Phase 3
Completed N=784
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
Novel 2009 Influenza H1N1
Source: ClinicalTrials.gov NCT00973700 ↗
Enrolled (actual)
784
Serious AEs
1.6%
Results posted
May 2011
Primary outcomePrimary: Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age — 26; 83; 95; 92 Percentages of Subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age |
26; 83; 95; 92; 88; 80 | — |
| PRIMARY Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age |
18; 93; 99; 98; 99; 100 | — |
| SECONDARY Age Distribution at Baseline |
NA; NA; 5.5; 5.7; 5.4; NA | — |
| SECONDARY Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years |
24; 23; 23; 93; 71; 79 | — |
| SECONDARY HI GMRs, in 3 to <9 Years and 9 to 17 Years |
31; 12; 16; 169; 35; 53 | — |
| SECONDARY HI GMR, in Adults 18 to 64 Years |
48; 35; 57; 43; 63; 115 | — |
| SECONDARY Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years |
100; 91; 96; 93; 96; 100 | — |
| SECONDARY Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age |
25; 31; 20; 1; 0; 0 | — |
| SECONDARY Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age |
37; 36; 29; 1; 1; 0 | — |
| SECONDARY Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age |
39; 26; 38; 56; 19; 3 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
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.
Data sourced from ClinicalTrials.gov (NCT00973700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.