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Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents

Last Updated: 2015-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

3604 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-07-31

Brief Summary

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The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Cohorts 1 + Cohort 2 (9-17 Yrs) cTIV

All subjects received one 0.5 mL IM injection, of cell culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 \[H1N1\]-like, A/Wisconsin/67/2005 \[H3N2\]-like, and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere

Group Type EXPERIMENTAL

Cell culture-derived influenza subunit vaccine (cTIV)

Intervention Type BIOLOGICAL

One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.

Cohorts 1 + Cohort 2 (9-17 Yrs) eTIV

All subjects received one 0.5 mL injection, of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 \[H1N1\]-like, A/Wisconsin/67/2005 \[H3N2\]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere.

Group Type ACTIVE_COMPARATOR

Egg derived influenza subunit vaccine (eTIV)

Intervention Type BIOLOGICAL

One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.

Cohort 3 (3-8 Yrs) cTIV

All subjects received two 0.5 mL injections, administered four weeks apart, of cell culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 \[H1N1\]-like, A/Wisconsin/67/2005 \[H3N2\]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere

Group Type EXPERIMENTAL

Cell culture-derived influenza subunit vaccine (cTIV)

Intervention Type BIOLOGICAL

Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.

Cohort 3 (3-8 Yrs) eTIV

All subjects received two 0.5 mL injections, administered four weeks apart of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 \[H1N1\]-like, A/Wisconsin/67/2005 \[H3N2\]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere

Group Type ACTIVE_COMPARATOR

Egg derived influenza subunit vaccine (eTIV)

Intervention Type BIOLOGICAL

Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.

Interventions

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Cell culture-derived influenza subunit vaccine (cTIV)

One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.

Intervention Type BIOLOGICAL

Egg derived influenza subunit vaccine (eTIV)

One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.

Intervention Type BIOLOGICAL

Cell culture-derived influenza subunit vaccine (cTIV)

Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.

Intervention Type BIOLOGICAL

Egg derived influenza subunit vaccine (eTIV)

Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Subjects aged 9 to 17 years (Cohorts 1 and 2) and 3 to 8 years (Cohort 3), whose parents/legal guardians have given written informed consent prior to study entry. Assent will be obtained from subjects according to age requirements of the ECs/IRBs;
2. In good health as determined by:

1. medical history,
2. physical examination,
3. clinical judgment of the Investigator;
3. Able to comply with all study procedures and available for all clinic visits and telephone calls scheduled in the study.

Exclusion Criteria

1. Any serious disease, such as:

1. cancer,
2. autoimmune disease (including rheumatoid arthritis),
3. diabetes mellitus,
4. chronic pulmonary disease,
5. acute or progressive hepatic disease,
6. acute or progressive renal disease;
2. History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
3. Known or suspected impairment/alteration of immune function, including:

1. use of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 60 days prior to Visit 1,
2. cancer chemotherapy,
3. receipt of immunostimulants within 60 days prior to Visit 1,
4. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
5. known HIV infection or HIV-related disease;
4. History of Guillain-Barré syndrome;
5. Bleeding diathesis;
6. Surgery planned during the study period;
7. Receipt of another investigational agent within 90 days, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
8. Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
9. Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
10. For subjects aged 3 to 8 years old, ever received two doses of an influenza vaccine in one influenza season;
11. Receipt of an influenza vaccine within 6 months prior to Visit 1;
12. Experienced a temperature 38.0°C \[100.4°F\]) and/or any acute illness within 3 days prior to Visit 1;
13. Pregnant or nursing mother;
14. Female of childbearing potential who is sexually active and has not used acceptable birth control measures for at least 2 months prior to study entry and who does not plan to use acceptable birth control measures during the 3 weeks following vaccination or refuses to have a urine pregnancy test prior to enrollment. Oral, injected, inserted or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control;
15. Children of research staff or those living with research staff directly involved with the clinical study. Research staff are individuals with direct study subject contact, indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.;
16. Any condition, which in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Site 09

Fayetteville, Arkansas, United States

Site Status

Site 10

Downey, California, United States

Site Status

Site 02

Bardstown, Kentucky, United States

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Site 14

Metairie, Louisiana, United States

Site Status

Site 01

St Louis, Missouri, United States

Site Status

Site 11

Omaha, Nebraska, United States

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Site 04

Edison, New Jersey, United States

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Site 05

Endwell, New York, United States

Site Status

Site 16

Fort Worth, Texas, United States

Site Status

Site 13

San Angelo, Texas, United States

Site Status

Site 12

San Antonio, Texas, United States

Site Status

Site 08

Bountiful, Utah, United States

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Site 07

Salt Lake City, Utah, United States

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Site 03

Salt Lake City, Utah, United States

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Site 06

Burke, Virginia, United States

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