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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:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00135486
First received: August 25, 2005
Last updated: November 23, 2006
Last verified: November 2006

August 25, 2005
November 23, 2006
March 2002
Not Provided
Prior to dose 1, 1 month (m) post doses 2, 3: antibody levels to SBA-MenC, anti-polysaccharide C (PSC) in all groups
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
  • Prior to dose 1, 1 m post doses 2, 3: anti-PRP
  • Prior to dose 1, 1 m post dose 3: anti-diphtheria, T, HBs, polio, PT, FHA, PRN
  • Solicited (days [d] 0–7), unsolicited (up to 30 d) adverse events (AEs) after each dose
  • Serious adverse events (SAEs)
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
Meningitis, Haemophilus
  • Biological: MenC-TT
  • Biological: Hib-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. Epub 2007 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
Not Provided
Not Provided

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
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00135486
711202/001
Not Provided
Not Provided
GlaxoSmithKline
Not Provided
Study Director: Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2006

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