Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years
1 other identifier
interventional
784
1 country
1
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
May 23, 2011
CompletedDecember 2, 2015
October 1, 2015
2 months
September 2, 2009
October 20, 2010
October 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).
Day 1 to day 387
Secondary Outcomes (8)
Age Distribution at Baseline
Baseline
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Day 1 to day 387
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Day 1 to day 387
HI GMR, in Adults 18 to 64 Years
Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
7 days and 21 days after each vaccination
- +3 more secondary outcomes
Study Arms (5)
2x7.5adj
EXPERIMENTALTwo doses of MF59 adjuvanted (adj) A/H1N1
7.5adj_1_8
EXPERIMENTALMF59 adjuvanted (adj) A/H1N1 on days 1 and 8
7.5adj_1_22
EXPERIMENTALMF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
15_1_22
EXPERIMENTALA/H1N1 on study days 1 and 22
2x15_1_22
EXPERIMENTALTwo doses of A/H1N1 (one in each arm) on study days 1 and 22
Interventions
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Eligibility Criteria
You may qualify if:
- Children, adolescents, and adults 3 to 64 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
You may not qualify if:
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
- For additional entry criteria, please refer to protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
San José, Costa Rica
Related Publications (1)
Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Della Cioppa G, Clemens R; Costa Rican H1N1 Vaccine Study Group. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin. 2011 Jan 1;7(1):58-66. doi: 10.4161/hv.7.1.13411. Epub 2011 Jan 1.
PMID: 21285531RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY DIRECTOR
Novartis Vaccines
Novartis Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 9, 2009
Study Start
August 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2010
Last Updated
December 2, 2015
Results First Posted
May 23, 2011
Record last verified: 2015-10