Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00952276 | A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly | PHASE2 | COMPLETED | 548 | — | — | Oct 1, 2009 | Mar 1, 2011 | Oct 3, 2011 | 15 | United States |
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
| Arm | Type | Description |
|---|---|---|
| A/H1N1 Vaccine Group 1 | EXPERIMENTAL | Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant) |
| A/H1N1 Vaccine Group 2 | EXPERIMENTAL | Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant) |
| A/H1N1 Vaccine Group 3 | ACTIVE_COMPARATOR | Participants will receive A/H1N1 vaccine formulation 3 |
| A/H1N1 Vaccine Group 4 | ACTIVE_COMPARATOR | Participants will receive A/H1N1 vaccine formulation 4 |
| Placebo Group 5 | PLACEBO_COMPARATOR | Participants will receive a placebo vaccine |
| Name | Type | Description |
|---|---|---|
| Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 |
| Monovalent Subvirion A/H1N1 influenza vaccine | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 |
| Normal saline solution | BIOLOGICAL | 0.5 mL, Intramuscular on Day 0 |
Inclusion Criteria : * Healthy adults aged 18 years or older on the day of inclusion * Informed consent has been signed and dated * Able to attend all scheduled visits and comply with all trial procedures * For a woman of child-bearing potential, use of an effective method of contraception or absti...