Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants

September 15, 2016 updated by: GlaxoSmithKline

Evaluate Immunogenicity, Reactogenicity, Safety of GSK Biologicals' MenC-TT Vaccine (2 Formulations) Given With Infanrix Hexa® + GSK Biologicals' Hib MenC-TT Vaccine (2 Formulations) Given With Infanrix Penta® to Infants in Mths 3,4,5 of Life

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind) + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood samples taken, before dose 1 and one month after dose 2 and dose 3.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers
Time Frame: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
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
Time Frame: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
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
Time Frame: Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Prior to vaccination, one month after the 2nd and 3rd vaccine doses
Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA
Time Frame: Prior to and one month after the 3rd vaccine dose
Prior to and one month after the 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL
Time Frame: Prior to and one month after the 3rd vaccine dose
Prior to and one month after the 3rd vaccine dose
Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL
Time Frame: Prior to and one month after the 3rd vaccine dose
Prior to and one month after the 3rd vaccine dose
Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL
Time Frame: Prior to and one month after the 3rd vaccine dose
Prior to and one month after the 3rd vaccine dose
Vaccine response to pertussis toxoid (PT)
Time Frame: Prior to 3rd vaccine dose
Prior to 3rd vaccine dose
Evaluation of anti-diphtheria antibody concentrations
Time Frame: Prior to 3rd vaccine dose
Prior to 3rd vaccine dose
Anti-poliovirus types 1, 2 and 3 antibody titers
Time Frame: Prior to and one month after the 3rd vaccine dose
Prior to and one month after the 3rd vaccine dose
Occurrence of solicited local injection site symptoms
Time Frame: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Occurrence of solicited systemic symptoms
Time Frame: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Occurrence of unsolicited non-serious adverse events (AEs)
Time Frame: Within one month (Day 0 30) after each vaccination
Within one month (Day 0 30) after each vaccination
Occurrence of any serious adverse events (SAEs)
Time Frame: Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose
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)
Time Frame: One month after the 3rd vaccine dose
One month after the 3rd vaccine dose
Vaccine response to filamentous haemagglutinin (FHA)
Time Frame: Prior to 3rd vaccine dose
Prior to 3rd vaccine dose
Vaccine response to filamentous haemagglutinin (FHA)
Time Frame: One month after the 3rd vaccine dose
One month after the 3rd vaccine dose
Vaccine response to pertactin (PRN)
Time Frame: Prior to 3rd vaccine dose
Prior to 3rd vaccine dose
Vaccine response to pertactin (PRN)
Time Frame: One month after the 3rd vaccine dose
One month after the 3rd vaccine dose
Evaluation of anti-diphtheria antibody concentrations
Time Frame: One month after the 3rd vaccine dose
One month after the 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations
Time Frame: Prior to 3rd vaccine dose
Prior to 3rd vaccine dose
Evaluation of anti-tetanus antibody concentrations
Time Frame: One month after the 3rd vaccine dose
One month after the 3rd vaccine dose
Evaluation of anti-HBs antibody concentrations
Time Frame: Prior to 3rd vaccine dose
Prior to 3rd vaccine dose
Evaluation of anti-HBs antibody concentrations
Time Frame: One month after the 3rd vaccine dose
One month after the 3rd vaccine dose
Evaluation of anti-PT antibody concentrations
Time Frame: Prior to 3rd vaccine dose
Prior to 3rd vaccine dose
Evaluation of anti-PT antibody concentrations
Time Frame: One month after the 3rd vaccine dose
One month after the 3rd vaccine dose
Evaluation of anti-FHA antibody concentrations
Time Frame: Prior to 3rd vaccine dose
Prior to 3rd vaccine dose
Evaluation of anti-FHA antibody concentrations
Time Frame: One month after the 3rd vaccine dose
One month after the 3rd vaccine dose
Evaluation of anti-PRN antibody concentrations
Time Frame: Prior to 3rd vaccine dose
Prior to 3rd vaccine dose
Evaluation of anti-PRN antibody concentrations
Time Frame: One month after the 3rd vaccine dose
One month after the 3rd vaccine dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (ACTUAL)

January 1, 2003

Study Completion (ACTUAL)

January 1, 2003

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (ESTIMATE)

August 26, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 711202/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Study Data/Documents

  1. Informed Consent Form
    Information identifier: 711202/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: 711202/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 711202/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 711202/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 711202/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: 711202/001
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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