A Phase 3 interventional study of TIVc and TIV in Influenza, sponsored by Novartis Vaccines. Completed at 16 sites in 2 countries. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-21.
Sponsored by Novartis Vaccines (formerly part of Novartis) · Phase 3, Interventional, and Prevention
The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to \< 18 years of age who are at risk of complications of influenza disease due to underlying diseases.
2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's enrollment of 430 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Novartis Vaccines is the lead sponsor of 165 studies on the registry; none are open to participants now.
First submitted before Novartis Vaccines left Novartis.
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Exclusion Criteria:
flu vaccine
Biological: TIVc
flu vaccine
Biological: TIV
Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain \[A/H1N1-like, A/H3N2-like, and B-like\]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere
A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain \[A/ H1N1-like, A/H3N2-like, and B-like\]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group
Safety was assessed in terms of number of the subjects (3 to \< 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
Time frame: Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata
Safety was assessed in terms of number of the subjects (3 to \<6 years,(≥ 6 to \< 9 years and 9 to \<18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
Time frame: Day 1 through Day 7 after any vaccination
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata
Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to \<18 years) and age sub-strata (3 to \<9 years and 9 to \<18 years)
Time frame: Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group)
Subjects were recruited from 12 centers in Spain and 4 centers from Italy.
| Milestone | TIVc (3 to <18 Years) | TIV (3 to <18 Years) |
|---|---|---|
| Started | 282 | 148 |
| Completed | 272 | 143 |
| Not completed | 10 | 5 |
| Withdrew: Lost to follow-up | 4 | 5 |
| Withdrew: Withdrawal by subject | 6 | 0 |
Safety was assessed in terms of number of the subjects (3 to \< 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
| Subjects | TIVc _inj 1 (3 to <18 Years) | TIVc_inj 2 (3 to <18 Years) | TIV_inj 1 (3 to <18 Years) | TIV_inj 2 (3 to <18 Years) |
|---|---|---|---|---|
| Any Local | 149 | 41 | 89 | 18 |
| Injection Site Tenderness | 25 | 20 | 17 | 6 |
| Injection Site Pain | 106 | 19 | 65 | 8 |
| Injection site erythema ,< 6 years | 8 | 3 | 4 | 4 |
| Injection site induration < 6 years | 7 | 5 | 4 | 3 |
| Injection site ecchymosis < 6 years | 6 | 1 | 3 | 3 |
| Injection site erythema >=6 years | 16 | 5 | 22 | 3 |
| Injection site induration >=6years | 22 | 3 | 23 | 3 |
| Injection site ecchymosis >= 6 years | 8 | 2 | 5 | 5 |
| Any Systemic | 117 | 29 | 55 | 8 |
| Change in eating habits | 12 | 6 | 7 | 2 |
| Chills | 32 | 6 | 9 | 0 |
| Diarrhea | 19 | 2 | 5 | 3 |
| Irritability | 14 | 5 | 7 | 2 |
| Sleepiness | 10 | 5 | 3 | 2 |
| Vomiting | 18 | 3 | 5 | 1 |
| Arthralgia | 24 | 0 | 9 | 0 |
| Fatigue | 28 | 4 | 16 | 0 |
| Headache | 35 | 8 | 24 | 1 |
| Loss of appetite | 30 | 5 | 16 | 2 |
| Myalgia | 35 | 5 | 14 | 0 |
| Nausea | 21 | 0 | 12 | 0 |
