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Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years

Primary Purpose

Prophylaxis of Avian Influenza

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

H5N1 Influenza Vaccine

About this trial

This is an interventional prevention trial for Prophylaxis of Avian Influenza focused on measuring Bird flu, seasonal influenza vaccine, influenza vaccine, prepandemic vaccine, virus strain with the potential to cause pandemic, toddlers, children, adolescents

Eligibility Criteria

6 Months - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy subjects

Exclusion Criteria:

Receipt of Seasonal Influenza Vaccine for season 2007/2008
Receipt of another vaccine within 3 weeks before and after each vaccination
Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant
Children who are in the local recommendation for influenza vaccination due to underlying diseases

Sites / Locations

University of Tampere Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

0.5mL of H5N1 vaccine 7.5ug

0.25 or 0.5mL of H5N1 vaccine

Outcomes

Primary Outcome Measures

safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart

Secondary Outcome Measures

safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1

safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies

Full Information

NCT ID

NCT00537524

First Posted

September 28, 2007

Last Updated

February 14, 2012

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00537524

Brief Title

Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years

Official Title

A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of an H5N1 Influenza Vaccine in Subjects Aged 6 Months to 17 Years

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination

6. Conditions and Keywords

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

Prophylaxis of Avian Influenza

Keywords

Bird flu, seasonal influenza vaccine, influenza vaccine, prepandemic vaccine, virus strain with the potential to cause pandemic, toddlers, children, adolescents

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

471 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

0.5mL of H5N1 vaccine 7.5ug

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

0.25 or 0.5mL of H5N1 vaccine

Intervention Type

Biological

Intervention Name(s)

H5N1 Influenza Vaccine

Intervention Description

Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).

Intervention Type

Biological

Intervention Name(s)

H5N1 Influenza Vaccine

Intervention Description

Two 0.25mL or 0.5mL injections of H5N1 influenza vaccine, administered 3 weeks apart, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).

Primary Outcome Measure Information:

Title

safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart

Time Frame

administered 3 weeks apart

Secondary Outcome Measure Information:

Title

safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1

Time Frame

12 months after primary immunization

Title

safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies

Time Frame

12 months after primary immunization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy subjects Exclusion Criteria: Receipt of Seasonal Influenza Vaccine for season 2007/2008 Receipt of another vaccine within 3 weeks before and after each vaccination Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant Children who are in the local recommendation for influenza vaccination due to underlying diseases

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines

Organizational Affiliation

Novartis Vaccines

Official's Role

Study Chair

Facility Information:

Facility Name

University of Tampere Medical School

City

Tampere

ZIP/Postal Code

33014

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

20819892

Citation

Vesikari T, Karvonen A, Tilman S, Borkowski A, Montomoli E, Banzhoff A, Clemens R. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics. 2010 Oct;126(4):e762-70. doi: 10.1542/peds.2009-2628. Epub 2010 Sep 6.

Results Reference

result

PubMed Identifier

22777094

Citation

Vesikari T, Forsten A, Borkowski A, Gaitatzis N, Banzhoff A, Clemens R. Homologous and heterologous antibody responses to a one-year booster dose of an MF59((R)) adjuvanted A/H5N1 pre-pandemic influenza vaccine in pediatric subjects. Hum Vaccin Immunother. 2012 Jul;8(7):921-8. doi: 10.4161/hv.20248. Epub 2012 Jul 1.

Results Reference

derived

Learn more about this trial

Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years

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