Vaxelis is indicated for primary and booster vaccination in infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B (HB), poliomyelitis and invasive diseases caused by Haemophilus influenzae type B (Hib). MedDRA version: 19.0 Level: LLT Classification code 10054187 Term: Polio immunization System Organ Class: 100000004865 MedDRA version: 19.0 Level: LLT Classification code 10069543 Term: Hemophilus influenzae type b immunization System Organ Class: 100000004865 MedDRA version
Conditions
Interventions
Trade Name: Vaxelis suspension for injection in pre-filled syringe
Product Name: Vaxelis
Product Code: V419-358
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Diphtheria Toxoid
Oth
Sponsors
MCM Vaccine B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: An individual must fulfill all of the following criteria in order to be eligible for study enrolment: 1. Healthy child of either gender, who has received a complete 3-dose primary series or a complete 2 dose primary series followed by a toddler dose with VAXELIS® or INFANRIX® hexa as part of the V419-007 or V419-008 study respectively; 2. Informed consent signed by the subject's parent(s) or legal representative. Are the trial subjects under 18? yes Number of subjects for this age range: 760 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting at least one of the following criteria will be ineligible for study enrolment: 1. Subject who has received any dose of HB containing vaccine at any time other than study vaccine in V419-007 or V419-008 study; 2. Subject with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study; 3. Subject who has received any dose of pertussis containing vaccine after completion of the V419-008 study; 4. Subject with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study; 5. Participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure*; 6. Subject who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion*; 7. Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008 studies; 8. Subject with suspected or known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopietic and lymphatic systems since completion of V419-007 or V419-008 studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To describe the percentage of subjects with anti-HBs concentration = 10 mIU/mL approximately 4 years after completion of a 3+1 schedule - To describe the percentage of subjects with anti-HBs concentration = 10 mIU/mL approximately 4 years after completion of a 2+1 schedule - To describe the percentage of subjects with anti-PT (Pertussis Toxin), anti FHA (Filamentous Hemagglutinin), anti-PRN (Pertactin) and anti-FIM (Fimbriae 2&3) concentration = LLOQ*, = 2 × LLOQ*, and = 4 × LLOQ*, 3 to 4 years after completion of a 2+1 schedule. * Lower Limit of Quantification (LLOQ) = 4 EU/mL for PT, PRN, FIM; LLOQ = 3 EU/mL for FHA;Secondary Objective: - To describe the anti-HBs levels in terms of geometric mean concentration (GMC) approximately 4 years after completion of a 3+1 schedule. - To describe the anti-HBs levels in terms of geometric mean concentration (GMC) approximately 4 years after completion of a 2+1 schedule - To describe the pertussis antibody levels in terms of GMC at 3 to 4 years after completion of a 2+1 schedule.;Primary end point(s): - The percentage of subjects with anti-HBs concentration = 10 mIU/mL - The percentages of subjects with anti-PT, anti-FHA, anti-PRN and anti FIM concentration = LLOQ*, = 2× LLOQ*, and = 4 × LLOQ* * Lower Limit of Quantification (LLOQ) = 4 EU/mL for PT, PRN, FIM; LLOQ = 3 EU/mL for FHA ;Timepoint(s) of evaluation of this end point: Approximately 4 years after completion of a primary series and toodler dose schedule with VAXELIS® or INFANRIX® hexa | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Anti-HBs GMC - Anti-PT, anti-FHA, anti-PRN, and anti-FIM GMCs;Timepoint(s) of evaluation of this end point: Approximately 4 years after completion of a primary series and toddler dose schedule with VAXELIS® or INFANRIX® hexa | — |
Countries
Finland
Contacts
Public ContactProject Manager
TFS Clinical Operations
Outcome results
None listed