The aim of the study is to to assess the immunogenicity and safety of a quadrivalent influenza vaccine in a multi-dose presentation compared to a quadrivalent influenza vaccine in single-dose presentation, in children aged 6 months to 17 years.
Participants aged 9 to 17 years will receive one dose of either the multi-dose quadrivalent influenza vaccine or the quadrivalent influenza vaccine in a single-dose presentation and participants aged 6 months to 8 years will receive 2 doses of either vaccine, 28 days apart. All participants will provide a pre-vaccination blood sample on Day 0 and a post-vaccination blood sample either on Day 28 (participants aged 9 to 17 years) or on Day 56 (participants aged 6 months to 8 years) for immunogenicity testing. All participants will be followed for safety evaluation up to 6 months after the last vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
301
0.5 mL, intramuscular
0.5 mL, intramuscular
Sanofi Pasteur Investigational Site 0001
Cuernavaca, Morelos, Mexico
Sanofi Pasteur Investigational Site 0002
Ecatepec de Morelos, State of Mexico, Mexico
Sanofi Pasteur Investigational Site 0003
Mexico City, Mexico
Geometric Mean Titers (GMTs) of Antibodies after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine
Anti-hemagglutinin (HA) antibody titers against the 4 influenza strains are assessed by a hemagglutination inhibition (HAI) assay
Time frame: Day 28 (post-last vaccination)
GMT Ratio after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine
Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. GMT ratio is assessed as the individual ratio of post-/pre-vaccination titers
Time frame: Day 28 (post-last vaccination)
Seroconversion Rates after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine
Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. Seroconversion is defined as either post-vaccination titer ≥ 40 (1/dil), or pre-vaccination titer ≥ 10 (1/dil) and ≥ 4-fold increase in post-vaccination titer
Time frame: Day 28 (post-last vaccination)
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine
Solicited injection site reactions are tenderness/pain,erythema, swelling, induration, ecchymosis, and solicited systemic reactions are fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability (for children ≤ 23 months), and fever, headache, malaise, myalgia, and shivering (for children 2 to 17 years)
Time frame: Day 0 (pre-vaccination) to Day 7 (after any vaccination)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.