Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam
- Conditions
- Influenza
- Interventions
- Biological: Quadrivalent Influenza Vaccine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Quadrivalent Influenza Vaccine Quadrivalent Influenza Vaccine Quadrivalent Influenza Vaccine (split-virion, inactivated) Northern hemisphere seasonal formulation 2018-2019
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Investigational Site Number 7040001
🇻🇳Viet Tri, Vietnam