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Immunogenicity and Safety Following a Single Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine (an Adjuvanted Sub-unit Influenza Vaccine and a Non-adjuvanted Split Virion Influenza Vaccine) in the Previous V70P2 Study

Primary Purpose

FLU

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

Influenza Trivalent Inactivated Vaccines

About this trial

This is an interventional prevention trial for FLU focused on measuring Influenza, vaccines, children

Eligibility Criteria

16 Months - 48 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

children up to 48 months of age, who received both doses of one of the two study vaccines in the previous V70P2 trial, whose parents/legal guardians have given written informed consent prior to study entry,
in good health as determined by:medical history, physical examination, clinical judgment of the investigator.

Exclusion Criteria:

Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start;
Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 15 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable);
Fever (defined as axillary temperature ≥ 38.0°C/rectal temperature ≥ 38.5°C) within the 7 days before enrolment;
Any serious disease including, for example:cancer,autoimmune disease (including rheumatoid arthritis),diabetes mellitus,chronic pulmonary disease,acute or progressive hepatic disease,acute or progressive renal disease;
Known or suspected impairment/alteration of immune function, for example, resulting from:receipt of immunosuppressive therapy (corticosteroid - except topical or inhaled steroids - or cancer chemotherapy),receipt of immunostimulants,receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,high risk for developing an immunocompromising disease;
Bleeding diathesis;
History of hypersensitivity to any component of the study medication or chemically related substances;
History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component;
Laboratory confirmed influenza disease in the past 6 months;
Surgery planned during the study period;
Receipt of another investigational vaccine or any investigational agent within 30 days prior to study start. All routine vaccines should be given according to local recommendations: routine vaccines or any other vaccines not foreseen in the protocol can be given after the active trial phase (i.e. 4 weeks after last vaccination in the respective season) has been concluded;
Participation to another trial of an investigational agent within 90 days of enrolment;
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Sites / Locations

University of Tampere Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the immunogenicity of a single 0.25mL or 0.5mL IM injection of two different influenza vaccines, in terms of post-immunization geometric mean titers (GMTs), as measured by HI test, in healthy children aged up to 48 months.

Secondary Outcome Measures

Immunogenicity of a single 0.25 or 0.5mL IM injection of two different influenza vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test in healthy children aged up to 48 months.

To evaluate the safety and tolerability of a single 0.25 or 0.5 mL IM injection of two different influenza vaccines in healthy children aged up to 48 months

Full Information

NCT ID

NCT00644540

First Posted

March 21, 2008

Last Updated

November 30, 2016

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00644540

Brief Title

Immunogenicity and Safety Following a Single Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine (an Adjuvanted Sub-unit Influenza Vaccine and a Non-adjuvanted Split Virion Influenza Vaccine) in the Previous V70P2 Study

Official Title

A Phase II, Observer-Blind, Parallel Groups, Single Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine in the Previous V70P2 Study.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary

The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. To evaluate the safety and tolerability of a single 0.25mL IM of injection influenza vaccines in healthy children aged up to 35 months; to evaluate the safety and tolerability of a single 0.50mL IM injection of influenza vaccines in healthy children aged up to 48 months.

6. Conditions and Keywords

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

FLU

Keywords

Influenza, vaccines, children

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Influenza Trivalent Inactivated Vaccines

Intervention Description

This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age. Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial. Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm.

Intervention Type

Biological

Intervention Name(s)

Influenza Trivalent Inactivated Vaccines

Intervention Description

Primary Outcome Measure Information:

Title

Time Frame

181 days

Secondary Outcome Measure Information:

Title

Time Frame

181 days

Title

To evaluate the safety and tolerability of a single 0.25 or 0.5 mL IM injection of two different influenza vaccines in healthy children aged up to 48 months

Time Frame

181 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Months

Maximum Age & Unit of Time

48 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: children up to 48 months of age, who received both doses of one of the two study vaccines in the previous V70P2 trial, whose parents/legal guardians have given written informed consent prior to study entry, in good health as determined by:medical history, physical examination, clinical judgment of the investigator. Exclusion Criteria: Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start; Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 15 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable); Fever (defined as axillary temperature ≥ 38.0°C/rectal temperature ≥ 38.5°C) within the 7 days before enrolment; Any serious disease including, for example:cancer,autoimmune disease (including rheumatoid arthritis),diabetes mellitus,chronic pulmonary disease,acute or progressive hepatic disease,acute or progressive renal disease; Known or suspected impairment/alteration of immune function, for example, resulting from:receipt of immunosuppressive therapy (corticosteroid - except topical or inhaled steroids - or cancer chemotherapy),receipt of immunostimulants,receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,high risk for developing an immunocompromising disease; Bleeding diathesis; History of hypersensitivity to any component of the study medication or chemically related substances; History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component; Laboratory confirmed influenza disease in the past 6 months; Surgery planned during the study period; Receipt of another investigational vaccine or any investigational agent within 30 days prior to study start. All routine vaccines should be given according to local recommendations: routine vaccines or any other vaccines not foreseen in the protocol can be given after the active trial phase (i.e. 4 weeks after last vaccination in the respective season) has been concluded; Participation to another trial of an investigational agent within 90 days of enrolment; Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines

Organizational Affiliation

Novartis

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

19840662

Citation

Vesikari T, Groth N, Karvonen A, Borkowski A, Pellegrini M. MF59-adjuvanted influenza vaccine (FLUAD) in children: safety and immunogenicity following a second year seasonal vaccination. Vaccine. 2009 Oct 23;27(45):6291-5. doi: 10.1016/j.vaccine.2009.02.004.

Results Reference

result

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