Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Infanrix Penta · 2 trials · 2 indications
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. |
| 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 (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 |
| 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: * 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...
Infanrix Penta is a vaccine being studied for use against Neisseria meningitidis and Haemophilus influenzae type b, two bacteria that cause serious infectious diseases. It is being developed as a combination vaccine to help prevent these infections, particularly in infants and young children.
Infanrix Penta is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's safety and effectiveness.
Infanrix Penta is currently in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 3 trials are designed to assess its immunogenicity and safety in the target population.
Infanrix Penta has been studied in two completed Phase 3 clinical trials. One trial, NCT00322335, assessed a booster dose in 230 participants in Spain. The other, NCT00327184, evaluated primary and booster vaccination in 709 infants in Finland and Italy.
Yes, Infanrix Penta is also known as Hib-MenC, referring to its components against Haemophilus influenzae type b and Neisseria meningitidis. The clinical trials listed under Infanrix Penta use the Hib-MenC name in their titles, indicating they refer to the same vaccine candidate.
Infanrix Penta targets two bacterial pathogens: Neisseria meningitidis, which can cause meningococcal disease, and Haemophilus influenzae type b, which can cause severe infections like meningitis and pneumonia. The vaccine is designed to elicit an immune response against these bacteria.