Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012)
Condition: Hepatitis B; Pertussis
MeSH terms: Hepatitis A; Hepatitis B; Whooping Cough; Hepatitis
Intervention: Blood Sample
Intervention description: Blood sample at approx. 4 years of age
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 754.0
Sex: All
Minimum age: 3 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immune response

Summary:

      This is a multicenter extension study of two European randomized, double-blind studies
      (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis
      antibody responses in healthy 4- to 5 year old children previously vaccinated with Vaxelis®
      or INFANRIX® hexa
    

Eligibility criteria:

        Inclusion Criteria

          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 participant's parent(s) or legal representative.

        Exclusion Criteria:

          1. Participant who has received any dose of hepatitis B (HB)-containing vaccine at any
             time other than study vaccine in V419-007 or V419-008 study.

          2. Participant with a history of diagnosis (clinical, serological or microbiological) of
             HB virus infection of the V419-007 or V419-008 study.

          3. Participant who has received any dose of pertussis-containing vaccine after completion
             of the V419-008 study.

          4. Participant 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. Participant 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. Participant 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.

               -  Criteria 5 and 6 are temporary exclusion criteria. If a participant meets
                  criteria 5 and/or 6 at the time of Visit 1, a further appointment is to be
                  scheduled to reassess the participant's eligibility.