NCT00586612 is a Phase 3 clinical trial of Menitorix™ in Haemophilus Influenzae Type b, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00586612?

NCT00586612 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00586612?

Interventions in NCT00586612: Menitorix™, Infanrix™ penta, Prevenar™, Infanrix™ IPV.

What condition does NCT00586612 study?

NCT00586612 studies Haemophilus Influenzae Type b, Neisseria Meningitidis.

Is NCT00586612 still recruiting?

NCT00586612 is currently completed. Last updated 27 August 2018.

Are results published for NCT00586612?

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

Last reviewed 2018-08-27 · How we verify

NCT00586612

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

Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants

Completed Phase 3 Results posted Last updated 27 August 2018

What this trial tests

Phase 3 trial testing Menitorix™ in Haemophilus Influenzae Type b in 313 participants. Completed in 30 December 2008.

Timeline

1 December 2007

Primary endpoint
30 December 2008

30 December 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	313
Start date	1 December 2007
Primary completion	30 December 2008
Estimated completion	30 December 2008
Sites	8 locations across Spain

Drugs / interventions tested

Menitorix™
Infanrix™ penta
Prevenar™
Infanrix™ IPV

Conditions studied

Haemophilus Influenzae Type b — all drugs for Haemophilus Influenzae Type b →
Neisseria Meningitidis — all drugs for Neisseria Meningitidis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 8 Weeks to 12 Weeks, any sex, with Haemophilus Influenzae Type b or Neisseria Meningitidis. 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 Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL) Primary · One month after the third vaccination

Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.

Group	Value	95% CI
Preterm Group	139
Full-term Group	141

Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8 Primary · One month after the third vaccination

rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.

Group	Value	95% CI
Preterm Group	142
Full-term Group	140

Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values Secondary · Before vaccination (at Day 0)

Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.

≥ 0.15 µg/mL

Group	Value	95% CI
Preterm Group	38
Full-term Group	43

≥ 1.0 µg/mL

Group	Value	95% CI
Preterm Group	5
Full-term Group	9

Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter Secondary · One month after the third vaccination

Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).

Group	Value	95% CI
Preterm Group	133
Full-term Group	134

Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values Secondary · Before vaccination (at Day 0)

rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.

≥ 1:8

Group	Value	95% CI
Preterm Group	16
Full-term Group	23

≥ 1:32

Group	Value	95% CI
Preterm Group	5
Full-term Group	11

≥ 1:128

Group	Value	95% CI
Preterm Group	0
Full-term Group	3

rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.

≥ 1:32

Group	Value	95% CI
Preterm Group	142
Full-term Group	139

≥ 1:128

Group	Value	95% CI
Preterm Group	135
Full-term Group	136

Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values Secondary · Before vaccination (at Day 0)

Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.

≥ 0.3 µg/mL

Group	Value	95% CI
Preterm Group	23
Full-term Group	36

≥ 2.0 µg/mL

Group	Value	95% CI
Preterm Group	3
Full-term Group	8

Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values Secondary · One month after the third dose

Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.

≥ 0.3 µg/mL

Group	Value	95% CI
Preterm Group	140
Full-term Group	141

≥ 2.0 µg/mL

Group	Value	95% CI
Preterm Group	127
Full-term Group	136

Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values Secondary · Before vaccination (at Day 0)

Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.

≥ 10 mIU/mL

Group	Value	95% CI
Preterm Group	89
Full-term Group	78

≥ 100 mIU/mL

Group	Value	95% CI
Preterm Group	3
Full-term Group	8

Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values Secondary · One month after the third dose

Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.

≥ 10 mIU/mL

Group	Value	95% CI
Preterm Group	128
Full-term Group	129

≥ 100 mIU/mL

Group	Value	95% CI
Preterm Group	109
Full-term Group	117

Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration Secondary · Before vaccination (at Day 0)

Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).

