Phase
Condition
Hepatitis B
Hepatitis
Liver Disorders
Treatment
N/AClinical Study ID
Ages 3-5 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Healthy child of either gender, who has received a complete 3-dose primary series or acomplete 2 dose primary series followed by a toddler dose with VAXELIS or INFANRIXhexa as part of the V419-007 or V419-008 study respectively.
Informed consent signed by the participant's parent(s) or legal representative.
Exclusion
Exclusion Criteria:
Participant who has received any dose of hepatitis B (HB)-containing vaccine at anytime other than study vaccine in V419-007 or V419-008 study.
Participant with a history of diagnosis (clinical, serological or microbiological) ofHB virus infection of the V419-007 or V419-008 study.
Participant who has received any dose of pertussis-containing vaccine after completionof the V419-008 study.
Participant with a history of diagnosis (clinical, serological or microbiological) ofinfection due to pertussis after completion of V419-008 study.
Participation at the time of study enrolment or in the 4 weeks preceding the studyenrolment in another clinical study investigating a vaccine, drug medical device, ormedical procedure*.
Participant who received immunoglobulins, blood or blood-derived products within 3months prior to inclusion*.
Receipt of immunosuppressive therapy or other immune-modifying drugs, such asanti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008studies.
Participant with suspected or known blood dyscrasias, leukemia, lymphomas of any typeor other malignant neoplasms affecting the haematopietic and lymphatic systems sincecompletion of V419-007 or V419-008 studies.
- Criteria 5 and 6 are temporary exclusion criteria. If a participant meetscriteria 5 and/or 6 at the time of Visit 1, a further appointment is to bescheduled to reassess the participant's eligibility.
Study Design
Connect with a study center
SPMSD Investigational Site 0007
Espoo,
FinlandSite Not Available
SPMSD Investigational Site 0005
Helsinki,
FinlandSite Not Available
SPMSD Investigational Site 0004
Jarvenpaa,
FinlandSite Not Available
SPMSD Investigational Site 0010
Kokkola,
FinlandSite Not Available
SPMSD Investigational Site 0008
Oulu,
FinlandSite Not Available
SPMSD Investigational Site 0003
Pori,
FinlandSite Not Available
SPMSD Investigational Site 0009
Seinajoki,
FinlandSite Not Available
SPMSD Investigational Site 0001
Tampere,
FinlandSite Not Available
SPMSD Investigational Site 0002
Turku,
FinlandSite Not Available
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