Study to evaluate persistence of antibodies after vaccination with meningococcal vaccine GSK 134612

Persistence of antibodies after vaccination with GSK Biologicals meningococcal vaccine GSK 134612 in adolescents and young adults.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000585

Enrollment

697

Registered

2010-09-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: GSK Biologicals meningococcal vaccine 134612: Vaccine administered in the primary vaccination study Control Intervention1: Mencevax ACWY: Vaccine administered in the primary vaccination

Eligibility

Inclusion criteria

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

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 subjects first visit. Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy Subjects who withdrew consent to be contacted for follow-up studies.

Design outcomes

Primary

Measure	Time frame
Persistence of immunogenicity with respect to components of the investigational vaccineTimepoint: 24, 36, 48 and 60 months post primary dose	—

Secondary

Measure	Time frame
Persistence of immunogenicity with respect to components of the investigational vaccine (on secondary readouts)Timepoint: 24, 36, 48 and 60 months post primary dose	—

Countries

India, Philippines

Contacts

Public ContactDr Shailesh Mehta

GlaxoSmithKline

shailesh.i.mehta@gsk.com00912224959611

Outcome results