Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).

January 3, 2020 updated by: GlaxoSmithKline

Study to Assess Immunogenicity and Reactogenicity of Three Doses of GSK Bio's Combined Hib-MenC Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV Vaccine and of Two Doses of Baxters Meningococcal C Conjugate Vaccine Co-admind With GSK Bio's DTPa-HBV-IPV/Hib Vaccine

This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alcorcon, Spain, 28922
        • GSK Investigational Site
      • Almeira, Spain, 4009
        • GSK Investigational Site
      • Badalona, Spain, 08916
        • GSK Investigational Site
      • Barcelona, Spain, 08025
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 08950
        • GSK Investigational Site
      • Bilbao, Spain, 48013
        • GSK Investigational Site
      • Burgos, Spain, 09005
        • GSK Investigational Site
      • Cordoba, Spain, 14004
        • GSK Investigational Site
      • Getafe, Spain, 28905
        • GSK Investigational Site
      • Leganes, Spain
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28047
        • GSK Investigational Site
      • Madrid, Spain, 28007
        • GSK Investigational Site
      • Malaga, Spain, 29010
        • GSK Investigational Site
      • Marid, Spain, 28040
        • GSK Investigational Site
      • Móstoles/Madrid, Spain, 28935
        • GSK Investigational Site
      • Palma de Mallorca, Spain, 07014
        • GSK Investigational Site
      • Sevilla, Spain, 41013
        • GSK Investigational Site
      • Sevilla, Spain, 41071
        • GSK Investigational Site
      • Valladolid, Spain, 47010
        • GSK Investigational Site
      • Velez, Malaga, Spain
        • GSK Investigational Site

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

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female infant between, & including, 0 & 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 & 42 weeks).
  • Written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period.
  • Administration of immunosuppressants or other immune-modifying drugs from birth.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine.
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease.
  • Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
At M7: Antibodies to PRP, MenC HBsAg

Secondary Outcome Measures

Outcome Measure
At M7: Abs. to all vaccine antigens
At M6: Abs. to PRP & MenC
Solicited (D0-3); unsol. events (D0-30); SAEs (full study)

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 (Actual)

September 30, 2003

Study Completion (Actual)

July 16, 2004

Study Registration Dates

First Submitted

July 14, 2006

First Submitted That Met QC Criteria

July 14, 2006

First Posted (Estimate)

July 17, 2006

Study Record Updates

Last Update Posted (Actual)

January 6, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217744/097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Study Data/Documents

  1. Clinical Study Report
    Information identifier: 217744/097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: 217744/097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 217744/097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 217744/097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 217744/097
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: 217744/097
    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.

Subscribe