Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01346592 |
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Recruitment Status :
Completed
First Posted : May 3, 2011
Results First Posted : May 6, 2014
Last Update Posted : March 26, 2015
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Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
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Brief Summary:
This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Influenza Disease | Biological: Trivalent split influenza vaccine (TIV) Biological: MF59-adjuvanted trivalent influenza vaccine (aTIV) Biological: Licensed comparator trivalent split influenza vaccine (comparator TIV) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 6104 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | A Phase III, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and Agriflu Compared to the Non-adjuvanted Trivalent Influenza Vaccine Fluzone in Children 6 to < 72 Months of Age |
| Study Start Date : | April 2011 |
| Actual Primary Completion Date : | July 2012 |
| Actual Study Completion Date : | July 2012 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Influenza Vaccines
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: aTIV (6 to <72 months)
Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
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Biological: MF59-adjuvanted trivalent influenza vaccine (aTIV)
Other Name: Fluad |
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Active Comparator: Comparator TIV (6 to <72 months)
Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
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Biological: Licensed comparator trivalent split influenza vaccine (comparator TIV)
Other Name: Fluzone |
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Active Comparator: TIV (6 to <72 months)
Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
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Biological: Trivalent split influenza vaccine (TIV)
Other Name: Agriflu |
Primary Outcome Measures :
- Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains [ Time Frame: Day 1, Day 50 ]The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
- Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains [ Time Frame: Day 50 ]
The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.
Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
- Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months) [ Time Frame: Day 1, Day 50 ]The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to <36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
- Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age [ Time Frame: Day 50 ]The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.
Secondary Outcome Measures :
- Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months) [ Time Frame: Day 1, Day 50 ]The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
- Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months) [ Time Frame: Day 50 ]The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion at three weeks after last vaccination against the three homologous vaccine strains.
- Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS [ Time Frame: Day 1, Day 50 ]The superiority of HI antibody responses, in subjects 6 to <72 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.
- Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS [ Time Frame: Day 50 ]The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion ≥4 fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.
- The HI GMTs Against Homologous Strains, by Vaccine Group [ Time Frame: Day 1, Day 29, Day 50, Day 209 ]The HI antibody titers against the three homologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.
- Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains [ Time Frame: Day 29, Day 50, Day 209 ]The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)and six months (day 209/day 1) after vaccination with either aTIV, licensed comparator or TIV.
- Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group [ Time Frame: Day 1, Day 29, Day 50, Day 209 ]The percentage of subjects demonstrating HI titers ≥40,against homologous strains, at three weeks and six months after vaccination with aTIV or licensed comparator or TIV.
- Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains [ Time Frame: Day 29, Day 50, Day 209 ]The percentage of subjects achieving seroconversion ≥4 fold increase in HI titers from baseline, against homologous strains, at three weeks and six months after vaccination with ATIV or licensed comparator or TIV.
- Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup [ Time Frame: Day 50 ]The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.
- Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup [ Time Frame: Day 50 ]The non-inferiority of HI antibody responses of aTIV to that of the licensed comparator TIV and to investigational TIV was assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk) , by age sub group.
- Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS [ Time Frame: Day 50 ]The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of of percentage of subjects achieving seroconversion or ≥4-fold increase in HI Titer at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.
- Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS [ Time Frame: Day 50 ]The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk), by age sub group.
- The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) [ Time Frame: Day 1, Day 50, Day 209 ]The HI antibody titers against the heterologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.
- Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains [ Time Frame: Day 50, Day 209 ]The percentage of subjects achieving seroconversion or ≥4 fold increase in HI titers from baseline, against heterologous strains, at three weeks and six months after last vaccination with aTIV or licensed comparator or TIV.
- Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination [ Time Frame: Day 1, Day 29 ]To demonstrate the GMTs at three weeks after one dose of aTIV are statistically significantly higher to the corresponding response's of comparator TIV and TIV.
- Number of Subjects Reporting Solicited Adverse Events After Vaccination [ Time Frame: Day 1 through Day 7 after any vaccination ]The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.
- Number of Subjects Reporting Unsolicited Adverse Events After Vaccination [ Time Frame: Day 1 to Day 394 ]The number of subjects reporting any unsolicited adverse events (AEs) between Day 1 to Day 50, serious adverse events (SAEs), AE leading to withdrawal (WD), new onset of chronic disease(NOCD), adverse events of special interest following vaccination with aTIV or licensed comparator or TIV throughout the study (Day 1 to Day 394).
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| Ages Eligible for Study: | 6 Months to 72 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
1.Children 6 months to 72 months of age.
Exclusion Criteria:Children
- Who had been hospitalized at the time of enrollment
- Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein
- Who had known impairment of the immune function
- Who had fever interfering with normal daily activities at the time of enrollment
- Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study
- Concomitant participation in another clinical study
- Who had surgery planned during the study period that in the investigator's opinion would have interfered with the study visits schedule.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346592
Locations
| Argentina | |
| 401 Paideia Jeronimo Salguero 2835 Piso 1 | |
| Buenos Aires, Argentina | |
| 402 Hospital de Ninos Gallo 130 | |
| Buenos Aires, Argentina | |
| 403 Instituto Medico Rio Cuarto Hipolito Yrigoyen 1020 | |
| Cordoba, Argentina | |
| 405 Hospital Pediatrico Nino Jesus Castro Barros 650 | |
| Cordoba, Argentina | |
| 406 Hospital Nostra Senora de la Misericordia Belgrano 1500 | |
| Cordoba, Argentina | |
| 407 Centro Pediatrico Caballito Directorio 1658 | |
| Cuidad Automa de Beunos Aires, Argentina, 1406 | |
| 409 Centro de Salud 16 Alpatacal y Chile | |
| Guaymallen, Argentina | |
| 408 Centro de Salud 31 Serpa y Republica del Libano | |
| Mendoza, Argentina | |
| Australia | |
| 206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital | |
| Adelaide, Australia, 5006 | |
| 201 Royal Children Hospital Department of Respiratory Medicine | |
| Herston, Australia, 4029 | |
| 205 Vaccine and Immunisation Research Group Murdoch Childrens Research Institute School Of Population Health | |
| Level 5 207 Bouverie St, Australia | |
| 202 Sydney Children Hospital Department of Immunology and Infectious Diseases | |
| Randwick, Australia, 2031 | |
| 204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead | |
| Westmead, Australia, 2145 | |
| Chile | |
| 502 Hospital Clinico Pontificia Universidad Catolica de Chile Marcoleta 357 | |
| Santiago, Chile | |
| 503 Clinica Tabancura Av Tabancura 1185 | |
| Santiago, Chile | |
| Philippines | |
| 111 DLSHI deCastro De La Salle Health Sciences Institute DBB B Dasmarinas | |
| Cavite, Philippines, 4114 | |
| 109 De La Salle Health Sciences Institute | |
| Dbbb Dasmarinas Cavite, Philippines, 4114 | |
| 110 De La Salle Health Sciences Institute | |
| Dbbb Dasmarinas Cavite, Philippines, 4114 | |
| 103 Philippine General Hospital Taft Avenue | |
| Manila, Philippines, 1000 | |
| 107 Philippine General Hospital Taft Avenue | |
| Manila, Philippines, 1000 | |
| 112 PGH Lim Philippine General Hospital Taft Avenue | |
| Manila, Philippines, 1000 | |
| 114 Philippine General Hospital Taft Avenue | |
| Manila, Philippines, 1000 | |
| 105 Mary Chiles General Hospital 667 Gastambide St Sampaloc Manila | |
| Manila, Philippines, 1008 | |
| 106 Research Institute for Tropical Medicine Alabang Muntinlupa | |
| Muntinlupa, Philippines | |
| 108 RITM Research Institute for Tropical Medicine Department of Health Compound FILINVEST Corporate City Alabang | |
| Muntinlupa, Philippines | |
| 101 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City | |
| Quezon City, Philippines | |
| 104 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City | |
| Quezon City, Philippines | |
| 113 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City | |
| Quezon City, Philippines | |
| 102 University of the East Ramon Magsaysay Memorial 64 Aurora Boulevard Barangay Dona Imelda | |
| Quezon, Philippines | |
| South Africa | |
| 305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue | |
| Benoni, South Africa, 1500 | |
| 304 Newgate Centre Suite 3 | |
| Johannesburg, South Africa, 2113 | |
| 303 Emmed Research | |
| Pretoria, South Africa, 0084 | |
| 301 Perinatal HIV Research Unit, Baragwanath Hospital | |
| Soweto, South Africa | |
| 302 Soweto Clinical Research | |
| Soweto, South Africa | |
Sponsors and Collaborators
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines | Novartis Vaccines |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Vaccines |
| ClinicalTrials.gov Identifier: | NCT01346592 History of Changes |
| Other Study ID Numbers: |
V70_29 |
| First Posted: | May 3, 2011 Key Record Dates |
| Results First Posted: | May 6, 2014 |
| Last Update Posted: | March 26, 2015 |
| Last Verified: | March 2015 |
Keywords provided by Novartis ( Novartis Vaccines ):
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Adjuvanted Trivalent Subunit Influenza Vaccine vaccine influenza |
adjuvant MF-59 pediatric |
Additional relevant MeSH terms:
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Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |