Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
- Conditions
- Prophylaxis of A(H1N1) 2009 Pandemic InfluenzaTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-005185-30-Outside-EU/EEA
- Lead Sponsor
- ovartis Vaccines and Diagnostics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 784
All subjects
• Individuals who were in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator.
Adult subjects only
Males and females 18 years to 64 years (inclusive)
1. Documented consent of individuals who provided consent after the nature of the study was explained according to local regulatory requirements
2. Individuals who were able to comply with all study procedures and were available for all clinic visits scheduled in the study
Pediatric subjects only
Males and females ages 3 to 17 years (inclusive)
1. Documented consent provided by parents or legal guardians after the nature of the study was explained to them according to local regulatory requirements
2. Individuals and parents/guardians who were able to comply with all study procedures and were available for all clinic visits scheduled in the study
3. For individuals age 10 years and older, informed assent to participate in the study after the nature of the study was explained to them in terms they could understand
Are the trial subjects under 18? yes
Number of subjects for this age range: 392
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
All subjects
1.Individuals with behavioral/cognitive impairment/psychiatric disease that, in opinion of investigator, might interfere with subject's ability to participate in study
2.Individuals with history of any illness that, in opinion of investigator, might interfere with results of the study/pose additional risk to subjects due to participation in study
3. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, egg proteins(incl. ovalbumin), polymyxin,neomycin,thimerosal(incl.mercury) /sodium ethylmercurothiosalicylate,betapropiolactone & nonylphenol ethoxylate.
4. History of serious disease,such as:
a. Cancer
b. cardiac,renal,hepatic,metabolic(incl. diabetes mellitus),
rheumatologic(incl. autoimmune disease eg. rheumatoid arthritis), neurologic (including history of atypical febrile seizure/history of Guillain-Barré disease) & hematologic(incl. bleeding diathesis)disease
c. underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia,any major congenital
abnormalities requiring surgery, chronic treatment, associated with
developmental delay
5. Known/suspected impairment/alteration of immune function, including:
a. chronic use of oral steroids within 60 Days prior to visit1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
b. receipt of immuno-stimulants within 60 Days prior to visit1
c. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to visit1/planned during full length of study
d.HIV infection/HIV-related disease
e.Heritable immunodeficiency
f.Abnormalities of splenic/thymic function
6.Pregnant/breast-feeding female
7.Any positive/indeterminate pregnancy test
8.If female, of childbearing potential”, sexually active, & has not used any of acceptable contraceptive methods” for at least 2 months prior to study entry
a.Of childbearing potential was defined as status post onset of menarche & not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy/ status after hysterectomy.
b.Acceptable birth control methods were defined as 1 or more of
following:
i.Hormonal contraceptive(any)
ii.Barriers(any) each & every time during intercourse
iii.Intrauterine device
iv.Monogamous relationship with vasectomized partner. Partner must
have been vasectomized for at least six months prior to subject’s study entry
9.If female of childbearing potential & sexually active,refusal to use an acceptable contraceptive method” through to 3 weeks after last study vaccination
10.If female of childbearing potential, refusal to submit for pregnancy testing prior to each study vaccination
11.Laboratory-confirmed or suspected influenza disease within 6 months prior to visit 1. Laboratory-confirmed” includes:
a.Positive serology result
b.Positive viral culture
c.Positive rapid antigen test
d.Suspected” influenza disease includes: subjects with influenza-like illness within the past 6 months with a household/intimate contact with
laboratory-confirmed” influenza disease
12. With the exception of seasonal influenza vaccine, receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
13. Subjects that received/planned to receive seasonal influenza vaccine with
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Immunogenicity Objective:<br>To evaluate vaccine 15mcg a/H1N1 S-OIV unadjuvanted hemagglutination inhibition (HI) assay results in the adult and pooled pediatric populations according to immunogenicity criteria defined by CBER recommendations.;Secondary Objective: Immunogenicity Objective:<br>To evaluate each A/H1N1 S-OIV vaccine group HI assay results in pediatric and adult populations according to immunogenicity criteria defined by EMEA recommendations (CHMP 2007, CHMP 2008).<br><br>Safety Objectives:<br>To evaluate the safety and tolerability of each A/H1N1 S-OIV vaccine group in pediatric and adult populations.<br>;Primary end point(s): - Percentage of Subjects With Seroconversion and HI Titer =1:40 in Children 3 to 17 Years of Age.<br>- Percentage of Subjects With Seroconversion and HI Titer = 1:40 in Adults 18 to 64 Years of Age<br>;Timepoint(s) of evaluation of this end point: - 21 days after each vaccination and 8 days after second vaccination <br>- 7 and 21 days after each vaccination
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Percentage of Subjects With Seroconversion and HI Titer =1:40, in 3 to <9 Years and 9 to 17 years<br>- HI GMRs, in 3 to <9 Years and 9 to 17 Years<br>- HI GMRs, in Adults 18 to 64 Years <br>- Percentage of Subjects With Seroconversion and HI Titer =1:40, in Adults 18 to 64 Years<br>- Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age<br>- Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age<br>- Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age<br>- Number of subjects reporting unsolicited AEs;Timepoint(s) of evaluation of this end point: - 7 days and 21 days after each vaccination <br>Safety endpoints:<br>- 7 days after each vaccination<br>- Throughout the study period