Invasive disease caused by Haemophilus type b and Neisseria meningitidis serogroups C and Y MedDRA version: 18.0 Level: LLT Classification code 10028910 Term: Neisseria meningitides meningitis System Organ Class: 100000004862 MedDRA version: 18.0 Level: LLT Classification code 10051931 Term: Neisseria infection NOS System Organ Class: 100000004862
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows: Year 1: 22 to 36 months of age. Year 3: 44 to 60 months of age. Year 5: 5 years post-dose 4 +/- 8 weeks •Written informed consent obtained from the parent or guardian of the subject. •Healthy subjects as established by medical history and clinical examination before entering into the study •Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006 Are the trial subjects under 18? yes Number of subjects for this age range: 487 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Children should not have: •received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine •had a history of H. influenzae type b, meningococcal serogroup C and Y diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. One year, three years, and five years after the fourth dose vaccination. 2. One year, three years, and five years after the fourth dose vaccination. 3. One year, three years, and five years after the fourth dose vaccination.;Primary end point(s): 1. Anti-PRP antibody concentrations. 2. hSBA-MenC antibody titers 3. hSBA-MenY antibody titers;Main Objective: •To evaluate the long-term antibody persistence induced by 4 doses of Hib-MenCY-TT as compared to 4 doses of ActHIB given at 2, 4, 6, and 12 to 15 months of age in terms of the percentage of subjects with antibody to anti-PRP >= 0.15 µg/mL. •To evaluate the long-term antibody persistence induced by 4 doses of Hib-MenCY-TT given at 2, 4, 6, and 12 to 15 months of age in terms of percentage of subjects with hSBA-MenC and hSBA-MenY titers >= 1:8. •To evaluate the long-term antibody persistence induced by 3 doses of ActHIB given at 2, 4, 6 months of age, and a single dose of Hib-MenCY-TT at 12 to 15 months of age in terms of the percentage of subjects with anti-PRP concen-trations ?0.15 µg/mL, hSBA-MenC and hSBA-MenY titers >= 1:8. Note: The hSBA-MenC and hSBA-MenY endpoint of titers >= 1:8 reflect the primary endpoint for the analysis of persistence years 3 and 5.;Secondary Objective: •To evaluate the long-term antibody persistence of the immune response to PRP in terms of the percent of subjects with anti-PRP >= 1.0 µg/mL and GMCs induced by 4 doses of Hib-MenCY-TT as compared to 4 doses of ActHIB given at 2, 4, 6, and 12 to 15 months of age. •To evaluate the long-term antibody persistence of the immune response to PRP induced by 3 doses ActHIB at 2, 4, and 6 months of age followed by a single dose of Hib-MenCY-TT at 12 to 15 months of age as compared to 4 doses of ActHIB given at 2, 4, 6, and 12 to 15 months of age. •To evaluate the long-term antibody persistence of anti-bodies to PRP, MenC and MenY in recipients of 4 doses of Hib-MenCY-TT given at 2, 4, 6, and 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. One year, three years, and five years after the fourth dose vaccination. 2. One year, three years, and five years after the fourth dose vaccination.;Secondary end point(s): 1. Anti-PRP GMCs and antibody concentrations 2. hSBA-MenC and hSBA-MenY GMTs and antibody titers | — |
Countries
United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed