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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 2 doses 0.5mL VAXIGRIP® at months 0, 1 |
|
| 2 | Active Comparator | 2 doses 0.25mL VAXIGRIP® at months 0, 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated Influenza Vaccine Trivalent Types A and B (Split Virion) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1) | Seroprotection rate: HI titers =>40 | 27-46 days after the second dose |
| Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1) | Seroprotection rate: HI titers =>40 | 27-46 days after the second dose |
| Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2) | Seroprotection rate: HI titers =>40 | 27-46 days after the second dose |
| Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2) | Seroprotection rate: HI titers =>40 | 27-46 days after the second dose |
| Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata) | 27-46 days after the second dose | |
| Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata) | Seroprotection rate: HI titers =>40 | 27-46 days after the second dose |
| Adverse Events: Fever After Either Dose - Infants 6-11 Months | Fever defined as temperature >= 38 C | 3 days after immunization |
| Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)- | Fever defined as temperature >= 38 C |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danuta M Skowronski, MD | BC Centre for Disease Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coquitlam | British Columbia | V3C 4J2 | Canada | |||
| Vaccine Evaluation Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21857263 | Derived | 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. | |
| 21768314 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5mL VAXIGRIP® | 2 doses 0.5mL VAXIGRIP® at months 0, 1 |
| FG001 | 0.25mL VAXIGRIP® | 2 doses 0.25mL VAXIGRIP® at months 0, 1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5mL VAXIGRIP® | 2 doses 0.5mL VAXIGRIP® at months 0, 1 |
| BG001 | 0.25mL VAXIGRIP® | 2 doses 0.25mL VAXIGRIP® at months 0, 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1) | Seroprotection rate: HI titers =>40 | Per Protocol | Posted | Jan 2012 | Number | participants | 27-46 days after the second dose |
|
|
Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.5mL VAXIGRIP® | 2 doses 0.5mL VAXIGRIP® at months 0, 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danuta M Skowronski, MD | British Columbia Centre for Disease Control | 604-660-6067 | danuta.skowronski@bccdc.ca |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C478242 | vaxigrip |
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|
|
| 3 days after immunization |
| Vancouver |
| British Columbia |
| Canada |
| Dalhousie University / IWK Health Centre | Halifax | Nova Scotia | Canada |
| McGill University Health Centre - Vaccine Study Centre | Montreal | Quebec | H9H4Y6 | Canada |
| Université de Laval - Unité de recherche en santé publique | Québec | Quebec | Canada |
| 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. |
| Lost to Follow-up |
|
| Failed to meet eligibility |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1) | Seroprotection rate: HI titers =>40 | Per Protocol | Posted | Jan 2012 | Number | participants | 27-46 days after the second dose |
|
|
|
| Primary | Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2) | Seroprotection rate: HI titers =>40 | Per Protocol | Posted | Jan 2012 | Number | participants | 27-46 days after the second dose |
|
|
|
| Primary | Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2) | Seroprotection rate: HI titers =>40 | Per Protocol | Posted | Jan 2012 | Number | participants | 27-46 days after the second dose |
|
|
|
| Primary | Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata) | Per Protocol | Posted | Jan 2012 | Number | participants | 27-46 days after the second dose |
|
|
|
| Primary | Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata) | Seroprotection rate: HI titers =>40 | Per Protocol | Posted | Jan 2012 | Number | participants | 27-46 days after the second dose |
|
|
|
| Primary | Adverse Events: Fever After Either Dose - Infants 6-11 Months | Fever defined as temperature >= 38 C | Per Protocol | Posted | Number | participants | 3 days after immunization |
|
|
|
| Primary | Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)- | Fever defined as temperature >= 38 C | Per Protocol | Posted | Number | participants | 3 days after immunization |
|
|
|
| 0 |
| 124 |
| 108 |
| 124 |
| EG001 | 0.25mL VAXIGRIP® | 2 doses 0.25mL VAXIGRIP® at months 0, 1 | 1 | 128 | 107 | 126 |
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tenderness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Decreased appetite | General disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Sleep disturbance | General disorders | Systematic Assessment |
|
| Upper Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Ocular | Eye disorders | Non-systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Teething | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Miscellaneous | General disorders | Non-systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |