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Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00464672
Enrollment
1893
Registered
2007-04-24
Start date
2007-04-30
Completion date
2007-12-31
Last updated
2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Egg-Derived, Healthy Children, Healthy Adolescents, Healthy Adults, Safety, Immunogenicity, Trivalent, Inactivated, Vaccination

Brief summary

This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry Clinical data needed to support the licensure of trivalent inactivated influenza vaccine, issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.

Interventions

BIOLOGICALInfluenza virus vaccine

Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

BIOLOGICALComparator influenza vaccine

Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

Sponsors

Novartis Vaccines
CollaboratorINDUSTRY
Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects 3 to 64 years of age

Exclusion criteria

* Receipt of other investigational products within 3 months or other vacine within 1 month; * Allergy to eggs, egg products, or any other vaccine component; * Laboratory confirmed influenza disease within 6 months; * Have previously received an influenza vaccination (3 to 8 years only);

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age21 days after vaccinationTo evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age21 days after vaccinationSeroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.

Secondary

MeasureTime frameDescription
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age21 days after vaccinationSeroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age21 days after vaccinationTo evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age7 days after vaccinationSolicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.
Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age50 days after last vaccinationTo descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age7 days after vaccinationSolicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.
Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age50 days after last vaccinationTo evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.7 days after each vaccinationSolicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.
Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age21 days after vaccinationImmunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age50 days after last vaccinationSeroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age21 days after vaccinationTo descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.

Countries

Argentina

Participant flow

Recruitment details

Approximately 6 weeks for enrollment with date of first enrolment on April 2007

Pre-assignment details

All enrolled subjects were included in the trial.

Participants by arm

ArmCount
Influenza Virus Vaccine
Injections of the investigational influenza virus vaccine were administered intramuscularly
1,262
Comparator Influenza Vaccine
Injections of the comparator influenza vaccine were administered intramuscularly
631
Total1,893

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyLost to Follow-up25100010
Overall Studywithdrawal of consent000194

Baseline characteristics

CharacteristicTotalInfluenza Virus VaccineComparator Influenza Vaccine
Age, Continuous
Adults 18 to 64 years of age
38.5 years
STANDARD_DEVIATION 12.5
38.8 years
STANDARD_DEVIATION 14.4
37.8 years
STANDARD_DEVIATION 12.6
Age, Continuous
Children/Adolescents 9 to 17 years of age
12.7 years
STANDARD_DEVIATION 2.6
12.7 years
STANDARD_DEVIATION 2.6
12.8 years
STANDARD_DEVIATION 2.6
Age, Continuous
Chilren 3 to 8 years of age
5.5 years
STANDARD_DEVIATION 1.7
5.5 years
STANDARD_DEVIATION 1.7
5.4 years
STANDARD_DEVIATION 1.7
Race/Ethnicity, Customized
Asian
2 participants2 participants0 participants
Race/Ethnicity, Customized
Caucasian
1747 participants1168 participants579 participants
Race/Ethnicity, Customized
Hispanic
144 participants92 participants52 participants
Sex/Gender, Customized
Female
1024 participants687 participants337 participants
Sex/Gender, Customized
Male
869 participants575 participants294 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
235 / 460128 / 233167 / 40080 / 199153 / 40291 / 199
serious
Total, serious adverse events
6 / 4602 / 2334 / 4000 / 1993 / 4023 / 199

Outcome results

Primary

Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age

Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.

Time frame: 21 days after vaccination

Population: The analysis was performed on the per-protocol (PP) population.

ArmMeasureValue (MEAN)
Influenza Virus Vaccine (A/H1N1)Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age74 Percentage of participants
Influenza Virus Vaccine (A/H3N2)Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age72 Percentage of participants
Influenza Virus Vaccine (Strain B)Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age77 Percentage of participants
Comparator Influenza Vaccine (A/H1N1)Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age86 Percentage of participants
Comparator Influenza Vaccine (A/H3N2)Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age89 Percentage of participants
Comparator Influenza Vaccine (Strain B)Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age74 Percentage of participants
Primary

Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age

To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.

Time frame: 21 days after vaccination

Population: The analysis was performed on the per-protocol (PP) population.

ArmMeasureValue (MEAN)
Influenza Virus Vaccine (A/H1N1)Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age93 Percentages of participants
Influenza Virus Vaccine (A/H3N2)Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age96 Percentages of participants
Influenza Virus Vaccine (Strain B)Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age91 Percentages of participants
Comparator Influenza Vaccine (A/H1N1)Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age99 Percentages of participants
Comparator Influenza Vaccine (A/H3N2)Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age100 Percentages of participants
Comparator Influenza Vaccine (Strain B)Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age86 Percentages of participants
Secondary

Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age

Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.

Time frame: 21 days after vaccination

Population: The analysis was done on the per protocol population

ArmMeasureValue (GEOMETRIC_MEAN)
Influenza Virus Vaccine (A/H1N1)Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age244 Titers
Influenza Virus Vaccine (A/H3N2)Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age219 Titers
Influenza Virus Vaccine (Strain B)Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age126 Titers
Comparator Influenza Vaccine (A/H1N1)Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age512 Titers
Comparator Influenza Vaccine (A/H3N2)Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age485 Titers
Comparator Influenza Vaccine (Strain B)Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age104 Titers
Secondary

Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age

To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.

Time frame: 50 days after last vaccination

Population: The analysis was performed on the per-protocol (PP)population.

ArmMeasureValue (GEOMETRIC_MEAN)
Influenza Virus Vaccine (A/H1N1)Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age625 Titers
Influenza Virus Vaccine (A/H3N2)Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age710 Titers
Influenza Virus Vaccine (Strain B)Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age157 Titers
Comparator Influenza Vaccine (A/H1N1)Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age716 Titers
Comparator Influenza Vaccine (A/H3N2)Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age1472 Titers
Comparator Influenza Vaccine (Strain B)Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age126 Titers
Secondary

Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age

To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.

Time frame: 21 days after vaccination

Population: The analysis was performed on the per-protocol (PP)population

ArmMeasureValue (GEOMETRIC_MEAN)
Influenza Virus Vaccine (A/H1N1)Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age960 Titers
Influenza Virus Vaccine (A/H3N2)Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age493 Titers
Influenza Virus Vaccine (Strain B)Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age144 Titers
Comparator Influenza Vaccine (A/H1N1)Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age1246 Titers
Comparator Influenza Vaccine (A/H3N2)Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age1463 Titers
Comparator Influenza Vaccine (Strain B)Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age114 Titers
Secondary

Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age

Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.

Time frame: 7 days after vaccination

Population: The analysis was performed on the safety population.

ArmMeasureGroupValue (NUMBER)
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeEcchymosis24 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeMalaise55 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeErythema27 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeMyalgia66 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgePain117 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeArthralgia30 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeSwelling29 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeHeadache108 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeAny Systemic Reaction147 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeSweating24 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeInduration38 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeFatigue46 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeChills21 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeFever10 participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeAny local reaction161 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeFever6 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeAny local reaction89 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeErythema12 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeInduration24 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeSwelling15 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeEcchymosis15 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgePain70 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeAny Systemic Reaction84 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeChills17 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeMalaise27 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeMyalgia37 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeArthralgia14 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeHeadache42 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeSweating11 participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of AgeFatigue24 participants
Secondary

Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age

Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.

Time frame: 7 days after vaccination

Population: The analysis was performed on the safety population.

ArmMeasureGroupValue (NUMBER)
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeEcchymosis9 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeMalaise18 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeErythema7 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeMyalgia35 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgePain117 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeArthralgia11 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeSwelling28 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeHeadache52 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeAny Systemic reaction91 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeSweating4 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeInduration28 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeFatigue25 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeChills18 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeFever1 Participants
Influenza Virus Vaccine (A/H1N1)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeAny local reaction134 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeFever4 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeAny local reaction62 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeErythema3 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeInduration13 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeSwelling14 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeEcchymosis1 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgePain58 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeAny Systemic reaction49 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeChills11 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeMalaise8 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeMyalgia25 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeArthralgia5 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeHeadache22 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeSweating3 Participants
Influenza Virus Vaccine (A/H3N2)Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of AgeFatigue9 Participants
Secondary

Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.

Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.

Time frame: 7 days after each vaccination

Population: The analysis was performed on the safety population.

ArmMeasureGroupValue (NUMBER)
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Any Local Reaction92 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Headache28 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Malaise21 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Induration11 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Myalgia19 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Arthralgia5 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Swelling22 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Erythema9 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Fatigue18 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Ecchymosis18 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Pain68 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Sweating5 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Any Systemic Reaction66 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Fever12 Participants
Influenza Virus Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Chills10 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Chills8 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Headache18 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Ecchymosis9 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Malaise12 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Erythema5 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Arthralgia2 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Sweating3 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Myalgia9 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Induration10 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Any Systemic Reaction38 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Fever3 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Fatigue9 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Pain40 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Swelling16 Participants
Influenza Virus Vaccine (A/H3N2)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Any Local Reaction56 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Chills8 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Any Local Reaction66 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Erythema3 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Induration13 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Swelling13 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Ecchymosis10 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Pain57 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Any Systemic Reaction41 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Malaise19 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Myalgia19 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Arthralgia5 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Headache15 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Sweating3 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Fatigue10 Participants
Influenza Virus Vaccine (Strain B)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Fever10 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Any Systemic Reaction21 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Erythema3 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Headache11 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Pain35 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Ecchymosis5 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Any Local Reaction39 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Sweating1 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Swelling8 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Induration8 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Fever5 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Myalgia10 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Malaise7 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Fatigue4 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Arthralgia1 Participants
Comparator Influenza Vaccine (A/H1N1)Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.Chills5 Participants
Secondary

Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age

Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.

Time frame: 50 days after last vaccination

Population: The analysis was performed on the per protocol (PP) population.

ArmMeasureValue (MEAN)
Influenza Virus Vaccine (A/H1N1)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age95 Percentage of participants
Influenza Virus Vaccine (A/H3N2)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age86 Percentage of participants
Influenza Virus Vaccine (Strain B)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age83 Percentage of participants
Comparator Influenza Vaccine (A/H1N1)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age97 Percentage of participants
Comparator Influenza Vaccine (A/H3N2)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age95 Percentage of participants
Comparator Influenza Vaccine (Strain B)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age79 Percentage of participants
Secondary

Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age

Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.

Time frame: 21 days after vaccination

Population: The analysis was performed on the per-protocol (PP)population.

ArmMeasureValue (MEAN)
Influenza Virus Vaccine (A/H1N1)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age92 Percentage of participants
Influenza Virus Vaccine (A/H3N2)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age67 Percentage of participants
Influenza Virus Vaccine (Strain B)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age81 Percentage of participants
Comparator Influenza Vaccine (A/H1N1)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age91 Percentage of participants
Comparator Influenza Vaccine (A/H3N2)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age92 Percentage of participants
Comparator Influenza Vaccine (Strain B)Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age73 Percentage of participants
Secondary

Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age

To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.

Time frame: 50 days after last vaccination

Population: The analysis was performed on the per-protocol (PP) population

ArmMeasureValue (MEAN)
Influenza Virus Vaccine (A/H1N1)Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age97 Percentage of participants
Influenza Virus Vaccine (A/H3N2)Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age100 Percentage of participants
Influenza Virus Vaccine (Strain B)Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age85 Percentage of participants
Comparator Influenza Vaccine (A/H1N1)Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age99 Percentage of participants
Comparator Influenza Vaccine (A/H3N2)Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age99 Percentage of participants
Comparator Influenza Vaccine (Strain B)Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age81 Percentage of participants
Secondary

Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age

To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.

Time frame: 21 days after vaccination

Population: The analysis was performed on the per-protocol (PP) population.

ArmMeasureValue (MEAN)
Influenza Virus Vaccine (A/H1N1)Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age99 Percentage of subjects
Influenza Virus Vaccine (A/H3N2)Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age100 Percentage of subjects
Influenza Virus Vaccine (Strain B)Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age93 Percentage of subjects
Comparator Influenza Vaccine (A/H1N1)Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age98 Percentage of subjects
Comparator Influenza Vaccine (A/H3N2)Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age100 Percentage of subjects
Comparator Influenza Vaccine (Strain B)Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age89 Percentage of subjects

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026