| Body Temp. ( >= 38C ) | 18 | 2 | 6 | 0 |
| Treatment of pain and or fever | 28 | 7 | 11 | 1 |
| Prevention of pain and or fever | 19 | 2 | 9 | 3 |
Safety was assessed in terms of number of the subjects (3 to \<6 years,(≥ 6 to \< 9 years and 9 to \<18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
| Subjects | TIVc_Non naive_inj 1 (3 to <6 Years) | TIVc_naive_inj 1 (3 to <6 Years) | TIVc_naive_inj 2 (3 to <6 Years) | TIV_Non naive_inj 1 (3 to <6 Years) | TIV_naive_inj 1 (3 to <6 Years) | TIV_naive_inj 2 (3 to <6 Years) | TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years) | TIVc_Naive_inj 1 (≥ 6 to < 9 Years) | TIVc_Naive_inj 2 (≥ 6 to < 9 Years) | TIV_Non Naive_inj 1 (≥ 6 to < 9 Years) | TIV_Naive_inj 1 (≥ 6 to < 9 Years) | TIV_Naive_inj 2 (≥ 6 to < 9 Years) | TIVc_Non Naive (9 to <18 Years) | TIV_Non Naive (9 to <18 Years) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any Local | 14 | 19 | 22 | 12 | 7 | 7 | 16 | 19 | 19 | 8 | 13 | 11 | 81 | 49 |
| Tenderness(N=28,49,49,19,15,15,0,0,0,0,0,0,0,0) | 10 | 15 | 20 | 11 | 6 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pain(N=0,0,0,0,0,0,26,32,31,16,22,22,138,72) | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 18 | 19 | 8 | 10 | 8 | 73 | 47 |
| Erythema27,50,50,18,15,15,26,34,32,16,23,23,131,61 | 7 | 1 | 3 | 4 | 0 | 4 | 1 | 3 | 5 | 4 | 5 | 3 | 5 | 2 |
| Injection site induration | 2 | 5 | 5 | 2 | 2 | 3 | 1 | 4 | 3 | 3 | 2 | 3 | 6 | 7 |
| Injection site ecchymosis | 2 | 4 | 1 | 2 | 1 | 3 | 2 | 3 | 2 | 0 | 3 | 5 | 0 | 0 |
| Any Systemic | 10 | 22 | 14 | 9 | 5 | 5 | 9 | 18 | 15 | 5 | 5 | 3 | 58 | 31 |
| Change in eating habits | 5 | 7 | 6 | 3 | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Chills28,50,48,19,15,14,25,33,31,16,22,23,138,72 | 2 | 5 | 3 | 2 | 0 | 0 | 3 | 3 | 3 | 1 | 0 | 0 | 19 | 6 |
| Diarrhea28,50,50,19,14,15,26,33,31,16,22,23,137,71 | 3 | 1 | 1 | 1 | 0 | 2 | 1 | 3 | 1 | 0 | 0 | 1 | 11 | 4 |
| Irritability | 6 | 8 | 5 | 5 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sleepiness(N=28,49,48,19,15,15,0,0,0,0,0,0,0,0) | 4 | 6 | 5 | 3 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vomiting28,50,50,19,15,15,26,33,31,16,22,23,138,72 | 3 | 4 | 2 | 1 | 0 | 1 | 0 | 3 | 1 | 1 | 0 | 0 | 8 | 3 |
| Arthralgia 0,0,0,0,0,0,26,32,30,16,20,21,136,72 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 4 | 0 | 1 | 1 | 0 | 18 | 7 |
| Fatigue 0,0,0,0,0,0,26,32,30,16,20,21,137,72 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 3 | 4 | 2 | 0 | 0 | 23 | 14 |
| Headache0,0,0,0,0,0,26,32,30,16,20,21,138,72 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 5 | 8 | 3 | 2 | 1 | 29 | 19 |
| Loss appetite 0,0,0,0,0,0,26,32,31,16,22,23,138,72 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 8 | 5 | 2 | 2 | 2 | 20 | 12 |
| Myalgia0,0,0,0,0,0,26,32,30,16,20,21,138,72 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 2 | 5 | 2 | 1 | 0 | 29 | 11 |
| Nausea 0,0,0,0,0,0,26,32,30,16,20,21,137,72 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 2 | 0 | 0 | 17 | 10 |
| Body Temp. ( >= 38C ) | 4 | 8 | 2 | 3 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 4 | 3 |
| Treatment of pain and or fever | 6 | 9 | 3 | 3 | 0 | 1 | 0 | 4 | 4 | 0 | 2 | 0 | 9 | 6 |
Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to \<18 years) and age sub-strata (3 to \<9 years and 9 to \<18 years)
