Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
- Conditions
- Influenza Virus
- Interventions
- Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)Biological: Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
- Registration Number
- NCT01964989
- Lead Sponsor
- Seqirus
- Brief Summary
Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10644
- Children, males and females, healthy or at high risk of complications from influenza, between ≥6 months to <72 months of age
- Documented consent provided by the subject's parent(s)/legal guardian(s)
- Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study procedures.
- Children with history of allergy to vaccine components.
- Additional eligibility criteria may be discussed by contacting the site
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description aQIV Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) flu vaccine non-adjuvanted comparator Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV) flu vaccine
- Primary Outcome Measures
Name Time Method Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
- Secondary Outcome Measures
Name Time Method Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age. ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to \<72 months of age with RT-PCR confirmed and culture confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer, in healthy subjects and subjects at risk of influenza related complications. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only ≥7 days and at ≥14 days after first vaccination up to day of second vaccination Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naive subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≥14 days after the first vaccination up to the day of the second vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) and GMT Ratios in Subjects ≥6 to <72 Months of Age Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects Pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination) and Day 181/209 (ie, 180 days after last vaccination) assessments; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms GMT and GMT Ratios at 21 Days After Last Vaccination in Healthy vs High Risk Subjects ≥6 to <72 Months of Age Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) HI GMT was assessed on Day 1 and Day 50 for vaccine naïve healthy vs high risk subjects; and HI GMT were assessed on Day 1 and Day 22 for vaccine non-naïve healthy vs high risk subjects; pooled GMT values across both naïve and non-naïve subjects are provided for Day 22/50 (ie, 21 days after last vaccination) assessments.
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Ratios (GMR) in Subjects ≥6 to <72 Months of Age Baseline (Day 1), Day 29, Day 50 and Day 209 for vaccine naïve subjects; Baseline (Day 1), Day 22 and Day 181 for vaccine non-naïve subjects The fold-increase in HI antibodies in response to vaccination was assessed as the GMR between all post-vaccination titers (ie, Day 29, 50, 209 for vaccine naïve subjects; Day 22, 181 for vaccine non-naïve subjects) and the baseline (Day 1) titer. Assessed GMRs thus correspond to Day 29/Day 1, Day 50/Day 1, and Day 209/Day 1 for vaccine naïve subjects and Day 22/Day 1 and Day 181/Day 1 for vaccine non-naïve subjects. Pooled GMR values across both naïve and non-naïve subjects are provided for Day (22/50)/Day 1 (ie, 21 days after last vaccination) and Day (181/209)/Day 1 (ie, 180 days after last vaccination); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.
Safety Endpoint: Number of Subjects With Solicited Local and Systemic AEs 7 days following each vaccination Subjects ≥6 to \<72 months of age reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with either aQIV or TIV/QIV.
Safety Endpoint: Number of Subjects With Unsolicited AEs, SAEs, AEs Leading to Withdrawal From the Study or Study Vaccination, NOCDs and AESIs Day 1 though Day 366 (vaccine non-naive)/Day 390 (vaccine naive) Safety was assessed in terms of number of subjects ≥6 to \<72 months of age reporting unsolicited reactions (Day 1 to Day 50 for vaccine naïve subjects and from Day 1 to Day 22 for vaccine non-naïve subjects); Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases,(NOCD), Adverse Events of Special Interests (AESI), AEs leading to withdrawal from the study or study vaccination after vaccination with either aQIV or TIV/QIV were collected up to 12 months after last vaccination.
Healthcare Utilization and Health Economic Endpoints: Number of Days of Daycare, School or Preschool Missed by Subjects Associated With RT-PCR-confirmed Influenza within a window of 14 days after influenza-like illness (ILI)-onset Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age Occurring at ≥7 Days and ≤21 Days After Last Vaccination, in All Subjects. ≥7 days and ≤21 days after the last vaccination Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was based on the number of vaccine naïve subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥7 days and ≤21 after the last vaccination. TIV was used as the comparator in Season 1; and QIV was used as the comparator in Season 2. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Seroconversion (SC) Rates and Difference in SC Rates at 21 Days in Subjects ≥6 to <72 Months of Age Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) SC rates were assessed on Day 1 and Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 1 and Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer\<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strain: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine.
comparison analysis (N=745 for aQIV, N=738 for comparator).Immunogenicity Endpoint: Hemagglutination Inhibition (HI) Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Geometric Mean Titers (GMTs) in Subjects ≥6 to <72 Months of Age 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) HI GMT was assessed 21 days after last vaccination (Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naive subjects) pooled GMT values across both naïve and non-naïve subjects are provided for the Day 22/50 (ie, 21 days after last vaccination); Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013-like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups.
