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

Influenza Clinical Trial

— CAIVT  

Official title:

A Randomized, Partially-Blinded, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent,Types A & B, Live Cold Adapted (CAIV-T) in Healthy Children Aged 6 to Less Than 36 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192322
• Other study ID #: D153-P002
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: February 15, 2012
• Start date: September 2001
• Est. completion date: December 2001

Study information

• Verified date: February 2012
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 36 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• CAIV-T 10^7
a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
• CAIVT 10^5
a single intranasal 0.2 mL dose of CAIV-T <10^5
• Placebo
a single intranasal 0.2 mL dose of placebo
• TIV
commercially available TIV injected intramuscularly

Locations

Country	Name	City	State
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Division of Allergy Immunology and Infectious Disease	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 again — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of influenza-specific immune response following receipt of CAIV-T.	The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.	Day 0 and Day 27	No
Secondary	Vaccine virus shedding	The number of subjects who shed influenza virus vaccine subtypes following vaccination.	Days 2, 6, and 13	No
Secondary	Measurement of influenza-specific immune response following receipt of CAIVT.	The immune responses were evaluated by mucosal IgA ELISA on nasal wash samples.	Day 0 and Day 27	No
Secondary	Measurement of influenza-specific immune responses following receipt of CAIVT	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).	Day 0, Day 6, and Day 13	No
Secondary	Assess the safety and tolerability of CAIV-T vaccine in healthy children.	Adverse events and serious adverse events were collect from Day 0 till the end of the study Day 27.	Day 0-27	Yes