Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years (NCT NCT02212106)
NCT ID: NCT02212106
Last Updated: 2015-10-16
Results Overview
The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to \< 101.3°F (≥ 38.0 to \< 38.5°C) • Moderate: ≥ 101.3 to \< 102.2°F (≥ 38.5 to \< 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
402 participants
Primary outcome timeframe
7 days after each administration of vaccine.
Results posted on
2015-10-16
Participant Flow
First Patient In: 22-SEP-2014, Last Patient In: 15-OCT-2014, Last Patient Last Visit: 05-DEC-2014. Number of activated sites that enrolled subjects: 11 (all based in USA).
Number of subjects screened: 407 Number of screen failures: 5 (Reason: all due to not meeting inclusion/exclusion criteria).
Participant milestones
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
|---|---|---|
|
Overall Study
STARTED
|
302
|
100
|
|
Overall Study
COMPLETED
|
292
|
96
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
Baseline characteristics by cohort
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
n=302 Participants
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
n=100 Participants
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.7 years
STANDARD_DEVIATION 1.05 • n=5 Participants
|
6.6 years
STANDARD_DEVIATION 1.02 • n=7 Participants
|
6.6 years
STANDARD_DEVIATION 1.04 • n=5 Participants
|
|
Age, Customized
Age 5 to < 9 years
|
302 participants
n=5 Participants
|
100 participants
n=7 Participants
|
402 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
302 participants
n=5 Participants
|
100 participants
n=7 Participants
|
402 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days after each administration of vaccine.Population: All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.
The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to \< 101.3°F (≥ 38.0 to \< 38.5°C) • Moderate: ≥ 101.3 to \< 102.2°F (≥ 38.5 to \< 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
Outcome measures
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
n=292 Participants
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
|---|---|---|
|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
Total
|
8.2 Percentage of subjects
|
—
|
|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
Mild
|
4.1 Percentage of subjects
|
—
|
|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
Moderate
|
2.1 Percentage of subjects
|
—
|
|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
Severe
|
2.1 Percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: 7 days after each administration of vaccine.Population: All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.
The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to \< 101.3°F (≥ 38.0 to \< 38.5°C) • Moderate: ≥ 101.3 to \< 102.2°F (≥ 38.5 to \< 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).
Outcome measures
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
n=98 Participants
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
|---|---|---|
|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
Total
|
9.2 Percentage of subjects
|
—
|
|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
Mild
|
1.0 Percentage of subjects
|
—
|
|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
Moderate
|
4.1 Percentage of subjects
|
—
|
|
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
Severe
|
4.1 Percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: 7 days after each administration of vaccine.Population: All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.
Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to \< 101.3º F (≥ 38.0 to \< 38.5º C). Moderate fever: ≥ 101.3 to \< 102.2º F (≥ 38.5 to \< 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).
Outcome measures
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
n=292 Participants
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
n=98 Participants
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
|---|---|---|
|
The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
Total
|
7.5 Percentage of subjects
|
5.1 Percentage of subjects
|
|
The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
Mild
|
4.1 Percentage of subjects
|
1.0 Percentage of subjects
|
|
The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
Moderate
|
1.7 Percentage of subjects
|
4.1 Percentage of subjects
|
|
The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
Severe
|
1.7 Percentage of subjects
|
0 Percentage of subjects
|
SECONDARY outcome
Timeframe: 7 days after each administration of vaccine.Population: All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.
The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
Outcome measures
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
n=292 Participants
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
n=98 Participants
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
|---|---|---|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total - mild
|
49.8 Percentage of subjects
|
46.9 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total - moderate
|
17.2 Percentage of subjects
|
15.3 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total - severe
|
3.4 Percentage of subjects
|
6.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Pain - total
|
64.4 Percentage of subjects
|
57.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Pain - mild
|
53.3 Percentage of subjects
|
42.9 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Pain - moderate
|
9.6 Percentage of subjects
|
13.3 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total
|
70.2 Percentage of subjects
|
68.4 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Pain - severe
|
1.7 Percentage of subjects
|
1.0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Redness - total
|
34.9 Percentage of subjects
|
37.8 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Redness - mild
|
26.8 Percentage of subjects
|
30.6 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Redness - moderate
|
7.2 Percentage of subjects
|
3.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Redness - severe
|
1.0 Percentage of subjects
|
4.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Swelling/Lump - total
|
29.8 Percentage of subjects
|
40.8 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Swelling/Lump - mild
|
21.0 Percentage of subjects
|
28.6 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Swelling/Lump - moderate
|
7.9 Percentage of subjects
|
8.2 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Swelling/Lump - severe
|
1.0 Percentage of subjects
|
4.1 Percentage of subjects
|
SECONDARY outcome
Timeframe: 7 days after each administration of vaccine.Population: All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.
