A Study to Describe the Safety Profile and Compare the Immune Response of 4 Different Formulations of an Investigational Tdap Vaccine When Compared to Licensed Tdap Vaccine in Young Adults in Canada

Phase 1

Completed

• Conditions: Diphtheria Immunisation (Healthy Volunteers); Tetanus Immunisation (Healthy Volunteers); Pertussis Immunisation (Healthy Volunteers)
• Interventions: Biological: Licensed Tdap vaccine; Biological: Investigational Tdap vaccine Formulation A; Biological: Investigational Tdap vaccine Formulation C; Biological: Investigational Tdap vaccine Formulation B; Biological: Investigational Tdap vaccine Formulation D

• Registration Number: NCT03958799
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The primary objectives of this study are:

* To describe the safety profile of each of the investigational vaccine formulations for all participants

* To describe the humoral and cell-mediated immune responses to all of the investigational vaccine formulations

* To evaluate the dose response to vaccine components

* To describe the magnitude, quality, and longevity of immune responses to each of the investigational vaccine formulations

Detailed Description

Study duration per participant is approximately 1 year, which will include a safety follow-up contact at 12 months after vaccination

Study Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-22
• Study Start: 2019-06-26
• Primary Completion: 2021-04-06
• Study Completion: 2021-04-06
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 8: Tdap	Licensed Tdap vaccine	TdaP administration, participation in Stage 1 and Stage 2
Group 2: IP Formulation A	Investigational Tdap vaccine Formulation A	IP Formulation A administration, participation in Stage 1
Group 5: IP Formulation C	Investigational Tdap vaccine Formulation C	IP Formulation C administration, participation in Stage 1 and Stage 2
Group 6: IP Formulation C	Investigational Tdap vaccine Formulation C	IP Formulation C administration, participation in Stage 1 and Stage 2
Group 1: Investigational Product (IP) Formulation A	Investigational Tdap vaccine Formulation A	IP Formulation A administration, participation in Stage 1 and Stage 2
Group 3: IP Formulation B	Investigational Tdap vaccine Formulation B	IP Formulation B administration, participation in Stage 1 and Stage 2
Group 7: IP Formulation D	Investigational Tdap vaccine Formulation D	IP Formulation D administration, participation in Stage 1 and Stage 2
Group 4: IP Formulation B	Investigational Tdap vaccine Formulation B	IP Formulation B administration, participation in Stage 1
Group 9: Tdap	Licensed Tdap vaccine	TdaP administration, participation in Stage 1

Primary Outcome Measures

Name	Time	Method
Number of participants reporting immediate adverse events (AEs)	Within 30 minutes post-vaccination	AEs, including those related to the product administered
Number of participants reporting unsolicited AEs	Within 30 days post-vaccination	AEs other than solicited reactions
Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities	Within 60 days post-vaccination	Haematological and biochemical laboratory parameters
GMCs of anti-tetanus toxoid immunoglobulins	From Day 0 to Day 360	Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL
Number of participants reporting serious adverse events (SAEs)	Up to 12 months post-vaccination	SAEs, including adverse event of special interest (AESIs)
Number of participants reporting medically attended adverse events (MAAEs)	Up to 12 months post-vaccination	MAAE: a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or emergency department
Geometric mean concentrations (GMCs) of anti-pertussis antigen immunoglobulins	From Day 0 to Day 360	Anti-pertussis antigen immunoglobulins concentration will be measured by mesoscale discovery electrochemiluminescence (MSD ECL)
Geometric means of antigen-specific cells	From Day 0 to Day 360	Antigen specific cells will be measured by FLUOROSPOT
Number of participants reporting solicited injection sites or systemic reactions	Within 7 days post-vaccination	Solicited reaction: adverse reaction prelisted in the case report book (CRB) Injection site reactions: pain, erythema, swelling Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
Number of participants reporting adverse events of special interest (AESIs)	Up to 12 months post-vaccination	AESIs are reported until the end of the safety follow-up period
GMCs of anti-diphtheria toxoid immunoglobulins	From Day 0 to Day 360	Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL
Percentages of antigen-specific cells	From Day 0 to Day 360	Antigen specific cells will be measured by FLUOROSPOT

Trial Locations

Locations (5)

Investigational Site Number 1240006; 🇨🇦 Halifax, Canada

Investigational Site Number 1240003; 🇨🇦 Truro, Canada

Investigational Site Number 1240004; 🇨🇦 Quebec, Canada

Investigational Site Number 1240009; 🇨🇦 Pierrefonds, Canada

Investigational Site Number 1240005; 🇨🇦 Sherbrooke, Canada