Infections, Meningococcal Clinical Trial
Official title:
Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age
Verified date | September 2020 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Status | Completed |
Enrollment | 1504 |
Est. completion date | January 6, 2009 |
Est. primary completion date | September 3, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 10 Years |
Eligibility | Inclusion Criteria: - Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol. - A male or female between, and including, 2 and 10 years of age at the time of vaccination. - Written informed consent obtained from the parent or guardian of the subject. - Free of obvious health problems as established by medical history and clinical examination before entering into the study. - Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge. Exclusion Criteria: - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. - Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine. - Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above). - Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y. - Previous vaccination with tetanus toxoid within the last month. - History of meningococcal disease. - Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.. - History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s). - Major congenital defects or serious chronic illness. - Acute disease at the time of enrolment. - Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. |
Country | Name | City | State |
---|---|---|---|
India | GSK Investigational Site | Goa | |
India | GSK Investigational Site | Indore | |
India | GSK Investigational Site | New Delhi | |
India | GSK Investigational Site | Vellore | |
Lebanon | GSK Investigational Site | Beirut | |
Philippines | GSK Investigational Site | Sampaloc, Manila | |
Saudi Arabia | GSK Investigational Site | Riyadh |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
India, Lebanon, Philippines, Saudi Arabia,
Memish ZA, Dbaibo G, Montellano M, Verghese VP, Jain H, Dubey AP, Bianco V, Van der Wielen M, Gatchalian S, Miller JM. Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile. Pediatr Infect Dis J. 2011 Apr;30(4):e56-62. doi: 10.1097/INF.0b013e31820e6e02. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (= 1:8). | One month after vaccination (Post-vaccination, study Month 1) | |
Primary | Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | Grade 3 symptom was defined as symptom that prevented normal, everyday activities. | During the 4-day (Days 0-3) post-vaccination period | |
Secondary | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (=) to the Cut-off Values | The cut-off values for the rSBA titers were = 1:8 and = 1:128 respectively. | Pre vaccination (Month 0) and post vaccination (Month 1) | |
Secondary | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Antibody titers were expressed as geometric mean titers (GMTs). | Pre vaccination (Month 0) and post vaccination (Month 1) | |
Secondary | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (=) the Cut-off Values | The cut-off values for anti-TT concentrations were = 0.1 international units per milliliter (IU/mL) and = 1.0 IU/mL respectively. | Pre vaccination (Month 0) and post vaccination (Month 1) | |
Secondary | Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Antibody concentrations were expressed as geometric mean concentrations (GMCs) | Pre vaccination (Month 0) and post vaccination (Month 1) | |
Secondary | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (=) the Cut-off Values | The cut-off values for anti-PS concentrations were = 0.3 microgram per milliliter (µg/mL) and = 2.0 µg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. | Pre vaccination (Month 0) and post vaccination, (Month 1) | |
Secondary | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in µg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. | Pre vaccination (Month 0) and post vaccination (Month 1) | |
Secondary | Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. | During the 4-day (Days 0-3) follow-up period after vaccination | |
Secondary | Number of Subjects = 6 Years of Age With Solicited Local Symptoms | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. | During the 4-day (Days 0-3) follow-up period after vaccination | |
Secondary | Number of Subjects < 6 Years of Age With Solicited General Symptoms | Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature = 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination. | During the 4-day (Days 0-3) follow-up period after vaccination | |
Secondary | Number of Subjects = 6 Years of Age With Solicited General Symptoms | Solicited general symptoms assessed were fatigue, fever (measured orally and temperature = 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination. | During the 4-day (Days 0-3) follow-up period after vaccination | |
Secondary | Number of Subjects Reporting Specific Adverse Events (AEs) | Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits. | From Day 0 up to 6 months after vaccination | |
Secondary | Number of Subjects Reporting Any Unsolicited Symptoms | Unsolicited symptom covers any symptom reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Up to one month (Day 0-Day 30) after vaccination | |
Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject. | From Day 0 up to 6 months after vaccination |
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