A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01461980
First received: September 28, 2011
Last updated: May 7, 2015
Last verified: May 2015
Results First Received: May 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Vaccines
Meningococcal Vaccines
Interventions: Biological: rLP2086 + MCV4 + Tdap
Biological: MCV4 + Tdap + saline
Biological: rLP2086 + saline

  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 2648 participants were enrolled in this study. Of these, 19 participants were randomized but did not receive study vaccination.

Reporting Groups
  Description
MCV4+Tdap+rLP2086 Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
MCV4+Tdap+Saline Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.

Participant Flow:   Overall Study
    MCV4+Tdap+rLP2086     MCV4+Tdap+Saline     Saline+Saline+rLP2086  
STARTED     888     878     882  
Vaccination 1     884     870     875  
Vaccination 2     802     819     799  
Vaccination 3     757     777     748  
COMPLETED     722     733     717  
NOT COMPLETED     166     145     165  
Unspecified                 9                 8                 6  
Medication error                 7                 5                 6  
Adverse Event                 12                 5                 6  
Protocol Violation                 12                 19                 16  
No longer meets eligibility criteria                 18                 9                 19  
Lost to Follow-up                 52                 53                 51  
No longer willing to participate                 52                 38                 54  
Randomized but not vaccinated                 4                 8                 7  



  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.
Intent-to-treat (ITT) population included all participants who were randomized.

Reporting Groups
  Description
MCV4+Tdap+rLP2086 Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
MCV4+Tdap+Saline Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Total Total of all reporting groups

Baseline Measures
    MCV4+Tdap+rLP2086     MCV4+Tdap+Saline     Saline+Saline+rLP2086     Total  
Number of Participants  
[units: participants]
  888     878     882     2648  
Age  
[units: Years]
Mean (Standard Deviation)
  10.6  (0.70)     10.6  (0.69)     10.6  (0.67)     10.6  (0.69)  
Gender  
[units: Participants]
       
Female     454     427     417     1298  
Male     434     451     465     1350  



  Outcome Measures
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1.  Primary:   Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens   [ Time Frame: 1 Month after Vaccination 1 ]

2.  Primary:   Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens   [ Time Frame: 1 Month after Vaccination 1 ]

3.  Primary:   Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens   [ Time Frame: 1 Month after Vaccination 1 ]

4.  Primary:   Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3   [ Time Frame: 1 Month after Vaccination 3 ]

5.  Secondary:   Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens   [ Time Frame: 1 Month after Vaccination 1 ]

6.  Secondary:   Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens   [ Time Frame: 1 Month after Vaccination 1 ]

7.  Secondary:   Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2   [ Time Frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2 ]

8.  Secondary:   Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)   [ Time Frame: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3 ]

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

10.  Other Pre-specified:   Immunogloblulin G (IgG) Measured by GMC   [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 1 ]

11.  Other Pre-specified:   Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level   [ Time Frame: 1 Month after Vaccination (Vac) 2, 3 ]

12.  Other Pre-specified:   Percentage of Participants With at Least One Adverse Event (AE)   [ Time Frame: Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months 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


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01461980     History of Changes
Other Study ID Numbers: B1971015, 6108A1-2005
Study First Received: September 28, 2011
Results First Received: May 7, 2015
Last Updated: May 7, 2015
Health Authority: United States: Food and Drug Administration