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

NCT ID: NCT00192322

Last Updated: 2012-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2001-12-31

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).

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

CAIV-T 10^5

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

Group Type: EXPERIMENTAL

CAIVT 10^5

Intervention Type: BIOLOGICAL

a single intranasal 0.2 mL dose of CAIV-T \<10\^5

CAIVT 10^7

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

Group Type: EXPERIMENTAL

CAIV-T 10^7

Intervention Type: BIOLOGICAL

a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)

Placebo

A single intranasal 0.2 mL dose of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

a single intranasal 0.2 mL dose of placebo

Trivalent inactivated vaccine (TIV)

A single intramuscular injection of commercially available vaccine

Group Type: ACTIVE_COMPARATOR

TIV

Intervention Type: BIOLOGICAL

commercially available TIV injected intramuscularly

Interventions

CAIV-T 10^7

a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)

Intervention Type: BIOLOGICAL

CAIVT 10^5

a single intranasal 0.2 mL dose of CAIV-T \<10\^5

Intervention Type: BIOLOGICAL

Placebo

a single intranasal 0.2 mL dose of placebo

Intervention Type: BIOLOGICAL

TIV

commercially available TIV injected intramuscularly

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

MedImmune

Principal Investigators

Robert Walker, MD

Role: PRINCIPAL_INVESTIGATOR

MedImmune LLC

Locations

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Division of Allergy Immunology and Infectious Disease

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Mendelman PM, Rappaport R, Cho I, Block S, Gruber W, August M, Dawson D, Cordova J, Kemble G, Mahmood K, Palladino G, Lee MS, Razmpour A, Stoddard J, Forrest BD. Live attenuated influenza vaccine induces cross-reactive antibody responses in children against an a/Fujian/411/2002-like H3N2 antigenic variant strain. Pediatr Infect Dis J. 2004 Nov;23(11):1053-5. doi: 10.1097/01.inf.0000143643.44463.b1.

Reference Type: RESULT

PMID: 15545863 (View on PubMed)

Other Identifiers

D153-P002

Identifier Type: -

Identifier Source: org_study_id