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CompletedNCT00645411Updated Nov 23, 2015Results posted

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

A Phase 2/3 interventional study of Cell culture-derived influenza subunit vaccine (cTIV) and Egg derived influenza subunit vaccine (eTIV) in Influenza, sponsored by Novartis. Completed at 60 sites in 7 countries. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-23.

Sponsored by Novartis · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
3,604
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Influenza

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Keywords

  • Influenza
  • Flu
  • Cell Culture-Derived
  • Egg-Derived
  • Healthy Children
  • Healthy Adolescents
  • Safety
  • Immunogenicity
  • Trivalent
  • Inactivated
  • Vaccination
03

In context

Influenza, Human

2,265 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's enrollment of 3,604 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

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Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
3,604 participants (actual)

Study arms

  • Experimental
    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

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

  • Active comparator
    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.

    Biological: Egg derived influenza subunit vaccine (eTIV)

  • Experimental
    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

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

  • Active comparator
    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

    Biological: Egg derived influenza subunit vaccine (eTIV)

Interventions

  • BiologicalCell 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.

  • BiologicalEgg 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.

  • BiologicalCell 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.

  • BiologicalEgg 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 50 post vaccination

  2. 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.

    Time frame: Day 50 post vaccination

Secondary outcomes

  1. 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

    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. GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.

    Time frame: Day 29 post vaccination

  2. 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.

    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. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is \>2.5.

    Time frame: Day 29 post vaccination

  3. 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

    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 vaccine. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \>70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.

    Time frame: Day 29 post vaccination

  4. 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

    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 antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be \>40%. According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.

    Time frame: Day 29 post vaccination

  5. Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children

    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,administered 4 weeks apart.

    Time frame: Day 29 and Day 50 post vaccination

  6. Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children

    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 vaccine, administered 4 weeks apart according to the CHMP criteria. The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is \>2.5

    Time frame: Day 29 and Day 50 post vaccination

  7. 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

    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 vaccine, administered 4 weeks apart. The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \>70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.

    Time frame: Day 29 and Day 50 post vaccination

  8. 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

    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 antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be \>40%. According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.

    Time frame: Day 29 and Day 50 post vaccination

  9. 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.

    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 vaccine .

    Time frame: up to 7 days after vaccination

  10. 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.

    To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.

    Time frame: up to 7 days after each vaccination

07

Results

Posted Jan 16, 2013

Participant flow

Participants were enrolled from 14 sites in Finland, 16 in the US, 9 in Croatia, 5 in Italy, 6 in Lithuania, 2 in Romania, 8 in Hungary.

Participant flow — Overall Study
MilestoneCohort 1+2 cTIV (9-17 Years)Cohort 1+2 eTIV (9-17 Years)Cohort 3 cTIV (3-8 Years)Cohort 3 eTIV (3-8 Years)
Started65631816081022
Completed6433121457919
Not completed136151103
Withdrew: Adverse event0002
Withdrew: Withdrawal by subject211921
Withdrew: Lost to follow-up10512475
Withdrew: Protocol violation1010
Withdrew: Inappropriate enrollment0041
Withdrew: Unable to classify0034

Outcome measures

PrimaryGeometric 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.

Time frame:
Day 50 post vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
TitersCohort 3 cTIV (3-8 Years)Cohort 3 eTIV (3-8 Years)
A/H1N1 (egg derived antigen assay)407 (358 to 462)477 (419 to 542)
A/H3N2 (egg derived antigen assay)768 (666 to 885)1293 (1121 to 1491)
B (egg derived antigen assay)25 (21 to 29)44 (38 to 51)
A/H1N1 (cell derived antigen assay) (N=522,513)563 (501 to 634)610 (542 to 686)
A/H3N2 (cell derived antigen assay) (N=522,513)858 (744 to 990)1329 (1152 to 1533)
B (cell derived antigen assay) (N=522,513)53 (46 to 62)62 (53 to 72)
Statistical analysis
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · ANOVA · Ratio of gmts: 0.85 · 95% CI 0.72 to 1.01
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · ANOVA · Ratio of gmts: 0.59 · 95% CI 0.49 to 0.72
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · ANOVA · Ratio of gmts: 0.56 · 95% CI 0.46 to 0.68
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · ANOVA · Ratio of gmts: 0.92 · 95% CI 0.79 to 1.08
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · ANOVA · Ratio of gmts: 0.65 · 95% CI 0.54 to 0.78
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · ANOVA · Ratio of gmts: 0.87 · 95% CI 0.71 to 1.06
PrimaryPercentages 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.

Time frame:
Day 50 post vaccination
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsCohort 3 cTIV (3-8 Years)Cohort 3 eTIV (3-8 Years)
A/H1N1 (egg derived antigen assay)94 (92 to 96)96 (94 to 97)
A/H3N2 (egg derived antigen assay)77 (73 to 81)86 (82 to 89)
B (egg derived antigen assay)38 (34 to 42)53 (49 to 58)
A/H1N1 (cell derived antigen assay) (N=522,513)96 (93 to 97)96 (94 to 98)
A/H3N2 (cell derived antigen assay) (N=522,513)80 (76 to 83)85 (82 to 88)
B (cell derived antigen assay) (N=522,513)58 (54 to 63)58 (54 to 63)
Statistical analysis
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · binomial or the method of Miettinen and · Difference in % (ctiv minus etiv): -1 · 95% CI -4 to 1
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · binomial or Miettinen & Nurimen method · Difference % (ctiv - etiv): -9 · 95% CI -13 to -4
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · binominal or Miettinen &Nurimen method · Difference % (ctiv minus etiv): -15 · 95% CI -21 to -9
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · binominal or Miettinen &Nurimen method · Difference % (ctiv minus etiv): -1 · 95% CI -3 to 2
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · binominal or Miettinen &Nurimen method · Difference % (ctiv minus etiv): -5 · 95% CI -9.5 to 0
  • Cohort 3 cTIV (3-8 Years) vs Cohort 3 eTIV (3-8 Years) · binominal or Miettinen &Nurimen method · Difference % (ctiv minus etiv): 0 · 95% CI -6 to 6
SecondaryGeometric 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

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. GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.

Time frame:
Day 29 post vaccination
Reported as:
Geometric mean · Titers
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
TitersCohort 1 cTIV (9-17 Years)Cohort 1 eTIV (9-17 Years)
Baseline (A/H1N1) egg derived antigen assay55 (42 to 72)78 (60 to 101)
Day 29 (A/H1N1) egg derived antigen assay879 (728 to 1062)1107 (918 to 1334)
Baseline (A/H3N2) egg derived antigen assay121 (94 to 155)151 (118 to 193)
Day 29 (A/H3N2) egg derived antigen assay706 (607 to 821)1857 (1598 to 2157)
Baseline (B) Egg derived antigen assay9.65 (8.2 to 11)9.92 (8.45 to 12)
Day 29 (B) egg derived antigen assay58 (48 to 71)105 (86 to 129)
Baseline(A/H1N1)Cell derived assay70 (53 to 92)90 (69 to 119)
Day 29 (A/H1N1) cell derived antigen assay1076 (886 to 1307)1296 (1069 to 1571)
Baseline(A/H3N2)cell derived assay(N=141,144)125 (98 to 158)144 (114 to 182)
Day 29 (A/H3N2) cell derived antigen assay676 (585 to 783)1651 (1429 to 1908)
Baseline(B)cell derived assay(N=141,144)22 (18 to 27)25 (21 to 30)
Day 29 (B) cell derived antigen assay136 (113 to 163)186 (155 to 222)
SecondaryGeometric 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.

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. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is \>2.5.

Time frame:
Day 29 post vaccination
Reported as:
Geometric mean · Ratio
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.
RatioCohort 1 cTIV (9-17 Years)Cohort 1 eTIV (9-17 Years)
Day 29 (A/H1N1)egg derived antigen assay16 (12 to 21)14 (11 to 19)
Day 29 (A/H3N2) egg derived antigen assay5.84 (4.43 to 7.7)12 (9.33 to 16)
Day 29 (B) egg derived antigen assay6.03 (4.77 to 7.62)11 (8.43 to 13)
Day29(A/H1N1)cell derived antigen assay(N=141,144)15 (12 to 21)14 (11 to 19)
Day29(A/H3N2)cell derived antigen assay(N=141,144)5.45 (4.21 to 7.06)11 (8.87 to 15)
Day29(B) cell derived antigen assay(N=141,144)6.15 (4.96 to 7.63)7.37 (5.96 to 9.12)
SecondaryPercentages 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

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 vaccine. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \>70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.

