Trial Outcomes & Findings for Study of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan (NCT NCT01967784)
NCT ID: NCT01967784
Last Updated: 2016-01-20
Results Overview
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and Day 21 post-vaccination
Results posted on
2016-01-20
Participant Flow
Study participants were enrolled from 18 October 2013 to 19 November 2013 at 2 clinical sites in Taiwan.
A total of 100 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in the study.
Participant milestones
| Measure |
Quadrivalent Influenza Vaccine
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan
Baseline characteristics by cohort
| Measure |
Quadrivalent Influenza Vaccine
n=100 Participants
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
|
|---|---|
|
Age, Categorical
<=18 years
|
100 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
Age Continuous
|
13.4 Years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Geometric mean titers were analyzed in the Immunogenicity Analysis Set.
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine
n=100 Participants
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
|
|---|---|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
A/California/07/2009 (H1N1); Pre-dose
|
257 Titers (1/dilution)
Interval 204.0 to 324.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
A/California/07/2009 (H1N1); Post-dose
|
589 Titers (1/dilution)
Interval 498.0 to 697.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
A/Texas/50/2012 (H3N2); Pre-dose
|
382 Titers (1/dilution)
Interval 301.0 to 484.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
A/Texas/50/2012 (H3N2); Post-dose
|
782 Titers (1/dilution)
Interval 649.0 to 944.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
B/Massachusetts/2/2012; Pre-dose
|
497 Titers (1/dilution)
Interval 366.0 to 674.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
B/Massachusetts/2/2012; Post-dose
|
1654 Titers (1/dilution)
Interval 1352.0 to 2024.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
B/Brisbane/60/2008; Pre-dose
|
186 Titers (1/dilution)
Interval 139.0 to 250.0
|
|
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
B/Brisbane/60/2008; Post-dose
|
856 Titers (1/dilution)
Interval 702.0 to 1045.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Seroprotection was analyzed in the Immunogenicity Analysis Set.
Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine
n=100 Participants
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
|
|---|---|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
A/California/07/2009 (H1N1); Pre-dose
|
95.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
A/California/07/2009 (H1N1); Post-dose
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
A/Texas/50/2012 (H3N2); Pre-dose
|
97.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
A/Texas/50/2012 (H3N2); Post-dose
|
99.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
B/Massachusetts/2/2012; Pre-dose
|
94.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
B/Massachusetts/2/2012; Post-dose
|
100.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
B/Brisbane/60/2008; Pre-dose
|
85.0 Percentage of participants
|
|
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
B/Brisbane/60/2008; Post-dose
|
100.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 21 post-vaccinationPopulation: Seroconversion or significant increase in influenza antibody titers was analyzed in the Immunogenicity Analysis Set.
Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine
n=100 Participants
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
|
|---|---|
|
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine
A/California/07/2009 (H1N1)
|
24.0 Percentage of participants
|
|
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine
A/Texas/50/2012 (H3N2)
|
20.0 Percentage of participants
|
|
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine
B/Massachusetts/2/2012
|
39.0 Percentage of participants
|
|
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine
B/Brisbane/60/2008
|
48.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 21 post-vaccinationPopulation: Geometric mean titers ratios were analyzed in the Immunogenicity Analysis Set.
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine
n=100 Participants
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
|
|---|---|
|
Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine
A/California/07/2009 (H1N1)
|
2.29 Titers ratio
Interval 1.93 to 2.71
|
|
Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine
A/Texas/50/2012 (H3N2)
|
2.05 Titers ratio
Interval 1.76 to 2.39
|
|
Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine
B/Massachusetts/2/2012
|
3.33 Titers ratio
Interval 2.57 to 4.31
|
|
Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine
B/Brisbane/60/2008
|
4.59 Titers ratio
Interval 3.63 to 5.81
|
PRIMARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site and systemic reactions were analyzed in the Safety Analysis Set.
Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \> 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine
n=100 Participants
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
|
|---|---|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Injection-site Induration
|
2.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Grade 3 Injection-site Induration
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Injection-site Ecchymosis
|
1.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Grade 3 Injection-site Ecchymosis
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Fever
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Grade 3 Fever
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Headache
|
8.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Grade 3 Headache
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Malaise
|
15.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Grade 3 Malaise
|
1.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Myalgia
|
45.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Grade 3 Myalgia
|
1.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Shivering
|
3.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Grade 3 Shivering
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Injection-site Pain
|
56.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Grade 3 Injection-site Pain
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Injection-site Erythema
|
6.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Grade 3 Injection-site Erythema
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Injection-site Swelling
|
4.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Grade 3 Injection-site Swelling
|
0 Percentage of participants
|
Adverse Events
Quadrivalent Influenza Vaccine
Serious events: 0 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quadrivalent Influenza Vaccine
n=100 participants at risk
Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
|
|---|---|
|
General disorders
Injection site Pain
|
56.0%
56/100 • Number of events 56 • Adverse event data were collected from Day 0 (post vaccination) up to Day 7 post vaccination.
|
|
General disorders
Injection site Erythema
|
6.0%
6/100 • Number of events 6 • Adverse event data were collected from Day 0 (post vaccination) up to Day 7 post vaccination.
|
|
Nervous system disorders
Headache
|
8.0%
8/100 • Number of events 8 • Adverse event data were collected from Day 0 (post vaccination) up to Day 7 post vaccination.
|
|
General disorders
Malaise
|
15.0%
15/100 • Number of events 15 • Adverse event data were collected from Day 0 (post vaccination) up to Day 7 post vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
45.0%
45/100 • Number of events 45 • Adverse event data were collected from Day 0 (post vaccination) up to Day 7 post vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
10/100 • Number of events 10 • Adverse event data were collected from Day 0 (post vaccination) up to Day 7 post vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER