Influenza
Conditions
Brief summary
To perform a variety of assays on blood, nasal washes, and cells obtained from healthy children for the purposes of further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA). • To assess nasal swab specimens to detect vaccine virus shedding.
Detailed description
This was a phase II, prospective, randomized, partially-blinded, placebo-controlled, outpatient study conducted at multiple sites throughout the US in healthy children aged 6 months to less than 36 months. Parents/guardians of subjects were asked to read and sign the informed consent before any study-related procedures were performed. Subjects at each study site were sequentially assigned to 1 of 2 separate blood sample groups referred to as cellular immunity or antibody secreting cell. Subjects within each blood sample group were then randomized 1:1:1:1 to receive a single intranasal dose of CAIV-T 10\^7 FFU per dose, CAIV-T 10\^5 FFU per dose, placebo or a commercially-available injectable trivalent influenza vaccine (TIV).
Interventions
BIOLOGICALCAIV-T 10^7
a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
BIOLOGICALCAIVT 10^5
a single intranasal 0.2 mL dose of CAIV-T \<10\^5
BIOLOGICALPlacebo
a single intranasal 0.2 mL dose of placebo
BIOLOGICALTIV
commercially available TIV injected intramuscularly
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 Months to 36 Months
Healthy volunteers
Yes
Inclusion criteria
* children at least 6 months of age and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination and clinical judgement; * whose parent/legal guardian has provided written informed consent after the nature of the study has been explained; * who, along with their parent or guardian, will be available for the one month duration of the trial (from enrollment to study completion);
Exclusion criteria
* whose parents or guardians 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 (see Section 4.2.2); * 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 component of the study vaccine, placebo or TIV; * who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational); * with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results. Note: A pregnant household member is not considered a contraindication to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of influenza-specific immune response following receipt of CAIV-T. | Day 0 and Day 27 | The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine virus shedding | Days 2, 6, and 13 | The number of subjects who shed influenza virus vaccine subtypes following vaccination. |
| Measurement of influenza-specific immune response following receipt of CAIVT. | Day 0 and Day 27 | The immune responses were evaluated by mucosal IgA ELISA on nasal wash samples. |
| Measurement of influenza-specific immune responses following receipt of CAIVT | Day 0, Day 6, and Day 13 | The immune responses were evaluated by assays of cellular immunity (IFN-gamma ELISPOT) and assays that measured the number of antibody secreting cells (B-cell ELISPOT). |
| Assess the safety and tolerability of CAIV-T vaccine in healthy children. | Day 0-27 | Adverse events and serious adverse events were collect from Day 0 till the end of the study Day 27. |
Countries
United States
Outcome results
None listed