Clinical trial NCT02759354: 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)
Official title: Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year-Old Children Previously Vaccinated With a 2-Dose or 3-Dose Infants Series and Toddler Dose With Vaxelis® or INFANRIX® Hexa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Pertussis
Keywords: Immune response
Lead sponsor: MCM Vaccines B.V.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
name: Sanofi Pasteur, a Sanofi Company
First posted: 2016-05-03
Enrollment: 754
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)
timeFrame: Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)
measure: Percentage of Participants Responding to Pertussis Toxin
timeFrame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
measure: Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
timeFrame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
measure: Percentage of Participants Responding to Pertussis Pertactin
timeFrame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
measure: Percentage of Participants Responding to Pertussis Fimbriae
timeFrame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Secondary outcomes:
measure: Geometric Mean Concentration of Antibodies to HBsAg
timeFrame: Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)
measure: Geometric Mean Concentration of Antibodies to Pertussis Toxin
timeFrame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
measure: Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
timeFrame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
measure: Geometric Mean Concentration of Antibodies to Pertussis Pertactin
timeFrame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
measure: Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
timeFrame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Other outcomes:
measure: Percentage of Participants With One or More Serious Adverse Events Related to Study Procedure
timeFrame: Up to 4 days following blood sample on Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Vesikari T, Xu J, Johnson DR, Hall J, Marcek T, Goveia MG, Acosta CJ, Lee AW. Hepatitis B and pertussis antibodies in 4- to 5-year-old children previously vaccinated with different hexavalent vaccines. Hum Vaccin Immunother. 2020 Apr 2;16(4):867-874. doi: 10.1080/21645515.2019.1673119. Epub 2019 Nov 5.