Trial Outcomes & Findings for Safety and Immune Response of Different Pediatric Combination Vaccines. (NCT NCT00255047)
NCT ID: NCT00255047
Last Updated: 2014-02-14
Results Overview
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer \> LLOQ; or a pre-dose 1 titer \> LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2167 participants
Primary outcome timeframe
30 Days post-dose 3 vaccination
Results posted on
2014-02-14
Participant Flow
Participants were enrolled from 10 November 2005 through 21 September 2006 in 38 Clinics in the Untied States.
A total of 2167 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on Stage I, up to the 3rd dose are presented.
Participant milestones
| Measure |
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 2: Pentacel®
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
Study Group 3: DTaP-IPV and ActHIB®
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 4: Pentacel®
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
538
|
535
|
546
|
548
|
|
Overall Study
COMPLETED
|
490
|
487
|
496
|
502
|
|
Overall Study
NOT COMPLETED
|
48
|
48
|
50
|
46
|
Reasons for withdrawal
| Measure |
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 2: Pentacel®
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
Study Group 3: DTaP-IPV and ActHIB®
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 4: Pentacel®
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
|---|---|---|---|---|
|
Overall Study
Serious Adverse Events
|
2
|
1
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
3
|
2
|
1
|
|
Overall Study
Protocol Violation
|
13
|
13
|
16
|
20
|
|
Overall Study
Lost to Follow-up
|
9
|
8
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
24
|
23
|
25
|
18
|
Baseline Characteristics
Safety and Immune Response of Different Pediatric Combination Vaccines.
Baseline characteristics by cohort
| Measure |
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®
n=538 Participants
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 2: Pentacel®
n=535 Participants
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
Study Group 3: DTaP-IPV and ActHIB®
n=546 Participants
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 4: Pentacel®
n=548 Participants
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
Total
n=2167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
538 Participants
n=5 Participants
|
535 Participants
n=7 Participants
|
546 Participants
n=5 Participants
|
548 Participants
n=4 Participants
|
2167 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
2.2 Months
STANDARD_DEVIATION 0.27 • n=5 Participants
|
2.1 Months
STANDARD_DEVIATION 0.27 • n=7 Participants
|
2.2 Months
STANDARD_DEVIATION 0.27 • n=5 Participants
|
2.1 Months
STANDARD_DEVIATION 0.28 • n=4 Participants
|
2.1 Months
STANDARD_DEVIATION 0.27 • n=21 Participants
|
|
Sex: Female, Male
Female
|
251 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
1016 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
287 Participants
n=5 Participants
|
293 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
1151 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
538 participants
n=5 Participants
|
535 participants
n=7 Participants
|
546 participants
n=5 Participants
|
548 participants
n=4 Participants
|
2167 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 Days post-dose 3 vaccinationPopulation: The vaccine response to pertussis antigens were determined in the per-protocol population.
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer \> LLOQ; or a pre-dose 1 titer \> LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
Outcome measures
| Measure |
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®
n=419 Participants
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 2: Pentacel®
n=405 Participants
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
Study Group 3: DTaP-IPV and ActHIB®
n=411 Participants
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 4: Pentacel®
n=424 Participants
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
|---|---|---|---|---|
|
Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Pertussis Toxoid (PT)
|
98 Percentage of Participants
|
99 Percentage of Participants
|
99 Percentage of Participants
|
99 Percentage of Participants
|
|
Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Pertactin (PRN)
|
94 Percentage of Participants
|
92 Percentage of Participants
|
94 Percentage of Participants
|
92 Percentage of Participants
|
|
Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Fimbriae Types 2 and 3 (FIM)
|
97 Percentage of Participants
|
96 Percentage of Participants
|
99 Percentage of Participants
|
97 Percentage of Participants
|
|
Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Filamentous Haemagglutinin (FHA)
