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.

Pfizer10 sites in 1 country184 target enrollmentJuly 2013

ConditionsInfections, Meningococcal

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infections, Meningococcal
Sponsor: Pfizer
Enrollment: 184
Locations: 10
Primary Endpoint: Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

November 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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