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| ID | Type | Description | Link |
|---|---|---|---|
| B1971008 | Other Identifier | Alias Study Number | |
| 2008-001457-18 | EudraCT Number |
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Following program review within Pfizer, decision was made not to go ahead with this study. This study is cancelled
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The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines |
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| 2 | Experimental | Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines |
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| 3 | Experimental | Control group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meningococcal B rLP2086 vaccine | Biological | vaccination |
| |
| Routine age appropriate childhood vaccines |
| Measure | Description | 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) |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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:
Does not include resolving syndromes due to birth trauma such as Erb palsy.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Mediterráneo | Almería | Almeria | 4007 | Spain | ||
| Hospital Clinico Universitario de Santiago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25077420 | Derived | Martinon-Torres F, Gimenez-Sanchez F, Bernaola-Iturbe E, Diez-Domingo J, Jiang Q, Perez JL. A randomized, phase 1/2 trial of the safety, tolerability, and immunogenicity of bivalent rLP2086 meningococcal B vaccine in healthy infants. Vaccine. 2014 Sep 8;32(40):5206-11. doi: 10.1016/j.vaccine.2014.07.049. Epub 2014 Jul 29. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice. |
| FG001 | rLP2086 20 mcg | Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
vaccination |
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| meningococcal B rLP2086 vaccine | Biological | vaccination |
|
| Routine age appropriate childhood vaccines | Biological | vaccination |
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| Routine age appropriate childhood vaccines | Biological | vaccination |
|
| 1 month after Dose 2, Dose 3; before Dose 4 |
| 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 |
| Santiado de Compostela |
| La Coruña |
| 15706 |
| Spain |
| Hospital Gral. Gregorio Maranon | Madrid | Madrid | 28007 | Spain |
| Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario de Mostóles | Mostóles | Madrid | 28935 | Spain |
| Hospital Virgen del Camino | Pamplona | Navarre | 31008 | Spain |
| Hospital Xeral de Vigo | Vigo | 36024 | Spain |
| FG002 | rLP2086 60 mcg | rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice. |
| BG001 | rLP2086 20 mcg | Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice. |
| BG002 | rLP2086 60 mcg | rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | days |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | 1 month after Dose 3 |
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| Secondary | Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain | 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. | Posted | 1 month after Dose 2, Dose 3; before Dose 4 |
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| 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 | 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. | Posted | 1 month after Dose 2, Dose 3; before Dose 4 |
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| Other Pre-specified | Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer | 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. | Posted | 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4 |
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| 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 | 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. | Posted | 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4 |
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| Other Pre-specified | Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains | 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. | Posted | 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4 |
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| Primary | Percentage of Participants With at Least One Adverse Event (AE) | Posted | Number | percentage of participants | From signing of informed consent form to completion of study (up to 2 years) |
|
|
AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice. | 0 | 14 | 3 | 14 | ||
| EG001 | rLP2086 20 mcg | Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice. | 4 | 22 | 4 | 22 | ||
| EG002 | rLP2086 60 mcg | rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice. | 1 | 10 | 2 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Meningitis aseptic | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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Immunogenicity results were not reported because the study was terminated due to the reactogenicity profile of the vaccine in infants prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
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| Male |
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