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Heterologous Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 in Subjects ≥6 to <72 Months of Age 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) Antibody persistence was assessed as the percentage of subjects with HI titer of ≥1:40 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects; Heterologous strains: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups.
Healthcare Utilization and Health Economic Endpoint: Number of Medical Visit for Respiratory Illness Associated With RT-PCR-confirmed Influenza within a window of 14 days after ILI-onset Healthcare Utilization and Health Economic Endpoint: Number of Employment Days Missed by Parent(s)/Guardian(s) of Subjects With RT-PCR-confirmed Influenza within a window of 14 days after ILI-onset Healthcare Utilization and Health Economic Endpoint: First-occurrence of RT-PCR-confirmed Moderate-to-severe Influenza Cases as Per Prespecified Criteria in Subjects ≥6 to <72 Months of Age in Season 2. ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Geometric Mean Titers (GMTs) in Vaccine Naive Subjects ≥6 to <72 Months of Age Day 29 and Day 50 GMTs for vaccine naïve subjects are provided by strain for Day 29 and Day 50; Nonadjuvanted TIV administered in Season 1 and nonadjuvanted QIV administered in Season 2; Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/ Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; For B/Victoria results from Season 2 only are presented for both vaccine groups and used in the vaccine comparison analysis.
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titer ≥ 1:40 and Percentage Differences at 180 Days After Last Vaccination in Subjects ≥6 to <72 Months of Age Baseline (Day 1) and 180 days after the last vaccination (Day 209 for vaccine naive subjects; Day 181 for vaccine non-naïve subjects) Antibody response was assessed as the percentage of subjects with HI titer of ≥1:40 at 180 days after last vaccination (ie, Day 209 for vaccine naïve subjects and Day 181 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented.
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Against Each of the Vaccine Strains in Terms of Percentage of Subjects With HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 in Subjects ≥6 to <72 Months of Age Baseline (Day 1) and 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) Antibody response was assessed as the percentage of subjects and differences of percentage of subjects with HI titers of ≥1:110, ≥1:151, ≥1:215, ≥1:330, and ≥1:629 at 21 days after last vaccination (ie, Day 50 for vaccine naïve subjects and Day 22 for vaccine non-naïve subjects). Results were then pooled across both vaccine naïve and non-naïve subjects. Homologous strains: A/H1N1=A/California/7/2009 pdm09-like virus, A/H3N2=A/Texas/50/2012, B/Yamagata=B/Massachusetts/2/2012 and B/Victoria=B/Brisbane/60/2008; B/Victoria results from Season 1 and Season 2 (aQIV) and Season 2 (comparator) are presented.
Immunogenicity Endpoint: HI Antibody Responses to aQIV vs TIV/QIV Heterologous Strains in Terms of Seroconversion (SC) Rates in Subjects ≥6 to <72 Months of Age 21 days after the last vaccination (Day 50 for vaccine naive subjects; Day 22 for vaccine non-naïve subjects) SC rates were assessed on Day 50 (ie, 21 days after two vaccinations) for vaccine naïve subjects; and on Day 22 (ie, 21 days after one vaccination) for vaccine non-naïve subjects; values pooled across naive and non-naive subjects are provided. Seroconversion is defined as HI ≥ 1:40 for subjects negative at baseline (ie, HI titer\<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (ie, HI titer ≥ 1:10); Heterologous strains include: H1N1=A/Brisbane/59/2007- like; H3N2 =A/Hong Kong/4801/2014; B/Yamagata=B/Phuket/3073/2013- like; B Victoria=B/Malaysia/2506/2004; For B/Victoria results from Season 2 only are presented for both vaccine groups
Trial Locations
- Locations (167)
266, Novartis Investigational Site
🇺🇸Cary, North Carolina, United States
182,Novartis Investigational Site
🇨🇦Toronto, Ontario, Canada
417, Novartis Investigational Site
🇺🇸Miami, Florida, United States
254, Novartis Investigational Site
🇺🇸Cleveland, Ohio, United States
003, Novartis Investigational Site
🇫🇮Helsinki, Finland
002, Novartis Investigational Site
🇫🇮Helsinki, Finland
004, Novartis Investigational Site
🇫🇮Järvenpää, Finland
006, Novartis Investigational Site
🇫🇮Oulu, Finland
008, Novartis Investigational Site
🇫🇮Seinäjoki, Finland
001, Novartis Investigational Site
🇫🇮Espoo, Finland
007, Novartis Investigational Site
🇫🇮Pori, Finland
010, Novartis Investigational Site
🇫🇮Turku, Finland
173, Novartis Investigational Site
🇲🇽Morelia, Michoacan, Mexico
176, Novartis Investigational Site
🇲🇽Durango, Mexico
170, Novartis Investigational Site
🇲🇽Mexico, Mexico
177, Novartis Investigational Site
🇲🇽Mexico, Mexico
301, Novartis Investigational Site
🇵🇭Manila, Philippines
303, Novartis Investigational Site
🇵🇭Muntinlupa, Philippines
042, Novartis Investigational Site
🇵🇱Katowice, Poland
044, Novartis Investigational Site
🇵🇱Wroclaw, Poland
80, Novartis Investigational Site
🇪🇸Sabadell, Barcelona, Spain
302, Novartis Investigational Site
🇵🇭Manila, Philippines
028, Novartis Investigational Site
🇮🇹Sassari, Italy
178, Novartis Investigational Site
🇲🇽Mexico, Mexico
175, Novartis Investigational Site
🇲🇽Mexico, Mexico
304, Novartis Investigational Site
🇵🇭Muntinlupa, Philippines
052, Novartis Investigational Site
🇵🇱Leczna, Poland
346, Novartis Investigational Site
🇨🇳Datong, Taipei City, Taiwan
051, Novartis Investigational Site
🇵🇱Oborniki Slaskie, Poland
046, Novartis Investigational Site
🇵🇱Osielsko, Poland
043, Novartis Investigational Site
🇵🇱Siemianowice Slaskie, Poland
327, Novartis Investigational Site
🇹🇭Ratchathewi, Bangkok, Thailand
077, Novartis Investigational Site
🇪🇸Madrid, Spain
323, Novartis Investigational Site
🇹🇭Pathum Wan, Bangkok, Thailand
306, Novartis Investigational Site
🇵🇭Alabang, Muntilupa, Philippines
305, Novartis Investigational Site
🇵🇭Muntinlupa, Philippines
344, Novartis Investigational Site
🇨🇳Taichung, Taiwan
345, Novartis Investigational Site
🇨🇳Taichung, Taiwan
040, Novartis Investigational Site
🇵🇱Debica, Poland
049, Novartis Investigational Site
🇵🇱Lubartow, Poland
047, Novartis Investigational Site
🇵🇱Tarnow, Poland
041, Novartis Investigational Site
🇵🇱Warszawa, Poland
045, Novartis Investigational Site
🇵🇱Wola, Poland
257, Novartis Investigational Site
🇵🇷Ponce, Puerto Rico
415, Novartis Investigational vaccine
🇵🇷San Juan, Puerto Rico
078, Novartis Investigational Site
🇪🇸Valencia, Spain
300, Novartis Investigational Site
🇵🇭Dasmariñas, Cavite, Philippines
075, Novartis Investigational Site
🇪🇸Santiago, Galicia, Spain
048, Novartis Investigational Site
🇵🇱Lodz, Poland
341, Novartis Investigational Site
🇨🇳Taipei City, Taiwan
325, Novartis Investigational Site
🇹🇭Pathum Thani, Prathumthani, Thailand
326, Novartis Investigational Site
🇹🇭Hat Yai, Songkhia, Thailand
343, Novartis Investigational Site
🇨🇳Banciao, New Taipei City, Taiwan
340, Novartis Investigational Site
🇨🇳Taipei City, Taiwan
342, Novartis Investigational Site
🇨🇳Taoyuan, Taiwan
321, Novartis Investigational Site
🇹🇭Bangkoknoi, Bangkok, Thailand
320, Novartis Investigational Site
🇹🇭Bangkok, Thailand
324, Novartis Investigational Site
🇹🇭Bangkok, Thailand
024, Novartis Investigational Site
