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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00322335 | Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC | PHASE3 | COMPLETED | 230 | — | — | May 1, 2006 | Sep 1, 2010 | Oct 20, 2016 | 12 | Spain |
The cut-off value for the rSBA-MenC titers was equal to or above 1:8. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
The cut-off value for the rSBA-MenC titers was equal to or above 1:32. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
The cut-off value for the rSBA-MenC titers was equal to or above 1:128. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Titers are expressed as Geometric Mean Titers (GMTs). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).
The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).
Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).
The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Concentrations for anti-PSC antibody were expressed as GMCs.
Serious adverse events 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.
| Arm | Type | Description |
|---|---|---|
| Menitorix/Pediarix Group | EXPERIMENTAL | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
| Infanrix hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | ACTIVE_COMPARATOR | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
| Infanrix hexa/Meningitec Group | ACTIVE_COMPARATOR | Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study. |
| Name | Type | Description |
|---|---|---|
| Haemophilus influenzae type b- and meningococcal (vaccine) | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo). |
| Infanrix™ penta | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age |
| Infanrix™ hexa | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM). |
| Engerix-B | BIOLOGICAL | Intramuscular injection into the thigh as a birth dose |
| NeisVac-C™ | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age. |
| Infanrix™ IPV/HIB | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 4 months of age |
| Meningitec™ | BIOLOGICAL | Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age |
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 in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who e...