NCT01900899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2013

Typical duration for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 17, 2019

Completed
Last Updated

June 17, 2019

Status Verified

March 1, 2019

Enrollment Period

4.3 years

First QC Date

June 27, 2013

Results QC Date

April 30, 2018

Last Update Submit

March 13, 2019

Conditions

Infections, Meningococcal

Keywords

HealthyImmunogenicityChildrenNeisseria meningitidisLong-term antibody persistenceSafetySerogroups A, C, W-135, and Y

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups

    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

    24, 36, 48, 60 and 72 months after booster Vaccination

  • Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)

    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

    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

    24, 36, 48, 60 and 72 months after booster Vaccination

Study Arms (2)

ACWY-TT group

EXPERIMENTAL

Subjects primed and boosted with the MenACWY-TT vaccine.

Procedure: Blood Sampling

MenCCRM group

ACTIVE COMPARATOR

Subjects primed and boosted with the Meningitec vaccine.

Procedure: Blood Sampling

Interventions

Blood SamplingPROCEDURE

At 2, 3, 4, 5, 6 years after booster vaccination.

ACWY-TT groupMenCCRM group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Espoo Vaccine Research Clinic

Espoo, 02230, Finland

Location

Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka

Helsinki, 00100, Finland

Location

Helsinki East Vaccine Research Clinic

Helsinki, 00930, Finland

Location

Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka

Jarvenpaa, 60100, Finland

Location

Tampereen yliopisto/ Oulun rokotetutkimusklinikka

Oulu, 90220, Finland

Location

Tampereen yliopisto/ Porin rokotetutkimusklinikka

Pori, 28100, Finland

Location

Seinajoki Vaccine Research Clinic

Seinäjoki, 60100, Finland

Location

Tampere Vaccine Research Clinic

Tampere, 33100, Finland

Location

Tampereen yliopisto/ Turun rokotetutkimusklinikka

Turku, 20520, Finland

Location

Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka

Vantaa, 01300, Finland

Location

Related Publications (1)

  • 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.

    PMID: 32284274DERIVED

Related Links

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2013

First Posted

July 17, 2013

Study Start

July 1, 2013

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

June 17, 2019

Results First Posted

June 17, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

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.

More information

Locations

FI(10)