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

Infections, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135486
• Other study ID #: 711202/001
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2005
• Last updated: September 15, 2016
• Start date: March 2002
• Est. completion date: January 2003

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Weeks to 16 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• MenC-TT

• Hib-MenC-TT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers = 1:8 & = 1:128 and titers		Prior to vaccination, one month after the 2nd and 3rd vaccine doses	No
Primary	Evaluation of anti-polysaccharide C (anti-PSC) antibody concentrations = 0.3 µg/mL & = 2 µg/mL and concentrations		Prior to vaccination, one month after the 2nd and 3rd vaccine doses	No
Primary	Evaluation of anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations = 0.15 µg/mL & = 1 µg/mL and concentrations		Prior to vaccination, one month after the 2nd and 3rd vaccine doses	No
Primary	Evaluation of anti-diphtheria antibody concentrations = 0.1 IU/mL by ELISA		Prior to and one month after the 3rd vaccine dose	No
Primary	Evaluation of anti-tetanus antibody concentrations = 0.1 IU/mL		Prior to and one month after the 3rd vaccine dose	No
Primary	Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations = 10 mIU/mL		Prior to and one month after the 3rd vaccine dose	No
Primary	Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers = 8 mIU/mL		Prior to and one month after the 3rd vaccine dose	No
Primary	Vaccine response to pertussis toxoid (PT)		Prior to 3rd vaccine dose	No
Primary	Evaluation of anti-diphtheria antibody concentrations		Prior to 3rd vaccine dose	No
Primary	Anti-poliovirus types 1, 2 and 3 antibody titers		Prior to and one month after the 3rd vaccine dose	No
Primary	Occurrence of solicited local injection site symptoms		During the solicited follow-up period (Day 0 7) following administration of each vaccine dose	No
Primary	Occurrence of solicited systemic symptoms		During the solicited follow-up period (Day 0 7) following administration of each vaccine dose	No
Primary	Occurrence of unsolicited non-serious adverse events (AEs)		Within one month (Day 0 30) after each vaccination	No
Primary	Occurrence of any serious adverse events (SAEs)		Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose	No
Primary	Vaccine response to pertussis toxoid (PT)		One month after the 3rd vaccine dose	No
Primary	Vaccine response to filamentous haemagglutinin (FHA)		Prior to 3rd vaccine dose	No
Primary	Vaccine response to filamentous haemagglutinin (FHA)		One month after the 3rd vaccine dose	No
Primary	Vaccine response to pertactin (PRN)		Prior to 3rd vaccine dose	No
Primary	Vaccine response to pertactin (PRN)		One month after the 3rd vaccine dose	No
Primary	Evaluation of anti-diphtheria antibody concentrations		One month after the 3rd vaccine dose	No
Primary	Evaluation of anti-tetanus antibody concentrations		Prior to 3rd vaccine dose	No
Primary	Evaluation of anti-tetanus antibody concentrations		One month after the 3rd vaccine dose	No
Primary	Evaluation of anti-HBs antibody concentrations		Prior to 3rd vaccine dose	No
Primary	Evaluation of anti-HBs antibody concentrations		One month after the 3rd vaccine dose	No
Primary	Evaluation of anti-PT antibody concentrations		Prior to 3rd vaccine dose	No
Primary	Evaluation of anti-PT antibody concentrations		One month after the 3rd vaccine dose	No
Primary	Evaluation of anti-FHA antibody concentrations		Prior to 3rd vaccine dose	No
Primary	Evaluation of anti-FHA antibody concentrations		One month after the 3rd vaccine dose	No
Primary	Evaluation of anti-PRN antibody concentrations		Prior to 3rd vaccine dose	No
Primary	Evaluation of anti-PRN antibody concentrations		One month after the 3rd vaccine dose	No

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.