Who is sponsoring NCT00327184?

NCT00327184 is sponsored by GlaxoSmithKline.

What condition does NCT00327184 study?

NCT00327184 studies Neisseria Meningitidis, Haemophilus Influenzae Type b.

Is NCT00327184 still recruiting?

NCT00327184 is currently completed. Last updated 6 October 2016.

Last reviewed 2016-10-06 · How we verify

NCT00327184

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

Study to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC Given With Infanrix™ Penta Versus NeisVac-C™ Given With Infanrix™ Hexa at 3, 5 Months of Age and Persistence Prior to a Hib-MenC Booster at 11 Months and Immunogenicity of the Booster

Completed Phase 3 Last updated 6 October 2016

What this trial tests

Phase 3 trial testing Haemophilus influenzae type b- and meningococcal serogroup C (vaccine) in Neisseria Meningitidis in 709 participants. Completed in 1 November 2006.

Timeline

1 April 2006

Primary endpoint
1 November 2006

1 November 2006

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	709
Start date	1 April 2006
Primary completion	1 November 2006
Estimated completion	1 November 2006
Sites	16 locations across Finland, Italy

Drugs / interventions tested

Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)
Infanrix Penta
Infanrix hexa (infanrix-hexa) — full drug profile →
Neis-Vac-C — full drug profile →

Conditions studied

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

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 6 Weeks to 12 Weeks, any sex, with Neisseria Meningitidis or Haemophilus Influenzae Type b. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

SBA-MenC titre
Time frame: One month after the second dose of the Primary Vaccination Phase.
Anti-PRP concentration
Time frame: One month after the second dose of the Primary Vaccination Phase

Sponsor's own description

The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 \& 5m) compared to NeisVac-C™ given with Infanrix™ hexa. The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior to the administration of the booster doses. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A combined Haemophilus influenzae type B Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when coadministered with diphtheria, tetanus, acellular pertussis hepatitis B-inactivated poliovirus at 3, 5 and 11 months of age: result
Vesikari T, Forstén A, Desole MG, Ferrera G, et al · · 2013 · cited 7× · PMID 23190785 · DOI 10.1097/inf.0b013e31827e22e3

Verify or expand the search:

Other GlaxoSmithKline trials

Trials by the same sponsor.

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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 NCT00327184 (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: 6 October 2016

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/NCT00327184.

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