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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2002

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2003

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2005

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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