A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01299480
First received: February 15, 2011
Last updated: June 2, 2015
Last verified: June 2015
Results First Received: November 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Meningococcal Vaccine
Intervention: Biological: Vaccine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1714 participants were enrolled in this study. Of these, 1 participant was not randomized but was vaccinated with Saline at Injection 1. This participant was included in safety population and not intent-to-treat population. Participant Flow includes only randomized intent to treat participants.

Reporting Groups
  Description
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month) Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month) Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month) Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month) Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month) Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.

Participant Flow:   Overall Study
    Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)     Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)     Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)     Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)     Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)  
STARTED     427     430     427     286     143  
COMPLETED     385     395     386     261     123  
NOT COMPLETED     42     35     41     25     20  
No longer willing to participate                 19                 17                 14                 13                 10  
Protocol Violation                 7                 5                 8                 1                 1  
Withdrawal by Subject                 3                 4                 7                 3                 4  
Adverse Event                 6                 4                 5                 4                 0  
Withdrawal due to pregnancy                 0                 1                 1                 0                 0  
Physician Decision                 1                 1                 0                 2                 0  
Lost to Follow-up                 3                 1                 2                 1                 2  
Unspecified                 3                 2                 3                 0                 3  
Started, but not vaccinated                 0                 0                 1                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month) Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month) Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month) Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month) Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month) Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
Total Total of all reporting groups

Baseline Measures
    Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)     Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)     Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)     Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)     Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)     Total  
Number of Participants  
[units: participants]
  427     430     427     286     143     1713  
Age, Customized  
[units: participants]
           
11- less than (<) 14 years     156     158     156     106     53     629  
14 - <19 years     271     272     271     180     90     1084  
Gender  
[units: participants]
           
Female     212     225     216     139     79     871  
Male     215     205     211     147     64     842  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants   [ Time Frame: 1 month after Injection 4 ]

2.  Primary:   Percentage of Participants Reporting At Least 1 Adverse Event (AE)   [ Time Frame: Injection 1 up to 1 month after Injection 4 ]

3.  Secondary:   Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants   [ Time Frame: 1 month after Injection 4 ]

4.  Secondary:   Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)   [ Time Frame: Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4 ]

5.  Secondary:   Percentage of Participants Achieving hSBA Titer >=LLOQ   [ Time Frame: Before Injection 1, 1 Month after Injection 2, 3, 4 ]

6.  Secondary:   Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level   [ Time Frame: Before Injection 1, 1 Month after Injection 2, 3, 4 ]

7.  Other Pre-specified:   Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer   [ Time Frame: 1 month after Injection 2, 3, 4 ]


  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


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01299480     History of Changes
Other Study ID Numbers: B1971012, 6108A1-2003, 2009-014493-18
Study First Received: February 15, 2011
Results First Received: November 21, 2014
Last Updated: June 2, 2015
Health Authority: Iceland: Ministry of Health and Social Security