At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 754 enrolled
Drug / intervention
Blood Sampleother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Blood Sample for Hepatitis B and Pertussis. Completed, enrolled 754 participants.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Pertussis
Countries--
CollaboratorsMerck Sharp & Dohme LLC, Sanofi Pasteur, a Sanofi Company
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartApr 2016
First PostedMay 2016
Primary CompletionJul 2016
Study CompletionAug 2016
TodayJul 2026
First PostedMay 3, 2016
Enrollment StartApr 26, 2016
Primary CompletionJul 29, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.2 years ago
Interventions
Blood Sampleother
Blood sample at approx. 4 years of age