Trial Outcomes & Findings for Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan (NCT NCT02005536)
NCT ID: NCT02005536
Last Updated: 2015-03-30
Results Overview
A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
Day 28 post-vaccination
Results posted on
2015-03-30
Participant Flow
Participants were enrolled from 02 December 2013 to 28 April 2014 at 4 Clinical trial centers in Japan.
A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. A subject with an exclusion criteria was later discovered and was excluded in the per-protocol analysis set.
Participant milestones
| Measure |
IMOVAX POLIO® Vaccine Group
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
Baseline characteristics by cohort
| Measure |
IMOVAX POLIO® Vaccine Group
n=60 Participants
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
|
|---|---|
|
Age, Categorical
<=18 years
|
60 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
|
4.0 years
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Anti-polio booster response was assessed in the per-protocol analysis set.
A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.
Outcome measures
| Measure |
IMOVAX POLIO® Vaccine Group
n=59 Participants
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
|
|---|---|
|
Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
Anti-polio 1
|
78.0 Percentage of participants
|
|
Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
Anti-polio 2
|
78.0 Percentage of participants
|
|
Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
Anti-polio 3
|
79.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccinationPopulation: Geometric mean titers was assessed in the per-protocol analysis set.
Anti-polio virus antibodies were assessed by virus neutralization assay.
Outcome measures
| Measure |
IMOVAX POLIO® Vaccine Group
n=59 Participants
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
|
|---|---|
|
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Anti-polio 1 (pre-vaccination)
|
312.6 Titers
Interval 241.8 to 404.1
|
|
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Anti-polio 1 (post-vaccination)
|
3794.9 Titers
Interval 3011.5 to 4782.1
|
|
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Anti-polio 2 (pre-vaccination)
|
795.4 Titers
Interval 591.8 to 1069.1
|
|
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Ant-polio 2 (post-vaccination)
|
9213.2 Titers
Interval 6754.5 to 12567.0
|
|
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Anti-polio 3 (pre-vaccination)
|
314.5 Titers
Interval 219.5 to 450.4
|
|
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Anti-polio 3 (post-vaccination)
|
5242.1 Titers
Interval 3912.9 to 7022.9
|
SECONDARY outcome
Timeframe: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccinationPopulation: Anti-polio booster response was assessed in the per-protocol analysis set.
Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay
Outcome measures
| Measure |
IMOVAX POLIO® Vaccine Group
n=59 Participants
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
|
|---|---|
|
Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
Anti-polio 1 (pre-vaccination)
|
100 Percentage of participants
|
|
Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
Anti-polio 1 (post-vaccination)
|
100 Percentage of participants
|
|
Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
Anti -polio 2 (pre-vaccination)
|
100 Percentage of participants
|
|
Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
Anti-polio 2 (post-vaccination)
|
100 Percentage of participants
|
|
Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
Anti-polio 3 (pre-vaccination)
|
98.3 Percentage of participants
|
|
Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
Anti-polio 3 (post-vaccination)
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 28 post-booster vaccinationPopulation: Geometric mean of individual titer ratios were assessed in the per-protocol analysis set.
Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values.
Outcome measures
| Measure |
IMOVAX POLIO® Vaccine Group
n=59 Participants
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
|
|---|---|
|
Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®
Anti-polio 1
|
12.1 Titer Ratio
Interval 8.5 to 17.4
|
|
Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®
Anti-polio 2
|
11.6 Titer Ratio
Interval 7.7 to 17.5
|
|
Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®
Anti-polio 3
|
16.7 Titer Ratio
Interval 9.8 to 28.4
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site and systemic reactions were assessed in all participants who received study vaccine (Safety Analysis Set).
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia.
Outcome measures
| Measure |
IMOVAX POLIO® Vaccine Group
n=60 Participants
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
|
|---|---|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Any Injection-site Pain
|
13 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Grade 3 Injection-site Pain
|
0 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Any Injection-site Erythema
|
41 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Grade 3 Injection-site Erythema
|
1 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Any Injection-site Swelling
|
21 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Grade 3 Injection-site Swelling
|
0 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Any Fever
|
8 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Grade 3 Fever
|
2 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Any Headache
|
4 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Grade 3 Headache
|
0 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Any Malaise
|
18 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Grade 3 Malaise
|
0 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Any Myalgia
|
1 Number of participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Grade 3 Myalgia
|
0 Number of participants
|
Adverse Events
IMOVAX POLIO® Vaccine Group
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IMOVAX POLIO® Vaccine Group
n=60 participants at risk
Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
|
|---|---|
|
General disorders
Injection Site Erythema
|
68.3%
41/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
General disorders
Injection Site Pain
|
21.7%
13/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
General disorders
Injection Site Swelling
|
35.0%
21/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
General disorders
Malaise
|
30.0%
18/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
Nervous system disorders
Headache
|
6.7%
4/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
General disorders
Fever
|
13.3%
8/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
Infections and infestations
Nasopharyngitis
|
18.3%
11/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
4/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
Infections and infestations
Gastroenterities
|
5.0%
3/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
Infections and infestations
Varicella
|
5.0%
3/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
4/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
|
General disorders
Pyrexia
|
8.3%
5/60 • Safety was evaluated from Day 0 (post-booster vaccination) up to Day 28 post-booster vaccination.
The total number (47) reporting other adverse events at the 5% frequency are those participants with solicited injection site and systemic reactions.
|
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