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)

MCM Vaccines

Status and phase: Completed; Phase 3

Conditions: Pertussis; Hepatitis B

Treatments: Other: Blood Sample

Study type: Interventional

Funder types: Industry

Identifiers

NCT02759354

2016-000274-37 (Other Identifier)

V419-012 (Other Identifier)

PRI03C (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 754 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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754 participants in 4 patient groups

Group Vaxelis (3+1)

Experimental group

Description:

Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007).

Treatment:

Other: Blood Sample

Group Infanrix hexa (3+1)

Active Comparator group

Description:

Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007).

Treatment:

Other: Blood Sample

Group Vaxelis (2+1)

Experimental group

Description:

Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008).

Treatment:

Other: Blood Sample

Group Infanrix hexa (2+1)

Active Comparator group

Description:

Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008).

Treatment:

Other: Blood Sample