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Monovalent Subvirion A/H1N1 Influenza vaccine · 1 trial · 2 indications
Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
| Arm | Type | Description |
|---|---|---|
| A/H1N1 Vaccine Group 1 | EXPERIMENTAL | Participants will receive A/H1N1 vaccine formulation 1 |
| A/H1N1 Vaccine Group 2 | EXPERIMENTAL | Participants will receive A/H1N1 vaccine formulation 2 |
| Placebo Group | PLACEBO_COMPARATOR | Participants will receive a placebo vaccine |
| Name | Type | Description |
|---|---|---|
| Monovalent Subvirion A/H1N1 Influenza vaccine | BIOLOGICAL | 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months) |
| Normal saline solution (placebo) | BIOLOGICAL | 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months) |
Inclusion Criteria : All subjects: * Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years * Subject and parent/guardian ...
Monovalent Subvirion A/H1N1 Influenza vaccine is an investigational vaccine being studied for the prevention of influenza, specifically swine-origin A/H1N1 influenza. It is designed for use in healthy children aged 6 months to 9 years. The vaccine is currently in Phase 2 clinical development and is not yet approved.
Monovalent Subvirion A/H1N1 Influenza vaccine is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing A/H1N1 influenza.
Monovalent Subvirion A/H1N1 Influenza vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the vaccine is not currently in active clinical trials.
Monovalent Subvirion A/H1N1 Influenza vaccine was studied in a completed Phase 2 clinical trial with the identifier NCT00952419. The trial, titled 'A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years,' enrolled 474 participants in the United States and was placebo-controlled and double-blind.
Monovalent Subvirion A/H1N1 Influenza vaccine is a monovalent vaccine targeting the A/H1N1 influenza strain, which is also referred to as swine-origin A/H1N1 influenza. In clinical trials, it is described as an A/H1N1 pandemic vaccine, indicating it is designed to protect against the pandemic strain of the virus.