Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old
Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT02035696
Collaborator
Novartis Vaccines (Industry)
671
27
4
12
24.9
2.1
Study Details
Study Description
Brief Summary
To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to < 48 months of age
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
671 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase I/II, Randomized, Observer-Blind, Multicenter Study to Evaluate Immunogenicity and Safety of Four Influenza Vaccines in Healthy Pediatric Subjects 6 to < 48 Months of Age.
Study Start Date
:
Dec 1, 2013
Actual Primary Completion Date
:
Jun 1, 2014
Actual Study Completion Date
:
Dec 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TIVc-High Dose Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine |
Biological: Trivalent influenza vaccine (TIVc)
|
| Experimental: TIVc-Full Dose Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine |
Biological: Trivalent influenza vaccine (TIVc)
|
| Experimental: TIVc- Half Dose Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine |
Biological: Trivalent influenza vaccine (TIVc)
|
| Active Comparator: TIVe Subjects (6 to <48 months old) received two doses of TIVe vaccine(IM/0.25mL -for ages 6 to <36 months and IM/ 0.5 mL -for ages 36 to <48 months) |
Biological: Trivalent influenza vaccine-licensed
Licensed influenza vaccine
|
Outcome Measures
Primary Outcome Measures
- Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine [Day 50/Day 1]
Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to <48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine
- Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine [Day 50 post vaccination]
Immunogenicity was assessed in terms number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer
- Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine [Day 1 to Day 3]
Differences in percentages of subjects (6 to <48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.
Secondary Outcome Measures
- Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine [Day 50 post vaccination]
Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers >40%
- Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine [Day 1, Day 50 post vaccination]
Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CBER criterion for pediatric population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70% The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be >70%
- Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine [Day 50 post vaccination over day 1]
Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CHMP criterion is mean geometric ratio (GMR) >2.5
- Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine [Day 50 post vaccination over day 1]
Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
- Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine [Day 1 and Day 50 post vaccination]
Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
- Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine [Day 1 and Day 50 post vaccination]
Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI
- Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine [Day 1 and Day 50 post vaccination]
Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI
- Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine [Day 1 to Day 7]
Safety was assessed in terms of number of subjects (6 to <48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)
- Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine [Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209]
Safety was assessed in terms of number of subjects (6 to <48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 [Post Vaccination] to Day 29 [Pre Clinic Visit] and Day 29 [Post Vaccination] to Day 50 [Pre Clinic Visit] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 48 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy subject, male or female, 6 through < 48 months of age at the time of enrollment, who has never previously received an influenza vaccine
