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

Infections, Meningococcal Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900899
• Other study ID #: MENACWY-TT-102
• Secondary ID: C09210012012-005
• Status: Completed
• Phase: Phase 3
• Start date: July 2013
• Est. completion date: November 2017

Study information

• Verified date: March 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Procedure:
• Blood Sampling
At 2, 3, 4, 5, 6 years after booster vaccination.

Locations

Country	Name	City	State
Finland	Espoo Vaccine Research Clinic	Espoo
Finland	Helsinki East Vaccine Research Clinic	Helsinki
Finland	Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka	Helsinki
Finland	Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka	Jarvenpaa
Finland	Tampereen yliopisto/ Oulun rokotetutkimusklinikka	Oulu
Finland	Tampereen yliopisto/ Porin rokotetutkimusklinikka	Pori
Finland	Seinajoki Vaccine Research Clinic	Seinajoki
Finland	Tampere Vaccine Research Clinic	Tampere
Finland	Tampereen yliopisto/ Turun rokotetutkimusklinikka	Turku
Finland	Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka	Vantaa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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

External Links

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