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Trivalent influenza virus vaccine live, intranasal · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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). |
| Name | Type | Description |
|---|---|---|
| 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: * Male or female, 6 months to less than 60 months of age (reached their 6th month but not yet reached their 5th year birthday) at the time of study vaccination * Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from ...
Trivalent influenza virus vaccine live, intranasal is an investigational live attenuated influenza vaccine given as a nasal spray. It is designed to protect against three influenza virus strains and is being studied in healthy infants and young children. It is a vaccine modality and remains in clinical development rather than approved for use.
It is being studied for the prevention of influenza in healthy infants and young children. The single completed Phase 2 trial enrolled 200 healthy volunteers aged 6 months and older in the United States. It is not an approved product and its use remains investigational.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of trivalent influenza virus vaccine live, intranasal. The company is responsible for the clinical development program for this intranasal live attenuated influenza vaccine candidate.
Trivalent influenza virus vaccine live, intranasal is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The candidate is investigational and has not been approved by the FDA.
Trivalent influenza virus vaccine live, intranasal has been evaluated 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. It enrolled 200 participants in the United States and used a controlled design.