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)

Last updated: May 27, 2020
Sponsor: MCM Vaccines B.V.
Overall Status: Completed

Phase

3

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT02759354
V419-012
PRI03C
2016-000274-37
V419-012
  • Ages 3-5
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria

  1. 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.

  2. Informed consent signed by the participant's parent(s) or legal representative.

Exclusion

Exclusion Criteria:

  1. 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.

  2. Participant with a history of diagnosis (clinical, serological or microbiological) ofHB virus infection of the V419-007 or V419-008 study.

  3. Participant who has received any dose of pertussis-containing vaccine after completionof the V419-008 study.

  4. Participant with a history of diagnosis (clinical, serological or microbiological) ofinfection due to pertussis after completion of V419-008 study.

  5. 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*.

  6. Participant who received immunoglobulins, blood or blood-derived products within 3months prior to inclusion*.

  7. Receipt of immunosuppressive therapy or other immune-modifying drugs, such asanti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008studies.

  8. 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

Total Participants: 754
Study Start date:
April 26, 2016
Estimated Completion Date:
August 01, 2016

Connect with a study center

  • SPMSD Investigational Site 0007

    Espoo,
    Finland

    Site Not Available

  • SPMSD Investigational Site 0005

    Helsinki,
    Finland

    Site Not Available

  • SPMSD Investigational Site 0004

    Jarvenpaa,
    Finland

    Site Not Available

  • SPMSD Investigational Site 0010

    Kokkola,
    Finland

    Site Not Available

  • SPMSD Investigational Site 0008

    Oulu,
    Finland

    Site Not Available

  • SPMSD Investigational Site 0003

    Pori,
    Finland

    Site Not Available

  • SPMSD Investigational Site 0009

    Seinajoki,
    Finland

    Site Not Available

  • SPMSD Investigational Site 0001

    Tampere,
    Finland

    Site Not Available

  • SPMSD Investigational Site 0002

    Turku,
    Finland

    Site Not Available

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