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St. Louis, Missouri 63104


Purpose:

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).


Criteria:

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.


Study is Available At:


Original ID:

V58P12


NCT ID:

NCT00645411


Secondary ID:

Eudract Number: 2007-0015


Study Acronym:


Brief Title:

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


Official Title:

A Combined Phase II/III, Observer-Blind, Randomized, Multi-center Study to Evaluate Safety, Tolerability and Immunogenicity of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Children


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

3 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

  • Hungary: National Institute of Pharmacy
  • Romania: National Medicines Agency
  • Lithuania: State Medicines Control Agency
  • ITALY: Agenzia Italiana del Farmaco (AIFA)
  • Finland: National Agency for Medicines (NAM)
  • United States: Food and Drug Administration
  • Croatia: Ministry of Health and Social Care


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

3604


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Vaccines
Study Chair
Novartis Vaccines

Study Dates

Start Date:October 2007
Completion Date:July 2008
Completion Type:Actual
Primary Completion Date:February 2008
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 15, 2013
First Received Date:March 21, 2008
First Results Date:November 21, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children
Time Frame:Day 29 and Day 50 post vaccination
Safety Issues:False
Description:To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV_f vaccine, administered 4 weeks apart. The criterion is met according to European (CHMP) guideline if the percentage of subj
Outcome Type:Secondary Outcome
Measure:Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children
Time Frame:Day 29 and Day 50 post vaccination
Safety Issues:False
Description:To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV_f vaccine, administered 4 weeks apart according to the CHMP criteria. The criterion is met according
Outcome Type:Secondary Outcome
Measure:Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children
Time Frame:Day 29 and Day 50 post vaccination
Safety Issues:False
Description:To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV_f,administered 4 weeks apart.
Outcome Type:Secondary Outcome
Measure:Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
Time Frame:Day 29 post vaccination
Safety Issues:False
Description:Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibod
Outcome Type:Secondary Outcome
Measure:Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
Time Frame:Day 29 post vaccination
Safety Issues:False
Description:To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV_f vaccine. This criterion is met according to European (CHMP) guideline if
Outcome Type:Secondary Outcome
Measure:Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
Time Frame:Day 29 post vaccination
Safety Issues:False
Description:Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV_f. The criterion is met according to European (CHMP) guideline if the mean geometric incr
Outcome Type:Secondary Outcome
Measure:Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
Time Frame:Day 29 post vaccination
Safety Issues:False
Description:To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV_f. GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen ass
Outcome Type:Primary Outcome
Measure:Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
Time Frame:Day 50 post vaccination
Safety Issues:False
Description:To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV_f) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all th
Outcome Type:Primary Outcome
Measure:Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
Time Frame:Day 50 post vaccination
Safety Issues:False
Description:To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV_f) influenza vaccine, for all three s
Outcome Type:Secondary Outcome
Measure:Number of Subjects Reporting Local* and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.
Time Frame:up to 7 days after each vaccination
Safety Issues:True
Description:To evaluate the safety and tolerability of the cTIV and the eTIV_f influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local* and systemic reactions after each vaccination.
Outcome Type:Secondary Outcome
Measure:Number of Subjects Reporting Local* and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
Time Frame:up to 7 days after vaccination
Safety Issues:True
Description:To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2)reporting local* and systemic reactions following of one injection of the cTIV or the eTIV_f vaccine .
Outcome Type:Secondary Outcome
Measure:Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children
Time Frame:Day 29 and Day 50 post vaccination
Safety Issues:False
Description:Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibod

Study Interventions

Intervention Type:Biological
Name:Cell culture-derived influenza subunit vaccine (cT
Description:One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
Arm Name:Cohorts 1 + Cohort 2 (9-17 Yrs) cTIV
Intervention Type:Biological
Name:Egg derived influenza subunit vaccine (eTIV_f)
Description:One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
Arm Name:Cohorts 1 + Cohort 2 (9-17 Yrs) eTIV_f
Intervention Type:Biological
Name:Cell culture-derived influenza subunit vaccine (cT
Description: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.
Arm Name:Cohort 3 (3-8 Yrs) cTIV
Intervention Type:Biological
Name:Egg derived influenza subunit vaccine (eTIV_f)
Description: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.
Arm Name:Cohort 3 (3-8 Yrs) eTIV_f

Study Arms

Study Arm Type:Experimental
Arm Name:Cohorts 1 + Cohort 2 (9-17 Yrs) cTIV
Description: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
Study Arm Type:Active Comparator
Arm Name:Cohorts 1 + Cohort 2 (9-17 Yrs) eTIV_f
Description: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.
Study Arm Type:Experimental
Arm Name:Cohort 3 (3-8 Yrs) cTIV
Description: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
Study Arm Type:Active Comparator
Arm Name:Cohort 3 (3-8 Yrs) eTIV_f
Description: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

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Novartis Vaccines

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Vesikari T, Block SL, Guerra F, Lattanzi M, Holmes S, Izu A, Gaitatzis N, Hilbert AK, Groth N. Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age. Pediatr Infect Dis J. 2012 May;31(5):494-500.
PMID:22301476

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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