Meningitis, Meningococcal
Conditions
Keywords
Meningococcal B vaccine, infants, safety, immunogenicity
Brief summary
The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
Interventions
BIOLOGICALmeningococcal B rLP2086 vaccine
vaccination
BIOLOGICALRoutine age appropriate childhood vaccines
vaccination
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 98 Days
Healthy volunteers
No
Inclusion criteria
* Investigators should always use good clinical judgment in considering a subject's overall fitness for trial participation. In addition, any condition that in the opinion of the investigator may interfere with the evaluation of study objectives should be carefully considered prior to enrolling subjects. * Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment. * Available for the entire consented period and whose parent/legal guardian can be reached by telephone. * Healthy infant as determined by medical history, physical examination, and judgment of the investigator. * Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Exclusion criteria
* Previous vaccination with licensed or investigational vaccines: meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, poliovirus, rotavirus, varicella, measles, mumps, or rubella. Any of the following illnesses/conditions that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study: * A previous anaphylactic reaction to any vaccine or vaccine-related component. * Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella. * Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. * Known or suspected immune deficiency or suppression. * History of culture-proven invasive disease caused by N meningitidis or Neisseria gonorrhoea. * Major known congenital malformation or serious chronic disorder. * Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb palsy. * Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies). * Received any investigational drugs, vaccines or devices (aside from those specified in the protocol) within 4 weeks before administration of the first dose of test article or at any time throughout the study. * Participation in purely observational studies is acceptable. * Infant who is a direct descendant (child, grandchild) of the study site personnel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain | 1 month after Dose 3 |
| Percentage of Participants With at Least One Adverse Event (AE) | From signing of informed consent form to completion of study (up to 2 years) |
Secondary
| Measure | Time frame |
|---|---|
| Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain | 1 month after Dose 2, Dose 3; before Dose 4 |
| Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain | 1 month after Dose 2, Dose 3; before Dose 4 |
Other
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving SBA Titer Levels >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Additional MnB Test Strains | 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4 |
| Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains | 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4 |
| Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer | 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4 |
Countries
Spain
Participant flow
Recruitment details
In this study, participants were to receive recombinant lipoprotein 2086 (rLP2086) vaccine at 2, 4, 6 and 12 months of age. Due to premature termination of study, only single dose of 20 or 60 microgram (mcg) of rLP2086 vaccine was administered at 2 months and planned treatments of rLP2086 vaccine 120 mcg and 200 mcg were not administered.
Participants by arm
| Arm | Count |
|---|---|
| Control Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice. | 14 |
| rLP2086 20 mcg Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice. | 22 |
| rLP2086 60 mcg rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice. | 10 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Discontinuation by Sponsor | 14 | 21 | 9 |
Baseline characteristics
| Characteristic | Control | rLP2086 20 mcg | rLP2086 60 mcg | Total |
|---|---|---|---|---|
| Age, Continuous | 63.6 days STANDARD_DEVIATION 11.57 | 64.0 days STANDARD_DEVIATION 10.02 | 71.6 days STANDARD_DEVIATION 11.35 | 65.5 days STANDARD_DEVIATION 11.03 |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 4 Participants | 22 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 6 Participants | 24 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 | 3 / 14 | 4 / 22 | 2 / 10 |
| serious Total, serious adverse events | 0 / 14 | 4 / 22 | 1 / 10 |
Outcome results
Primary
Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
Time frame: 1 month after Dose 3
Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Primary
Percentage of Participants With at Least One Adverse Event (AE)
Time frame: From signing of informed consent form to completion of study (up to 2 years)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percentage of Participants With at Least One Adverse Event (AE) | 21.4 percentage of participants |
| rLP2086 20 mcg | Percentage of Participants With at Least One Adverse Event (AE) | 31.8 percentage of participants |
| rLP2086 60 mcg | Percentage of Participants With at Least One Adverse Event (AE) | 20.0 percentage of participants |
Secondary
Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
Time frame: 1 month after Dose 2, Dose 3; before Dose 4
Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Secondary
Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain
Time frame: 1 month after Dose 2, Dose 3; before Dose 4
Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Other Pre-specified
Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer
Time frame: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Other Pre-specified
Percentage of Participants Achieving SBA Titer Levels >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Additional MnB Test Strains
Time frame: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Other Pre-specified
Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains
Time frame: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4
Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.