Phase 3
N=754
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)
Hepatitis B · Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT02759354 ↗Enrolled (actual)
754
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg) — 70.16; 82.01; 65.75; 83.68 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Blood Sample (Other)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- MCM Vaccines B.V.
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg) |
70.16; 82.01; 65.75; 83.68 | — |
| PRIMARY Percentage of Participants Responding to Pertussis Toxin |
58.43; 41.49; 40.45; 21.81; 14.61; 3.72 | — |
| PRIMARY Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin |
80.92; 88.30; 46.82; 70.74; 26.01; 45.21 | — |
| PRIMARY Percentage of Participants Responding to Pertussis Pertactin |
66.11; 72.63; 43.89; 51.05; 15.56; 18.42 | — |
| PRIMARY Percentage of Participants Responding to Pertussis Fimbriae |
94.35; 3.28; 88.14; 2.19; 69.49; 1.09 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to HBsAg |
24.43; 51.30; 19.44; 71.00 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to Pertussis Toxin |
5.31; 3.64 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin |
6.62; 11.05 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to Pertussis Pertactin |
5.94; 7.19 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to Pertussis Fimbriae |
25.99; 2.13 | — |
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
- 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.
- Informed consent signed by the participant's parent(s) or legal representative.
Exclusion Criteria
- 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.
- Participant with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study.
- Participant who has received any dose of pertussis-containing vaccine after completion of the V419-008 study.
- Participant with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study.
- 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*.
- Participant who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion*.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02759354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.