Neisseria Meningitidis, Haemophilus Influenzae Type b
Conditions
Keywords
Humans, Meningococcal vaccines, Immunogenicity, Vaccines, H. influenzae type b vaccine, Conjugate, Toddlers, Comparative study, Neisseria meningitidis
Brief 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.
Detailed description
In this long-term follow-up study, no new subjects will be recruited. All subjects participating in this long-term follow-up study should have already participated in a previous study. No vaccine will be administered during the persistence phase of the study. This Protocol Posting has been updated following Protocol amendment 3, September 2009.
Interventions
BIOLOGICALMenHibrix (Hib-MenCY-TT)
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
BIOLOGICALHib conjugate vaccine (ActHIB)
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Months to 60 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter | One year, three years, and five years after the fourth dose vaccination. | Results up to 5 years after the fourth dose are presented. |
| 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) | One year, three years, and five years after the fourth dose vaccination. | Results up to 5 years after the fourth dose are presented. |
| 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) | One year, three years, and five years after the fourth dose vaccination. | Results up to 5 years after the fourth dose are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 | One year, three years, and five years after the fourth dose vaccination. | Results up to 5 years after the fourth dose are presented. |
| Anti-PRP Geometric Mean Concentrations (GMCs) | One year, three years, and five years after the fourth dose vaccination. | Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL). Results up to 5 years after the fourth dose are presented. |
| Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 | One year, three years, and five years after the fourth dose vaccination. | Results up to 5 years after the fourth dose are presented. |
| hSBA-MenY Geometric Mean Titers (GMTs) | One year, three years, and five years after the fourth dose vaccination. | Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition. Results up to 5 years after the fourth dose are presented. |
| Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter | One year, three years, and five years after the fourth dose vaccination. | Results up to 5 years after the fourth dose are presented. |
| hSBA-MenC Geometric Mean Titers (GMTs) | One year, three years, and five years after the fourth dose vaccination. | Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition. Results up to 5 years after the fourth dose are presented. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MenHibrix 4-dose Group Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study. | 138 |
| ActHIB 4-dose Group Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study. | 70 |
| ActHIB 3-dose + MenHibrix 4th-dose Group Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study. | 62 |
| Total | 270 |
Baseline characteristics
| Characteristic | MenHibrix 4-dose Group | ActHIB 4-dose Group | ActHIB 3-dose + MenHibrix 4th-dose Group | Total |
|---|---|---|---|---|
| Age, Continuous Months | 27.4 Months STANDARD_DEVIATION 3.37 | 28.2 Months STANDARD_DEVIATION 4.05 | 28.4 Months STANDARD_DEVIATION 3.69 | 27.8 Months STANDARD_DEVIATION 3.64 |
| Gender Female | 67 Participants | 35 Participants | 33 Participants | 135 Participants |
| Gender Male | 71 Participants | 35 Participants | 29 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 138 | 0 / 70 | 0 / 62 |
Outcome results
Primary
Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenHibrix 4-dose Group | Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter | Year 3 (N=61; 28; 36) | 60 Subjects |
| MenHibrix 4-dose Group | Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter | Year 1 (N=116; 51; 46) | 116 Subjects |
| MenHibrix 4-dose Group | Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter | Year 5 (N=84; 39; 37) | 83 Subjects |
| ActHIB 4-dose Group | Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter | Year 3 (N=61; 28; 36) | 26 Subjects |
| ActHIB 4-dose Group | Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter | Year 1 (N=116; 51; 46) | 49 Subjects |
| ActHIB 4-dose Group | Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter | Year 5 (N=84; 39; 37) | 36 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter | Year 1 (N=116; 51; 46) | 46 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter | Year 5 (N=84; 39; 37) | 36 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter | Year 3 (N=61; 28; 36) | 36 Subjects |
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)
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenHibrix 4-dose Group | 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) | Year 3 (N=59; 27; 35) | 48 Subjects |
| MenHibrix 4-dose Group | 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) | Year 1 (N=116; 52; 48) | 112 Subjects |
| MenHibrix 4-dose Group | 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) | Year 5 (N=76; 38; 34) | 63 Subjects |
| ActHIB 4-dose Group | 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) | Year 3 (N=59; 27; 35) | 3 Subjects |
| ActHIB 4-dose Group | 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) | Year 1 (N=116; 52; 48) | 12 Subjects |
| ActHIB 4-dose Group | 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) | Year 5 (N=76; 38; 34) | 8 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | 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) | Year 1 (N=116; 52; 48) | 34 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | 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) | Year 5 (N=76; 38; 34) | 25 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | 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) | Year 3 (N=59; 27; 35) | 20 Subjects |
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)
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenHibrix 4-dose Group | 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) | Year 3 (N=58; 26; 34) | 39 Subjects |
| MenHibrix 4-dose Group | 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) | Year 1 (N=105; 50; 47) | 88 Subjects |
| MenHibrix 4-dose Group | 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) | Year 5 (N=82; 38; 35) | 57 Subjects |
| ActHIB 4-dose Group | 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) | Year 3 (N=58; 26; 34) | 4 Subjects |
| ActHIB 4-dose Group | 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) | Year 1 (N=105; 50; 47) | 0 Subjects |
| ActHIB 4-dose Group | 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) | Year 5 (N=82; 38; 35) | 7 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | 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) | Year 1 (N=105; 50; 47) | 31 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | 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) | Year 5 (N=82; 38; 35) | 19 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | 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) | Year 3 (N=58; 26; 34) | 19 Subjects |
Secondary
Anti-PRP Geometric Mean Concentrations (GMCs)
Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL). Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix 4-dose Group | Anti-PRP Geometric Mean Concentrations (GMCs) | Year 3 (N=61; 28; 36) | 1.169 µg/mL |
| MenHibrix 4-dose Group | Anti-PRP Geometric Mean Concentrations (GMCs) | Year 1 (N=116; 51; 46) | 2.400 µg/mL |
| MenHibrix 4-dose Group | Anti-PRP Geometric Mean Concentrations (GMCs) | Year 5 (N=84; 39; 37) | 1.248 µg/mL |
| ActHIB 4-dose Group | Anti-PRP Geometric Mean Concentrations (GMCs) | Year 3 (N=61; 28; 36) | 1.031 µg/mL |
| ActHIB 4-dose Group | Anti-PRP Geometric Mean Concentrations (GMCs) | Year 1 (N=116; 51; 46) | 1.943 µg/mL |
| ActHIB 4-dose Group | Anti-PRP Geometric Mean Concentrations (GMCs) | Year 5 (N=84; 39; 37) | 0.803 µg/mL |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Anti-PRP Geometric Mean Concentrations (GMCs) | Year 1 (N=116; 51; 46) | 1.162 µg/mL |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Anti-PRP Geometric Mean Concentrations (GMCs) | Year 5 (N=84; 39; 37) | 0.689 µg/mL |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Anti-PRP Geometric Mean Concentrations (GMCs) | Year 3 (N=61; 28; 36) | 0.898 µg/mL |
Secondary
hSBA-MenC Geometric Mean Titers (GMTs)
Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition. Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix 4-dose Group | hSBA-MenC Geometric Mean Titers (GMTs) | Year 3 (N= 59; 27; 35) | 41.9 Titer |
| MenHibrix 4-dose Group | hSBA-MenC Geometric Mean Titers (GMTs) | Year 1 (N= 116; 52; 48) | 150.1 Titer |
| MenHibrix 4-dose Group | hSBA-MenC Geometric Mean Titers (GMTs) | Year 5 (N= 76; 38; 34) | 69.8 Titer |
| ActHIB 4-dose Group | hSBA-MenC Geometric Mean Titers (GMTs) | Year 3 (N= 59; 27; 35) | 2.7 Titer |
| ActHIB 4-dose Group | hSBA-MenC Geometric Mean Titers (GMTs) | Year 1 (N= 116; 52; 48) | 3.9 Titer |
| ActHIB 4-dose Group | hSBA-MenC Geometric Mean Titers (GMTs) | Year 5 (N= 76; 38; 34) | 3.6 Titer |
| ActHIB 3-dose + MenHibrix 4th-dose Group | hSBA-MenC Geometric Mean Titers (GMTs) | Year 1 (N= 116; 52; 48) | 26.3 Titer |
