	0.367 – 0.521
Meningitec Group	0.452	0.355 – 0.574

anti-D [M 1]

Group	Value	95% CI
Nimenrix + Infanrix-hexa Group	7.636	6.889 – 8.465
Nimenrix Group	0.404	0.335 – 0.487
Infanrix-Hexa Group	7.292	6.362 – 8.358
Meningitec Group	5.201	4.243 – 6.376

anti-D [M 2]

Group	Value	95% CI
Nimenrix Group	8.561	7.553 – 9.703
Infanrix-Hexa Group	5.21	4.623 – 5.872

Adverse events — posted to ClinicalTrials.gov

Time frame: SAEs were reported throughout the entire study period (Day 0 - Month 7). Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nimenrix + Infanrix-hexa Group

Serious: 10/222 (5%)

Deaths: 0/222

Nimenrix Group

Serious: 8/220 (4%)

Deaths: 0/220

Infanrix-Hexa Group

Serious: 11/224 (5%)

Deaths: 1/224

Meningitec Group

Serious: 6/127 (5%)

Deaths: 0/127

Serious adverse events (28 terms)

Reaction	System	Nimenrix + Infanrix-hexa G…	Nimenrix Group	Infanrix-Hexa Group	Meningitec Group
Febrile convulsion	Nervous system disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Gastroenteritis rotavirus	Infections and infestations	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Concussion	Injury, poisoning and procedural complications	—	—	—	—
Animal bite	Injury, poisoning and procedural complications	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—
Skull fracture	Injury, poisoning and procedural complications	—	—	—	—
Hypersensitivity	Immune system disorders	—	—	—	—
Bronchospasm	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Cyst	General disorders	—	—	—	—
Drowning	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Aphthous stomatitis	Gastrointestinal disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Iron deficiency	Metabolism and nutrition disorders	—	—	—	—
Gastroenteritis norovirus	Infections and infestations	—	—	—	—
Bronchopneumonia	Infections and infestations	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Coxsackie viral infection	Infections and infestations	—	—	—	—
Croup infectious	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Pneumonia respiratory syncytial viral	Infections and infestations	—	—	—	—
Subcutaneous abscess	Infections and infestations	—	—	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Nimenrix + Infanrix-hexa G…	Nimenrix Group	Infanrix-Hexa Group	Meningitec Group
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—
Irritability	Psychiatric disorders	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Swelling	General disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—

Most-reported serious reactions: Febrile convulsion, Gastroenteritis, Gastroenteritis rotavirus, Bronchitis, Concussion, Animal bite, Contusion, Skull fracture.

Data from ClinicalTrials.gov NCT00508261 adverse events section.

Sponsor's own description

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Publications & conference data

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

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
Conjugate Meningococcal Vaccines Development: GSK Biologicals Experience.
Miller JM, Mesaros N, Van Der Wielen M, Baine Y. · · 2011 · cited 18× · PMID 21991444 · DOI 10.4061/2011/846756
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

Verify or expand the search:

Other trials of Meningococcal vaccine GSK134612

Trials testing the same drug.

NCT01939158 — Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT · Phase 3 · completed
NCT01755689 — Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administr · Phase 3 · completed
NCT01767376 — Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When C · Phase 3 · completed
NCT01641042 — Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subje · Phase 3 · completed
NCT00955682 — Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612 · Phase 3 · 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 NCT00508261 (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: 24 January 2019

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/NCT00508261.

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