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

Primary Purpose

Infections, Meningococcal

Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
Blood Sampling
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Meningococcal focused on measuring Healthy, Immunogenicity, Children, Neisseria meningitidis, Long-term antibody persistence, Safety, Serogroups A, C, W-135, and Y

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Espoo Vaccine Research Clinic
  • Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka
  • Helsinki East Vaccine Research Clinic
  • Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka
  • Tampereen yliopisto/ Oulun rokotetutkimusklinikka
  • Tampereen yliopisto/ Porin rokotetutkimusklinikka
  • Seinajoki Vaccine Research Clinic
  • Tampere Vaccine Research Clinic
  • Tampereen yliopisto/ Turun rokotetutkimusklinikka
  • Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACWY-TT group

MenCCRM group

Arm Description

Subjects primed and boosted with the MenACWY-TT vaccine.

Subjects primed and boosted with the Meningitec vaccine.

Outcomes

Primary Outcome Measures

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
Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.

Secondary Outcome Measures

Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
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.
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.

Full Information

First Posted
June 27, 2013
Last Updated
March 13, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01900899
Brief Title
Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Healthy, Immunogenicity, Children, Neisseria meningitidis, Long-term antibody persistence, Safety, Serogroups A, C, W-135, and Y

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACWY-TT group
Arm Type
Experimental
Arm Description
Subjects primed and boosted with the MenACWY-TT vaccine.
Arm Title
MenCCRM group
Arm Type
Active Comparator
Arm Description
Subjects primed and boosted with the Meningitec vaccine.
Intervention Type
Procedure
Intervention Name(s)
Blood Sampling
Intervention Description
At 2, 3, 4, 5, 6 years after booster vaccination.
Primary Outcome Measure Information:
Title
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
Description
Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame
24 months after booster Vaccination
Title
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
Description
Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame
36 months after booster Vaccination
Title
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
Description
Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame
48 months after booster Vaccination
Title
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
Description
Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame
60 months after booster Vaccination
Title
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
Description
Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame
72 months after booster Vaccination
Secondary Outcome Measure Information:
Title
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Description
Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame
24, 36, 48, 60 and 72 months after booster Vaccination
Title
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Description
Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame
24, 36, 48, 60 and 72 months after booster Vaccination
Title
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to the Month 72 after booster vaccination (up to 6 years)
Title
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Description
Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame
24, 36, 48, 60 and 72 months after booster Vaccination
Title
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Description
Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame
24, 36, 48, 60 and 72 months after booster Vaccination

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Espoo Vaccine Research Clinic
City
Espoo
ZIP/Postal Code
02230
Country
Finland
Facility Name
Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Helsinki East Vaccine Research Clinic
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka
City
Jarvenpaa
ZIP/Postal Code
60100
Country
Finland
Facility Name
Tampereen yliopisto/ Oulun rokotetutkimusklinikka
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Tampereen yliopisto/ Porin rokotetutkimusklinikka
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Seinajoki Vaccine Research Clinic
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
Tampere Vaccine Research Clinic
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Tampereen yliopisto/ Turun rokotetutkimusklinikka
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka
City
Vantaa
ZIP/Postal Code
01300
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
32284274
Citation
Vesikari T, Forsten A, Laudat F, Li P, Van Der Wielen M, Hezareh M, Perez JL, Webber C. Long-term antibody persistence after a booster dose of quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in healthy 5-year-old children. Vaccine. 2020 May 8;38(22):3902-3908. doi: 10.1016/j.vaccine.2020.02.030. Epub 2020 Apr 11.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=MENACWY-TT-102&StudyName=A+Phase+Iii%2C+Open%2C+Multi-centre%2C+Controlled+Study+To+Evaluate+The+Long-term+Antibody+Persistence+At+2%2C+3%2C+4%2C+5+And+6+Years+After+A+Booster+Dose+Of+Meningococcal+Serogroup+A%2C+C%2C+W-135%2C+Y-+Tetanus+Toxoid+Conjugate+Vaccine+%28menacwy-tt%29+Or+Meningitec+%28registried%29+Administered+In+Healthy+5-year-old+Children+In+Study+Menacwy-tt-048+Ext%3A+039+Y2%2C+3%2C+4%2C+5+%28112036%29%2C+Who+Were+Primed+With+The+Same+Vaccine+In+Study+Menacwy-tt-039+%28109670%29+At+12+Through+23+Months+Of+Age.
Description
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Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children

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