Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
2009-2010 Trivalent Influenza Virus Vaccine · 1 trial · 1 indication
Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: \>103.1°F; Abnormal crying: \>3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: \>102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity. (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering. Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: \>10 cm; Fever \>102.1°F; Headache, Malaise, Myalgia \& Shivering: Significant, prevents daily activity.
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Participants will receive the 2009-2010 Trivalent Influenza Vaccine (TIV) (Pediatric dose have no preservatives) |
| Study Group 2 | ACTIVE_COMPARATOR | Participants will receive the 2008-2009 Trivalent Influenza Vaccine (TIV) |
| Study Group 3 | ACTIVE_COMPARATOR | Participants will receive the Quadrivalent Influenza Vaccine (QIV) |
| Name | Type | Description |
|---|---|---|
| 2009-2010 Trivalent Influenza Virus Vaccine | BIOLOGICAL | 0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular. |
| 2008-2009 Trivalent Influenza Virus Vaccine | BIOLOGICAL | 0.25 mL, Intramuscular; 0.5 mL, Intramuscular. |
| Quadrivalent Influenza Virus Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria : * Subject is ≥ 6 months to \< 5 years of age or 18 years of age or older on the day of inclusion. * Parent/legal guardian (if the subject is ≥ 6 months to \< 5 years of age) or adult subject (if 18 years of age or older) is willing and able to attend scheduled visits and to com...
2009-2010 Trivalent Influenza Virus Vaccine is an investigational vaccine being studied for the prevention of influenza. It is currently in Phase 2 clinical development and is intended for use in children and adults. The vaccine is being developed by Sanofi (SNY) as a seasonal influenza vaccine.
2009-2010 Trivalent Influenza Virus Vaccine is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing influenza.
2009-2010 Trivalent Influenza Virus Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, involving 600 participants in the United States.
2009-2010 Trivalent Influenza Virus Vaccine has been studied in one completed Phase 2 clinical trial with the identifier NCT00988143. The trial, titled 'A Study of Influenza Virus Vaccines in Children and Adults,' enrolled 600 participants aged 6 months and older in the United States and was active-controlled.
2009-2010 Trivalent Influenza Virus Vaccine is a seasonal influenza vaccine candidate designed to protect against three strains of the influenza virus. It is being developed as a trivalent vaccine for the 2009-2010 season. The vaccine is still investigational and not yet approved for public use.