Phase 3
N=270
Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
Neisseria Meningitidis · Haemophilus Influenzae Type b
Bottom Line
View on ClinicalTrials.gov: NCT00359983 ↗Enrolled (actual)
270
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter — 116; 49; 46; 60 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MenHibrix (Hib-MenCY-TT) (Biological); Hib conjugate vaccine (ActHIB) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter |
116; 49; 46; 60; 26; 36 | — |
| PRIMARY Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA) |
112; 12; 34; 48; 3; 20 | — |
| PRIMARY Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA) |
88; 0; 31; 39; 4; 19 | — |
| SECONDARY Anti-PRP Geometric Mean Concentrations (GMCs) |
2.400; 1.943; 1.162; 1.169; 1.031; 0.898 | — |
| SECONDARY Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter |
88; 35; 24; 33; 14; 14 | — |
| SECONDARY hSBA-MenC Geometric Mean Titers (GMTs) |
150.1; 3.9; 26.3; 41.9; 2.7; 16.0 | — |
| SECONDARY Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 |
112; 12; 34; 48; 3; 20 | — |
| SECONDARY hSBA-MenY Geometric Mean Titers (GMTs) |
128.8; 2.0; 41.1; 29.9; 3.5; 16.6 | — |
| SECONDARY Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 |
89; 0; 31; 39; 4; 19 | — |
Summary
This study is evaluating antibody persistence at 1, 3 & 5 years post-fourth dose (i.e., at 2, 4 & 6 years of age, respectively) in subjects vaccinated in a previous study.
This protocol posting deals with objectives & outcome measures of the extension phase at years 1, 3 and 5. The objectives & outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129).
This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.
Eligibility 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
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
Data sourced from ClinicalTrials.gov (NCT00359983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.