Time frame:
Day 29 post vaccination
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsCohort 1 cTIV (9-17 Years)Cohort 1 eTIV (9-17 Years)
Prevaccination (A/H1N1)egg derived antigen assay65 (57 to 73)75 (67 to 82)
Day 29 (A/H1N1) egg derived antigen assay99 (96 to 100)99 (95 to 100)
Prevaccination (A/H3N2) egg derived antigen assay82 (74 to 88)86 (79 to 91)
Day 29 (A/H3N2) egg derived antigen assay100 (97 to 100)100 (97 to 100)
Prevaccination(B)egg derived antigen assay17 (11 to 24)13 (8 to 19)
Day 29 (B) egg derived antigen assay75 (67 to 82)84 (77 to 90)
Prevaccination (H1N1)cell derived assay(N=141,144)67 (59 to 75)78 (71 to 85)
Day 29 (A/H1N1)cell derived antigen assay99 (96 to 100)98 (94 to 100)
Prevaccination (H3N2)cell derived assay(N=141,144)83 (76 to 89)86 (79 to 91)
Day 29 (A/H3N2) cell derived antigen assay100 (97 to 100)100 (97 to 100)
Prevaccination (B) cell derived assay(N=141,144)40 (32 to 49)47 (38 to 55)
Day 29 (B) cell derived antigen assay95 (90 to 98)94 (89 to 98)
SecondaryPercentages 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

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 antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be \>40%. According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.

Time frame:
Day 29 post vaccination
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsCohort 1 cTIV (9-17 Years)Cohort 1 eTIV (9-17 Years)
Day 29 (A/H1N1) egg derived antigen assay77 (70 to 84)77 (69 to 84)
Day 29 (A/H3N2) egg derived antigen assay56 (48 to 65)77 (69 to 84)
Day 29 (B) egg derived antigen assay56 (48 to 65)71 (63 to 78)
Day29(A/H1N1)cell derived antigen assay(N=141,144)74 (66 to 81)74 (66 to 81)
Day29(A/H3N2)cell derived antigen assay(N=141,144)52 (44 to 61)78 (70 to 84)
Day29(B)cell derived antigen assay (N=141,144)63 (55 to 71)69 (61 to 76)
SecondaryGeometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children

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,administered 4 weeks apart.

Time frame:
Day 29 and Day 50 post vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children
TitersCohort 3 cTIV (3-8 Years)Cohort 3 eTIV (3-8 Years)
Baseline (A/H1N1) egg derived antigen assay16 (14 to 18)15 (13 to 17)
Day29(A/H1N1)egg derived antigen assay(N=515,507)152 (124 to 186)157 (128 to 192)
Day50(A/H1N1)egg derived antigen assay407 (358 to 462)477 (419 to 542)
Baseline (A/H3N2) egg derived antigen assay68 (58 to 80)74 (63 to 87)
Day29(A/H3N2)egg derived antigen assay(N=515,507)584 (478 to 713)1075 (880 to 1312)
Day50(A/H3N2)egg derived antigen assay768 (666 to 885)1293 (1121 to 1491)
Baseline (B) egg derived antigen assay6.16 (5.86 to 6.48)6.24 (5.93 to 6.56)
Day29(B) egg derived antigen assay (N=515,507)19 (16 to 22)27 (23 to 33)
Day 50 (B) egg derived antigen assay25 (21 to 29)44 (38 to 51)
Baseline (A/H1N1) cell derived antigen assay19 (16 to 22)17 (14 to 19)
Day 29 (A/H1N1) cell derived antigen assay234 (194 to 283)192 (159 to 232)
Day50(A/H1N1)cell derived antigen assay(N=522,513)563 (501 to 634)610 (542 to 686)
Baseline (A/H3N2) cell derived antigen assay75 (64 to 88)85 (72 to 99)
Day 29 (A/H3N2) cell derived antigen assay653 (536 to 795)1099 (903 to 1339)
Day50(A/H3N2)cell derived antigen assay(N=522,513)858 (744 to 990)1329 (1152 to 1533)
Baseline (B) cell derived antigen assay8.22 (7.59 to 8.9)8.72 (8.05 to 9.45)
Day 29 (B) cell derived antigen assay29 (24 to 36)36 (30 to 44)
Day50 (B) cell derived antigen assay(N=522,513)53 (46 to 62)62 (53 to 72)
SecondaryGeometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children

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 vaccine, administered 4 weeks apart according to the CHMP criteria. The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is \>2.5

Time frame:
Day 29 and Day 50 post vaccination
Reported as:
Geometric mean · Ratio
Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children
RatioCohort 3 cTIV (3-8 Years)Cohort 3 eTIV (3-8 Years)
Day29 (A/H1N1)egg derived antigen assay(N=515,507)9.58 (8.37 to 11)11 (9.36 to 12)
Day 50 (A/H1N1) egg derived antigen assay25 (23 to 28)33 (29 to 36)
Day29 (A/H3N2)egg derived antigen assay(N=515,507)8.65 (7.4 to 10)15 (13 to 17)
Day 50 (A/H3N2) egg derived antigen assay11 (9.84 to 13)17 (15 to 20)
Day 29 (B) egg derived assay (N=515,5073.04 (2.59 to 3.57)4.36 (3.71 to 5.12)
Day 50 (B) egg derived antigen assay3.99 (3.49 to 4.57)7.04 (6.15 to 8.07)
Day 29 (A/H1N1) cell derived antigen assay13 (11 to 14)12 (10 to 13)
Day50(A/H1N1)cell derived antigen assay(N=522,51330 (27 to 34)37 (33 to 42)
Day 29 (A/H3N2) cell derived antigen assay8.73 (7.54 to 10)13 (11 to 15)
Day50(A/H3N2)cell derived antigen assay(N=522,513)12 (10 to 13)16 (14 to 18)
Day 29 (B) cell derived antigen assay3.59 (3.08 to 4.19)4.14 (3.55 to 4.82)
Day 50 (B) cell derived antigen assay(N=522,513)6.5 (5.75 to 7.34)7.06 (6.24 to 7.99)
SecondaryPercentages 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

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 vaccine, administered 4 weeks apart. The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is \>70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.

Time frame:
Day 29 and Day 50 post vaccination
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsCohort 3 cTIV (3-8 Years)Cohort 3 eTIV (3-8 Years)
Prevaccination (A/H1N1) egg derived antigen assay35 (30 to 39)31 (27 to 35)
Day29(A/H1N1)egg derived antigen assay (N=515,507)72 (68 to 76)68 (64 to 72)
Day 50 (A/H1N1) egg derived antigen assay96 (94 to 98)97 (95 to 98)
Prevaccination (A/H3N2) egg derived antigen assay67 (62 to 71)70 (66 to 74)
Day29(A/H3N2)egg derived antigen assay(N=515,507)87 (84 to 90)85 (82 to 88)
Day50 (A/H3N2) egg derived antigen assay96 (94 to 98)94 (91 to 96)
Prevaccination (B) egg derived antigen assay4 (3 to 7)4 (3 to 6)
Day 29 (B) egg derived antigen assay (N=515,507)35 (30 to 39)40 (36 to 45)
Day 50 (B) egg derived antigen assay40 (35 to 44)55 (51 to 95)
Prevaccination (A/H1N1) cell derived antigen assay36 (32 to 40)33 (29 to 38)
Day 29 (A/H1N1) cell derived antigen assay82 (78 to 85)76 (72 to 80)
Day50(A/H1N1)cell derived antigen assay(N=522,513)98 (97 to 99)98 (96 to 99)
Prevaccination (A/H3N2) cell derived antigen assay71 (67 to 75)75 (71 to 79)
Day 29 (A/H3N2) cell derived antigen assay89 (86 to 92)85 (82 to 88)
Day50(A/H3N2)cell derived antigen assay(N=522,513)98 (96 to 99)93 (91 to 95)
Prevaccination (B) cell derived antigen assay11 (8 to 14)12 (10 to 16)
Day 29 (B) cell derived antigen assay43 (39 to 47)45 (40 to 49)
Day 50 (B) cell derived antigen assay (N=522,513)60 (56 to 65)62 (57 to 66)
SecondaryPercentages 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

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 antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be \>40%. According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.

Time frame:
Day 29 and Day 50 post vaccination
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsCohort 3 cTIV (3-8 Years)Cohort 3 eTIV (3-8 Years)
Day29(A/H1N1) egg derived antigen assay(N=515,507)70 (66 to 74)67 (63 to 72)
Day 50 (H1N1) egg derived antigen assay94 (92 to 96)96 (94 to 97)
Day29(A/H3N2) egg derived antigen assay(N=515,507)65 (61 to 70)78 (74 to 81)
Day 50 (A/H3N2) egg derived antigen assay77 (73 to 81)86 (82 to 89)
Day29(B) egg derived antigen assay(N=515,507)33 (29 to 37)38 (34 to 43)
Day 50 (B) egg derived antigen assay38 (34 to 42)53 (49 to 58)
Day 29 (A/H1N1) cell derived antigen assay79 (75 to 83)75 (70 to 78)
Day50(A/H1N1)cell derived antigen assay(N=522,513)96 (93 to 97)96 (94 to 98)
Day 29 (A/H3N2) cell derived antigen assay70 (66 to 74)76 (72 to 80)
Day50(A/H3N2)cell derived antigen assay(N=522,513)80 (76 to 83)85 (82 to 88)
Day 29 (B) cell derived antigen assay40 (36 to 44)41 (37 to 45)
Day 50(B)cell derived antigen assay(N=522,513)58 (54 to 63)58 (54 to 63)
SecondaryNumber 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.

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 vaccine .

Time frame:
up to 7 days after vaccination
Reported as:
Number · Subjects
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.
SubjectsCohort 1+2 cTIV (9-17 Years)Cohort 1+2 eTIV (9-17 Years)
Any Local276141
Injection site pain220120
Injection site erythema9145
Injection site induration4428
Injection site ecchymosis3410
Injection site swelling3217
Any Systemic18895
Chills2613
Malaise6034
Myalgia9959
Arthralgia2717
Headache9244
Sweating143
Fatigue5741
Fever (≥38C) (N=651,316)53
Any Other4437
Stayed at home (n=649,316)910
Analgesic Medication Used4231
SecondaryNumber 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.

To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.

Time frame:
up to 7 days after each vaccination
Reported as:
Number · Subjects
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.
SubjectsCohort 3 cTIV (3-8 Years)Cohort 3 eTIV (3-8 Years)
Injection site pain653398
Injection site erythema337206
Injection site induration14184
Injection site ecchymosis14499
Injection site swelling11985
Chills7068
Malaise156117
Myalgia202119
Arthralgia6528
Headache182144
Sweating4728
Fatigue210170
Fever (≥ 38C)7560
Oral temp; 38 to <38.9 C (N=1598,1013)4843
Stayed at home (N=1582,1003,1519, 955)7763
Analgesic Medication Used221148
Oral temp; 39 to < 40 C (N=1598,1013)1615
Oral temp; ≥ 40 C (N=1598,1013)61

Adverse events

Collected over Throughout the study period (Day 1-181 for Cohorts 1 and 2, and Day 1-209 for cohort 3). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1+2 cTIV (9-17 Years)—5/652 (0.8%)328/652 (50.3%)
Cohort 1+2 eTIV (9-17 Years)—3/316 (0.9%)168/316 (53.2%)
Cohort 3 cTIV (3-8 Yrs; 1st Vaccination)—2/1,599 (0.1%)799/1,599 (50%)
Cohort 3 eTIV (3-8 Yrs; 1st Vaccination)—0/1,013 (0%)507/1,013 (50%)
Cohort 3 cTIV (3-8 Yrs; 2nd Vaccination)—7/1,557 (0.4%)670/1,557 (43%)
Cohort 3 eTIV (3-8 Yrs; 2nd Vaccination)—5/977 (0.5%)413/977 (42.3%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventCohort 1+2 cTIV (9-17 Years)Cohort 1+2 eTIV (9-17 Years)Cohort 3 cTIV (3-8 Yrs; 1st Vaccination)Cohort 3 eTIV (3-8 Yrs; 1st Vaccination)Cohort 3 cTIV (3-8 Yrs; 2nd Vaccination)Cohort 3 eTIV (3-8 Yrs; 2nd Vaccination)
InfluenzaInfections and infestations0/6521/3160/15990/10130/15570/977
Pneumonia bacterialInfections and infestations0/6521/3160/15990/10130/15570/977
Streptococcal bacteraemiaInfections and infestations0/6521/3160/15990/10130/15570/977
Ovarian torsionReproductive system and breast disorders0/6521/3160/15990/10130/15570/977
Abdominal painGastrointestinal disorders1/6520/3160/15990/10130/15570/977
Appendix disorderGastrointestinal disorders1/6520/3160/15990/10130/15570/977
Pelvic abscessInfections and infestations1/6520/3160/15990/10130/15570/977
Viral infectionInfections and infestations1/6520/3160/15990/10130/15570/977
Body height below normalInvestigations1/6520/3160/15990/10130/15570/977
DehydrationMetabolism and nutrition disorders1/6520/3160/15990/10130/15570/977
Most frequent other events
Most frequent other events
EventCohort 1+2 cTIV (9-17 Years)Cohort 1+2 eTIV (9-17 Years)Cohort 3 cTIV (3-8 Yrs; 1st Vaccination)Cohort 3 eTIV (3-8 Yrs; 1st Vaccination)Cohort 3 cTIV (3-8 Yrs; 2nd Vaccination)Cohort 3 eTIV (3-8 Yrs; 2nd Vaccination)
Injection site painGeneral disorders220/652120/316451/1599251/1013421/1557266/977
MyalgiaMusculoskeletal and connective tissue disorders99/65259/316141/159976/1013100/155767/977
HeadacheNervous system disorders99/65247/316143/1599111/101394/155773/977
Injection site erythemaGeneral disorders91/65245/316197/1599138/1013209/1557118/977
FatigueGeneral disorders57/65241/316155/1599119/101399/155782/977
MalaiseGeneral disorders60/65234/316103/159978/101376/155750/977
Injection site indurationGeneral disorders44/65228/31687/159944/101366/155751/977
CoughRespiratory, thoracic and mediastinal disorders10/6524/316124/159975/101370/155751/977
PyrexiaGeneral disorders12/6525/31688/159973/101363/155744/977
Injection site haemorrhageGeneral disorders34/65210/31698/159960/101352/155743/977

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cohort 1+2 cTIV (9-17 Years)Cohort 1+2 eTIV (9-17 Years)Cohort 3 cTIV (3-8 Years)Cohort 3 eTIV (3-8 Years)Total
Mean12.6 ± 2.612.6 ± 2.55.5 ± 1.75.4 ± 1.77.4 ± 3.7
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1+2 cTIV (9-17 Years)Cohort 1+2 eTIV (9-17 Years)Cohort 3 cTIV (3-8 Years)Cohort 3 eTIV (3-8 Years)Total
Female3041547954941747
Male3521648135281857
08

