Clinical Trial Results:
A Phase 4, Single-Arm, Open-Label Study Describing The Safety And Immunogenicity of Bexsero in Healthy Subjects Aged 12 Years to Less Than (<) 19 Years
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Summary
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EudraCT number |
2014-003822-42 |
Trial protocol |
DK |
Global end of trial date |
20 Jan 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Aug 2016
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First version publication date |
13 Aug 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
B1971048
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Pfizer ClinicalTrials.gov Call Center
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer, Inc., Pfizer ClinicalTrials.gov Call Center, 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer, Inc., Pfizer ClinicalTrials.gov Call Center, 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Apr 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Jan 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To describe the immune response, relative to baseline status, following receipt of Bexsero as measured by serum bactericidal assay using human complement (hSBA) performed with a panel of Neisseria meningitidis serogroup B (MnB) test strains assessed 1 month after the second vaccination with Bexsero vaccine.
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Protection of trial subjects |
This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
11 Mar 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 71
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Worldwide total number of subjects |
71
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EEA total number of subjects |
71
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
62
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Adults (18-64 years) |
9
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||
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Pre-assignment
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Screening details |
A total of 71 subjects were enrolled in this study. Of these, 68 subjects received study vaccination. | ||||||||||||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||
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Arms
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Arm title
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Bexsero | ||||||||||||||||
Arm description |
Subjects received at least 1 vaccination of Bexsero at Month 0,-2 visits. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Bexsero
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Investigational medicinal product code |
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Other name |
Neisseria meningitidis serogroup B bivalent recombinant lipoprotein 2086 vaccine (rLP2086)
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Bexsero was administered intramuscularly by injecting 0.5 milliliter (mL) into the upper deltoid muscle at Visit 1 (Month 0) and Visit 2 (Month 2).
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Baseline characteristics reporting groups
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Reporting group title |
Bexsero
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Reporting group description |
Subjects received at least 1 vaccination of Bexsero at Month 0,-2 visits. | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Bexsero
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Reporting group description |
Subjects received at least 1 vaccination of Bexsero at Month 0,-2 visits. | ||
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End point title |
Percentage of Subjects With 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level [1] | ||||||||||||||||
End point description |
Immunogenicity was assessed in terms of percentage of subjects achieving 4-fold rise on the serotype-specific antibody titer from pre vaccination (Day 1) to 1 month post Vaccination 2, for each of the 4 primary MnB test strains. Evaluable immunogenicity population included eligible subjects who received scheduled investigational product, had pre and post Vaccination 2 blood drawn at pre-specified time points, had valid and determinate assay results for the proposed analysis, received no prohibited vaccines and had no other major protocol deviations. Here, 'n' signifies evaluable subjects included in analysis for the given strain.
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End point type |
Primary
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End point timeframe |
1 month after Vaccination 2
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 [2] | ||||||||||||||||||||||||||||||||
End point description |
Local reactions were reported using an electronic diary. Pain was scaled as any (any pain at injection site); mild (did not interfere with activity); moderate (interfered with activity); severe (prevented daily activity). Redness and swelling were scaled as any (greater than or equal to [>=] 2.5 centimeters [cm]); mild (2.5 cm to 5.0 cm); moderate (5.5 cm to 10.0 cm); severe (greater than [>] 10.0 cm). Vaccination 1 safety population included all subjects who received at least 1 dose of Bexsero vaccine and had safety information available from Vaccination 1 until prior to Vaccination 2.
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End point type |
Primary
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End point timeframe |
Within 7 days after Vaccination 1
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 [3] | ||||||||||||||||||||||||||||||||
End point description |
Local reactions were reported using an electronic diary. Pain was scaled as any (any pain at injection site); mild (did not interfere with activity); moderate (interfered with activity); severe (prevented daily activity). Redness and swelling were scaled as any (>=2.5 cm); mild (2.5 cm to 5.0 cm); moderate (5.5 cm to 10.0 cm); severe (>10.0 cm). Vaccination 2 safety population included all subjects who received at least 1 dose of Bexsero vaccine and had safety information available from Vaccination 2 to post Vaccination 2 blood drawn.
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End point type |
Primary
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End point timeframe |
Within 7 days after Vaccination 2
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 [4] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Systemic events (fever [oral temperature >=38 degrees Celsius {C}], vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain), were reported using an electronic diary. Vaccination 1 safety population included all subjects who received at least 1 dose of Bexsero vaccine and had safety information available from Vaccination 1 until prior to Vaccination 2.
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End point type |
Primary
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End point timeframe |
Within 7 days after Vaccination 1
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 [5] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Systemic events (fever [oral temperature >=38 degrees C], vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain), were reported using an electronic diary. Vaccination 2 safety population included all subjects who received at least 1 dose of Bexsero vaccine and had safety information available from Vaccination 2 to post Vaccination 2 blood drawn.
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End point type |
Primary
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End point timeframe |
Within 7 days after Vaccination 2
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 1 [6] | ||||||||||||
End point description |
Vaccination 1 safety population included all subjects who received at least 1 dose of Bexsero vaccine and had safety information available from Vaccination 1 until prior to Vaccination 2.
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End point type |
Primary
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End point timeframe |
Within 7 days after Vaccination 1
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects With Use of Antipyretic Medication Within 7 Days After Vaccination 2 [7] | ||||||||||||
End point description |
Vaccination 2 safety population included all subjects who received at least 1 dose of Bexsero vaccine and had safety information available from Vaccination 2 to post Vaccination 2 blood drawn.
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End point type |
Primary
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End point timeframe |
Within 7 days after Vaccination 2
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Vaccination 1 (Day 1) to 5 months after last administration of Bexsero
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Adverse event reporting additional description |
Same event may appear as both an adverse event (AE) and serious AE (SAE). An event may be categorized as SAE in 1 subject and as nonserious in other subject, or 1 subject may have experienced both SAE and nonserious during the study. Safety population included all subjects who received at least 1 dose of Bexsero vaccine, had safety data available.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Bexsero
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Reporting group description |
Subjects received at least 1 vaccination of Bexsero at Month 0,-2 visits. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
