MedTrace Logo

The PertADO Geneva Trial

NCT02946190 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-05-08

No results posted yet for this study

Summary

This is a phase II, randomized double-center, and observer-blind controlled pilot vaccine trial in 11 to 15 years old healthy subjects to assess the immunogenicity of the genetically detoxified pertussis toxin (rPT) included in a novel acellular pertussis vaccine (Pertagen®) manufactured by BioNet-Asia when delivered by the intramuscular route to adolescents previously primed and boosted with chemically-detoxified PT, along with Td-pur® and in comparison with that of Boostrix® dTpa.

At Day 0, eligible volunteers will undergo a venous bleed for the determination of baseline values and enter the randomization scheme, being allocated to one of two groups: A (Pertagen® + Td-pur®), B (Boostrix® dTpa).

Randomized participants will receive one dose of Pertagen® and Td-pur® (Group A) or 1 dose of Boostrix® dTpa (Group B) by intramuscular injection in the deltoid. All subjects will be observed in the Plateforme de Recherché Pédiatrique for 30 minutes after immunization.

Post-immunization local and systemic reactions will be followed up for 7 days after immunization. Adverse events will be followed for 28 days after immunization.

At Day 28, a second visit (study end visit) will take place for safety evaluation and blood draw for immunogenicity evaluation.

Blood draws performed on Day 0 (Baseline) and Day 28 will be used to evaluate immune response to study vaccines.

The primary statistical analysis will be performed with visit 2 (Day 28) data to compare the immunogenicity and safety of one dose of Pertagen®, given simultaneously with Td-pur®, to those elicited by Boostrix® dTpa.

Conditions

  • Pertussis

Interventions

BIOLOGICAL

Pertagen® aP + Td-pur®

see arm/group descriptions

BIOLOGICAL

Boostrix® dTpa

see arm/group descriptions

Sponsors & Collaborators

  • BioNet-Asia Co., Ltd.

    collaborator INDUSTRY

  • Siegrist Claire-Anne

    lead OTHER

Principal Investigators

  • Claire-Anne Siegrist, MD · Center for Vaccinology, Medical Faculty (UNIGE) and University Hospitals of Geneva (HUG), CMU

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-27
Primary Completion
2017-03-09
Completion
2017-03-09

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02946190 on ClinicalTrials.gov