Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as FluMist, Live attenuated influenza virus (LAIV)
Trivalent influenza virus vaccine live, intranasal · 6 trials · 4 indications
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2)for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
Counts of antibody secreting cells (ASCs) per 10\^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein \[FLU\] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 1
Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10\^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 42 days after Dose 1. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein \[FLU\]) after adjusting plate background response at 28 to 42 days after Dose 1
Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10\^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 35 days after Dose 2. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein \[FLU\]) after adjusting plate background response at 28 to 35 days after Dose 2
Distribution of IFN-alpha/beta gene signature scores at 7 to 10 days after Dose 1. IFN alpha/beta gene signature scores were calculated as the average fold change in a panel of 21 type 1 IFN-inducible genes. The distribution of IFN alpha/beta gene signature scores ranged from -4 to 4, with -4 representing the lowest level of activity and 4 representing the highest level of activity. The percentage of subjects by IFN-alpha/beta gene signature score for each treatment group were compared.
Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 \[H1N1\]; A/Wyoming/03/2003 \[H3N2\] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 \[H1N1\]; A/Wyoming/03/2003 \[H3N2\] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 \[H1N1\]; A/Wyoming/03/2003 \[H3N2\] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by PCR based assays. Viral shedding (A/New Caledonia/20/99 \[H1N1\]; A/Wyoming/03/2003 \[H3N2\] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like\]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus.
Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs for this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability.
An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | FluMist |
| 2 | PLACEBO_COMPARATOR | Placebo |
| 3 | PLACEBO_COMPARATOR | Placebo |
| FluMist, Influenza Virus Vaccine Live | EXPERIMENTAL | FluMist, Influenza Virus Vaccine Live, Intranasal |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | ACTIVE_COMPARATOR | TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular |
| Cohort 1: Participants Between 6 to < 24 Months Age | EXPERIMENTAL | Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like). |
| Cohort 2: Participants Between 24 to < 60 Months Age | EXPERIMENTAL | Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like). |
| FluMist | ACTIVE_COMPARATOR | The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains. During the 2005 enrollment period, the three 2004/2005 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/Wyoming/03/2003(H3N2), and B/Jilin/20/2003). During the 2006 and 2007 enrollment periods, the three 2005/2006 influenza virus strains were used: A/New Caledonia/20/99(H1N1), A/California/7/2004(H3N2), and B/Jiangsu/10/2003 (B/Shanghai/361/2002-like. |
| Placebo | PLACEBO_COMPARATOR | Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). |
| Name | Type | Description |
|---|---|---|
| FluMist | BIOLOGICAL | - |
| Placebo | OTHER | A single dose of either bivalent vaccine or placebo mist by intranasal spray on Study Day 0 |
| TIV, Trivalent Inactivated Influenza Virus Vaccine | BIOLOGICAL | 0.25 mL will be administered intramuscularly for each of two doses |
| FluMist, Influenza Virus Vaccine Live | BIOLOGICAL | 0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses |
| Trivalent influenza virus vaccine live, intranasal | BIOLOGICAL | A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains. |
Inclusion Criteria: * Males or females, 18 to 49 years of age (not yet reached their 50th birthday) at the time of study vaccination * Healthy by medical history and health assessment * Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effectiv...
Trivalent influenza virus vaccine live, intranasal is a live vaccine candidate designed to be given through the nose rather than by injection. It is being developed by AstraZeneca PLC (ticker AZN) and is in Phase 2 clinical development. It is intended to protect against three influenza virus strains.
Trivalent influenza virus vaccine live, intranasal is being studied for the prevention of influenza. The Phase 2 trial NCT00344305 evaluated shedding and safety in infants and young children, a population that includes children as young as 6 months old. The specific indications for the vaccine have not been disclosed.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of trivalent influenza virus vaccine live, intranasal. AstraZeneca is a global biopharmaceutical company. The vaccine candidate is part of its pipeline of investigational products.
Trivalent influenza virus vaccine live, intranasal is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed for this candidate.
Trivalent influenza virus vaccine live, intranasal has been studied in one completed Phase 2 trial, NCT00344305, titled A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children. The trial enrolled 200 participants in the United States and included healthy volunteers aged 6 months and older.