NCT00135486

Brief Summary

The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2002

Shorter than P25 for phase_2

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

March 1, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

August 25, 2005

Last Update Submit

September 15, 2016

Conditions

Infections, Meningococcal

Keywords

Haemophilus Influenzae type b/Meningococcal vaccineProphylaxis meningococcal serogroup C disease, Hib diseases

Outcome Measures

Primary Outcomes (30)

  • Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers

    Prior to vaccination, one month after the 2nd and 3rd vaccine doses

  • Evaluation of anti-polysaccharide C (anti-PSC) antibody concentrations ≥ 0.3 µg/mL & ≥ 2 µg/mL and concentrations

    Prior to vaccination, one month after the 2nd and 3rd vaccine doses

  • Evaluation of anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL & ≥ 1 µg/mL and concentrations

    Prior to vaccination, one month after the 2nd and 3rd vaccine doses

  • Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA

    Prior to and one month after the 3rd vaccine dose

  • Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL

    Prior to and one month after the 3rd vaccine dose

  • Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL

    Prior to and one month after the 3rd vaccine dose

  • Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL

    Prior to and one month after the 3rd vaccine dose

  • Vaccine response to pertussis toxoid (PT)

    Prior to 3rd vaccine dose

  • Evaluation of anti-diphtheria antibody concentrations

    Prior to 3rd vaccine dose

  • Anti-poliovirus types 1, 2 and 3 antibody titers

    Prior to and one month after the 3rd vaccine dose

  • Occurrence of solicited local injection site symptoms

    During the solicited follow-up period (Day 0 7) following administration of each vaccine dose

  • Occurrence of solicited systemic symptoms

    During the solicited follow-up period (Day 0 7) following administration of each vaccine dose

  • Occurrence of unsolicited non-serious adverse events (AEs)

    Within one month (Day 0 30) after each vaccination

  • Occurrence of any serious adverse events (SAEs)

    Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose

  • Vaccine response to pertussis toxoid (PT)

    One month after the 3rd vaccine dose

  • Vaccine response to filamentous haemagglutinin (FHA)

    Prior to 3rd vaccine dose

  • Vaccine response to filamentous haemagglutinin (FHA)

    One month after the 3rd vaccine dose

  • Vaccine response to pertactin (PRN)

    Prior to 3rd vaccine dose

  • Vaccine response to pertactin (PRN)

    One month after the 3rd vaccine dose

  • Evaluation of anti-diphtheria antibody concentrations

    One month after the 3rd vaccine dose

  • Evaluation of anti-tetanus antibody concentrations

    Prior to 3rd vaccine dose

  • Evaluation of anti-tetanus antibody concentrations

    One month after the 3rd vaccine dose

  • Evaluation of anti-HBs antibody concentrations

    Prior to 3rd vaccine dose

  • Evaluation of anti-HBs antibody concentrations

    One month after the 3rd vaccine dose

  • Evaluation of anti-PT antibody concentrations

    Prior to 3rd vaccine dose

  • Evaluation of anti-PT antibody concentrations

    One month after the 3rd vaccine dose

  • Evaluation of anti-FHA antibody concentrations

    Prior to 3rd vaccine dose

  • Evaluation of anti-FHA antibody concentrations

    One month after the 3rd vaccine dose

  • Evaluation of anti-PRN antibody concentrations

    Prior to 3rd vaccine dose

  • Evaluation of anti-PRN antibody concentrations

    One month after the 3rd vaccine dose

Interventions

MenC-TTBIOLOGICAL
Hib-MenC-TTBIOLOGICAL
Also known as: MenC-TT

Eligibility Criteria

Age8 Weeks - 16 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy male or female infants, 8 to 16 weeks of age at the time of the first vaccination.

You may not qualify if:

  • Previous vaccination against OR history of OR exposure since birth to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
  • Planned administration/administration of a vaccine not foreseen in the study since birth.
  • 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, allergic disease or reactions likely to be exacerbated by any component of the vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schmitt HJ, Maechler G, Habermehl P, Knuf M, Saenger R, Begg N, Boutriau D. Immunogenicity, reactogenicity, and immune memory after primary vaccination with a novel Haemophilus influenzae-Neisseria meningitidis serogroup C conjugate vaccine. Clin Vaccine Immunol. 2007 Apr;14(4):426-34. doi: 10.1128/CVI.00377-06. Epub 2007 Feb 7.

    PMID: 17287313DERIVED

Related Links

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

March 1, 2002

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

September 16, 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

Informed Consent Form (711202/001)Access
Study Protocol (711202/001)Access
Dataset Specification (711202/001)Access
Statistical Analysis Plan (711202/001)Access
Clinical Study Report (711202/001)Access
Individual Participant Data Set (711202/001)Access