E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The prevention of Influenza Virus in infants and young children ages 6 to < 60 months of age. |
|
E.1.1.1 | Medical condition in easily understood language |
To prevent flu virus in infants and young children. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study was to describe the proportion of individuals who shed vaccine strain viruses. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study were:
• To describe the duration of shedding of vaccine viruses
• To quantitate shed vaccine viruses
• To describe the genotypic and phenotypic stability of shed vaccine viruses
• To describe the safety and tolerability of FluMist
• To describe the safety and tolerability of FluMist in relation to shedding |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 HIPAA authorization obtained from the subject's parent/legal representative
- Ability of the subject's parent/legal representative to understand and comply with the
requirements of the study
- Subject's parent/legal representative available by telephone
- Ability to complete follow-up period of 180 days after study vaccination as required by the
protocol |
|
E.4 | Principal exclusion criteria |
- History of hypersensitivity to any component of trivalent influenza virus vaccine live, intranasal, including egg or egg products,
monosodium glutamate, or porcine gelatin
- History of hypersensitivity to gentamicin
- History of Guillain-Barré syndrome
- Medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled), by parent/legal representative report or chart review, within the 42 days prior to study vaccination (i.e., children with recent persistent asthma were excluded); or history of severe persistent asthma according to the criteria described in the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report
- Acute febrile (≥100.0°F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to study vaccination
- Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
- Household contact who was immunocompromised (subjects were also to avoid close contact with immunocompromised individuals for at least 21 days after study vaccination)
- Use of aspirin or aspirin-containing products within the 30 days prior to study vaccination, or expected receipt through 180 days after study vaccination
- Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within the 14 days prior to study vaccination, or expected receipt through 28 days after study vaccination
- Use of any intranasal medication within the 14 days prior to study vaccination, or expected receipt through 28 days after study vaccination
- Administration of any live virus vaccine within the 30 days prior to study vaccination, or expected receipt through 30 days after study vaccination
- Administration of any inactivated (i.e., non-live) vaccine within the 14 days prior to study vaccination, or expected receipt through 14 days after study vaccination
- Receipt of any investigational agent within the 30 days prior to study vaccination, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert was permitted)
- Receipt of any blood product within the 90 days prior to study vaccination, or expected receipt through 28 days after study vaccination
- Family member or household contact who was an employee of the research center or otherwise involved with the conduct of the study
- Any condition that in the opinion of the investigator would have interfered with evaluation of the vaccine or interpretation of study results |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint was the proportion of subjects who shed vaccine virus. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The secondary endpoints of the study included:
• Duration of vaccine virus shedding
• Quantitation of shed vaccine virus
• Genotypic and phenotypic stability of shed vaccine virus
• REs and AEs through 28 days post vaccination
• SAEs and SNMCs through 180 days post vaccination
• REs in relation to vaccine virus shedding |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Open-label, single arm study |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |