Influenza
Conditions
Brief summary
A safety study to compare, over a 7 day period, the fever rates following one dose of either Influenza Virus Vaccine or placebo administered outside the influenza season to healthy children and adolescents aged 6 to less than 18 years.
Detailed description
This was a prospective, randomized, double-blind, placebo-controlled, study. Subjects were randomized to receive either CAIV-T or Placebo. All subjects were healthy children and adolescents aged at least 6 years of age and less than 18 years of age at the time of enrollment.
Interventions
The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10\^7+/-0.5 fluorescent focus units (FFU) (equivalent to 10\^7+/-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A/New Caledonia/20/99; Influenza Cold Adapted Virus Type H3N2, strain A/ Panama/2007/99; Influenza Cold Adapted Virus Type B, strain B/Hong Kong/ 330/01.
BIOLOGICALPlacebo
The placebo consisted of physiologic normal saline.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* who are aged 6 to less than 18 years at the time of enrolment * who, if female and is of child bearing potential is using reliable method of hormonal and/or non-hormonal contraception (which includes cervical cap, diaphragm, condoms, with spermicide or IUD) during sexual intercourse throughout the entire study period; has provided a negative pregnancy test (with detection limit of less than or equal to 25mL/ml) no more than 24 hours prior to the study vaccine administration and agreed to avoid pregnancy during participation in the study. N.B.lactating females are excluded from the study. * who are in good health as determined by medical history, physical examination and clinical judgement * whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained * who, along with their parent(s)/legal guardian(s) will be available until completion of the study * whose parent(s)/legal guardian(s), can be reached by study staff for the post vaccination contacts(telephone, clinic or home visit)
Exclusion criteria
* who along with their parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period * with any serious chronic disease (e.g. with signs of cardiac or renal failure or severe malnutrition) including progressive neurological disease * with Down's syndrome or other known cytogenetic disorders * with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents * who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study * have an immunosuppressed or an immunocompromised individual living in the same household * with a documented history of hypersensitivity to egg or egg protein or any other components of CAIV-T or placebo * who have a history of Guillain-Barre Syndrome (GBS) * for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study * who, in the two weeks prior to entry into the study, received a dose of influenza treatment (commercial or investigational) * who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study * who, at anytime prior to study enrollment, received any influenza vaccine (commercial or investigational) * with asthma requiring regular medical follow up or hospitalization during the preceding year * with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results * Note: Pregnancy in any person who has regular contact with the subjects is not a contraindication to enrollment or ongoing participation of the subject in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with fever greater than or equal to 39.1C oral | Days 0-7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with any reactogenicity | Day 0-7 | Following vaccination the following reactions were reported daily: runny nose/nasal congestion, sore throat, cough, vomiting, decreased activity level, decreased appetite, irritability, abdominal pain together with oral temperature were referred to as prompted systemic reactions. |
| Number of subjects with any adverse events | Days 0-7 | Adverse events were defined as any untoward, undesired or unexpected clinical event in the form of signs, symptoms, disease or laboratory or physiological observations that occurred in a temporal relationship to the use of a WVR product, regardless of causal relationship. |
| Number of subjects with any serious adverse events | Days 0-21 | A Serious AE was an AE that occurred after any dose that: resulted in death, regardless of cause; was life-threatening; required in-patient hospitalization or prolonged an existing hospitalization; resulted in a persistent or significant disability or incapacity; resulted in cancer; resulted in a congenital anomaly or birth defect (in the offspring of a vaccine recipient, where applicable). |
Countries
Belgium, Poland, United Kingdom
Outcome results
None listed