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Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity (TITRE)

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza Vaccines, Infant, Dose-Response Relationship, Immunologic

Eligibility Criteria

6 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Child healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination
Child between and including 6 months of age and 23 months of age (up to and including the day before 24 months of age)
Child is available and can complete all relevant procedures during the entire study period
Parent or legal guardian is available and can be reached by phone during the entire study period
Parent/guardian provides written informed consent
Parent/guardian is fluent in English

Exclusion Criteria:

Child has history of laboratory-confirmed influenza
Child has history of any prior influenza immunization
Child has history of anaphylactic reaction to any component of the vaccine (i.e. egg)
Child has received immune globulin or other blood products within the prior six weeks
Child has received injected or oral steroids within the prior six weeks (inhaled or topical steroids allowed)
Child has a bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopenia, coagulation disorder, anti-coagulant therapy)
Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period
Child is scheduled to receive a live vaccine (notably measles, mumps, rubella or varicella vaccines) during the study period
Child has a health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child

Sites / Locations

Vaccine Evaluation Centre
Dalhousie University / IWK Health Centre
McGill University Health Centre - Vaccine Study Centre
Université de Laval - Unité de recherche en santé publique

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

2 doses 0.5mL VAXIGRIP® at months 0, 1

2 doses 0.25mL VAXIGRIP® at months 0, 1

Outcomes

Primary Outcome Measures

Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)

Seroprotection rate: HI titers =>40

Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)

Seroprotection rate: HI titers =>40

Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)

Seroprotection rate: HI titers =>40

Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)

Seroprotection rate: HI titers =>40

Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)

Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)

Seroprotection rate: HI titers =>40

Adverse Events: Fever After Either Dose - Infants 6-11 Months

Fever defined as temperature >= 38 C

Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-

Fever defined as temperature >= 38 C

Secondary Outcome Measures

Full Information

NCT ID

NCT00710866

First Posted

July 7, 2008

Last Updated

July 11, 2011

Sponsor

British Columbia Centre for Disease Control

1. Study Identification

Unique Protocol Identification Number

NCT00710866

Brief Title

Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity

Acronym

TITRE

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

British Columbia Centre for Disease Control

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to compare the antibody response and reaction rates in children age 6-23 months when they are given either the currently recommended schedule of two 0.25ml doses of influenza vaccine one month apart or two 0.5ml doses of influenza vaccine, one month apart.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza Vaccines, Infant, Dose-Response Relationship, Immunologic

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

262 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

2 doses 0.5mL VAXIGRIP® at months 0, 1

Arm Title

Arm Type

Active Comparator

Arm Description

2 doses 0.25mL VAXIGRIP® at months 0, 1

Intervention Type

Biological

Intervention Name(s)

Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion)

Other Intervention Name(s)

VAXIGRIP®

Intervention Description

Arm 1 (experimental group) received two spaced injections of the 0.5 mL (full) dose while arm 2 (comparison group) received the currently recommended two spaced injections of 0.25mL (half) dose of trivalent inactivated split virion influenza vaccine (VAXIGRIP®) manufactured by Sanofi Pasteur, Lyon, France.

Primary Outcome Measure Information:

Title

Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)

Description

Seroprotection rate: HI titers =>40

Time Frame

27-46 days after the second dose

Title

Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)

Description

Seroprotection rate: HI titers =>40

Time Frame

27-46 days after the second dose

Title

Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)

Description

Seroprotection rate: HI titers =>40

Time Frame

27-46 days after the second dose

Title

Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)

Description

Seroprotection rate: HI titers =>40

Time Frame

27-46 days after the second dose

Title

Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)

Time Frame

27-46 days after the second dose

Title

Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)

Description

Seroprotection rate: HI titers =>40

Time Frame

27-46 days after the second dose

Title

Adverse Events: Fever After Either Dose - Infants 6-11 Months

Description

Fever defined as temperature >= 38 C

Time Frame

3 days after immunization

Title

Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-

Description

Fever defined as temperature >= 38 C

Time Frame

3 days after immunization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

23 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Child healthy (stable chronic conditions acceptable) as established by health assessment interview and verbal history-directed health examination Child between and including 6 months of age and 23 months of age (up to and including the day before 24 months of age) Child is available and can complete all relevant procedures during the entire study period Parent or legal guardian is available and can be reached by phone during the entire study period Parent/guardian provides written informed consent Parent/guardian is fluent in English Exclusion Criteria: Child has history of laboratory-confirmed influenza Child has history of any prior influenza immunization Child has history of anaphylactic reaction to any component of the vaccine (i.e. egg) Child has received immune globulin or other blood products within the prior six weeks Child has received injected or oral steroids within the prior six weeks (inhaled or topical steroids allowed) Child has a bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (thrombocytopenia, coagulation disorder, anti-coagulant therapy) Child is or will be enrolled in any other clinical trial of a drug, vaccine or medical device during the study period Child is scheduled to receive a live vaccine (notably measles, mumps, rubella or varicella vaccines) during the study period Child has a health condition which, in the opinion of the investigator, would interfere with the evaluation or pose a health risk to the child

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danuta M Skowronski, MD

Organizational Affiliation

BC Centre for Disease Control

Official's Role

Principal Investigator

Facility Information:

City

Coquitlam

State/Province

British Columbia

ZIP/Postal Code

V3C 4J2

Country

Canada

Facility Name

Vaccine Evaluation Centre

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

Dalhousie University / IWK Health Centre

City

Halifax

State/Province

Nova Scotia

Country

Canada

Facility Name

McGill University Health Centre - Vaccine Study Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H9H4Y6

Country

Canada

Facility Name

Université de Laval - Unité de recherche en santé publique

City

Québec

State/Province

Quebec

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

21857263

Citation

Skowronski DM, Hottes TS, De Serres G, Ward BJ, Janjua NZ, Sabaiduc S, Chan T, Petric M. Influenza Beta/Victoria antigen induces strong recall of Beta/Yamagata but lower Beta/Victoria response in children primed with two doses of Beta/Yamagata. Pediatr Infect Dis J. 2011 Oct;30(10):833-9. doi: 10.1097/INF.0b013e31822db4dc.

Results Reference

derived

PubMed Identifier

21768314

Citation

Skowronski DM, Hottes TS, Chong M, De Serres G, Scheifele DW, Ward BJ, Halperin SA, Janjua NZ, Chan T, Sabaiduc S, Petric M. Randomized controlled trial of dose response to influenza vaccine in children aged 6 to 23 months. Pediatrics. 2011 Aug;128(2):e276-89. doi: 10.1542/peds.2010-2777. Epub 2011 Jul 18.

Results Reference

derived

Learn more about this trial

Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity

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