Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01266993 | Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children | PHASE3 | COMPLETED | 271 | — | — | Jan 3, 2011 | May 17, 2014 | Nov 23, 2020 | 24 | France, Germany |
| NCT01144663 | Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines | PHASE3 | COMPLETED | 2,095 | — | — | Jul 1, 2010 | Sep 10, 2013 | Dec 31, 2020 | 44 | Estonia, Germany +1 |
| NCT00514904 | Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects | PHASE3 | COMPLETED | 1,504 | — | — | Sep 18, 2007 | Jan 6, 2009 | Oct 27, 2020 | 7 | India, Lebanon +2 |
| NCT00465816 | Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612 | PHASE3 | COMPLETED | 611 | — | — | Apr 11, 2007 | Apr 28, 2008 | Jun 8, 2018 | 6 | Denmark, Sweden |
| NCT00715910 | The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Adolescents/Adults | PHASE2 | COMPLETED | 818 | — | — | Jul 1, 2008 | Oct 1, 2013 | Nov 27, 2014 | 10 | United States |
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
The pre-defined cut-off value of the assay for the rSBA titers was greater than or equal to (≥) 1:8. These analyses have been performed by the Health Protection Agency (HPA) laboratory.
The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.
The cut-off value for rSBA-MenC titers was ≥ 1:8.
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).
Grade 3 symptom was defined as symptom that prevented normal, everyday activities.
The rSBA titers were expressed as geometric mean titers (GMTs).
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.
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).
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
| Arm | Type | Description |
|---|---|---|
| Nimenrix Group | EXPERIMENTAL | Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Nimenrix vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Nimenrix vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Menjugate Group | EXPERIMENTAL | Healthy male or female subjects aged 2 through 10 years old, who were primed with one dose of Menjugate vaccine during the primary 111414 study (NCT00674583), additionally received one booster dose of Menjugate vaccine in the current study, at Month 68, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Nimenrix 3 Group | EXPERIMENTAL | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age. |
| Nimenrix 2 Group | EXPERIMENTAL | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age. |
| NeisVac-C Group | ACTIVE_COMPARATOR | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age. |
| Mencevax ACWY Group | ACTIVE_COMPARATOR | Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. |
| Nimenrix + Twinrix Group | EXPERIMENTAL | Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6. |
| Twinrix Group | ACTIVE_COMPARATOR | Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6. |
| Nimenrix 1 Group | EXPERIMENTAL | Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination |
| Menactra Group | ACTIVE_COMPARATOR | Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination |
| Nimenrix Naive Group | EXPERIMENTAL | Subjects 15 to \<31 years of age at the time of primary vaccination with 1 dose of Nimenrix vaccine at year 5 of the current study |
| Nimenrix Pooled Group | EXPERIMENTAL | Pooled group of subjects 10-25 years of age from Nimenrix 1 and Nimenrix 2 groups in the primary study (NCT00454909) who had received 1 dose of Nimenrix vaccine in that study and will receive a booster dose in this current study. |
| Menactra Booster Group | ACTIVE_COMPARATOR | Subjects 11-25 years of age who had received 1 dose of Menactra vaccine in primary study (NCT00454909) and will receive 1 dose of Nimenrix vaccine in this current study. |
| Name | Type | Description |
|---|---|---|
| Nimenrix (GSK134612 vaccine) | BIOLOGICAL | Intramuscular, 1 dose |
| Menjugate | BIOLOGICAL | Intramuscular, 1 dose |
| Nimenrix™ | BIOLOGICAL | 4- or 3-dose intramuscular injection |
| Menjugate® | BIOLOGICAL | 3-dose intramuscular injection |
| NeisVac-CTM | BIOLOGICAL | 3-dose intramuscular injection |
| Infanrix™ hexa | BIOLOGICAL | 4-dose intramuscular injection |
| Synflorix™ | BIOLOGICAL | 4-dose intramuscular injection |
| Nimenrix | BIOLOGICAL | Single dose, intramuscular injection |
| Mencevax | BIOLOGICAL | Single dose, subcutaneous injection |
| Nimenrix (Meningococcal vaccine 134612) | BIOLOGICAL | Single dose intramuscular injection |
| Twinrix | BIOLOGICAL | 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. |
| Blood sampling | PROCEDURE | Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61). |
Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female who was primed with MenACWY-TT or Menjugate in the primary vaccination...