Anti-PRP (n=140, 138)

Group	Value	95% CI
Preterm Group	0.116	0.101 – 0.133
Full-term Group	0.140	0.117 – 0.167

Anti-PSC (n=142, 137)

Group	Value	95% CI
Preterm Group	0.19	0.17 – 0.22
Full-term Group	0.25	0.21 – 0.30

Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration Secondary · One month after the third dose

Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).

Anti-PRP (n= 140, 142)

Group	Value	95% CI
Preterm Group	10.437	8.398 – 12.970
Full-term Group	10.473	8.547 – 12.833

Anti-PSC (n= 140, 141)

Group	Value	95% CI
Preterm Group	6.34	5.57 – 7.22
Full-term Group	7.46	6.67 – 8.34

Adverse events — posted to ClinicalTrials.gov

Time frame: For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Preterm Group

Serious: 22/163 (13%)

Deaths: —

Full-term Group

Serious: 10/150 (7%)

Deaths: —

Serious adverse events (25 terms)

Reaction	System	Preterm Group	Full-term Group
Bronchiolitis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Bronchospasm	Respiratory, thoracic and mediastinal disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Gastroenteritis rotavirus	Infections and infestations	—	—
Respiratory syncytial virus bronchiolitis	Infections and infestations	—	—
Apnoea	Respiratory, thoracic and mediastinal disorders	—	—
Candidiasis	Infections and infestations	—	—
Conjunctivitis	Eye disorders	—	—
Escherichia urinary tract infection	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Lower respiratory tract infection	Infections and infestations	—	—
Malnutrition	Metabolism and nutrition disorders	—	—
Meningococcal sepsis	Infections and infestations	—	—
Osteomyelitis	Infections and infestations	—	—
Pyelonephritis acute	Infections and infestations	—	—
Streptococcal sepsis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Cellulitis	Infections and infestations	—	—
Bronchitis	Infections and infestations	—	—
Bronchopneumonia	Infections and infestations	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Otitis media acute	Infections and infestations	—	—
Respiratory tract infection	Infections and infestations	—	—
Arthritis bacterial	Infections and infestations	—	—

Other adverse events (18 terms — click to expand)

Reaction	System	Preterm Group	Full-term Group
Irritability/fussiness	General disorders	—	—
Redness	General disorders	—	—
Swelling	General disorders	—	—
Drowsiness	General disorders	—	—
Redness	General disorders	—	—
Pain	General disorders	—	—
Loss of appetite	General disorders	—	—
Pain	General disorders	—	—
Swelling	General disorders	—	—
Fever	General disorders	—	—
Irritability/fussiness	General disorders	—	—
Fever	General disorders	—	—
Loss of appetite	General disorders	—	—
Drowsiness	General disorders	—	—
Injection site nodule	General disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Vomiting	Gastrointestinal disorders	—	—
Injection site haematoma	General disorders	—	—

Most-reported serious reactions: Bronchiolitis, Pneumonia, Bronchospasm, Upper respiratory tract infection, Gastroenteritis rotavirus, Respiratory syncytial virus bronchiolitis, Apnoea, Candidiasis.

Data from ClinicalTrials.gov NCT00586612 adverse events section.

Sponsor's own description

The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity \& safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta) \& Wyeth's 7-valent pneumococcal conjugate vaccine (Prevenar™) in preterm infants as a 3-dose primary vaccination course during the first 6 months of life (at 2, 4, 6 months of age) and of a booster dose of Menitorix™ when co-administered with GSK Biologicals' DTPa-IPV vaccine (Infanrix IPV) and Wyeth's Prevenar in the second year of life (16-18 months of age). The control is a group of full-term infants receiving the same vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Menitorix™

Trials testing the same drug.

NCT00871338 — Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants · Phase 2 · completed

Other GlaxoSmithKline trials

Trials by the same sponsor.

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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 NCT00586612 (US National Library of Medicine, public domain)
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: 27 August 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/NCT00586612.

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