The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
Outcome measures
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
n=292 Participants
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
n=98 Participants
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
|---|---|---|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Nausea - mild
|
5.5 Percentage of subjects
|
6.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Diarrhea - total
|
5.1 Percentage of subjects
|
11.2 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total
|
40.8 Percentage of subjects
|
44.9 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total - mild
|
28.4 Percentage of subjects
|
21.4 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total - moderate
|
8.6 Percentage of subjects
|
19.4 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total - severe
|
3.8 Percentage of subjects
|
4.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Headache - total
|
14.7 Percentage of subjects
|
23.5 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Headache - mild
|
11.4 Percentage of subjects
|
12.2 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Headache - moderate
|
3.1 Percentage of subjects
|
10.2 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Headache - severe
|
0.3 Percentage of subjects
|
1.0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Malaise - total
|
8.9 Percentage of subjects
|
14.3 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Malaise - mild
|
7.2 Percentage of subjects
|
9.2 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Malaise - moderate
|
1.0 Percentage of subjects
|
5.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Malaise - severe
|
0.7 Percentage of subjects
|
0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Muscle ache (myalgia) - total
|
24.3 Percentage of subjects
|
23.5 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Muscle ache (myalgia) - mild
|
20.0 Percentage of subjects
|
15.3 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Muscle ache (myalgia) - moderate
|
3.4 Percentage of subjects
|
7.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Muscle ache (myalgia) - severe
|
1.0 Percentage of subjects
|
1.0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Diarrhea - mild
|
3.8 Percentage of subjects
|
6.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Diarrhea - moderate
|
1.0 Percentage of subjects
|
4.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Diarrhea - severe
|
0.3 Percentage of subjects
|
1.0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Nausea - total
|
6.8 Percentage of subjects
|
9.2 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Nausea - moderate
|
0.7 Percentage of subjects
|
2.0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Nausea - severe
|
0.7 Percentage of subjects
|
1.0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Vomiting - total
|
2.7 Percentage of subjects
|
2.0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Vomiting - mild
|
2.1 Percentage of subjects
|
0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Vomiting - moderate
|
0.3 Percentage of subjects
|
1.0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Vomiting - severe
|
0.3 Percentage of subjects
|
1.0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Fever - total
|
8.2 Percentage of subjects
|
9.2 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Fever - mild
|
4.1 Percentage of subjects
|
1.0 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Fever - moderate
|
2.1 Percentage of subjects
|
4.1 Percentage of subjects
|
|
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Fever - severe
|
2.1 Percentage of subjects
|
4.1 Percentage of subjects
|
SECONDARY outcome
Timeframe: 7 days after each administration of vaccine.Population: All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.
The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.
Outcome measures
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
n=292 Participants
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
n=98 Participants
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
|---|---|---|
|
The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total
|
14.0 Percentage of subjects
|
22.4 Percentage of subjects
|
|
The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total - mild
|
8.2 Percentage of subjects
|
12.2 Percentage of subjects
|
|
The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total - moderate
|
5.8 Percentage of subjects
|
10.2 Percentage of subjects
|
|
The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Total - severe
|
0.7 Percentage of subjects
|
1.0 Percentage of subjects
|
SECONDARY outcome
Timeframe: 7 days after each administration of vaccine.Population: All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.
The number of subjects experiencing at least one SAE.
Outcome measures
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
n=292 Participants
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
n=98 Participants
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
|---|---|---|
|
The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
|
1 Number of subjects
|
0 Number of subjects
|
Adverse Events
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
Serious events: 1 serious events
Other events: 222 other events
Deaths: 0 deaths
Comparator Quadrivalent Influenza Virus Vaccine
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
n=292 participants at risk
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
n=98 participants at risk
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
|---|---|---|
|
Psychiatric disorders
Delirium febrile
|
0.34%
1/292 • Number of events 1 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
0.00%
0/98 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
Other adverse events
| Measure |
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
n=292 participants at risk
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
Comparator Quadrivalent Influenza Virus Vaccine
n=98 participants at risk
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
|
|---|---|---|
|
Nervous system disorders
Headache
|
14.7%
43/292 • Number of events 55 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
23.5%
23/98 • Number of events 32 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
|
General disorders
Pain
|
64.4%
188/292 • Number of events 230 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
57.1%
56/98 • Number of events 71 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
|
General disorders
Redness
|
34.9%
102/292 • Number of events 117 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
37.8%
37/98 • Number of events 44 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
|
General disorders
Swelling / lump
|
29.8%
87/292 • Number of events 101 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
40.8%
40/98 • Number of events 50 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
|
General disorders
Malaise
|
8.9%
26/292 • Number of events 32 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
14.3%
14/98 • Number of events 18 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
|
General disorders
Fever
|
8.2%
24/292 • Number of events 25 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
9.2%
9/98 • Number of events 11 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
15/292 • Number of events 19 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
11.2%
11/98 • Number of events 16 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
|
Gastrointestinal disorders
Nausea
|
6.8%
20/292 • Number of events 22 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
9.2%
9/98 • Number of events 9 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.3%
71/292 • Number of events 80 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
23.5%
23/98 • Number of events 26 • 7 days after each vaccination.
Overall data (following first \& second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER