NCT00258700

Brief Summary

The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15 months of age.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
478

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2005

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 28, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

November 24, 2005

Last Update Submit

September 20, 2016

Conditions

Haemophilus Influenzae Type bNeisseria Meningitidis

Outcome Measures

Primary Outcomes (1)

  • 1 m after the 3rd dose of primary vaccination: SBA-MenC titre ≥ 1:8 (seroprotection status), anti-PRP concentration ≥ 0.15 µg/ml. 42 d after the booster vaccination: SBA-MenC titre ≥ 1:128, anti-PRP concentration ≥ 1 μg/ml

Secondary Outcomes (1)

  • Antibody levels to all vaccine antigens:1 m post dose 3, prior to & 42 d post booster. After each dose: Solicited (d 0-3, local & general), unsolicited (d 0-30) & MMR specific (d 0-42) symptoms. SAEs (whole study).

Interventions

Haemophilus influenzae type b- and meningococcal (vaccine)BIOLOGICAL

Eligibility Criteria

Age6 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy male or female, between, and including, 6 and 12 weeks of age.
  • Born after a gestation period between 36 and 42 weeks
  • Vaccination with hepatitis B at birth and at 6 to 12 weeks (concomitantly with the first study vaccine), accepted although not mandatory

You may not qualify if:

  • Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with the exception of Bacille Calmette Guerin (BCG) and hepatitis B vaccines.
  • History of H. influenzae type b and /or meningococcal serogroup C disease.
  • Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio or Hib disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • A family history of congenital or hereditary immunodeficiency
  • History of any neurologic disorders or seizures
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

GSK Investigational Site

Bydgoszcz, 85-021, Poland

Location

GSK Investigational Site

Gdansk, 80-394, Poland

Location

GSK Investigational Site

Kielce, 25-711, Poland

Location

GSK Investigational Site

Krakow, 31-202, Poland

Location

GSK Investigational Site

Lodz, 91-347, Poland

Location

GSK Investigational Site

Poznan, 61-709, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Trzebnica, 55-100, Poland

Location

GSK Investigational Site

Łęczna, 21-010, Poland

Location

GSK Investigational Site

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Related Publications (1)

  • Pace D, Snape M, Westcar S, Oluwalana C, Yu LM, Begg N, Wysocki J, Czajka H, Maechler G, Boutriau D, Pollard AJ. A novel combined Hib-MenC-TT glycoconjugate vaccine as a booster dose for toddlers: a phase 3 open randomised controlled trial. Arch Dis Child. 2008 Nov;93(11):963-70. doi: 10.1136/adc.2007.136036. Epub 2008 May 7.

    PMID: 18463125DERIVED

Related Links

MeSH Terms

Conditions

Haemophilus Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Pasteurellaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2005

First Posted

November 28, 2005

Study Start

February 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

September 21, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Individual Participant Data Set (103974 (primary study))Access
Study Protocol (103974 (primary study))Access
Dataset Specification (103974 (primary study))Access
Clinical Study Report (103974 (primary study))Access
Informed Consent Form (103974 (primary study))Access
Statistical Analysis Plan (103974 (primary study))Access

Locations

GB(1)PL(9)