Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Haemophilus influenzae type b- and meningococcal (vaccine), Haemophilus influenzae type b- and meningococcal serogroup C, Haemophilus influenzae type b and meningococcal serogroup C
Haemophilus influenzae type b- and meningococcal · 6 trials · 2 indications
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
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 |
|---|---|---|
| Meningitec + Hiberix Group | ACTIVE_COMPARATOR | Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| Menitorix Group | EXPERIMENTAL | Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. |
| 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. |
| Group Hib-MenC | EXPERIMENTAL | Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of Hib-MenC + Infanrix™ penta vaccines. |
| Group NeisVac-C | ACTIVE_COMPARATOR | Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines. |
| Name | Type | Description |
|---|---|---|
| Haemophilus influenzae type b and meningococcal serogroup C (vaccine) | BIOLOGICAL | One intramuscular dose at 12-18 months of age |
| Priorix™ | BIOLOGICAL | One subcutaneous dose at 12-18 months of age |
| Hiberix™ | BIOLOGICAL | One intramuscular dose at 12-18 months of age. |
| Meningitec™ | BIOLOGICAL | One intramuscular dose at 12-18 months of age |
| 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 |
| Haemophilus influenzae type b- and meningococcal serogroup C (vaccine) | BIOLOGICAL | Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age. |
| Infanrix Penta | BIOLOGICAL | Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age. |
| Infanrix hexa | BIOLOGICAL | Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age |
| Neis-Vac-C | BIOLOGICAL | Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age |
Inclusion Criteria: Primary phase: * Subjects whom 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 18 months of age at the time of vaccination. * Written informed consent obtained fr...