A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00808028
First received: December 12, 2008
Last updated: March 27, 2015
Last verified: March 2015
Results First Received: March 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind;   Primary Purpose: Prevention
Condition: Meningitis, Meningococcal
Interventions: Biological: meningococcal B rLP2086 vaccine.
Other: normal saline (placebo)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
rLP2086 60 Microgram (mcg) Given on a 0, 2-, 6-month schedule in Stage 1
rLP2086 120 mcg Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
rLP2086 200 mcg Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.

Participant Flow for 2 periods

Period 1:   Stage 1 (6 Months)
    Control     rLP2086 60 Microgram (mcg)     rLP2086 120 mcg     rLP2086 200 mcg  
STARTED     121     22 [1]   198     198  
COMPLETED     116     21 [1]   191     183  
NOT COMPLETED     5     1     7     15  
Withdrawal by Subject                 3                 0                 2                 5  
Unspecified                 1                 0                 2                 4  
Parent/legal guardian request                 0                 1                 1                 3  
Adverse Event                 0                 0                 1                 2  
Lost to Follow-up                 1                 0                 1                 0  
Protocol Violation                 0                 0                 0                 1  
[1] Participants in rLP2086 60 mcg group participated only in Stage 1 and were not eligible for Stage 2

Period 2:   Stage 2 (Followed up to 48 Months )
    Control     rLP2086 60 Microgram (mcg)     rLP2086 120 mcg     rLP2086 200 mcg  
STARTED     80 [1]   0     170     151  
COMPLETED     69 [1]   0     141     128  
NOT COMPLETED     11     0     29     23  
Withdrawal by Subject                 6                 0                 9                 11  
Protocol Violation                 0                 0                 1                 0  
Lost to Follow-up                 2                 0                 8                 7  
Failed to return                 2                 0                 5                 4  
Adverse Event                 1                 0                 1                 0  
Unspecified                 0                 0                 1                 1  
Parent's or guardian request                 0                 0                 2                 0  
Death                 0                 0                 1                 0  
Non-compliance                 0                 0                 1                 0  
[1] Out of 511 completed participants in Stage 1, 89 did not enter Stage 2



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The stage 1 intent-to-treat (ITT) population included all randomized participants who received at least 1 vaccination and have at least 1 valid and determinate assay result from blood samples drawn during stage 1.

Reporting Groups
  Description
Control Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
rLP2086 60 mcg Given on a 0, 2-, 6-month schedule in Stage 1.
rLP2086 120 mcg Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
rLP2086 200 mcg Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Total Total of all reporting groups

Baseline Measures
    Control     rLP2086 60 mcg     rLP2086 120 mcg     rLP2086 200 mcg     Total  
Number of Participants  
[units: participants]
  121     22     198     198     539  
Age  
[units: Years]
Mean (Standard Deviation)
  13.8  (2.05)     13.3  (1.84)     14.3  (2.11)     14.0  (2.01)     14.0  (2.05)  
Gender  
[units: Participants]
         
Female     61     11     113     103     288  
Male     60     11     85     95     251  



  Outcome Measures
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1.  Primary:   Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2   [ Time Frame: Before vaccination 1 up to 1 month after vaccination 2 ]

2.  Primary:   Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3   [ Time Frame: Before vaccination 1 up to 1 month after vaccination 3 ]

3.  Primary:   Percentage of Participants With Atleast One Adverse Event (AE): Stage 1   [ Time Frame: Vaccination 1 upto 1 Month after vaccination 3 ]

4.  Primary:   Percentage of Participants With Atleast One Adverse Event (AE): Stage 2   [ Time Frame: 6 month after vaccination 3 up to 48 months ]

5.  Secondary:   Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level   [ Time Frame: 1 month before vaccination 1, 1 month after vaccination 2, 3 ]

6.  Other Pre-specified:   Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B   [ Time Frame: Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00808028     History of Changes
Other Study ID Numbers: 6108A1-2001, B1971005, 2008-007789-51
Study First Received: December 12, 2008
Results First Received: March 27, 2015
Last Updated: March 27, 2015
Health Authority: Australia: Human Research Ethics Committee