Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
April 19, 2017 updated by: Novartis Vaccines
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
654
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Delegacion Tlalpan, Mexico, 14000
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Arkansas
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Bentonville, Arkansas, United States, 72712
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Fort Smith, Arkansas, United States, 72903
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California
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Canoga Park, California, United States, 91306
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Dinuba, California, United States, 93618
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Fresno, California, United States, 93703
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Long Beach, California, United States, 90806
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Los Angeles, California, United States, 90015
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Madera, California, United States, 93637
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Torrance, California, United States, 90503
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Indiana
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New Albany, Indiana, United States, 47150
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Kansas
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Newton, Kansas, United States, 67114
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Wichita, Kansas, United States, 67207
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Kentucky
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Bardstown, Kentucky, United States, 40004
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Massachusetts
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Woburn, Massachusetts, United States, 01801
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North Dakota
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Fargo, North Dakota, United States, 58104
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Ohio
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Dayton, Ohio, United States, 45406
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Huber Heights, Ohio, United States, 45424
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
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South Carolina
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Charleston, South Carolina, United States, 29406
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Spartanburg, South Carolina, United States, 29303
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Tennessee
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Lebanon, Tennessee, United States, 37087
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Texas
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Dallas, Texas, United States, 75230
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Houston, Texas, United States, 77055
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Utah
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Provo, Utah, United States, 84604
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Saint George, Utah, United States, 84790
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South Jordan, Utah, United States, 84095
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West Jordan, Utah, United States, 84088
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Virginia
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Charlottesville, Virginia, United States, 22902
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 2 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children 6 to 35 months 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 3.75_(50)MF59
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
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3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
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Experimental: 7.5_(0)MF59
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
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3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
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Experimental: 7.5_(50)MF59
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
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Experimental: 15_(0)MF59
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
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3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Antibody Responses After the First and Second Vaccinations
Time Frame: 21 days after each vaccination
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CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
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21 days after each vaccination
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Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Time Frame: Day 1 to 7
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Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
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Day 1 to 7
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Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Time Frame: Day 22 to 28
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Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
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Day 22 to 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Immunogenicity Measurement by Geometric Mean Titers (GMT)
Time Frame: 21 days after each vaccination
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Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.
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21 days after each vaccination
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Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Time Frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Subgroup analysis based on receipt of recent seasonal vaccination.
Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
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Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Time Frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Subgroup analysis based on receipt of recent seasonal vaccination.
Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
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Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Antibody Response Based on Baseline Seropositivity
Time Frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10
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Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Time Frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).
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Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Antibody Persistence by Geometric Mean Titers (GMT)
Time Frame: 6 months (Day 202) and 12 months (Day 387) after second vaccination
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Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.
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6 months (Day 202) and 12 months (Day 387) after second vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
October 15, 2009
First Submitted That Met QC Criteria
October 15, 2009
First Posted (Estimate)
October 16, 2009
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
April 19, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V112_06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.