Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children (CAIVT)

MedImmune

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: CAIVT 10^5; Biological: TIV; Biological: CAIV-T 10^7; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00192322

D153-P002

Details and patient eligibility

About

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.

Full 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).

Enrollment: 173 patients

Sex: All

Ages: 6 to 36 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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173 participants in 4 patient groups, including a placebo group

CAIV-T 10^5

Experimental group

Description:

a single intranasal 0.2 mL dose of liquid CAIV-T 10\^5 (approximately 0.1 mL into each nostril)

Treatment:

Biological: CAIVT 10^5

CAIVT 10^7

Experimental group

Description:

A single intranasal 0.2 mL dose of liquid CAIV-T 10\^7 (approximately 0.1 mL into each nostril)

Treatment:

Biological: CAIV-T 10^7

Placebo

Placebo Comparator group

Description:

A single intranasal 0.2 mL dose of placebo

Treatment:

Biological: Placebo

Trivalent inactivated vaccine (TIV)

Active Comparator group

Description:

A single intramuscular injection of commercially available vaccine

Treatment:

Biological: TIV