Healthy
Conditions
Keywords
Adolescent, Meningococcal, Safety
Brief summary
Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents
Interventions
BIOLOGICALrLP2086
Vaccine administered at 0, 1, and 6 months
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria * Aged 8 to 14 years at the time of enrollment. * Healthy male or female subjects * Negative urine pregnancy test for female subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 | 1 month after Dose 2 |
| Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 | 1 month after Dose 3 |
| Percentage of Participants With at Least One Adverse Event (AE) | Dose 1 up to 1 month after Dose 3 |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Twinrix Given on a 0, 1-, 6- month schedule | 21 |
| Initial Formulation rLP2086 20 mcg Given on a 0, 1-, 6- month schedule | 16 |
| Initial Formulation rLP2086 60 mcg Given on a 0, 1-, 6- month schedule | 45 |
| Initial Formulation rLP2086 200 mcg Given on a 0, 1-, 6- month schedule | 45 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Parent/legal guardian request | 0 | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Twinrix | Initial Formulation rLP2086 20 mcg | Initial Formulation rLP2086 60 mcg | Initial Formulation rLP2086 200 mcg |
|---|---|---|---|---|---|
| Age, Continuous | 10.34 years STANDARD_DEVIATION 1.25 | 10.19 years STANDARD_DEVIATION 1.44 | 10.69 years STANDARD_DEVIATION 0.95 | 10.31 years STANDARD_DEVIATION 1.24 | 10.31 years STANDARD_DEVIATION 1.29 |
| Sex: Female, Male Female | 69 Participants | 10 Participants | 9 Participants | 22 Participants | 28 Participants |
| Sex: Female, Male Male | 58 Participants | 11 Participants | 7 Participants | 23 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 19 / 21 | 15 / 16 | 42 / 45 | 44 / 45 |
| serious Total, serious adverse events | 0 / 21 | 2 / 16 | 3 / 45 | 3 / 45 |
Outcome results
Primary
Percentage of Participants With at Least One Adverse Event (AE)
Time frame: Dose 1 up to 1 month after Dose 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Twinrix | Percentage of Participants With at Least One Adverse Event (AE) | 90.5 percentage of participants |
| Initial Formulation rLP2086 20 mcg | Percentage of Participants With at Least One Adverse Event (AE) | 93.8 percentage of participants |
| Initial Formulation rLP2086 60 mcg | Percentage of Participants With at Least One Adverse Event (AE) | 93.3 percentage of participants |
| Initial Formulation rLP2086 200 mcg | Percentage of Participants With at Least One Adverse Event (AE) | 97.8 percentage of participants |
Primary
Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3
Time frame: 1 month after Dose 3
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Twinrix | Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 | PMB1745 (N=19, 16, 41, 43) | 0.0 percentage of participants |
| Twinrix | Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 | PMB17 (N=18, 16, 41, 43) | 0.0 percentage of participants |
| Initial Formulation rLP2086 20 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 | PMB17 (N=18, 16, 41, 43) | 87.5 percentage of participants |
| Initial Formulation rLP2086 20 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 | PMB1745 (N=19, 16, 41, 43) | 68.8 percentage of participants |
| Initial Formulation rLP2086 60 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 | PMB1745 (N=19, 16, 41, 43) | 70.7 percentage of participants |
| Initial Formulation rLP2086 60 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 | PMB17 (N=18, 16, 41, 43) | 82.9 percentage of participants |
| Initial Formulation rLP2086 200 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 | PMB1745 (N=19, 16, 41, 43) | 90.7 percentage of participants |
| Initial Formulation rLP2086 200 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3 | PMB17 (N=18, 16, 41, 43) | 95.3 percentage of participants |
Primary
Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2
Time frame: 1 month after Dose 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Twinrix | Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 | PMB1745 (N=19, 15, 44, 42) | 0.0 percentage of participants |
| Twinrix | Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 | PMB17 (N=18, 16, 44, 42) | 0.0 percentage of participants |
| Initial Formulation rLP2086 20 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 | PMB17 (N=18, 16, 44, 42) | 18.8 percentage of participants |
| Initial Formulation rLP2086 20 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 | PMB1745 (N=19, 15, 44, 42) | 33.3 percentage of participants |
| Initial Formulation rLP2086 60 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 | PMB1745 (N=19, 15, 44, 42) | 63.6 percentage of participants |
| Initial Formulation rLP2086 60 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 | PMB17 (N=18, 16, 44, 42) | 52.3 percentage of participants |
| Initial Formulation rLP2086 200 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 | PMB1745 (N=19, 15, 44, 42) | 83.3 percentage of participants |
| Initial Formulation rLP2086 200 mcg | Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 | PMB17 (N=18, 16, 44, 42) | 61.9 percentage of participants |