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Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01900899
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of this study is to evaluate the long-term antibody persistence as well as safety of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039 (NCT00474266) at 12 through 23 months of age.

Condition or disease Intervention/treatment Phase
Infections, Meningococcal Procedure: Blood Sampling Phase 3

Detailed Description:
The subjects in this study will be allocated to the same groups as in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682). No vaccine will be administered during this long-term persistence study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A PHASE III, OPEN, MULTI-CENTRE, CONTROLLED STUDY TO EVALUATE THE LONG-TERM ANTIBODY PERSISTENCE AT 2, 3, 4, 5 AND 6 YEARS AFTER A BOOSTER DOSE OF MENINGOCOCCAL SEROGROUP A, C, W-135, Y- TETANUS TOXOID CONJUGATE VACCINE (MENACWY-TT) OR MENINGITEC (REGISTERED) ADMINISTERED IN HEALTHY 5-YEAR-OLD CHILDREN IN STUDY MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), WHO WERE PRIMED WITH THE SAME VACCINE IN STUDY MENACWY-TT-039 (109670) AT 12 THROUGH 23 MONTHS OF AGE.
Actual Study Start Date : July 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: ACWY-TT group
Subjects primed and boosted with the MenACWY-TT vaccine.
 Procedure: Blood Sampling
At 2, 3, 4, 5, 6 years after booster vaccination.
Active Comparator: MenCCRM group
Subjects primed and boosted with the Meningitec vaccine.
 Procedure: Blood Sampling
At 2, 3, 4, 5, 6 years after booster vaccination.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination [ Time Frame: 24 months after booster Vaccination ]
    Serogroups included MenA, MenC, MenW-135 and MenY.

  2. Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination [ Time Frame: 36 months after booster Vaccination ]
    Serogroups included MenA, MenC, MenW-135 and MenY.

  3. Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination [ Time Frame: 48 months after booster Vaccination ]
    Serogroups included MenA, MenC, MenW-135 and MenY.

  4. Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination [ Time Frame: 60 months after booster Vaccination ]
    Serogroups included MenA, MenC, MenW-135 and MenY.

  5. Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination [ Time Frame: 72 months after booster Vaccination ]
    Serogroups included MenA, MenC, MenW-135 and MenY.


Secondary Outcome Measures :
  1. Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups [ Time Frame: 24, 36, 48, 60 and 72 months after booster Vaccination ]
    Serogroups included MenA, MenC, MenW-135 and MenY.

  2. Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups [ Time Frame: 24, 36, 48, 60 and 72 months after booster Vaccination ]
    Serogroups included MenA, MenC, MenW-135 and MenY.

  3. Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) [ Time Frame: Baseline up to the Month 72 after booster vaccination (up to 6 years) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.

  4. Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups [ Time Frame: 24, 36, 48, 60 and 72 months after booster Vaccination ]
    Serogroups included MenA, MenC, MenW-135 and MenY.

  5. Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups [ Time Frame: 24, 36, 48, 60 and 72 months after booster Vaccination ]
    Serogroups included MenA, MenC, MenW-135 and MenY.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

  • Child in care.
  • History of meningococcal disease.
  • Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900899


Locations
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Finland
Espoo Vaccine Research Clinic
Espoo, Finland, 02230
Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka
Helsinki, Finland, 00100
Helsinki East Vaccine Research Clinic
Helsinki, Finland, 00930
Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka
Jarvenpaa, Finland, 60100
Tampereen yliopisto/ Oulun rokotetutkimusklinikka
Oulu, Finland, 90220
Tampereen yliopisto/ Porin rokotetutkimusklinikka
Pori, Finland, 28100
Seinajoki Vaccine Research Clinic
Seinajoki, Finland, 60100
Tampere Vaccine Research Clinic
Tampere, Finland, 33100
Tampereen yliopisto/ Turun rokotetutkimusklinikka
Turku, Finland, 20520
Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka
Vantaa, Finland, 01300
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] January 4, 2016
Statistical Analysis Plan  [PDF] February 15, 2016

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01900899    
Other Study ID Numbers: MENACWY-TT-102
C0921001 ( Other Identifier: Alias Study Number )
2012-005816-25 ( EudraCT Number )
200088 ( Other Identifier: Alias Study Number )
First Posted: July 17, 2013    Key Record Dates
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Healthy
Immunogenicity
Children
Neisseria meningitidis
 Long-term antibody persistence
Safety
Serogroups A, C, W-135, and Y
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections