Who is sponsoring NCT00454909?

NCT00454909 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00454909?

Interventions in NCT00454909: Meningococcal vaccine 134612, Menactra®.

What condition does NCT00454909 study?

NCT00454909 studies Infections, Meningococcal.

Is NCT00454909 still recruiting?

NCT00454909 is currently completed. Last updated 8 June 2018.

Are results published for NCT00454909?

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

Last reviewed 2018-06-08 · How we verify

NCT00454909

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

Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.

Completed Phase 2 Results posted Last updated 8 June 2018

What this trial tests

Phase 2 trial testing Meningococcal vaccine 134612 in Infections, Meningococcal in 873 participants. Completed in 11 April 2008.

Timeline

23 April 2007

Primary endpoint
31 October 2007

11 April 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	873
Start date	23 April 2007
Primary completion	31 October 2007
Estimated completion	11 April 2008
Sites	10 locations across United States

Drugs / interventions tested

Meningococcal vaccine 134612 — full drug profile →
Menactra®

Conditions studied

Infections, Meningococcal — all drugs for Infections, Meningococcal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 10 to 25, 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 Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value Primary · At Day 0 (PRE)

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.

hSBA-MenA

Group	Value	95% CI
Nimenrix 11-25Y Group	49
Menactra Group	13
Nimenrix 10Y Group	5

hSBA-MenC

Group	Value	95% CI
Nimenrix 11-25Y Group	275
Menactra Group	113
Nimenrix 10Y Group	40

hSBA-MenW-135

Group	Value	95% CI
Nimenrix 11-25Y Group	114
Menactra Group	51
Nimenrix 10Y Group	11

hSBA-MenY

Group	Value	95% CI
Nimenrix 11-25Y Group	269
Menactra Group	94
Nimenrix 10Y Group	31

Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value Primary · At Month 1

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.

hSBA-MenA

Group	Value	95% CI
Nimenrix 11-25Y Group	415
Menactra Group	118
Nimenrix 10Y Group	70

hSBA-MenC

Group	Value	95% CI
Nimenrix 11-25Y Group	490
Menactra Group	171
Nimenrix 10Y Group	78

hSBA-MenW-135

Group	Value	95% CI
Nimenrix 11-25Y Group	438
Menactra Group	114
Nimenrix 10Y Group	73

hSBA-MenY

Group	Value	95% CI
Nimenrix 11-25Y Group	492
Menactra Group	139
Nimenrix 10Y Group	76

Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value Secondary · At Day 0 (PRE) and Month 1

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

hSBA-MenA, PRE

Group	Value	95% CI
Nimenrix 11-25Y Group	68
Menactra Group	18
Nimenrix 10Y Group	7

hSBA-MenA, Month 1

Group	Value	95% CI
Nimenrix 11-25Y Group	421
Menactra Group	118
Nimenrix 10Y Group	71

hSBA-MenC, PRE

Group	Value	95% CI
Nimenrix 11-25Y Group	276
Menactra Group	114
Nimenrix 10Y Group	40

hSBA-MenC, Month 1

Group	Value	95% CI
Nimenrix 11-25Y Group	490
Menactra Group	171
Nimenrix 10Y Group	78

hSBA-MenW-135, PRE

Group	Value	95% CI
Nimenrix 11-25Y Group	118
Menactra Group	51
Nimenrix 10Y Group	11

hSBA-MenW-135, Month 1

Group	Value	95% CI
Nimenrix 11-25Y Group	441
Menactra Group	117
Nimenrix 10Y Group	73

hSBA-MenY, PRE

Group	Value	95% CI
Nimenrix 11-25Y Group	273
Menactra Group	94
Nimenrix 10Y Group	32

hSBA-MenY, Month 1

Group	Value	95% CI
Nimenrix 11-25Y Group	492
Menactra Group	139
Nimenrix 10Y Group	76

hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Secondary · At Day 0 (PRE) and Month 1

Antibody titers are presented as geometric mean titers (GMTs).

hSBA-MenA, PRE

Group	Value	95% CI
Nimenrix 11-25Y Group	2.6	2.5 – 2.8
Menactra Group	2.4	2.2 – 2.6
Nimenrix 10Y Group	2.4	2.1 – 2.9

hSBA-MenA, Month 1

Group	Value	95% CI
Nimenrix 11-25Y Group	57.2	48.8 – 67.0
Menactra Group	36.0	26.1 – 49.7
Nimenrix 10Y Group	91.5	64.0 – 130.8

hSBA-MenC, PRE

Group	Value	95% CI
Nimenrix 11-25Y Group	12.8	10.9 – 15.1
Menactra Group	17.9	13.5 – 23.6
Nimenrix 10Y Group	9.7	6.7 – 14.2

hSBA-MenC, Month 1

Group	Value	95% CI
Nimenrix 11-25Y Group	506.7	419.1 – 612.5
Menactra Group	285.8	214.7 – 380.5
Nimenrix 10Y Group	765.9	505.3 – 1160.9

hSBA-MenW-135, PRE

Group	Value	95% CI
Nimenrix 11-25Y Group	5.7	4.8 – 6.8
Menactra Group	8.6	6.1 – 12.1
Nimenrix 10Y Group	4.2	2.8 – 6.4

hSBA-MenW-135, Month 1

Group	Value	95% CI
Nimenrix 11-25Y Group	124.2	106.2 – 145.2
Menactra Group	74.1	51.1 – 107.5
Nimenrix 10Y Group	153.8	109.9 – 215.1

hSBA-MenY, PRE

Group	Value	95% CI
Nimenrix 11-25Y Group	22.6	18.3 – 27.8
Menactra Group	27.6	19.0 – 40.2
Nimenrix 10Y Group	13.7	8.0 – 23.6

hSBA-MenY, Month 1

Group	Value	95% CI
Nimenrix 11-25Y Group	260.0	225.2 – 300.2
Menactra Group	110.6	77.6 – 157.9
Nimenrix 10Y Group	315.0	223.6 – 443.7

Number of Subjects With Any and Grade 3 Solicited Local Symptoms Secondary · During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period

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 50 millimeters (mm) of injection site.

Pain, Any, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	317
Menactra Group	105
Nimenrix 10Y Group	48

Pain, Grade 3, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	9
Menactra Group	2
Nimenrix 10Y Group	0

Redness, Any, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	77
Menactra Group	21
Nimenrix 10Y Group	15

Redness, Grade 3, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	9
Menactra Group	0
Nimenrix 10Y Group	2

Swelling, Any, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	62
Menactra Group	13
Nimenrix 10Y Group	18

Swelling, Grade 3, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	11
Menactra Group	1
Nimenrix 10Y Group	3

Pain, Any, D0-7

Group	Value	95% CI
Nimenrix 11-25Y Group	318
Menactra Group	105
Nimenrix 10Y Group	48

Pain, Grade 3, D0-7

Group	Value	95% CI
Nimenrix 11-25Y Group	9
Menactra Group	2
Nimenrix 10Y Group	0

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Secondary · During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period

Assessed solicited general symptoms were fatigue, fever \[defined as orally temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Fatigue, Any, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	156
Menactra Group	55
Nimenrix 10Y Group	24

Fatigue, Grade 3, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	10
Menactra Group	2
Nimenrix 10Y Group	3

Fatigue, Related, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	139
Menactra Group	49
Nimenrix 10Y Group	21

Fever (orally), Any, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	34
Menactra Group	11
Nimenrix 10Y Group	6

Fever (orally), Grade 3, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	0
Menactra Group	0
Nimenrix 10Y Group	0

Fever (orally), Related, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	28
Menactra Group	9
Nimenrix 10Y Group	5

Gastrointestinal symptoms, Any, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	87
Menactra Group	26
Nimenrix 10Y Group	11

Gastrointestinal symptoms, Grade 3, D0-3

Group	Value	95% CI
Nimenrix 11-25Y Group	4
Menactra Group	2
Nimenrix 10Y Group	0

Number of Subjects With Any Unsolicited Adverse Events (AEs) Secondary · During the 31-day (Days 0-30) follow-up period after vaccination

