Who is sponsoring NCT00718666?

NCT00718666 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00718666?

Interventions in NCT00718666: Meningococcal vaccine GSK134612.

What condition does NCT00718666 study?

NCT00718666 studies Infections, Meningococcal.

Is NCT00718666 still recruiting?

NCT00718666 is currently completed. Last updated 26 June 2019.

Are results published for NCT00718666?

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

Last reviewed 2019-06-26 · How we verify

NCT00718666

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

The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers

Completed Phase 2 Results posted Last updated 26 June 2019

What this trial tests

Phase 2 trial testing Meningococcal vaccine GSK134612 in Infections, Meningococcal in 387 participants. Completed in 28 March 2014.

Timeline

20 October 2008

Primary endpoint
13 November 2013

28 March 2014

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	387
Start date	20 October 2008
Primary completion	13 November 2013
Estimated completion	28 March 2014
Sites	14 locations across United States

Drugs / interventions tested

Meningococcal vaccine GSK134612 — full drug profile →

Conditions studied

Infections, Meningococcal — all drugs for Infections, Meningococcal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 2 to 6, 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) (hSBA) Titers ≥ the Cut-off Primary · At Year 1 (12 months post primary vaccination)

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was greater than or equal to ( ≥) 1:8.

hSBA-MenA, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y1	21
Nimenrix 2 Group Y1	28

hSBA-MenC, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y1	91
Nimenrix 2 Group Y1	103

hSBA-MenW-135, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y1	93
Nimenrix 2 Group Y1	111

hSBA-MenY, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y1	88
Nimenrix 2 Group Y1	111

Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Primary · At Year 3 (36 months post primnary vaccination)

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.

hSBA-MenA, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	14
Nimenrix 2 Group Y3	16

hSBA-MenC, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	57
Nimenrix 2 Group Y3	68

hSBA-MenW-135, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	54
Nimenrix 2 Group Y3	82

hSBA-MenY, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	53
Nimenrix 2 Group Y3	59

Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values Primary · At Year 5 (60 months post primary vaccination)

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.

hSBA-MenA, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y5	20
Nimenrix 2 Group Y5	27

hSBA-MenC, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y5	45
Nimenrix 2 Group Y5	53

hSBA-MenW-135, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y5	40
Nimenrix 2 Group Y5	62

hSBA-MenY, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y5	32
Nimenrix 2 Group Y5	49

Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values Secondary · At Year 1 (12 months post vaccination)

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.

hSBA-MenA, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y1	23
Nimenrix 2 Group Y1	29

hSBA-MenC, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y1	91
Nimenrix 2 Group Y1	103

hSBA-MenW-135, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y1	93
Nimenrix 2 Group Y1	111

hSBA-MenY, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y1	89
Nimenrix 2 Group Y1	111

Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values Secondary · At Year 3 (36 months post primary vaccination)

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.

hSBA-MenA, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y3	14
Nimenrix 2 Group Y3	19

hSBA-MenC, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y3	59
Nimenrix 2 Group Y3	69

hSBA-MenW-135, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y3	54
Nimenrix 2 Group Y3	82

hSBA-MenY, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y3	53
Nimenrix 2 Group Y3	59

Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values Secondary · At Year 5 (60 months post primary vaccination)

hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.

hSBA-MenA, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y5	20
Nimenrix 2 Group Y5	27

hSBA-MenC, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y5	47
Nimenrix 2 Group Y5	56

hSBA-MenW-135, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y5	40
Nimenrix 2 Group Y5	62

hSBA-MenY, ≥ 1:4

Group	Value	95% CI
Nimenrix 1 Group Y5	32
Nimenrix 2 Group Y5	49

hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers Secondary · At Year 1 (12 months post primary vaccination)

Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.

hSBA-MenA

Group	Value	95% CI
Nimenrix 1 Group Y1	3.7	2.9 – 4.8
Nimenrix 2 Group Y1	4.1	3.2 – 5.2

hSBA-MenC

Group	Value	95% CI
Nimenrix 1 Group Y1	70.5	50.4 – 98.5
Nimenrix 2 Group Y1	72.4	53.3 – 98.4

hSBA-MenW-135

Group	Value	95% CI
Nimenrix 1 Group Y1	127.9	87.3 – 187.3
Nimenrix 2 Group Y1	204.6	163.6 – 255.9

hSBA-MenY

Group	Value	95% CI
Nimenrix 1 Group Y1	55.6	38.1 – 81.1
Nimenrix 2 Group Y1	86.2	65.8 – 112.9

hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers Secondary · At Year 3 (36 months post primary vaccination)

Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.

hSBA-MenA

Group	Value	95% CI
Nimenrix 1 Group Y3	3.5	2.6 – 4.6
Nimenrix 2 Group Y3	3.4	2.7 – 4.3

hSBA-MenC

Group	Value	95% CI
Nimenrix 1 Group Y3	31.2	18.9 – 51.6
Nimenrix 2 Group Y3	29.8	18.9 – 47

hSBA-MenW-135

Group	Value	95% CI
Nimenrix 1 Group Y3	29	18 – 46.9
Nimenrix 2 Group Y3	63.9	44 – 92.8

hSBA-MenY

Group	Value	95% CI
Nimenrix 1 Group Y3	22	14 – 34.5
Nimenrix 2 Group Y3	20.5	13.6 – 30.8

hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers Secondary · At Year 5 (60 months post primary vaccination)

Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.

hSBA-MenA

Group	Value	95% CI
Nimenrix 1 Group Y5	4.6	3.3 – 6.3
Nimenrix 2 Group Y5	6.6	4.5 – 9.8

hSBA-MenC

Group	Value	95% CI
Nimenrix 1 Group Y5	40.7	22.7 – 73.1
Nimenrix 2 Group Y5	38.2	22.5 – 64.9

hSBA-MenW-135

Group	Value	95% CI
Nimenrix 1 Group Y5	24.2	14.4 – 40.7
Nimenrix 2 Group Y5	53.7	35.8 – 80.4

hSBA-MenY

Group	Value	95% CI
Nimenrix 1 Group Y5	26	14.1 – 47.8
Nimenrix 2 Group Y5	37.9	24.3 – 59.2

Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay Secondary · At Year 1 (12 months post primary vaccination)

rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.

rSBA-MenA, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y1	90
Nimenrix 2 Group Y1	101

rSBA-MenA, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y1	71
Nimenrix 2 Group Y1	80

rSBA-MenC, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y1	83
Nimenrix 2 Group Y1	96

rSBA-MenC, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y1	46
Nimenrix 2 Group Y1	54

rSBA-MenW-135, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y1	97
Nimenrix 2 Group Y1	114

rSBA-MenW-135, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y1	82
Nimenrix 2 Group Y1	89

rSBA-MenY, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y1	96
Nimenrix 2 Group Y1	113

rSBA-MenY, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y1	85
Nimenrix 2 Group Y1	100

Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement Secondary · At Year 3 (36 months post primary vaccination)

rSBA-MenA, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	65
Nimenrix 2 Group Y3	82

rSBA-MenA, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y3	51
Nimenrix 2 Group Y3	65

rSBA-MenC, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	60
Nimenrix 2 Group Y3	75

rSBA-MenC, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y3	32
Nimenrix 2 Group Y3	40

rSBA-MenW-135, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	68
Nimenrix 2 Group Y3	88

rSBA-MenW-135, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y3	56
Nimenrix 2 Group Y3	69

rSBA-MenY, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	69
Nimenrix 2 Group Y3	89

rSBA-MenY, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y3	62
Nimenrix 2 Group Y3	78

rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. Titers were determined by Public Health England (PHE) laboratory assay.

rSBA-MenA, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	38
Nimenrix 2 Group Y3	44

rSBA-MenA, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y3	23
Nimenrix 2 Group Y3	24

rSBA-MenC, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	27
Nimenrix 2 Group Y3	30

rSBA-MenC, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y3	18
Nimenrix 2 Group Y3	15

rSBA-MenW-135, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	36
Nimenrix 2 Group Y3	35

rSBA-MenW-135, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y3	24
Nimenrix 2 Group Y3	23

rSBA-MenY, ≥ 1:8

Group	Value	95% CI
Nimenrix 1 Group Y3	39
Nimenrix 2 Group Y3	45

rSBA-MenY, ≥ 1:128

Group	Value	95% CI
Nimenrix 1 Group Y3	21
Nimenrix 2 Group Y3	24

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period; Serious adverse events (SAEs): during the entire study period (from Day 0 up to Month 54).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nimenrix 1 Group

Serious: 0/38 (0%)

Deaths: 0/38

Nimenrix 2 Group

Serious: 0/46 (0%)

Deaths: 0/46

Nimenrix Naive Group

Serious: 1/100 (1%)

Deaths: 0/100

Serious adverse events (1 terms)

Reaction	System	Nimenrix 1 Group	Nimenrix 2 Group	Nimenrix Naive Group
Humerus fracture	Injury, poisoning and procedural complications	—	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Nimenrix 1 Group	Nimenrix 2 Group	Nimenrix Naive Group
Pain	General disorders	—	—	—
Redness	General disorders	—	—	—
Swelling	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Headache	General disorders	—	—	—
Gastrointestinal symptoms	General disorders	—	—	—
Fever	General disorders	—	—	—
Injection site bruising	Injury, poisoning and procedural complications	—	—	—

Most-reported serious reactions: Humerus fracture.

Data from ClinicalTrials.gov NCT00718666 adverse events section.

Sponsor's own description

In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune response of a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination will also be evaluated. In addition, the immune response to a dose of vaccine GSK134612 administered to age-matched controls not previously given a meningococcal vaccine will be evaluated. This protocol posting has been updated further to protocol amendment 2, dated 28 october 2010. The sections impacted are summary, study design, outcome measures, intervention, and eligibility criteria.

Publications & conference data

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

Deciphering the role of nanoparticles for management of bacterial meningitis: an update on recent studies.
Sharma N, Zahoor I, Sachdeva M, Subramaniyan V, et al · · 2021 · cited 17× · PMID 34545518 · DOI 10.1007/s11356-021-16570-y
Five-year Antibody Persistence and Booster Response After 1 or 2 Doses of Meningococcal A, C, W and Y Tetanus Toxoid Conjugate Vaccine in Healthy Children.
Klein NP, Baine Y, Kolhe D, Baccarini CI, et al · · 2016 · cited 11× · PMID 26928521 · DOI 10.1097/inf.0000000000001123

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 NCT00718666 (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: 26 June 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/NCT00718666.

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

NCT00718666

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 (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Meningococcal vaccine GSK134612

Other GlaxoSmithKline trials

Verify against primary sources