Study locations

60 sites
  • Site 09
    Fayetteville, Arkansas 72703, United States
  • Site 10
    Downey, California 90241, United States
  • Site 02
    Bardstown, Kentucky 40004, United States
  • Site 14
    Metairie, Louisiana 70006, United States
  • Site 01
    St Louis, Missouri 63104, United States
  • Site 11
    Omaha, Nebraska 68134, United States
  • Site 04
    Edison, New Jersey 08817, United States
  • Site 05
    Endwell, New York 13760, United States
  • Site 16
    Fort Worth, Texas 76135, United States
  • Site 13
    San Angelo, Texas 76904, United States
  • Site 12
    San Antonio, Texas 78205, United States
  • Site 08
    Bountiful, Utah 84010, United States
  • Site 07
    Salt Lake City, Utah 84109, United States
  • Site 03
    Salt Lake City, Utah 84121, United States
  • Site 06
    Burke, Virginia 22105, United States
  • Site 15
    Spokane, Washington 99202, United States
  • Site 27:Institute of Public Health
    Zagreb, City of Zagreb, Croatia
  • Site 29: Institute of Public Health
    Zagreb, City of Zagreb, Croatia
  • Site 40:Spec. Pediatric Dispensary
    Zagreb, City of Zagreb, Croatia
  • Site 49: Spec. Pediatric Dispensary
    Zagreb, City of Zagreb, Croatia
  • Site 50: Spec. Pediatric Dispensary
    Zagreb, City of Zagreb, Croatia
  • Site 86: Spec. Pediatric Dispensary
    Zagreb, City of Zagreb, Croatia
  • Site 44:Spec. Pediatric Dispensary
    Đakovo, Dakovo, Croatia
  • Site 43: Spec. Pediatric Dispensary
    Sisak, Sisak, Croatia
  • Site 83
    Ljudevita Gaja 2, Djakovo, Croatia
  • Site 70: Espoon rokotetutkimusklinikka
    Heikintori, Espoo 02100, Finland
  • Site 71: Etelä-Helsingin rokotetutkimusklinikka
    Helsinki, Helsinki 00100, Finland
  • Site 72: Itä-Helsingin rokotetutkimusklinikka
    Helsinki, Helsinki 00930, Finland
  • Site 76: Järvenpään rokotetutkimusklinikka
    Jarvenpaa, Järvenpää 04400, Finland
  • Site 79: Kokkola Vaccine Research Clinic
    Rantakatu 7, Kokkola 67100, Finland
  • Site 77: Kotkan rokotetutkimusklinikka
    Kotka, Kotka 48600, Finland
  • Site 78: Kuopio Vaccine Research Clinic
    Microkatu 1,Osa/Section A, 3rd Floor Pl1188, Kuopio 70211, Finland
  • Site 67: Lahden rokotetutkimusklinikka
    Lahti, Lahti 15140, Finland
  • Site 75: Oulun rokotetutkimusklinikka
    Oulu, Oulu 90100, Finland
  • Site 66: Tampereen rokotetutkimusklinikka
    Tampere, Pirkanmaa 33100, Finland
  • Site 68: Porin rokotetutkimusklinikka
    Pori, Pori 28120, Finland
  • Site 69: Turun rokotetutkimusklinikka
    Turku, Turku 20520, Finland
  • Site 73: Itä-Vantaan rokotetutkimusklinikka
    Vantaa, Vantaa 01300, Finland
  • Site 74: Länsi-Vantaan rokotetutkimusklinikka
    Vantaa, Vantaa 01600, Finland
  • Site 57: Házi Gyermekorvosi Rendelő
    Budapest, Budapest 1042, Hungary
  • Site 53: Heim Pál Gyermekkórház
    Budapest, Budapest 1089, Hungary
  • Site 52: Ferencvárosi Gyermekorvos Kft.
    Budapest, Budapest 1097, Hungary
  • Site 56: Házi Gyermekorvosi Rendelő
    Budapest, Budapest 1136, Hungary
  • Site 54: Házi Gyermekorvosi Rendelő
    Budapest, Budapest 1173, Hungary
  • Site 51: 5053. számú Gyermekorvosi Rendelő
    Miskolc, Miskolc 3534, Hungary
  • Site 55: Revamed kft.
    Nyíregyháza, Nyíregyháza 4481, Hungary
  • Site 59: Vas Megyei Markusovszky Lajos, Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház
    Szombathely, Szombathely 9700, Hungary
  • Site 42: Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva
    Ferrara, Ferrara 44100, Italy
  • Site 47: Dipartimento Scienze della Salute, Sezione di Igiene e Medicina Preventiva, Univesità di Genova
    Genova, Genova 16132, Italy
  • Site 41: Ospedale Maggiore della Carità-Clinica Pediatrica
    Novara, Novara 28100, Italy
  • Site 46: USL 2 Perugia, Distretto del perugino, Centro di Salute n. 4 (Madonna Alta) e n. 6 (Ellera di Corciano del distretto del perugino)
    Perugia, Perugia 06070, Italy
  • Site 45: AUSL 7
    Ragusa, Ragusa 97100, Italy
  • Site 35
    Kaunas, Kaunas County 48259, Lithuania
  • Site 36
    Vilnius, Vilnius County 01117, Lithuania
  • Site 32
    Vilnius, Vilnius County 02169, Lithuania
  • Site 34
    Vilnius, Vilnius County 04318, Lithuania
  • Site 31
    Vilnius, Vilnius County 10207, Lithuania
  • Site 33
    Vilnius, Vilnius County 11200, Lithuania
  • Site 25
    Campulung Muscel, Argeş 115100, Romania
  • Site 21
    Craiova, Dolj 200642, Romania
09

References and documents

Publications

  • 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. doi: 10.1097/INF.0b013e31824bb179. PubMed 22301476 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00645411
Lead sponsor
Novartis
Collaborators
Novartis Vaccines
Responsible party
Sponsor
First posted
Mar 27, 2008
Start date
Oct 2007
Primary completion
Feb 2008
Completion
Jul 2008
Results posted
Jan 16, 2013
Last update
Nov 23, 2015

Study contacts

Novartis Vaccines
study chair · Novartis Vaccines

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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