Phase 3
Completed N=2,719
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
Source: ClinicalTrials.gov NCT00973349 ↗Enrolled (actual)
2,719
Serious AEs
5.7%
Results posted
May 2011
Primary outcomePrimary: Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age — 129; 126; 135; 134 Participants
Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age |
129; 126; 135; 134; 133; 135 | — |
| PRIMARY Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age |
122; 119; 126; 122; 136; 141 | — |
| SECONDARY Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age |
299; 238; 379; 551; 536; 538 | — |
| SECONDARY Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age |
121; 118; 126; 125; 116; 121 | — |
| SECONDARY Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age |
130; 127; 135; 131; 153; 155 | — |
| SECONDARY Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age |
19; 15; 23; 33; 40; 36 | — |
| SECONDARY Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age |
67; 38; 51; 78; 27; 57 | — |
| SECONDARY Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age |
46; 32; 39; 42; 35; 43 | — |
| SECONDARY Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age |
18; 8; 22; 30; 15; 27 | — |
| SECONDARY Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age |
12; 8; 17; 16; 17; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Adults 18 years of age and older 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.
- Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
- For additional entry criteria, please refer to protocol.
Data sourced from ClinicalTrials.gov (NCT00973349). 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.