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
Nimenrix 11-25Y Group	104
Menactra Group	37
Nimenrix 10Y Group	13

Number of Subjects With Serious Adverse Events (SAEs) Secondary · From Day 0 to Month 6

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
Nimenrix 11-25Y Group	5
Menactra Group	2
Nimenrix 10Y Group	2

Number of Subjects With New Onset Chronic Illness(es) (NOCI) Secondary · From Day 0 to Month 6

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

Group	Value	95% CI
Nimenrix 11-25Y Group	8
Menactra Group	2
Nimenrix 10Y Group	1

Number of Subjects Reporting Rash Secondary · From Day 0 to Month 6

Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.

Group	Value	95% CI
Nimenrix 11-25Y Group	14
Menactra Group	3
Nimenrix 10Y Group	2

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits Secondary · From Day 0 to Month 6

Group	Value	95% CI
Nimenrix 11-25Y Group	24
Menactra Group	9
Nimenrix 10Y Group	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nimenrix 11-25Y Group

Serious: 5/587 (1%)

Deaths: 0/587

Menactra Group

Serious: 2/197 (1%)

Deaths: 0/197

Nimenrix 10Y Group

Serious: 2/88 (2%)

Deaths: 0/88

Serious adverse events (12 terms)

Reaction	System	Nimenrix 11-25Y Group	Menactra Group	Nimenrix 10Y Group
Appendicitis	Infections and infestations	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—
Cellulitis	Infections and infestations	—	—	—
Lower limb fracture	Injury, poisoning and procedural complications	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—
Post procedural diarrhoea	Injury, poisoning and procedural complications	—	—	—
Procedural nausea	Injury, poisoning and procedural complications	—	—	—
Procedural vomiting	Injury, poisoning and procedural complications	—	—	—
Respiratory distress	Respiratory, thoracic and mediastinal disorders	—	—	—
Suicidal ideation	Psychiatric disorders	—	—	—
Swelling	General disorders	—	—	—
Type 1 diabetes mellitus	Metabolism and nutrition disorders	—	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Nimenrix 11-25Y Group	Menactra Group	Nimenrix 10Y Group
Pain (Days 0-7)	General disorders	—	—	—
Pain (Days 0-3)	General disorders	—	—	—
Headache (Days 0-7)	General disorders	—	—	—
Fatigue (Days 0-7)	General disorders	—	—	—
Headache (Days 0-3)	General disorders	—	—	—
Fatigue (Days 0-3)	General disorders	—	—	—
Gastrointestinal (Days 0-7)	General disorders	—	—	—
Gastrointestinal (Days 0-3)	General disorders	—	—	—
Redness (Days 0-3)	General disorders	—	—	—
Redness (Days 0-7)	General disorders	—	—	—
Swelling (Days 0-7)	General disorders	—	—	—
Swelling (Days 0-3)	General disorders	—	—	—
Fever/Orally (Days 0-7)	General disorders	—	—	—
Fever/Orally (Days 0-3)	General disorders	—	—	—

Most-reported serious reactions: Appendicitis, Ankle fracture, Cellulitis, Lower limb fracture, Pancreatitis, Post procedural diarrhoea, Procedural nausea, Procedural vomiting.

Data from ClinicalTrials.gov NCT00454909 adverse events section.

Sponsor's own description

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.

Publications & conference data

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

Routinely vaccinating adolescents against meningococcus: targeting transmission & disease.
Vetter V, Baxter R, Denizer G, Sáfadi MA, et al · · 2016 · cited 53× · PMID 26651380 · DOI 10.1586/14760584.2016.1130628
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
Five-year Antibody Persistence and Booster Response to a Single Dose of Meningococcal A, C, W and Y Tetanus Toxoid Conjugate Vaccine in Adolescents and Young Adults: An Open, Randomized Trial.
Baxter R, Baine Y, Kolhe D, Baccarini CI, et al · · 2015 · cited 25× · PMID 26237742 · DOI 10.1097/inf.0000000000000866
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

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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 NCT00454909 (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: 8 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/NCT00454909.

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