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Safety Study to Evaluate FluMist in Immunocompromised Children
Phase 1 trial testing FluMist in Cancer in 20 participants. Completed in 1 May 2008.
| Lead sponsor | MedImmune LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 20 |
| Start date | 1 August 2005 |
| Primary completion | 1 March 2008 |
| Estimated completion | 1 May 2008 |
| Sites | 5 locations across United States |
MedImmune LLC — full company profile →
Adults 5 to 17, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 8 | |
| Placebo | 9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 1 | |
| Placebo | 3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 6 | |
| Placebo | 10 |
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.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 0 | |
| Placebo | 0 |
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 3 | |
| Placebo | 0 |
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 2 | |
| Placebo | 0 |
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 0 | |
| Placebo | 0 |
Number of participants with nasal swab samples that contained vaccine-like virus are reported. Sample was collected at this time point only if health assessment indicated presence of a respiratory illness, including otitis media.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 0 | |
| Placebo | 0 |
Number of participants with nasal swab samples that contained vaccine-like virus are reported.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0 |
Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 8.6 | ± 7.4 |
| Placebo | 4.8 | ± 8.3 |
Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 83.6 | ± 8.9 |
| Placebo | 89.1 | ± 10.3 |
Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes.
| Group | Value | 95% CI |
|---|---|---|
| FluMist | 47.3 | ± 9.8 |
| Placebo | 46.7 | ± 7.5 |
Time frame: Adverse events were collected from the time of investigational product administration through Day 42. Serious adverse events were collected from the time of study drug administration through Day 180.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | FluMist |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Bacteraemia | Infections and infestations | — | — |
| Herpes zoster | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | — | — |
| Reaction | System | Placebo | FluMist |
|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Conjunctivitis | Eye disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Oral pain | Gastrointestinal disorders | — | — |
| Fungal skin infection | Infections and infestations | — | — |
| Animal scratch | Injury, poisoning and procedural complications | — | — |
| Ankle fracture | Injury, poisoning and procedural complications | — | — |
| Oral intake reduced | Metabolism and nutrition disorders | — | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Dysuria | Renal and urinary disorders | — | — |
| Dysmenorrhoea | Reproductive system and breast disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Sneezing | Respiratory, thoracic and mediastinal disorders | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | — | — |
| Skin chapped | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: Febrile neutropenia, Bacteraemia, Herpes zoster, Pneumonia, Abortion spontaneous.
Data from ClinicalTrials.gov NCT00112112 adverse events section.
The main purpose of this study is to get information about the safety of a flu vaccine spray, called FluMist, in children with cancer. The study is also being done to find out how much and how long the vaccine spray can be found in the nose.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00112112.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing