NCT00645411|CompletedPhase 2ResultsDMC

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

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 and Adolescents

Novartis ClinicalTrials.gov

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2 other identifiers

V58P12Eudract Number: 2007-001534-13

Study Type

interventional

Target

3,604

Locations

7 countries

Sites

Timeline

RegisteredMar 2008

StartedOct 2007

CompletionJul 2008

Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

3,604

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2007

Shorter than P25 for phase_2

Geographic Reach

7 countries

60 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

October 1, 2007

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed

4.5 years until next milestone

Results Posted

Study results publicly available

January 16, 2013

Completed

Last Updated

November 23, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

March 21, 2008

Results QC Date

November 21, 2012

Last Update Submit

October 20, 2015

Conditions

Influenza

Keywords

InfluenzaFluCell Culture-DerivedEgg-DerivedHealthy ChildrenHealthy AdolescentsSafetyImmunogenicityTrivalentInactivatedVaccination

Outcome Measures

Primary Outcomes (2)

Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
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) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age. GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
Day 50 post vaccination
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
To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age. Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay.
Day 50 post vaccination

Secondary Outcomes (10)

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
Day 29 post vaccination
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.
Day 29 post vaccination
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
Day 29 post vaccination
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
Day 29 post vaccination
Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children
Day 29 and Day 50 post vaccination
+5 more secondary outcomes

Study Arms (4)

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

EXPERIMENTAL

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

Biological: Cell culture-derived influenza subunit vaccine (cTIV)

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

ACTIVE COMPARATOR

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.

Biological: Egg derived influenza subunit vaccine (eTIV)

Cohort 3 (3-8 Yrs) cTIV

EXPERIMENTAL

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

Biological: Cell culture-derived influenza subunit vaccine (cTIV)

Cohort 3 (3-8 Yrs) eTIV

ACTIVE COMPARATOR

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

Biological: Egg derived influenza subunit vaccine (eTIV)

Interventions

Cell culture-derived influenza subunit vaccine (cTIV)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) cTIV

Egg derived influenza subunit vaccine (eTIV)BIOLOGICAL

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

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

Eligibility Criteria

Age3 Years - 17 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

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;
In good health as determined by:
medical history,
physical examination,
clinical judgment of the Investigator;
Able to comply with all study procedures and available for all clinic visits and telephone calls scheduled in the study.

You may not qualify if:

Any serious disease, such as:
cancer,
autoimmune disease (including rheumatoid arthritis),
diabetes mellitus,
chronic pulmonary disease,
acute or progressive hepatic disease,
acute or progressive renal disease;
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;
Known or suspected impairment/alteration of immune function, including:
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,
cancer chemotherapy,
receipt of immunostimulants within 60 days prior to Visit 1,
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,
known HIV infection or HIV-related disease;
History of Guillain-Barré syndrome;
+12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Novartislead
Novartis Vaccinescollaborator

Study Sites (60)

Site 09

Fayetteville, Arkansas, 72703, United States

Location

Site 10

Downey, California, 90241, United States

Location

Site 02

Bardstown, Kentucky, 40004, United States

Location

Site 14

Metairie, Louisiana, 70006, United States

Location

Site 01

St Louis, Missouri, 63104, United States

Location

Site 11

Omaha, Nebraska, 68134, United States

Location

Site 04

Edison, New Jersey, 08817, United States

Location

Site 05

Endwell, New York, 13760, United States

Location

Site 16

Fort Worth, Texas, 76135, United States

Location

Site 13

San Angelo, Texas, 76904, United States

Location

Site 12

San Antonio, Texas, 78205, United States

Location

Site 08

Bountiful, Utah, 84010, United States

Location

Site 07

Salt Lake City, Utah, 84109, United States

Location

Site 03

Salt Lake City, Utah, 84121, United States

Location

Site 06

Burke, Virginia, 22105, United States

Location

Site 15

Spokane, Washington, 99202, United States

Location

Site 27:Institute of Public Health