Phase 2
N=805
Sanofi H1N1 + TIV - Adults and Elderly
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00943878 ↗Enrolled (actual)
805
Serious AEs
4.6%
Results posted
May 2011
Primary outcome: Primary: Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine — 90; 87; 91; 82 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Trivalent inactivated influenza vaccine (Biological); Inactivated H1N1 Vaccine (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine |
90; 87; 91; 82 | — |
| PRIMARY Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine |
81; 79; 88; 75 | — |
| PRIMARY Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine |
84; 83; 89; 78 | — |
| PRIMARY Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine |
78; 72; 78; 68 | — |
| PRIMARY Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination |
12; 12; 7; 13; 30; 41 | — |
| PRIMARY Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination |
14; 8; 12; 10; 29; 29 | — |
| PRIMARY Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination |
6; 8; 5; 5; 17; 15 | — |
| PRIMARY Number of Participants Reporting Fever After the First Vaccination |
0; 1; 0; 0 | — |
| PRIMARY Number of Participants Reporting Fever After the Second Vaccination |
0; 2; 0; 3 | — |
| PRIMARY Number of Participants Reporting Fever After the Third Vaccination |
0; 0; 1; 0 | — |
| PRIMARY Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination |
26; 32; 26; 11; 45; 46 | — |
| PRIMARY Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination |
28; 22; 30; 19; 51; 44 | — |
| PRIMARY Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination |
32; 57; 46; 48; 71; 93 | — |
| PRIMARY Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination |
12; 14; 13; 11; 21; 14 | — |
| PRIMARY Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination |
11; 9; 5; 8; 15; 7 | — |
| PRIMARY Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination |
32; 33; 27; 31; 19; 16 | — |
| PRIMARY Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination |
29; 27; 29; 35; 29; 18 | — |
| PRIMARY Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination |
31; 40; 30; 37; 28; 27 | — |
| PRIMARY Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination |
34; 19; 21; 37; 12; 20 | — |
| PRIMARY Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination |
30; 25; 26; 30; 27; 17 | — |
| SECONDARY Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination |
46; 40; 38; 39; 52; 48 | — |
| SECONDARY Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination |
66; 62; 53; 57; 37; 27 | — |
| SECONDARY Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine |
85; 77; 85; 75 | — |
| SECONDARY Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine |
80; 73; 72; 65 | — |
| SECONDARY Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination |
79; 77; 78; 81; 84; 80 | — |
| SECONDARY Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination |
85; 82; 81; 87; 86; 80 | — |
| SECONDARY Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine |
89; 82; 87; 80 | — |
| SECONDARY Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine |
83; 78; 81; 71 | — |
Summary
The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. Participants will include up to 850 healthy adults, ages 18 and older. Participants will receive 2 H1N1 vaccines in addition to placebo (inactive substance) and the seasonal flu shot over 3 study visits about 21 days apart. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in the study for about 8 months.
Eligibility Criteria
Inclusion Criteria
- Are males or non-pregnant females age 18 and older, inclusive.
- Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
- Are in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and targeted physical examination based on medical history. A stable chronic medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company etc, or that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this inclusion criterion.
- Are able to understand and comply with planned study procedures.
- Provide written informed consent prior to initiation of any study procedures.
Exclusion Criteria
- Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal and chicken protein).
- Have a positive urine or serum pregnancy test within 24 hours prior to vaccination (if female of childbearing potential), or women who are breastfeeding.
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 micrograms (mcg)/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
- Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
- Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
- Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during the study period (prior to Day 180 after the third vaccination).
- Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the last vaccination.
- Has received a licensed 2009-2010 seasonal influenza vaccine.
- Have an acute or chronic medical condition that, in the opinion of the investigator, would render vacci
Data sourced from ClinicalTrials.gov (NCT00943878). 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.