Persistence of antibodies after vaccination with GSK Biologicals’ menin-gococcal vaccine GSK 134612 in adolescents and young adults
- Conditions
- Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and/or YMedDRA version: 18.0Level: LLTClassification code 10028911Term: Neisseria meningitidis infection NOSSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10070124Term: Neisseria meningitidis test positiveSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2012-005641-21-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 689
• Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol
• A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069 (MENACWY-TT-036)
• Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed as-sent 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 689
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 259
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject’s first visit
• History of meningococcal disease
• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069 (MENACWY-TT-036)
• Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history
• Administration of immunoglobulines 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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: At 24, 36, 48, and 60 months after primary vaccination of adolescents with MenACWY-TT or Mencevax™ ACWY vaccine, to evaluate the persistence of meningococcal antibodies in terms of percentage of subjects with rSBA titres = 8 for each of the four serogroups<br>;Secondary Objective: • At 24, 36, 48 and 60 months after primary vaccination of adolescents with MenACWY-TT or Mencevax™ ACWY vaccine, to evaluate the persistence of meningococcal A, C, W-135 and Y antibodies in terms of rSBA titres for each of the four serogroups<br>• At 24 months after primary vaccination of adolescents with MenACWY-TT or Mencevax™ ACWY vaccine, to evaluate the persistence of meningococcal A, C, W-135 and Y antibodies in terms of anti-polysaccharide (PS) concentrations, for each of the four serogroups;Primary end point(s): Meningococcal rSBA titres = 1:8;Timepoint(s) of evaluation of this end point: 24, 36, 48 and 60 months post primary dose
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Meningococcal rSBA titres <br>• Anti-meningococcal polysaccharide antibody concentrations;Timepoint(s) of evaluation of this end point: • 24, 36, 48 and 60 months post primary dose<br>• 24 months post primary dose