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

NCT00710866 | Completed Phase 3 Results DMC

• 1 other identifier: PHAC 6273-15-2008/4160872
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 5

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.

Conditions

Influenza

Keywords

Influenza Vaccines; Infant; Dose-Response Relationship, Immunologic

Outcome Measures

Primary Outcomes (8)

• 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

  3 days after immunization

Study Arms (2)

1

EXPERIMENTAL

2 doses 0.5mL VAXIGRIP® at months 0, 1

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

2

ACTIVE COMPARATOR

2 doses 0.25mL VAXIGRIP® at months 0, 1

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

Interventions

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.

Also known as: VAXIGRIP®

1; 2

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Centre for Disease Control: lead

Study Sites (5)

Unknown Facility

Coquitlam, British Columbia, V3C 4J2, Canada

Location

Vaccine Evaluation Centre

Vancouver, British Columbia, Canada

Location

Dalhousie University / IWK Health Centre

Halifax, Nova Scotia, Canada

Location

McGill University Health Centre - Vaccine Study Centre

Montreal, Quebec, H9H4Y6, Canada

Location

Université de Laval - Unité de recherche en santé publique

Québec, Quebec, Canada

Location

Related Publications (2)

• 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.

  PMID: 21857263 DERIVED

• 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.

  PMID: 21768314 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Danuta M Skowronski, MD
• Organization: British Columbia Centre for Disease Control

danuta.skowronski@bccdc.ca

604-660-6067

Study Officials

• Danuta M Skowronski, MD

  BC Centre for Disease Control

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 8, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 4, 2011
• Results First Posted: August 4, 2011

Record last verified: 2011-07

Locations

CA (5)