| ActHIB 3-dose + MenHibrix 4th-dose Group | hSBA-MenC Geometric Mean Titers (GMTs) | Year 5 (N= 76; 38; 34) | 44.2 Titer |
| ActHIB 3-dose + MenHibrix 4th-dose Group | hSBA-MenC Geometric Mean Titers (GMTs) | Year 3 (N= 59; 27; 35) | 16.0 Titer |
Secondary
hSBA-MenY Geometric Mean Titers (GMTs)
Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition. Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix 4-dose Group | hSBA-MenY Geometric Mean Titers (GMTs) | Year 1 (N= 105; 50; 47) | 128.8 Titer |
| MenHibrix 4-dose Group | hSBA-MenY Geometric Mean Titers (GMTs) | Year 3 (N= 58; 26; 34) | 29.9 Titer |
| MenHibrix 4-dose Group | hSBA-MenY Geometric Mean Titers (GMTs) | Year 5 (N= 82; 38; 35) | 26.8 Titer |
| ActHIB 4-dose Group | hSBA-MenY Geometric Mean Titers (GMTs) | Year 5 (N= 82; 38; 35) | 3.6 Titer |
| ActHIB 4-dose Group | hSBA-MenY Geometric Mean Titers (GMTs) | Year 3 (N= 58; 26; 34) | 3.5 Titer |
| ActHIB 4-dose Group | hSBA-MenY Geometric Mean Titers (GMTs) | Year 1 (N= 105; 50; 47) | 2.0 Titer |
| ActHIB 3-dose + MenHibrix 4th-dose Group | hSBA-MenY Geometric Mean Titers (GMTs) | Year 5 (N= 82; 38; 35) | 17.8 Titer |
| ActHIB 3-dose + MenHibrix 4th-dose Group | hSBA-MenY Geometric Mean Titers (GMTs) | Year 3 (N= 58; 26; 34) | 16.6 Titer |
| ActHIB 3-dose + MenHibrix 4th-dose Group | hSBA-MenY Geometric Mean Titers (GMTs) | Year 1 (N= 105; 50; 47) | 41.1 Titer |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenHibrix 4-dose Group | Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter | Year 3 (N=61; 28; 36) | 33 Subjects |
| MenHibrix 4-dose Group | Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter | Year 1 (N= 116; 51; 46) | 88 Subjects |
| MenHibrix 4-dose Group | Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter | Year 5 (N= 84; 39; 37) | 47 Subjects |
| ActHIB 4-dose Group | Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter | Year 3 (N=61; 28; 36) | 14 Subjects |
| ActHIB 4-dose Group | Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter | Year 1 (N= 116; 51; 46) | 35 Subjects |
| ActHIB 4-dose Group | Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter | Year 5 (N= 84; 39; 37) | 17 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter | Year 1 (N= 116; 51; 46) | 24 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter | Year 5 (N= 84; 39; 37) | 10 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter | Year 3 (N=61; 28; 36) | 14 Subjects |
Secondary
Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenHibrix 4-dose Group | Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 | Year 3 (N= 59; 27; 35) | 48 Subjects |
| MenHibrix 4-dose Group | Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 | Year 1 (N= 116; 52; 48) | 112 Subjects |
| MenHibrix 4-dose Group | Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 | Year 5 (N= 76; 38; 34) | 63 Subjects |
| ActHIB 4-dose Group | Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 | Year 3 (N= 59; 27; 35) | 3 Subjects |
| ActHIB 4-dose Group | Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 | Year 1 (N= 116; 52; 48) | 12 Subjects |
| ActHIB 4-dose Group | Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 | Year 5 (N= 76; 38; 34) | 8 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 | Year 1 (N= 116; 52; 48) | 34 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 | Year 5 (N= 76; 38; 34) | 26 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4 | Year 3 (N= 59; 27; 35) | 20 Subjects |
Secondary
Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Population: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenHibrix 4-dose Group | Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 | Year 3 (N= 58; 26; 34) | 39 Subjects |
| MenHibrix 4-dose Group | Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 | Year 1 (N= 105; 50; 47) | 89 Subjects |
| MenHibrix 4-dose Group | Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 | Year 5 (N= 82; 38; 35) | 57 Subjects |
| ActHIB 4-dose Group | Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 | Year 3 (N= 58; 26; 34) | 4 Subjects |
| ActHIB 4-dose Group | Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 | Year 1 (N= 105; 50; 47) | 0 Subjects |
| ActHIB 4-dose Group | Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 | Year 5 (N= 82; 38; 35) | 7 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 | Year 1 (N= 105; 50; 47) | 31 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 | Year 5 (N= 82; 38; 35) | 19 Subjects |
| ActHIB 3-dose + MenHibrix 4th-dose Group | Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4 | Year 3 (N= 58; 26; 34) | 19 Subjects |