|
86 Percentage of Participants
|
96 Percentage of Participants
|
95 Percentage of Participants
|
96 Percentage of Participants
|
PRIMARY outcome
Timeframe: 30 Days post-dose 3 vaccinationPopulation: Four-fold rise titers (seroconversion) were evaluated in the per-protocol population
Outcome measures
| Measure |
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®
n=419 Participants
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 2: Pentacel®
n=405 Participants
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
Study Group 3: DTaP-IPV and ActHIB®
n=411 Participants
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 4: Pentacel®
n=424 Participants
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
|---|---|---|---|---|
|
Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Pertussis Toxoid (PT)
|
89 Percentage of participants
|
92 Percentage of participants
|
92 Percentage of participants
|
92 Percentage of participants
|
|
Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Filamentous Haemagglutinin (FHA)
|
54 Percentage of participants
|
75 Percentage of participants
|
77 Percentage of participants
|
77 Percentage of participants
|
|
Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Pertactin (PRN)
|
71 Percentage of participants
|
67 Percentage of participants
|
76 Percentage of participants
|
68 Percentage of participants
|
|
Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Fimbriae Types 2 and 3 (FIM)
|
86 Percentage of participants
|
85 Percentage of participants
|
94 Percentage of participants
|
90 Percentage of participants
|
PRIMARY outcome
Timeframe: 30 Days post-dose 3 vaccination.Population: Geometric mean titers were evaluated in the per-protocol immunogenicity population
Outcome measures
| Measure |
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®
n=422 Participants
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 2: Pentacel®
n=406 Participants
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
Study Group 3: DTaP-IPV and ActHIB®
n=414 Participants
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 4: Pentacel®
n=425 Participants
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Pertussis Toxoid (EU/mL)
|
66.48 Titers
Interval 62.54 to 70.67
|
96.8 Titers
Interval 91.4 to 102.4
|
116.86 Titers
Interval 110.6 to 123.47
|
97.8 Titers
Interval 92.5 to 103.3
|
|
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Diphtheria (IU/mL)
|
0.32 Titers
Interval 0.29 to 0.36
|
0.3 Titers
Interval 0.3 to 0.4
|
0.37 Titers
Interval 0.33 to 0.41
|
0.3 Titers
Interval 0.3 to 0.3
|
|
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Tetanus toxoid (IU/mL, ≥ 0.01)
|
0.97 Titers
Interval 0.91 to 1.04
|
0.8 Titers
Interval 0.7 to 0.8
|
1.09 Titers
Interval 1.02 to 1.17
|
0.8 Titers
Interval 0.7 to 0.8
|
|
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Poliovirus Types 1 (≥ 1:8 dil)
|
719.83 Titers
Interval 645.73 to 802.42
|
397.7 Titers
Interval 342.8 to 461.5
|
776.44 Titers
Interval 676.85 to 890.68
|
468.3 Titers
Interval 406.3 to 539.8
|
|
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Poliovirus Types 2 (≥ 1:8 dil)
|
734.50 Titers
Interval 668.28 to 807.28
|
699.5 Titers
Interval 623.6 to 784.6
|
1203.20 Titers
Interval 1082.31 to 1337.6
|
812.5 Titers
Interval 727.3 to 907.7
|
|
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Poliovirus Types 3 (≥ 1:8 dil)
|
916.90 Titers
Interval 829.15 to 1013.92
|
666.6 Titers
Interval 584.7 to 760.0
|
1115.00 Titers
Interval 976.11 to 1273.65
|
819.9 Titers
Interval 715.8 to 939.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Filamentous Haemagglutinin (EU/mL)
|
22.51 Titers
Interval 20.94 to 24.2
|
53.0 Titers
Interval 49.7 to 56.6
|
56.88 Titers
Interval 53.26 to 60.74
|
54.1 Titers
Interval 50.9 to 57.4
|
|
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Pertactin (EU/mL)
|
33.63 Titers
Interval 30.92 to 36.58
|
32.5 Titers
Interval 29.5 to 35.9
|
44.70 Titers
Interval 40.95 to 48.8
|
32.5 Titers
Interval 29.5 to 35.8
|
|
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Fimbriae Types 2 and 3 (EU/mL)
|
181.66 Titers
Interval 166.62 to 198.06
|
188.5 Titers
Interval 173.9 to 204.3
|
273.10 Titers
Interval 254.83 to 292.67
|
199.0 Titers
Interval 184.3 to 214.8
|
|
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Polyribosylribitol Phosphate-Tetanus Toxoid; μg/mL
|
2.38 Titers
Interval 2.01 to 2.81
|
2.5 Titers
Interval 2.2 to 2.9
|
3.76 Titers
Interval 3.25 to 4.34
|
2.5 Titers
Interval 2.2 to 2.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 days post-vaccination 3Population: Solicited injection site and systemic reactions were evaluated in the intend-to-treat (ITT) population
Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.
