Study in Adolescents/Adults to Evaluate the Persistence up to 3.5 Yrs of GSK Biologicals Meningococcal Vaccine 134612

Infections, Meningococcal Clinical Trial

Official title:

Assess Long Term Persistence of a Primary Dose of GSK Biologicals' Meningococcal Vaccine 134612 Versus One Dose of Mencevax™ ACWY in Healthy Adolescents/Young Adults (15 to 19 Years at Vaccination)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390143
• Other study ID #: 108595 Mth18
• Secondary ID: 108596108598
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2006
• Last updated: October 21, 2016
• Start date: February 2007
• Est. completion date: May 2009

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This study will investigate the long-term protection offered by GSK Biologicals' meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at 15 to 19 years of age. This extension phase starts 18 months after vaccination and part of the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled. This protocol posting deals with objectives & outcome measures of the extension phase 18, 30 and 42 months after vaccination. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Description:

Subjects were previously vaccinated at 15 to 19 years of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™ ACWY. This extension phase starts 18 months after vaccination and part of the subjects will be enrolled in this extension phase. No additional vaccines will be administered during this study and no new subjects will be enrolled. The subjects will have three blood samples taken: at 18, 30 and 42 months after vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.

• A male or female, who was primed with meningococcal vaccine 134612 or Mencevax™ ACWY in the primary vaccination study 18 months before the first persistence assessment and who completed that study.

• Written informed consent obtained from the subject/ from the parent or guardians of the subject.

• Written informed assent obtained from the subject, as applicable, at the time of study entry.

Exclusion Criteria:

• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• Meningococcal vaccine 134612
One intramuscular dose during the primary study
• Mencevax™ ACWY
One subcutaneous dose during the primary study

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Østergaard L, Van der Wielen M, Bianco V, Miller JM. Persistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT). Int J Infect Dis. 2013 Mar;17(3):e173-6. doi: 10.1016/j.ijid.2012.10.001. Epub 2012 Dec 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meningococcal rSBA titres.		At the start of this persistence study and 12 and 24 months later.	No
Primary	Anti-meningococcal polysaccharide concentrations		At the start of this persistence study and 12 and 24 months later.	No
Primary	Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation.		From the last study contact of the primary vaccination study to the end of this persistence study.	No

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.