Nimenrix (Meningococcal vaccine 134612)
BiologicalSingle dose intramuscular injection
NCT Number: NCT00465816
This study will demonstrate the non-inferiority of GSK Biologicals' meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years. There will be 3 groups in this study.
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Notify Me11 year–17 year
All sexes
Interventional
Phase 3
GSK Investigational Site, Aarhus N, Denmark
All subjects of groups A and B will have 4 blood samples taken, all subjects of group C will have 3 blood samples taken.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose intramuscular injection
3-dose intramuscular injection. Twinrix Adult will be administered to subjects aged 16 years and above and Twinrix Junior will be administered to subjects aged from 11 years up to and including 15 years of age.
Time frame: At 1 month after vaccination with Nimenrix vaccine (Month 1)
The rSBA titers were expressed as geometric mean titers (GMTs).
Time frame: At 1 month after the third dose of Twinrix vaccine (Month 7)
A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
Time frame: At 1 month after the third dose of Twinrix vaccine (Month 7)
A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
Time frame: At 1 month after vaccination with Nimenrix vaccine (Month 1)
Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titre greater than or equal to 1:8].
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).
Time frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)
The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
The rSBA titers were expressed as geometric mean titers.
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Time frame: At 7 months after vaccination with Nimenrix (At Month 7)
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Time frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)
The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).
Time frame: During a 4-day period (Days 0-3) after Nimenrix vaccination
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During a 4-day period (Days 0-3) after each Twinrix vaccination, and across doses
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During a 4-day period (Days 0-3) after each vaccine dose and across doses
Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group.
Time frame: Up to 1 month after each vaccine dose
Unsolicited AE covers any AE 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.
Time frame: During the entire study (up to Month 7)
Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.
Time frame: During the entire study (up to Month 7)
Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: During the entire study (up to Month 7)
Time frame: During the entire study (up to Month 7)
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.
GlaxoSmithKline
Industry
Non-inferiority of GSK Biologicals' Meningococcal Vaccine 134612 Given Concomitantly With GSK Biologicals' Twinrix™ Versus 134612 Alone and Twinrix™ Alone in Healthy Subjects Aged 11 Through 17 Years.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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