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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00135486
First received: August 25, 2005
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Infections, Meningococcal
Biological: MenC-TT
Biological: Hib-MenC-TT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA [ Time Frame: Prior to and one month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL [ Time Frame: Prior to and one month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Vaccine response to pertussis toxoid (PT) [ Time Frame: Prior to 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-diphtheria antibody concentrations [ Time Frame: Prior to 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Anti-poliovirus types 1, 2 and 3 antibody titers [ Time Frame: Prior to and one month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of solicited local injection site symptoms [ Time Frame: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of solicited systemic symptoms [ Time Frame: During the solicited follow-up period (Day 0 7) following administration of each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited non-serious adverse events (AEs) [ Time Frame: Within one month (Day 0 30) after each vaccination ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Vaccine response to pertussis toxoid (PT) [ Time Frame: One month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Vaccine response to filamentous haemagglutinin (FHA) [ Time Frame: Prior to 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Vaccine response to filamentous haemagglutinin (FHA) [ Time Frame: One month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Vaccine response to pertactin (PRN) [ Time Frame: Prior to 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Vaccine response to pertactin (PRN) [ Time Frame: One month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-diphtheria antibody concentrations [ Time Frame: One month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-tetanus antibody concentrations [ Time Frame: Prior to 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-tetanus antibody concentrations [ Time Frame: One month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-HBs antibody concentrations [ Time Frame: Prior to 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-HBs antibody concentrations [ Time Frame: One month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-PT antibody concentrations [ Time Frame: Prior to 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-PT antibody concentrations [ Time Frame: One month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-FHA antibody concentrations [ Time Frame: Prior to 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-FHA antibody concentrations [ Time Frame: One month after the 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-PRN antibody concentrations [ Time Frame: Prior to 3rd vaccine dose ] [ Designated as safety issue: No ]
  • Evaluation of anti-PRN antibody concentrations [ Time Frame: One month after the 3rd vaccine dose ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: March 2002
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: MenC-TT Biological: Hib-MenC-TT
    Other Name: MenC-TT
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.
  Eligibility

Ages Eligible for Study:   8 Weeks to 16 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135486

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 711202/001
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 711202/001
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 711202/001
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 711202/001
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 711202/001
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 711202/001
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00135486     History of Changes
Other Study ID Numbers: 711202/001 
Study First Received: August 25, 2005
Last Updated: September 15, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
Haemophilus Influenzae type b/Meningococcal vaccine
Prophylaxis meningococcal serogroup C disease, Hib diseases

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016