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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

August 25, 2005
September 15, 2016
March 2002
January 2003   (final data collection date for primary outcome measure)
  • 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 ]
Prior to dose 1, 1 m post doses 2, 3, antibody levels to SBA-MenC, anti-PSC in all groups
Complete list of historical versions of study NCT00135486 on ClinicalTrials.gov Archive Site
Not Provided
Prior to dose 1, 1 m post doses 2, 3: anti-PRP. Prior to dose 1, 1 m post dose 3: anti-diphteria, T, HBs, polio, PT, FHA, PRN. Solicited (d 0–7), unsolicited (up to 30 d) AEs after each dose. SAEs
Not Provided
Not Provided
 
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Infections, Meningococcal
  • Biological: MenC-TT
  • Biological: Hib-MenC-TT
    Other Name: MenC-TT
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
January 2003
January 2003   (final data collection date for primary outcome measure)

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
Both
8 Weeks to 16 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Germany
 
NCT00135486
711202/001
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP