Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612

Infections, Meningococcal Clinical Trial

Official title:

Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974363
• Other study ID #: 112148
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2009
• Last updated: March 21, 2016
• Start date: September 2009
• Est. completion date: May 2013

Study information

• Verified date: March 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaPhilippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial Summary

Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.

Description:

Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 697
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.

• A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.

• Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.

• History of meningococcal disease; such cases will be documented.

• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.

• Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.

• Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy

• Subjects who withdrew consent to be contacted for follow-up studies.

Study Design

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

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Procedure:
• Blood Sampling
A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study

Locations

Country	Name	City	State
India	GSK Investigational Site	Goa
India	GSK Investigational Site	Indore
India	GSK Investigational Site	New Delhi
India	GSK Investigational Site	Pune
Philippines	GSK Investigational Site	Muntinlupa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

India,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence of immunogenicity with respect to components of the investigational vaccine		24, 36, 48 and 60 months post primary dose	No
Secondary	Persistence of immunogenicity with respect to components of the investigational vaccine (on secondary readouts)		24, 36, 48 and 60 months post primary dose	No