-
Individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up
Exclusion Criteria:
-
Individuals recently vaccinated against influenza
-
Subjects with contraindications to receive influenza vaccine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 116 | Phoenix | Arizona | United States | |
| 2 | Site 119 | Tucson | Arizona | United States | |
| 3 | Site 109 | Little Rock | Arkansas | United States | |
| 4 | Site 112 | Long Beach | California | United States | |
| 5 | Site 113 | Ontario | California | United States | |
| 6 | Site 117 | San Diego | California | United States | |
| 7 | Site 114 | West Covina | California | United States | |
| 8 | Site 107 | Thornton | Colorado | United States | |
| 9 | Site 108 | Miami Beach | Florida | United States | |
| 10 | Site 111 | Miami | Florida | United States | |
| 11 | Site 121 | Gainesville | Georgia | United States | |
| 12 | Site 101 | Omaha | Nebraska | United States | |
| 13 | Site 104 | Omaha | Nebraska | United States | |
| 14 | Site 105 | Omaha | Nebraska | United States | |
| 15 | Site 106 | Omaha | Nebraska | United States | |
| 16 | Site 103 | Youngstown | Ohio | United States | |
| 17 | Site 102 | Charleston | South Carolina | United States | |
| 18 | Site 115 | Houston | Texas | United States | |
| 19 | Site 118 | Saint George | Utah | United States | |
| 20 | Site 110 | Salt Lake City | Utah | United States | |
| 21 | Site 120 | Spokane | Washington | United States | |
| 22 | Site 502 | Kuopio | Finland | ||
| 23 | Site 506 | Tampere | Finland | ||
| 24 | Site 301 | Manila | Philippines | ||
| 25 | Site 302 | Muntinlupa | Philippines | ||
| 26 | Site 201 | Bangkok | Thailand | ||
| 27 | Site 202 | Bangkok | Thailand |
Sponsors and Collaborators
- Seqirus
- Novartis Vaccines
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT02035696
Other Study ID Numbers:
- V58P16
- 2013-002081-39
First Posted:
Jan 14, 2014
Last Update Posted:
Jul 10, 2018
Last Verified:
Jun 1, 2018
Keywords provided by Seqirus
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 6 centers in the United States, 1 center in Finland, 2 centers in Thailand, 2 centers in Philippines |
|---|---|
| Pre-assignment Detail | All enrolled Subjects were included in the trial |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Period Title: Overall Study | ||||
| STARTED | 174 | 166 | 167 | 164 |
| COMPLETED | 171 | 163 | 164 | 161 |
| NOT COMPLETED | 3 | 3 | 3 | 3 |
Baseline Characteristics
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine | Total of all reporting groups |
| Overall Participants | 174 | 166 | 167 | 164 | 671 |
| Age (Months) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Months] |
25.3
(11.5)
|
25.0
(11.5)
|
25.6
(11.5)
|
25.3
(11.9)
|
25.3
(11.6)
|
| Sex: Female, Male (Count of Participants) | |||||
| FEMALE |
84
48.3%
|
82
49.4%
|
77
46.1%
|
87
53%
|
330
49.2%
|
| MALE |
90
51.7%
|
84
50.6%
|
90
53.9%
|
77
47%
|
341
50.8%
|
Outcome Measures
| Title | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to <48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine |
| Time Frame | Day 50/Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on Per Protocol (PP) population i.e. all subjects in the FAS Efficacy/Immunogenicity Set who are not excluded due to reasons defined prior to unblinding or analysis |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 156 | 147 | 141 | 145 |
| A/H1N1 |
7.82
|
5.5
|
5.93
|
3.69
|
| A/H3N2 |
10.53
|
10.84
|
6.47
|
11.95
|
| B |
5.18
|
4.27
|
3.87
|
6.65
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TIVc-High Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 1 |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.65 to 1.52 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TIVc-High Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios at Day 50 |
| Estimated Value | 2.11 | |
| Confidence Interval |
(2-Sided) 95% 1.5 to 2.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TIVc-High Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios at Day 1 |
| Estimated Value | 0.68 | |
| Confidence Interval |
(2-Sided) 95% 0.43 to 1.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TIVc-High Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 50 |
| Estimated Value | 0.71 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 0.87 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TIVc-High Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 1 |
| Estimated Value | 1 | |
| Confidence Interval |
(2-Sided) 95% 0.92 to 1.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TIVc-High Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios at Day 50 |
| Estimated Value | 0.78 | |
| Confidence Interval |
(2-Sided) 95% 0.6 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | TIVc-Full Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 1 |
| Estimated Value | 1.27 | |
| Confidence Interval |
(2-Sided) 95% 0.83 to 1.96 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | TIVc-Full Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 50 |
| Estimated Value | 1.6 | |
| Confidence Interval |
(2-Sided) 95% 1.13 to 2.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | TIVc-Full Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 1 |
| Estimated Value | 0.52 | |
| Confidence Interval |
(2-Sided) 95% 0.33 to 0.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | TIVc-Full Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 50 |
| Estimated Value | 0.64 | |
| Confidence Interval |
(2-Sided) 95% 0.52 to 0.78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | TIVc-Full Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios at Day 1 |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 95% 0.89 to 1.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | TIVc-Full Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 50 |
| Estimated Value | 0.64 | |
| Confidence Interval |
(2-Sided) 95% 0.49 to 0.84 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | TIVc- Half Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 1 |
| Estimated Value | 1.02 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 1.58 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | TIVc- Half Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios at Day 50 |
| Estimated Value | 1.62 | |
| Confidence Interval |
(2-Sided) 95% 1.14 to 2.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | TIVc- Half Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 1 |
| Estimated Value | 0.74 | |
| Confidence Interval |
(2-Sided) 95% 0.47 to 1.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | TIVc- Half Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios at Day 50 |
| Estimated Value | 0.46 | |
| Confidence Interval |
(2-Sided) 95% 0.38 to 0.57 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | TIVc- Half Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 1 |
| Estimated Value | 0.94 | |
| Confidence Interval |
(2-Sided) 95% 0.87 to 1.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | TIVc- Half Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios at Day 50 |
| Estimated Value | 0.57 | |
| Confidence Interval |
(2-Sided) 95% 0.44 to 0.75 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Immunogenicity was assessed in terms number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer |
| Time Frame | Day 50 post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP population |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 156 | 147 | 141 | 145 |
| A/H1N1_Day 50 |
83
|
81
|
79
|
74
|
| A/H3N2_Day 50 |
94
|
90
|
87
|
92
|
| B_Day 50 |
69
|
69
|
62
|
80
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TIVc-High Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Differences |
| Estimated Value | 10 | |
| Confidence Interval |
(2-Sided) 95% 0 to 18.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TIVc-High Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Differences |
| Estimated Value | 2 | |
| Confidence Interval |
(2-Sided) 95% -4 to 8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TIVc-High Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group differences |
| Estimated Value | -11 | |
| Confidence Interval |
(2-Sided) 95% -21.1 to -1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | TIVc-Full Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Differences |
| Estimated Value | 7 | |
| Confidence Interval |
(2-Sided) 95% -2.5 to 16.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | TIVc-Full Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group differences |
| Estimated Value | -3 | |
| Confidence Interval |
(2-Sided) 95% -9.5 to 4.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | TIVc-Full Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Differences |
| Estimated Value | -11 | |
| Confidence Interval |
(2-Sided) 95% -20.5 to -1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | TIVc- Half Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Differences |
| Estimated Value | 6 | |
| Confidence Interval |
(2-Sided) 95% -4.2 to 15.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | TIVc- Half Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2 | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Differences |
| Estimated Value | -6 | |
| Confidence Interval |
(2-Sided) 95% -13.4 to 1.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | TIVc- Half Dose, TIVe |
|---|---|---|
| Comments | Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10% | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Differences |
| Estimated Value | -18 | |
| Confidence Interval |
(2-Sided) 95% -27.8 to -7.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine |
|---|---|
| Description | Differences in percentages of subjects (6 to <48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response. |
| Time Frame | Day 1 to Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PPSd-All subjects in the FASd who:Correctly received the vaccine (i.e., received the vaccine to which the subjects is randomized and at the scheduled time points). |
| Arm/Group Title | TIVc-High Dose-TIVe | TIVc-Full Dose-TIVe | TIVc- Half Dose-TIVe |
|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 305 | 294 | 291 |
| Severe solicited local AEs |
0.000
0%
|
0.000
0%
|
0.000
0%
|
| Severe solicited systemic AEs |
0.040
0%
|
0.000
0%
|
0.000
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TIVc-High Dose |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Desirability Index Score |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TIVc-Full Dose |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Desirability Index Score |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | TIVc- Half Dose |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Desirability Index Score |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe. | |
| Title | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers >40% |
| Time Frame | Day 50 post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on Full analysis set |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 170 | 164 | 161 | 159 |
| A/H1N1 |
84
|
80
|
82
|
73
|
| A/H3N2 |
94
|
91
|
88
|
93
|
| B |
68
|
70
|
63
|
79
|
| Title | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CBER criterion for pediatric population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70% The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be >70% |
| Time Frame | Day 1, Day 50 post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on FAS |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 170 | 164 | 161 | 159 |
