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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00126984 | Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine | PHASE2 | COMPLETED | 508 | — | — | Jul 1, 2005 | Feb 1, 2008 | Oct 7, 2016 | 42 | Austria, Germany |
| NCT00196976 | Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old | PHASE2 | COMPLETED | 461 | — | — | Mar 24, 2005 | Mar 3, 2006 | Jun 8, 2018 | 17 | Austria, Greece |
A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers \< 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Subjects of 12-14 months of age or 3-5 years of age who will receive formulation A |
| Group B | EXPERIMENTAL | Subjects of 12-14 months of age or 3-5 years of age who will receive formulation B |
| Group C | EXPERIMENTAL | Subjects of 12-14 months of age or 3-5 years of age who will receive formulation C |
| Group D | EXPERIMENTAL | Subjects of 12-14 months of age or 3-5 years of age who will receive formulation D |
| Group E | ACTIVE_COMPARATOR | Subjects of 12-14 months of age who will receive Meningitec and subjects of 3-5 years of age who will receive Mencevax ACWY. |
| GSK134612A Form1 (T), Primary Group | EXPERIMENTAL | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. |
| GSK134612A Form2 (T), Primary Group | EXPERIMENTAL | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. |
| GSK134612A Form3 (T), Primary Group | EXPERIMENTAL | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. |
| GSK134612A Form4 (T), Primary Group | EXPERIMENTAL | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. |
| Control (T), Primary Group | ACTIVE_COMPARATOR | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. |
| GSK134612A Form1 (C), Primary Group | EXPERIMENTAL | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). |
| GSK134612A Form2 (C), Primary Group | EXPERIMENTAL | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). |
| GSK134612A Form3 (C), Primary Group | EXPERIMENTAL | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). |
| GSK134612A Form4 (C), Primary Group | EXPERIMENTAL | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). |
| Control (C), Primary Group | ACTIVE_COMPARATOR | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533). |
| GSK134612A Form1 (T), Booster Group | EXPERIMENTAL | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534). |
| Control (T), Booster Group | ACTIVE_COMPARATOR | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534). |
| GSK134612A Form1 (C), Booster Group | EXPERIMENTAL | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination. |
| Control (C), Booster Group | ACTIVE_COMPARATOR | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination. |
| Name | Type | Description |
|---|---|---|
| Conjugated meningococcal ACWY-TT (vaccine) | BIOLOGICAL | One intramuscular dose during the primary vaccination |
| DTPa/Hib containing vaccine | BIOLOGICAL | One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age |
| Meningitec | BIOLOGICAL | One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age |
| Mencevax ACWY | BIOLOGICAL | One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E) |
| DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) | BIOLOGICAL | One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only |
| DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) | BIOLOGICAL | One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only |
| Meningitec™ | BIOLOGICAL | One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age |
| Mencevax™ACWY | BIOLOGICAL | One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E) |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol * A male or female between, and including, 12 and 14 months or 3 and 5 years of age at the time of the first vaccination * Written informed consent obt...