Back to resultsStudy to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MenC-TT
Hib-MenC-TT
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring Haemophilus Influenzae type b/Meningococcal vaccine, Prophylaxis meningococcal serogroup C disease, Hib diseases
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers
Evaluation of anti-polysaccharide C (anti-PSC) antibody concentrations ≥ 0.3 µg/mL & ≥ 2 µg/mL and concentrations
Evaluation of anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL & ≥ 1 µg/mL and concentrations
Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA
Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL
Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL
Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL
Vaccine response to pertussis toxoid (PT)
Evaluation of anti-diphtheria antibody concentrations
Anti-poliovirus types 1, 2 and 3 antibody titers
Occurrence of solicited local injection site symptoms
Occurrence of solicited systemic symptoms
Occurrence of unsolicited non-serious adverse events (AEs)
Occurrence of any serious adverse events (SAEs)
Vaccine response to pertussis toxoid (PT)
Vaccine response to filamentous haemagglutinin (FHA)
Vaccine response to filamentous haemagglutinin (FHA)
Vaccine response to pertactin (PRN)
Vaccine response to pertactin (PRN)
Evaluation of anti-diphtheria antibody concentrations
Evaluation of anti-tetanus antibody concentrations
Evaluation of anti-tetanus antibody concentrations
Evaluation of anti-HBs antibody concentrations
Evaluation of anti-HBs antibody concentrations
Evaluation of anti-PT antibody concentrations
Evaluation of anti-PT antibody concentrations
Evaluation of anti-FHA antibody concentrations
Evaluation of anti-FHA antibody concentrations
Evaluation of anti-PRN antibody concentrations
Evaluation of anti-PRN antibody concentrations
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00135486
Brief Title
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Haemophilus Influenzae type b/Meningococcal vaccine, Prophylaxis meningococcal serogroup C disease, Hib diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
MenC-TT
Intervention Type
Biological
Intervention Name(s)
Hib-MenC-TT
Other Intervention Name(s)
MenC-TT
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA
Time Frame
Prior to and one month after the 3rd vaccine dose
Title
Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL
Time Frame
Prior to and one month after the 3rd vaccine dose
Title
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
Title
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
Title
Vaccine response to pertussis toxoid (PT)
Time Frame
Prior to 3rd vaccine dose
Title
Evaluation of anti-diphtheria antibody concentrations
Time Frame
Prior to 3rd vaccine dose
Title
Anti-poliovirus types 1, 2 and 3 antibody titers
Time Frame
Prior to and one month after the 3rd vaccine dose
Title
Occurrence of solicited local injection site symptoms
Time Frame
During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Title
Occurrence of solicited systemic symptoms
Time Frame
During the solicited follow-up period (Day 0 7) following administration of each vaccine dose
Title
Occurrence of unsolicited non-serious adverse events (AEs)
Time Frame
Within one month (Day 0 30) after each vaccination
Title
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
Title
Vaccine response to pertussis toxoid (PT)
Time Frame
One month after the 3rd vaccine dose
Title
Vaccine response to filamentous haemagglutinin (FHA)
Time Frame
Prior to 3rd vaccine dose
Title
Vaccine response to filamentous haemagglutinin (FHA)
Time Frame
One month after the 3rd vaccine dose
Title
Vaccine response to pertactin (PRN)
Time Frame
Prior to 3rd vaccine dose
Title
Vaccine response to pertactin (PRN)
Time Frame
One month after the 3rd vaccine dose
Title
Evaluation of anti-diphtheria antibody concentrations
Time Frame
One month after the 3rd vaccine dose
Title
Evaluation of anti-tetanus antibody concentrations
Time Frame
Prior to 3rd vaccine dose
Title
Evaluation of anti-tetanus antibody concentrations
Time Frame
One month after the 3rd vaccine dose
Title
Evaluation of anti-HBs antibody concentrations
Time Frame
Prior to 3rd vaccine dose
Title
Evaluation of anti-HBs antibody concentrations
Time Frame
One month after the 3rd vaccine dose
Title
Evaluation of anti-PT antibody concentrations
Time Frame
Prior to 3rd vaccine dose
Title
Evaluation of anti-PT antibody concentrations
Time Frame
One month after the 3rd vaccine dose
Title
Evaluation of anti-FHA antibody concentrations
Time Frame
Prior to 3rd vaccine dose
Title
Evaluation of anti-FHA antibody concentrations
Time Frame
One month after the 3rd vaccine dose
Title
Evaluation of anti-PRN antibody concentrations
Time Frame
Prior to 3rd vaccine dose
Title
Evaluation of anti-PRN antibody concentrations
Time Frame
One month after the 3rd vaccine dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Weeks
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
17287313
Citation
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. doi: 10.1128/CVI.00377-06. Epub 2007 Feb 7.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
711202/001
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
711202/001
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
711202/001
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
711202/001
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
711202/001
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
711202/001
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
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