| A/H1N1: Day 1 |
26
|
32
|
29
|
26
|
| A/H1N1: Day 50 |
86
|
85
|
86
|
77
|
| A/H3N2: Day 1 |
45
|
40
|
48
|
52
|
| A/H3N2: Day 50 |
98
|
98
|
97
|
99
|
| B: Day 1 |
2
|
0
|
1
|
3
|
| B: Day 50 |
69
|
70
|
63
|
80
|
| Title | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CHMP criterion is mean geometric ratio (GMR) >2.5 |
| Time Frame | Day 50 post vaccination over day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on FAS |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 170 | 164 | 161 | 159 |
| A/H1N1 |
12
|
8.58
|
8.94
|
5.14
|
| A/H3N2 |
12
|
13
|
7.68
|
14
|
| B |
6.14
|
5.29
|
4.72
|
7.57
|
| Title | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine |
| Time Frame | Day 50 post vaccination over day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PPS |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 156 | 148 | 141 | 147 |
| A/H1N1 |
7.84
|
5.81
|
5.98
|
17.82
|
| A/H3N2 |
8.4
|
8.97
|
5.58
|
8.9
|
| B |
12.78
|
10.43
|
9.99
|
17.55
|
| Title | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine |
| Time Frame | Day 1 and Day 50 post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PPS |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 156 | 147 | 141 | 145 |
| A/H1N1: Day 1: HI titers ≥1:110 |
26
|
31
|
26
|
26
|
| A/H1N1: Day 50: HI titers ≥1:110 |
78
|
80
|
71
|
59
|
| A/H3N2: Day 1: HI titers ≥1:110 |
40
|
37
|
43
|
47
|
| A/H3N2: Day 50: HI titers ≥1:110 |
88
|
86
|
82
|
97
|
| B: Day 1: HI titers ≥1:110 |
1
|
0
|
0
|
0
|
| B: Day 50: HI titers ≥1:110 |
40
|
30
|
24
|
39
|
| A/H1N1: Day 1: HI titers ≥1:151 |
25
|
30
|
26
|
25
|
| A/H1N1: Day 50: HI titers ≥1:151 |
76
|
76
|
70
|
58
|
| A/H3N2: Day 1: HI titers ≥1:151 |
40
|
37
|
43
|
47
|
| A/H3N2: Day 50: HI titers ≥1:150 |
88
|
86
|
81
|
97
|
| B: Day 1: HI titers ≥1:151 |
0
|
0
|
0
|
0
|
| B: Day 50: HI titers ≥1:151 |
40
|
30
|
23
|
39
|
| A/H1N1: Day 1: HI titers ≥1:330 |
12
|
14
|
11
|
11
|
| A/H1N1: Day 50: HI titers ≥1:330 |
51
|
50
|
43
|
34
|
| A/H3N2: Day 1: HI titers ≥1:330 |
16
|
12
|
13
|
21
|
| A/H3N2: Day 50: HI titers ≥1:330 |
62
|
56
|
52
|
68
|
| B: Day 1: HI titers ≥1:330 |
0
|
0
|
0
|
0
|
| B: Day 50: HI titers ≥1:330 |
4
|
4
|
3
|
8
|
| A/H1N1: Day 1: HI titers ≥1:629 |
9
|
12
|
11
|
8
|
| A/H1N1: Day 50: HI titers ≥1:629 |
48
|
47
|
43
|
33
|
| A/H3N2: Day 1: HI titers ≥1:629 |
16
|
12
|
12
|
21
|
| A/H3N2: Day 50: HI titers ≥1:629 |
62
|
56
|
52
|
68
|
| B: Day 1: HI titers ≥1:629 |
0
|
0
|
0
|
0
|
| B: Day 50: HI titers ≥1:629 |
4
|
3
|
3
|
7
|
| Title | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI |
| Time Frame | Day 1 and Day 50 post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PPS |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 156 | 148 | 141 | 147 |
| A/H1N1 |
94
|
93
|
91
|
97
|
| A/H3N2 |
95
|
94
|
94
|
94
|
| B |
92
|
92
|
93
|
97
|
| Title | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI |
| Time Frame | Day 1 and Day 50 post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PPS |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 156 | 148 | 141 | 147 |
| A/H1N1 |
87
|
89
|
84
|
95
|
| A/H3N2 |
85
|
85
|
82
|
80
|
| B |
83
|
87
|
83
|
96
|
| Title | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Safety was assessed in terms of number of subjects (6 to <48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination) |
| Time Frame | Day 1 to Day 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses was done on solicited safety data set. 4 subjects (3 subjects from the TIVe group, and 1 subject from the full dose TIVc group, were excluded from the solicited safety set analyses (6h -day3, day4-day7 and 6h - day 7) as these subjects did not provide any post vaccination solicited safety data |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 174 | 165 | 167 | 161 |
| Any local AEs |
64
|
56
|
60
|
54
|
| Injection site tenderness |
50
|
