Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
- Conditions
- Influenza
- Interventions
- Biological: MF59-eH1N1
- Registration Number
- NCT00972816
- Lead Sponsor
- Novartis Vaccines
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1357
- Children 3 to < 9 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 7.5_(50) MF59 MF59-eH1N1 7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 3.75_(50)MF59 MF59-eH1N1 3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22 7.5_(100) MF59 MF59-eH1N1 7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22 15_(100) MF59 MF59-eH1N1 15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22 30_(0) MF59 MF59-eH1N1 30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 7.5_(0) MF59 MF59-eH1N1 7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 15_(0) MF59 MF59-eH1N1 15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22 15_(50)MF59 MF59-eH1N1 15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
- Primary Outcome Measures
Name Time Method Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations Day 22, Day 29, Day 43, Day 202 and Day 387 HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for \<65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity.
PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively.
PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.
PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
- Secondary Outcome Measures
Name Time Method Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group Day 22, Day 29, Day 43, Day 202 and Day 387 Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group.
PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively.
PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010. Day 22, Day 29, Day 43 HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is \> 40%.The percentage of subjects achieving an HI titer ≥ 40 is \> 70% and The GMR is \> 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.
Number of Participants Reporting Unsolicited Adverse Events (AEs) Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 Day 1, Day 22, Day 29, Day 43 Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines
Subgroups without recent seasonal flu vaccine:
PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively.
PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively.
Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively.
PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectivelyAntibody Response Based on Baseline Seropositivity Day 22, Day 29 and Day 43 Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.
Subgroups with baseline HI titer \< 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively.
Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively.Geometric Mean Titers (GMTs) Based on Baseline Seropositivity Day 1, Day 22, Day 29, Day 43 Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.
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).Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination 7 days after first vaccination Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination 7 days after second vaccination Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)
Trial Locations
- Locations (33)
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Clinical Research Center of Nevada
🇺🇸Henderson, Nevada, United States
1st International Research Centers
🇺🇸Thornton, Colorado, United States
Center for Clincal Trials, LLC
🇺🇸Paramount, California, United States
UPMC/Community Medicine (pediatrics)
🇺🇸Greenville, Pennsylvania, United States
Pediatric Alliance - Greentree Division (pediatrics)
🇺🇸Pittsburgh, Pennsylvania, United States
Omega Clinical Research
🇺🇸Warwick, Rhode Island, United States
J.Lewis Research, Inc./Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Heartland Research Associates LLC
🇺🇸Newton, Kansas, United States
Bluegrass Clinical Research, Inc (Brownsboro for drug shipment)
🇺🇸Louisville, Kentucky, United States
Premier Health Research Center, LLC
🇺🇸Downey, California, United States
Madera Family Medical Group
🇺🇸Madera, California, United States
Center for Clinical Trials of San Gabriel
🇺🇸West Covina, California, United States
Meridien Clinical Research
🇺🇸Omaha, Nebraska, United States
Children's Health Care -West
🇺🇸Erie, Pennsylvania, United States
Capital Pediatrics and Adolescent Ctr.
🇺🇸Raleigh, North Carolina, United States
Dr. Senders and Associates, Pediatrics
🇺🇸Cleveland, Ohio, United States
Instituto Nacional de Ciencias
🇲🇽Tlalpan, Mexico
Pediatric Healthcare of NW Houston
🇺🇸Tomball, Texas, United States
PI-Coor Clinical Research
🇺🇸Burke, Virginia, United States
Rockwood Research Center
🇺🇸Spokane, Washington, United States
J. Lewis Research, Inc./Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
IPS Research
🇺🇸Oklahoma City, Oklahoma, United States
Research Across America
🇺🇸Dallas, Texas, United States
Pediatrics and Adolescent Medicine
🇺🇸Woodstock, Georgia, United States
Bluegrass Clinical Research, Inc.
🇺🇸New Albany, Indiana, United States
Pediatric Physicians Research, Inc.
🇺🇸Jefferson Hills, Pennsylvania, United States
The Portland Clinic LLP
🇺🇸Beaverton, Oregon, United States
Northern Illinois Research Associates
🇺🇸Dekalb, Illinois, United States
West Houston Clinical Research Service
🇺🇸Houston, Texas, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States