Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Q/LAIV · 3 trials · 2 indications
Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains. .
Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% confidence intervals (CIs) for the ratios of strain-specific HAI GMTs for the specified comparisons. The GMT ratio = GMT in comparator (All FluMist group) divided by the GMT in the Q/LAIV-BFS arm.
| Arm | Type | Description |
|---|---|---|
| Q/LAIV (MEDI3250) | EXPERIMENTAL | Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], B/Victoria \[B/Malaysia/2506/2004\], and B/Yamagata \[B/Florida/4/2006\]). |
| FluMist/B/Yamagata | EXPERIMENTAL | FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 \[South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], and B/Yamagata \[B/Florida/4/2006\]) |
| FluMist/B/Victoria | EXPERIMENTAL | FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], and B/Victoria \[B/Malaysia/2506/2004\]). |
| Q/LAIV-BFS (MEDI8662) | EXPERIMENTAL | Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006). |
| Name | Type | Description |
|---|---|---|
| Q/LAIV (MEDI3250) | BIOLOGICAL | 10 \^7.0 ± 0.5 FFU/dose of each of 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria |
| FluMist/B/Yamagata | BIOLOGICAL | 10 \^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Yamagata |
| FluMist/B/Victoria | BIOLOGICAL | 10 \^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria |
| Q/LAIV-BFS (MEDI8662) | BIOLOGICAL | A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0. |
Inclusion Criteria: * Male or female * Age 2 through 17 years at the time of randomization * Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU, and written informed assent if applicable) obtained from the subject/legal represe...
Q/LAIV is an investigational quadrivalent live attenuated influenza vaccine being studied for use in healthy adults and children, or those with stable underlying chronic medical conditions or chronic illness. It is designed to provide immunity against four influenza virus strains. The vaccine is administered to individuals aged 2 years and older.
Q/LAIV is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the vaccine's immunogenicity in adults and children.
Q/LAIV is in Phase 3 clinical development. It has completed Phase 2 and Phase 3 trials, with no active trials currently ongoing. The vaccine is investigational and has not been approved by regulatory authorities, as it remains under clinical evaluation.
Q/LAIV has completed three clinical trials: NCT00860067 (Phase 2) and NCT00952705 (Phase 3) in adults aged 18 to 49, and NCT01091246 (Phase 3) in children aged 2 years and older. All trials were conducted in the United States with healthy volunteers or those with stable chronic conditions.
Yes, Q/LAIV is also known as MEDI8662. In clinical trial NCT00952705, the vaccine is referred to as MEDI8662, which is a quadrivalent live attenuated influenza vaccine. This alternative name is used in research documentation to identify the same investigational product.