🇮🇹Pisa, Italy
236, Novartis Investigational Site
🇺🇸Salt Lake City, Utah, United States
212, Novartis Investigational Site
🇺🇸Salt Lake City, Utah, United States
246, Novartis Investigational Site
🇺🇸Salt Lake City, Utah, United States
076, Novartis Investigational Site
🇪🇸Madrid, Spain
074, Novartis Investigational Site
🇪🇸Granada, Spain
79, Novartis Investigational Site
🇪🇸Malaga, Spain
259, Novartis Investigational Site
🇺🇸Anaheim, California, United States
222, Novartis Investigational Site
🇺🇸Chandler, Arizona, United States
267, Novartis Investigational Site
🇺🇸Harrisburg, Arkansas, United States
213, Novartis Investigational Site
🇺🇸Baldwin Park, California, United States
407, Novartis Investigational Site
🇺🇸Downey, California, United States
411, Novartis Investigational Site
🇺🇸Ontario, California, United States
238, Novartis Investigational Site
🇺🇸La Puente, California, United States
202, Novartis Investigational Site
🇺🇸Paramount, California, United States
250, Novartis Investigational Site
🇺🇸San Diego, California, United States
293, Novartis Investigational Site
🇺🇸San Francisco, California, United States
416, Novartis Investigational Site
🇺🇸Hialeah, Florida, United States
229, Novartis Investigational Site
🇺🇸Boca Raton, Florida, United States
249, Novartis Investigational Site
🇺🇸Denver, Colorado, United States
243, Novartis Investigational Site
🇺🇸Colorado Springs, Colorado, United States
412, Novartis Investigational Site
🇺🇸Homestead, Florida, United States
287, Novartis Investigational Site
🇺🇸Hialeah, Florida, United States
224, Novartis Investigational Site
🇺🇸Melbourne, Florida, United States
285, Novartis Investigational Site
🇺🇸Miami, Florida, United States
404, Novartis Investigational Site
🇺🇸Miami, Florida, United States
277,Novartis Investigational Site
🇺🇸Miami, Florida, United States
234, Novartis Investigational Site
🇺🇸Opa-locka, Florida, United States
410, Novartis Investigational Site
🇺🇸Sarasota, Florida, United States
268, Novartis Investigational Site
🇺🇸Peoria, Illinois, United States
401, Novartis iNvestiagtional Site
🇺🇸Atlanta, Georgia, United States
209, Novartis Investigational Site
🇺🇸Augusta, Kansas, United States
299, Novartis Investigational Site
🇺🇸DeKalb, Illinois, United States
210, Novartis Investigational Site
🇺🇸Newton, Kansas, United States
211, Novartis Investigational Site
🇺🇸Wichita, Kansas, United States
274 Novartis Investigational Site
🇺🇸Park City, Kansas, United States
269, Novartis Investigational Site
🇺🇸Bardstown, Kentucky, United States
265, Novartis Investigational Site
🇺🇸Haughton, Louisiana, United States
408, Novartis Investigational Site
🇺🇸Mangham, Louisiana, United States
233, Novartis Investigational Site
🇺🇸Metairie, Louisiana, United States
418, Novartis Investigational SIte
🇺🇸Monroe, Louisiana, United States
225, Novartis Investigational Site
🇺🇸Metairie, Louisiana, United States
278, Novartis Investigational Site
🇺🇸Saint Paul, Minnesota, United States
263, Novartis Investigational Site
🇺🇸Frederick, Maryland, United States
262, Novartis Investigational site
🇺🇸Annapolis, Maryland, United States
405, Novartis Investigational Site
🇺🇸Silver Spring, Maryland, United States
221, Novartis Investigational Site
🇺🇸Bellevue, Nebraska, United States
219, Novartis Investigational Site
🇺🇸Fremont, Nebraska, United States
288, Novartis Investigational Site
🇺🇸Omaha, Nebraska, United States
402, Novartis Investigational Site
🇺🇸Omaha, Nebraska, United States
244, Novartis Investigational Site
🇺🇸Henderson, Nevada, United States
228, Novartis Investigational Site
🇺🇸Omaha, Nebraska, United States
286, Novartis Investigational site
🇺🇸Las Vegas, Nevada, United States
255, Novartis Investigational Site
