Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam

Phase 3

Completed

• Conditions: Influenza

• Registration Number: NCT03765437
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The primary objective of this study is to describe the safety of the Quadrivalent Influenza Vaccine (QIV). Safety is assessed throughout the study period, and includes solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 28, and serious adverse events occurring throughout the study.

Detailed Description

Study duration for previously unvaccinated participants aged 6 months to 8 years is approximately 56 days. Study duration for previously vaccinated participants aged 6 months to 8 years and any participant aged 9 years and older is approximately 28 days.

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Study Start: 2019-01-15
• Primary Completion: 2019-03-17
• Study Completion: 2019-03-17
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants reporting solicited injection site reactions or systemic reactions	Within 7 days after vaccination	Injection site reactions: tenderness/pain, erythema, swelling, induration, and haemorrhage.; Systemic reactions: participants ≤ 23 months: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability; participants 2 years and older: fever, headache, malaise, myalgia, and shivering.

Trial Locations

Locations (1)

Investigational Site Number 7040001; 🇻🇳 Viet Tri, Vietnam