43
|
42
|
45
|
| Injection site erythema |
19
|
24
|
24
|
17
|
| Injection site induration |
13
|
14
|
9
|
8
|
| Injection site ecchymosis |
9
|
9
|
7
|
7
|
| Any Systemic |
78
|
72
|
69
|
66
|
| Chills |
7
|
5
|
7
|
9
|
| Change in eating habits |
29
|
35
|
28
|
29
|
| Sleepiness |
30
|
28
|
21
|
24
|
| Irritability |
30
|
31
|
29
|
27
|
| Vomiting |
21
|
20
|
22
|
14
|
| Diarrhea |
31
|
31
|
29
|
34
|
| Fever (≥ 38°C ) |
15
|
20
|
21
|
21
|
| Prophylactic use of antipyretics/analgesics |
9
|
21
|
25
|
13
|
| Therapeutic use of antipyretics/analgesics |
17
|
21
|
24
|
22
|
| Title | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine |
|---|---|
| Description | Safety was assessed in terms of number of subjects (6 to <48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 [Post Vaccination] to Day 29 [Pre Clinic Visit] and Day 29 [Post Vaccination] to Day 50 [Pre Clinic Visit] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination) |
| Time Frame | Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analyses was done on unsolicited safety data set i.e. all subjects in the exposed set who have post-vaccination unsolicited AE data |
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe |
|---|---|---|---|---|
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| Measure Participants | 174 | 166 | 167 | 164 |
| Any AEs(after any vaccination) |
102
|
107
|
91
|
94
|
| Possibly/probably related AEs (after any vaccin.) |
38
|
43
|
43
|
35
|
| Any AEs(after vaccination 1) |
79
|
84
|
69
|
76
|
| Any AEs(after vaccination 2) |
56
|
64
|
50
|
48
|
| Possibly/probably related AEs (after vaccination 1 |
30
|
33
|
31
|
31
|
| Possibly/probably related AEs (after vaccination 2 |
11
|
20
|
18
|
14
|
| Any SAE |
4
|
8
|
10
|
6
|
| Any possibly/probably related SAE |
0
|
0
|
0
|
0
|
| Any AE leading to premature withdrawal from study |
0
|
0
|
0
|
0
|
| New onset of chronic disease |
0
|
1
|
1
|
1
|
| Death |
0
|
0
|
0
|
0
|
Adverse Events
| Time Frame | Throughout the study period, up to day 209 post vaccination. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination. A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event | |||||||||
| Arm/Group Title | TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe | Total | |||||
| Arm/Group Description | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | Subjects (6 to <48 months old) received two doses of TIVe vaccine | Total number of subjects | |||||
All Cause Mortality |
||||||||||
| TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe | Total | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe | Total | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/174 (2.3%) | 8/166 (4.8%) | 10/167 (6%) | 6/164 (3.7%) | 28/671 (4.2%) | |||||
| Gastrointestinal disorders | ||||||||||
| GASTRITIS | 1/174 (0.6%) | 0/166 (0%) | 0/167 (0%) | 0/164 (0%) | 1/671 (0.1%) | |||||
| INGUINAL HERNIA | 0/174 (0%) | 0/166 (0%) | 1/167 (0.6%) | 0/164 (0%) | 1/671 (0.1%) | |||||
| General disorders | ||||||||||
| PYREXIA | 0/174 (0%) | 0/166 (0%) | 1/167 (0.6%) | 0/164 (0%) | 1/671 (0.1%) | |||||
| Infections and infestations | ||||||||||
| BRONCHITIS | 0/174 (0%) | 2/166 (1.2%) | 0/167 (0%) | 1/164 (0.6%) | 3/671 (0.4%) | |||||
| PHARYNGITIS | 0/174 (0%) | 0/166 (0%) | 1/167 (0.6%) | 0/164 (0%) | 1/671 (0.1%) | |||||
| PNEUMONIA | 0/174 (0%) | 2/166 (1.2%) | 2/167 (1.2%) | 0/164 (0%) | 4/671 (0.6%) | |||||
| VARICELLA | 0/174 (0%) | 0/166 (0%) | 0/167 (0%) | 1/164 (0.6%) | 1/671 (0.1%) | |||||
| ABSCESS | 0/174 (0%) | 0/166 (0%) | 1/167 (0.6%) | 0/164 (0%) | 1/671 (0.1%) | |||||
| AMOEBIASIS | 0/174 (0%) | 0/166 (0%) | 1/167 (0.6%) | 1/164 (0.6%) | 2/671 (0.3%) | |||||
| GASTROENTERITIS | 2/174 (1.1%) | 0/166 (0%) | 1/167 (0.6%) | 1/164 (0.6%) | 4/671 (0.6%) | |||||
| HAND-FOOT-AND-MOUTH DISEASE | 0/174 (0%) | 0/166 (0%) | 0/167 (0%) | 1/164 (0.6%) | 1/671 (0.1%) | |||||
