## Protocol Section
### Identification Module
**NCT ID:** NCT00111579

**Brief Title:** Study to Evaluate the Immune Responses of Trivalent Cold-Adapted Influenza Vaccine (CAIV-T) Compared With (TIV)

**Official Title:** A Prospective, Randomized, Open-Label Study to Evaluate the Immune Responses of Trivalent Cold-Adapted Influenza Vaccine (CAIV-T) Compared With Trivalent Inactivated Vaccine (TIV) in Children 6 to <36 Months of Age

#### Organization Study ID Info
**ID:** MI-CP123
#### Organization
**Class:** INDUSTRY
**Full Name:** MedImmune LLC
### Status Module
#### Completion Date
**Date:** 2006-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-07-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-07-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2006-01

**Type:** ACTUAL

#### Start Date
**Date:** 2005-05

**Status Verified Date:** 2008-07

#### Study First Post Date
**Date:** 2005-05-24
**Type:** ESTIMATED
**Study First Submit Date:** 2005-05-23
**Study First Submit QC Date:** 2005-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** MedImmune LLC

#### Responsible Party

**Old Name Title:** Chris Ambrose, Dir. Medical Affairs

**Old Organization:** MedImmune LLC

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to describe the level of serum antibody conferred by CAIV-T and TIV against homotypic and heterotypic influenza virus strains.

### Conditions Module

**Conditions:**

- Influenza

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 52

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** CAIV-T

**Intervention Names:**

- Biological: CAIV-T

**Label:** 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** TIV

**Intervention Names:**

- Other: TIV

**Label:** 2

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** A total vol. of 0.2 mL will be administered intranasally (approx. 0.1 mL into each nostril)for ea. of two doses.

**Name:** CAIV-T

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** A total vol. of 0.25 will be administered intramuscularly for each of two doeses.

**Name:** TIV

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** The following immunogenicity endpoints: The strain-specific HAI seroconversion rates (≥ 4-fold increase) among baseline seronegative participants (HAI titer ≤ 1:4), by dose number

**Time Frame:** Day 28 post final vaccination

**Measure:** The proportion of participants achieving ≥ 4-fold increase in strain-specific HAI titer from baseline in all participants regardless of baseline serostatus, by dose number

**Time Frame:** Day 28 post final vaccination

#### Secondary Outcomes

**Measure:** Safety endpoints include: AEs SAEs and significant new medical conditions for all participants

**Time Frame:** Day 28 post vaccination

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or Female
* Ages 6 to but less than 36 months (reached their 6th month but have not yet reached their 3rd birthday) at the time of randomization
* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the participant's parent/legal representative
* Ability of the parent/legal representative to understand and comply with the requirements of the study
* Parent/legal representative available by telephone
* Ability to complete follow-up period of 180 days after final study vaccination, as required by the protocol

Exclusion Criteria:

* History of hypersensitivity to any component of CAIV-T or TIV, including egg or egg products, monosodium glutamate, porcine gelatin or thimerosal
* History of hypersensitivity to gentamicin
* Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
* Household contact who is immunocompromised (participants should also avoid close contact with immunocompromised individuals for at least 21 days after each study vaccination)
* History of Guillain-Barre syndrome
* Medically diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled), by parent/legal representative report or chart review, within the 42 days prior to randomization (i.e., children with recent persistent asthma are excluded); or history of severe persistent asthma, according to the criteria described in the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma - Update on Selected Topics 2002
* Acute febrile (not greater than 100.0 degrees F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within 72 hours prior to either study vaccination
* Use of aspirin or aspirin-containing products within 30 days prior to randomization, or expected use through 180 days after final study vaccination
* Receipt of any prior influenza vaccine
* Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to randomization, or expected use through 180 days after final study vaccination
* Administration of any live virus vaccine within 30 days prior to randomization, or expected receipt through 30 days after final study vaccination
* Administration of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization, or expected receipt within 14 days before, or 14 days after, either study vaccination
* Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 180 days after final study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
* Receipt of any blood product within 90 days prior to randomization, or expected receipt through 180 days after final study vaccination
* Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
* Any condition that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of the study results

**Healthy Volunteers:** True

**Maximum Age:** 36 Months

**Minimum Age:** 6 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Layton

**Country:** United States

**Facility:** Wee Care Pediatrics

**State:** Utah

**Zip:** 84041

**Location 2:**

**City:** Ogden

**Country:** United States

**Facility:** Bear Care Pediatrics

**State:** Utah

**Zip:** 84405

**Location 3:**

**City:** Pleasant Grove

**Country:** United States

**Facility:** Alpine Pediatrics

**State:** Utah

**Zip:** 84062

**Location 4:**

**City:** Provo

**Country:** United States

**Facility:** Utah Valley Pediatrics

**State:** Utah

**Zip:** 84604

**Location 5:**

**City:** South Jordan

**Country:** United States

**Facility:** Families First Pediatrics

**State:** Utah

**Zip:** 84095

#### Overall Officials

**Official 1:**

**Affiliation:** MedImmune LLC

**Name:** Robert Walker, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000009976

- Term: Orthomyxoviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M10295

- Name: Influenza, Human

- Relevance: HIGH

- As Found: Influenza

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12902

- Name: Orthomyxoviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007251

- Term: Influenza, Human

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