| Subjects | TIVc (3 to <18 Years) | TIV (3 to <18 Years) | TIVc_Naive (3 to <9 Years) | TIVc_Non Naive (3 to <9 Years) | TIVc_Non Naive (9 to <18 Years) | TIV_Naive (3 to <9 Years) | TIV_Non Naive (3 to <9 Years) | TIV_Non Naive (9 to <18 Years) |
|---|---|---|---|---|---|---|---|---|
| Any AEs | 213 | 111 | 77 | 46 | 90 | 32 | 29 | 50 |
| Any possibly related AEs | 17 | 12 | 7 | 3 | 7 | 5 | 3 | 4 |
| SAEs | 12 | 4 | 4 | 2 | 6 | 0 | 2 | 2 |
| Possibly or probably related SAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AEs leading to NOCD | 3 | 1 | 1 | 0 | 2 | 0 | 1 | 0 |
| Medically Attended AEs | 187 | 94 | 71 | 38 | 78 | 28 | 24 | 42 |
| AEs leading to vaccine/study withdrawal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Collected over Solicited local,systemic AEs collected -day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2, unsolicited AEs -Day 1 through Day 29 post 1st vaccination and Day 29 to Day 57 post 2nd vaccination. SAEs Day 1 through end of study. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TIVc (3 to <18 Years) | — | 12/278 (4.3%) | 246/278 (88.5%) |
| TIV (3 to <18 Years) | — | 4/148 (2.7%) | 126/148 (85.1%) |
| Total | — | 16/426 (3.8%) | 372/426 (87.3%) |
| Event | TIVc (3 to <18 Years) | TIV (3 to <18 Years) | Total |
|---|---|---|---|
| PNEUMONIAInfections and infestations | 2/278 | 0/148 | 2/426 |
| VOMITINGGastrointestinal disorders | 1/278 | 1/148 | 2/426 |
| MASTOIDITISInfections and infestations | 0/278 | 1/148 | 1/426 |
| POST PROCEDURAL COMPLICATIONInjury, poisoning and procedural complications | 0/278 | 1/148 | 1/426 |
| DECREASED APPETITEMetabolism and nutrition disorders | 0/278 | 1/148 | 1/426 |
| ASTHMATIC CRISISRespiratory, thoracic and mediastinal disorders | 1/278 | 1/148 | 2/426 |
| LYMPHADENITISBlood and lymphatic system disorders | 1/278 | 0/148 | 1/426 |
| SICKLE CELL ANAEMIA WITH CRISISBlood and lymphatic system disorders | 1/278 | 0/148 | 1/426 |
| GASTROENTERITISInfections and infestations | 1/278 | 0/148 | 1/426 |
| GASTROENTERITIS VIRALInfections and infestations | 1/278 | 0/148 | 1/426 |
| Event | TIVc (3 to <18 Years) | TIV (3 to <18 Years) | Total |
|---|---|---|---|
| INJECTION SITE PAINGeneral disorders | 147/278 | 86/148 | 233/426 |
| INJECTION SITE ERYTHEMAGeneral disorders | 32/278 | 32/148 | 64/426 |
| INJECTION SITE INDURATIONGeneral disorders | 35/278 | 31/148 | 66/426 |
| HEADACHENervous system disorders | 42/278 | 26/148 | 68/426 |
| MYALGIAMusculoskeletal and connective tissue disorders | 40/278 | 14/148 | 54/426 |
| PYREXIAGeneral disorders | 37/278 | 21/148 | 58/426 |
| CHILLSGeneral disorders | 36/278 | 9/148 | 45/426 |
| NASOPHARYNGITISInfections and infestations | 35/278 | 19/148 | 54/426 |
| DECREASED APPETITEMetabolism and nutrition disorders | 33/278 | 17/148 | 50/426 |
| FATIGUEGeneral disorders | 31/278 | 16/148 | 47/426 |
| Age, Continuous(year) | TIVc (3 to <18 Years) | TIV (3 to <18 Years) | Total |
|---|---|---|---|
| Mean | 8.7 ± 4.0 | 9.0 ± 3.9 | 8.8 ± 4.0 |
| Sex: Female, Male(Participants) | TIVc (3 to <18 Years) | TIV (3 to <18 Years) | Total |
|---|---|---|---|
| FEMALE | 121 | 63 | 184 |
| MALE | 161 | 85 | 246 |
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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