The aim of the study was to generate immunogenicity and safety data in the whole population to support registration of the Quadrivalent Influenza Vaccine (QIV) in India: Primary objective: * To describe in each age group the immune response induced by a single injection (participants aged \>9 years) or 2 injections (participants aged 6 months to 8 years) of QIV. Secondary objective: * To describe in each age group the safety profile of QIV.
All participants were vaccinated with the QIV (split-virion, inactivated) Northern Hemisphere (NH) or Southern Hemisphere (SH) formulations by the intramuscular (IM) route. Immunogenicity of the vaccine was assessed at baseline (Day 0) and 28 days after the last injection. Safety data were collected up to 28 days after each injection. Serious adverse events (SAEs) were collected throughout the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
0.25 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Vadodara, Gujarat, India
Unnamed facility
Mandya, Karnataka, India
Unnamed facility
Pune, Maharashtra, India
Unnamed facility
Mumbai, Parel, India
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer \>=40 (1/dilution\[dil\]) at pre-vaccination and at post-final vaccination.
Time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer \<10 (1/dil) and post-vaccination titer \>=40 (1/dil), and Significant increase was defined as pre-vaccination titer \>=10 (1/dil) and \>= 4-fold increase of post-vaccination titer.
Time frame: 28 days post-final vaccination (post-vaccination)
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
1. Solicited injection site reactions: * Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:\>=50 mm) * Age \>=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities \[age 2-11 years\], significant interference with daily activities \[age \>=12 years\]; Erythema and Swelling \>=50 mm \[age 2-11 years\], \>100 mm \[age \>=12 years\]) 2. Solicited systemic reactions: * Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:\>39.5 degree Celsius; Vomiting:\>=6 episodes/24 hours; Crying abnormal:\>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses \>=3 feeds/meals or most feeds/meals; Irritability: inconsolable) * Age \>=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever\>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)
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0.5 mL, Intramuscular
Unnamed facility
Pimpri, Pune, India
Unnamed facility
Ludhiana, Punjab, India
Unnamed facility
Kolkata, West Bengal, India
Unnamed facility
Bangalore, India
Time frame: Within 7 days after any vaccination