| PERIORBITAL CELLULITIS | 0/174 (0%) | 1/166 (0.6%) | 0/167 (0%) | 0/164 (0%) | 1/671 (0.1%) | |||||
| PHARYNGOTONSILLITIS | 0/174 (0%) | 0/166 (0%) | 1/167 (0.6%) | 0/164 (0%) | 1/671 (0.1%) | |||||
| PSEUDOMONAL SEPSIS | 0/174 (0%) | 0/166 (0%) | 0/167 (0%) | 1/164 (0.6%) | 1/671 (0.1%) | |||||
| SUBCUTANEOUS ABSCESS | 0/174 (0%) | 1/166 (0.6%) | 0/167 (0%) | 0/164 (0%) | 1/671 (0.1%) | |||||
| UPPER RESPIRATORY TRACT INFECTION | 0/174 (0%) | 0/166 (0%) | 1/167 (0.6%) | 0/164 (0%) | 1/671 (0.1%) | |||||
| VIRAL INFECTION | 0/174 (0%) | 0/166 (0%) | 0/167 (0%) | 1/164 (0.6%) | 1/671 (0.1%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| ANIMAL BITE | 1/174 (0.6%) | 2/166 (1.2%) | 1/167 (0.6%) | 1/164 (0.6%) | 5/671 (0.7%) | |||||
| Nervous system disorders | ||||||||||
| FEBRILE CONVULSION | 1/174 (0.6%) | 2/166 (1.2%) | 1/167 (0.6%) | 3/164 (1.8%) | 7/671 (1%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| ASTHMA | 0/174 (0%) | 2/166 (1.2%) | 1/167 (0.6%) | 0/164 (0%) | 3/671 (0.4%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| URTICARIA | 1/174 (0.6%) | 0/166 (0%) | 0/167 (0%) | 0/164 (0%) | 1/671 (0.1%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| TIVc-High Dose | TIVc-Full Dose | TIVc- Half Dose | TIVe | Total | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 142/174 (81.6%) | 133/166 (80.1%) | 141/167 (84.4%) | 127/164 (77.4%) | 543/671 (80.9%) | |||||
| Gastrointestinal disorders | ||||||||||
| DIARRHOEA | 32/174 (18.4%) | 32/166 (19.3%) | 30/167 (18%) | 36/164 (22%) | 130/671 (19.4%) | |||||
| VOMITING | 21/174 (12.1%) | 20/166 (12%) | 22/167 (13.2%) | 14/164 (8.5%) | 77/671 (11.5%) | |||||
| General disorders | ||||||||||
| INFLUENZA LIKE ILLNESS | 20/174 (11.5%) | 38/166 (22.9%) | 35/167 (21%) | 37/164 (22.6%) | 130/671 (19.4%) | |||||
| INJECTION SITE ERYTHEMA | 30/174 (17.2%) | 36/166 (21.7%) | 32/167 (19.2%) | 29/164 (17.7%) | 127/671 (18.9%) | |||||
| INJECTION SITE HAEMORRHAGE | 9/174 (5.2%) | 10/166 (6%) | 8/167 (4.8%) | 7/164 (4.3%) | 34/671 (5.1%) | |||||
| INJECTION SITE INDURATION | 13/174 (7.5%) | 16/166 (9.6%) | 12/167 (7.2%) | 10/164 (6.1%) | 51/671 (7.6%) | |||||
| INJECTION SITE PAIN | 56/174 (32.2%) | 48/166 (28.9%) | 47/167 (28.1%) | 47/164 (28.7%) | 198/671 (29.5%) | |||||
| PYREXIA | 22/174 (12.6%) | 28/166 (16.9%) | 32/167 (19.2%) | 22/164 (13.4%) | 104/671 (15.5%) | |||||
| CHILLS | 7/174 (4%) | 5/166 (3%) | 7/167 (4.2%) | 9/164 (5.5%) | 28/671 (4.2%) | |||||
| Infections and infestations | ||||||||||
| NASOPHARYNGITIS | 19/174 (10.9%) | 17/166 (10.2%) | 22/167 (13.2%) | 25/164 (15.2%) | 83/671 (12.4%) | |||||
| RHINITIS | 22/174 (12.6%) | 30/166 (18.1%) | 19/167 (11.4%) | 26/164 (15.9%) | 97/671 (14.5%) | |||||
| UPPER RESPIRATORY TRACT INFECTION | 48/174 (27.6%) | 44/166 (26.5%) | 53/167 (31.7%) | 41/164 (25%) | 186/671 (27.7%) | |||||
| BRONCHITIS | 6/174 (3.4%) | 11/166 (6.6%) | 12/167 (7.2%) | 12/164 (7.3%) | 41/671 (6.1%) | |||||
| Gastroenteritis | 17/174 (9.8%) | 17/166 (10.2%) | 15/167 (9%) | 15/164 (9.1%) | 64/671 (9.5%) | |||||
| Impetigo | 6/174 (3.4%) | 8/166 (4.8%) | 10/167 (6%) | 6/164 (3.7%) | 30/671 (4.5%) | |||||
| Nervous system disorders | ||||||||||
| SOMNOLENCE | 30/174 (17.2%) | 28/166 (16.9%) | 21/167 (12.6%) | 24/164 (14.6%) | 103/671 (15.4%) | |||||
| Psychiatric disorders | ||||||||||
| EATING DISORDER | 29/174 (16.7%) | 35/166 (21.1%) | 28/167 (16.8%) | 29/164 (17.7%) | 121/671 (18%) | |||||
| IRRITABILITY | 34/174 (19.5%) | 37/166 (22.3%) | 34/167 (20.4%) | 29/164 (17.7%) | 134/671 (20%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Clinical Trial Disclosure Manager |
|---|---|
| Organization | Seqirus |
| Phone | |
| Seqirus.ClinicalTrials@Seqirus.com |
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT02035696
Other Study ID Numbers:
- V58P16
- 2013-002081-39
First Posted:
Jan 14, 2014
Last Update Posted:
Jul 10, 2018
Last Verified:
Jun 1, 2018