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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 developed by AstraZeneca PLC. It is designed to be given as a nasal vaccine rather than by injection. The vaccine has been studied in Phase 3 clinical trials in children and adults, including people who are healthy or have stable chronic medical conditions.
Q/LAIV is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The vaccine candidates in this program include Q/LAIV (MEDI3250) and Q/LAIV-BFS (MEDI8662), both of which have been evaluated in company-sponsored clinical studies conducted in the United States.
Q/LAIV has been studied in Phase 3 clinical development. Three trials of the vaccine have been completed, including two Phase 3 studies and one Phase 2 study, with no trials currently listed as active. It is an investigational vaccine and is not described as approved by the FDA.
Q/LAIV has been evaluated in three completed trials. NCT01091246 tested the immunogenicity of quadrivalent live attenuated influenza vaccine in children. NCT00952705 studied Q/LAIV-BFS (MEDI8662) in adults aged 18 to 49, and NCT00860067 studied quadrivalent LAIV in the same adult age group. All three were conducted in the United States.
Yes. Q/LAIV is also known as Q/LAIV (MEDI3250), and the related formulation Q/LAIV-BFS is also known as MEDI8662. These names refer to the same AstraZeneca quadrivalent live attenuated influenza vaccine program, so searches for MEDI3250 or MEDI8662 refer to the same investigational asset.
The Q/LAIV clinical program enrolled a total of 5,912 participants across three completed trials. The studies were randomized, double-blind, and actively controlled, and they enrolled healthy volunteers as well as people with stable chronic illness. The largest trial, NCT01091246, enrolled 2,312 children aged 2 years and older.