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

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.

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.

Study Overview

• Status: Completed
• Conditions: Infections, Meningococcal
• Intervention / Treatment: Procedure: Blood Sampling

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 Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland, 02230
    • Espoo Vaccine Research Clinic
  • Helsinki, Finland, 00930
    • Helsinki East Vaccine Research Clinic
  • Helsinki, Finland, 00100
    • Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka
  • Jarvenpaa, Finland, 60100
    • Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka
  • Oulu, Finland, 90220
    • Tampereen yliopisto/ Oulun rokotetutkimusklinikka
  • Pori, Finland, 28100
    • Tampereen yliopisto/ Porin rokotetutkimusklinikka
  • Seinajoki, Finland, 60100
    • Seinäjoki Vaccine Research Clinic
  • Tampere, Finland, 33100
    • Tampere Vaccine Research Clinic
  • Turku, Finland, 20520
    • Tampereen yliopisto/ Turun rokotetutkimusklinikka
  • Vantaa, Finland, 01300
    • Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months after booster Vaccination
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.	36 months after booster Vaccination
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.	48 months after booster Vaccination
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.	60 months after booster Vaccination
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.	72 months after booster Vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24, 36, 48, 60 and 72 months after booster Vaccination
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups	Serogroups included MenA, MenC, MenW-135 and MenY.	24, 36, 48, 60 and 72 months after booster Vaccination
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.	Baseline up to the Month 72 after booster vaccination (up to 6 years)
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.	24, 36, 48, 60 and 72 months after booster Vaccination
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups	Serogroups included MenA, MenC, MenW-135 and MenY.	24, 36, 48, 60 and 72 months after booster Vaccination

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Children; Healthy; Immunogenicity; Neisseria meningitidis; Serogroups A, C, W-135, and Y; Long-term antibody persistence
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: MENACWY-TT-102; C0921001 (Other Identifier: Alias Study Number); 2012-005816-25 (EudraCT Number); 200088 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No