🇺🇸Binghamton, New York, United States
264, Novartis Investigational Site
🇺🇸Syracuse, New York, United States
414, Novartis Investigational Site
🇺🇸Brooklyn, New York, United States
409, Novartis Investigational Site
🇺🇸Boone, North Carolina, United States
403, Novartis Investigational Site
🇺🇸Clyde, North Carolina, United States
281, Novartis Investigational Site
🇺🇸Dayton, Ohio, United States
245, Novartis Investigational Site
🇺🇸Dayton, Ohio, United States
281, Novartis Investigational vaccines
🇺🇸Dayton, Ohio, United States
256, Novartis Investigational Site
🇺🇸Tulsa, Oklahoma, United States
292, Novartis Investigational Site
🇺🇸Erie, Pennsylvania, United States
406, novartis Investigational Site
🇺🇸Barnwell, South Carolina, United States
270, Novartis Investigational Site
🇺🇸Scottdale, Pennsylvania, United States
220, Novartis Investigational Site
🇺🇸Anderson, South Carolina, United States
291, Novartis Investigational vaccine
🇺🇸Spartanburg, South Carolina, United States
232, Novartis Investigational Site
🇺🇸Moncks Corner, South Carolina, United States
283, Novartis Investigational Site
🇺🇸Nashville, Tennessee, United States
247, Novartis Investigational Site
🇺🇸Fort Worth, Texas, United States
217, Novartis Investigational Site
🇺🇸Fort Worth, Texas, United States
260, Novartis Investigational Site
🇺🇸Tomball, Texas, United States
214, Novartis Investigational Site
🇺🇸San Angelo, Texas, United States
295, Novartis Investigational Site
🇺🇸Layton, Utah, United States
400, Novartis investigational Site
🇺🇸San Antonio, Texas, United States
279, Novartis Investigational Site
🇺🇸Spanish Fork, Utah, United States
282, Novartis Investigational Site
🇺🇸Syracuse, Utah, United States
201, Novartis Investigational Site
🇺🇸West Jordan, Utah, United States
271, Novartis Investigational Site
🇺🇸West Jordan, Utah, United States
294, Novartis Investigational Site
🇺🇸West Haven, Utah, United States
009, Novartis Investigational Site
🇫🇮Tampere, Finland
251, Novartis Investigational Site
🇺🇸Burke, Virginia, United States
296, Novartis Investigational Site
🇺🇸Vienna, Virginia, United States
180, Novartis Investigational Site
🇨🇦Newmarket, Ontario, Canada
184, Novartis Investigational Site
🇨🇦Sudbury, Ontario, Canada
186, Novartis Investigational Site
🇨🇦Quebec, Canada
183, Novartis Investigational Site
🇨🇦Québec, Canada
005, Novartis Investigational Site
🇫🇮Kokkola, Finland
011, Novartis Investigational Site
🇫🇮Vantaa, Finland
030, Novartis Investigational Site
🇮🇹Florence, Italy
023, Novartis Investigational Site
🇮🇹Genova, Italy
020, Novartis Investigational Site
🇮🇹Milano, Italy
026, Novartis Investigational Site
🇮🇹Milano, Italy
025, Novartis Investigational Site
🇮🇹Napoli, Italy
021, Novartis Investigational Site
🇮🇹Novara, Italy
022, Novartis Investigational Site
🇮🇹Padova, Italy
280, Novartis Investigational Site
🇺🇸Anaheim, California, United States
240, Novartis Investigational Site
🇺🇸Akron, Ohio, United States
050, Novartis Investigational Site
🇵🇱Warszawa, Poland
415, Novartis Investigational Site
🇵🇷San Juan, Puerto Rico
297, Novartis Investigational Site
🇺🇸Orlando, Florida, United States
297, Novartis Investigational vaccine
🇺🇸Orlando, Florida, United States
226, Novartis Investigational Site
🇺🇸Louisville, Kentucky, United States
248, Novartis Investigational Site
🇺🇸Louisville, Kentucky, United States
207, Novartis Investigational Site
🇺🇸Louisville, Kentucky, United States
290, Novartis Investigational Site
🇺🇸Louisville, Kentucky, United States
272, Novartis Investigational Site
🇺🇸Charleston, South Carolina, United States
208, Novartis Investigational Site
🇺🇸Austin, Texas, United States
322, Novartis Investigational Site
🇹🇭Bangkoknoi, Bangkok, Thailand