Outcome measures
| Measure |
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®
n=538 Participants
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 2: Pentacel®
n=535 Participants
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
Study Group 3: DTaP-IPV and ActHIB®
n=546 Participants
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 4: Pentacel®
n=548 Participants
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
|---|---|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Solicited Injection Site Reaction
|
203 Participants
|
160 Participants
|
164 Participants
|
160 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Erythema
|
34 Participants
|
28 Participants
|
21 Participants
|
18 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Grade 3 Erythema Any dose (>50 mm)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Tenderness
|
186 Participants
|
152 Participants
|
150 Participants
|
148 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Grd 3 Tenderness (cries when inj. limb is moved)
|
11 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Grade 3 Vomitting (≥3 episodes)
|
9 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Anormal crying
|
144 Participants
|
114 Participants
|
125 Participants
|
133 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Grade 3 Lethargy (disabling)
|
4 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Appetite decreased
|
84 Participants
|
72 Participants
|
85 Participants
|
65 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Swelling
|
12 Participants
|
18 Participants
|
10 Participants
|
14 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Grade 3 Swelling Any dose (>50 mm)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Solicited Systemic Reaction
|
311 Participants
|
303 Participants
|
328 Participants
|
309 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Fever
|
102 Participants
|
102 Participants
|
124 Participants
|
94 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Grade 3 Fever (> 39.5 C)
|
3 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Vomitting
|
49 Participants
|
40 Participants
|
41 Participants
|
42 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Grade 3 Abnormal crying (Inconsolable > 3 hrs)
|
3 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Lethargy
|
114 Participants
|
97 Participants
|
100 Participants
|
91 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Grade 3 Appetite decreased (skips ≥ 2 meals)
|
4 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Any Irritability
|
242 Participants
|
239 Participants
|
254 Participants
|
242 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Grade 3 Irritability (continuously for >3 hours)
|
5 Participants
|
12 Participants
|
11 Participants
|
11 Participants
|
Adverse Events
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®
Serious events: 18 serious events
Other events: 399 other events
Deaths: 0 deaths
Study Group 2: Pentacel®
Serious events: 18 serious events
Other events: 394 other events
Deaths: 0 deaths
Study Group 3: DTaP-IPV and ActHIB®
Serious events: 21 serious events
Other events: 421 other events
Deaths: 0 deaths
Study Group 4: Pentacel®
Serious events: 11 serious events
Other events: 414 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®
n=538 participants at risk
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 2: Pentacel®
n=535 participants at risk
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
Study Group 3: DTaP-IPV and ActHIB®
n=546 participants at risk
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 4: Pentacel®
n=548 participants at risk
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Congenital aortic anomaly
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/546 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Congenital, familial and genetic disorders
Congenital ventricular septal defect
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Congenital, familial and genetic disorders
Hepatic arteriovenous malformation
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Gastrointestinal disorders
Acquired pyloric stenosis
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Gastrointestinal disorders
Intussusception
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
General disorders
Pyrexia
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
General disorders
Sudden infant death syndrome
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
General disorders
Upper extremity mass
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Abscess limb
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Bronchiolitis
|
1.3%
7/538 • Number of events 7 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.75%
4/535 • Number of events 4 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
1.1%
6/546 • Number of events 6 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.55%
3/548 • Number of events 3 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Croup infectious
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.36%
2/548 • Number of events 2 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.55%
3/546 • Number of events 3 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/546 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/546 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Influenza
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Kawasaki´s disease
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/546 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Meningitis viral
|
0.37%
2/538 • Number of events 2 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Otitis media
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/546 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/546 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/546 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Sepsis
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Urinary tract infection
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Viral infection
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.37%
2/546 • Number of events 2 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.37%
2/535 • Number of events 2 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.37%
2/546 • Number of events 2 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Metabolism and nutrition disorders
General nutrition disorder
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Nervous system disorders
Convulsion
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.55%
3/546 • Number of events 4 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 3 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Nervous system disorders
Hypotonic-hyporesponsive episode
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/546 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.19%
1/538 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.37%
2/538 • Number of events 2 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/546 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/535 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.18%
1/548 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/538 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.19%
1/535 • Number of events 1 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/546 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
0.00%
0/548 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
Other adverse events
| Measure |
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®
n=538 participants at risk
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 2: Pentacel®
n=535 participants at risk
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
Study Group 3: DTaP-IPV and ActHIB®
n=546 participants at risk
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
|
Study Group 4: Pentacel®
n=548 participants at risk
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
39/538 • Number of events 44 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
6.4%
34/535 • Number of events 37 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
7.5%
41/546 • Number of events 43 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
7.5%
41/548 • Number of events 43 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Gastrointestinal disorders
Teething
|
6.5%
35/538 • Number of events 44 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
6.2%
33/535 • Number of events 43 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
5.5%
30/546 • Number of events 40 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
6.2%
34/548 • Number of events 48 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
General disorders
Pyrexia
|
5.0%
27/538 • Number of events 35 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
6.2%
33/535 • Number of events 34 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
4.0%
22/546 • Number of events 25 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
4.6%
25/548 • Number of events 27 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Bronchiolitis
|
4.5%
24/538 • Number of events 27 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
6.4%
34/535 • Number of events 37 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
5.1%
28/546 • Number of events 30 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
2.9%
16/548 • Number of events 17 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Otitis media
|
13.4%
72/538 • Number of events 86 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
18.1%
97/535 • Number of events 117 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
17.0%
93/546 • Number of events 109 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
13.7%
75/548 • Number of events 94 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Upper respiratory tract infection
|
26.6%
143/538 • Number of events 164 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
26.4%
141/535 • Number of events 167 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
24.5%
134/546 • Number of events 162 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
25.7%
141/548 • Number of events 167 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Infections and infestations
Viral infection
|
3.0%
16/538 • Number of events 17 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
5.8%
31/535 • Number of events 32 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
3.7%
20/546 • Number of events 22 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
4.2%
23/548 • Number of events 23 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
37/538 • Number of events 42 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
9.2%
49/535 • Number of events 54 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
8.2%
45/546 • Number of events 51 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
8.0%
44/548 • Number of events 47 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.5%
51/538 • Number of events 59 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
9.2%
49/535 • Number of events 57 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
9.2%
50/546 • Number of events 59 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
7.7%
42/548 • Number of events 46 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
General disorders
Injection site erythema
|
16.9%
90/532 • Number of events 174 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
12.2%
65/533 • Number of events 83 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
11.9%
64/538 • Number of events 107 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
12.2%
66/543 • Number of events 82 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
General disorders
Injection site swelling
|
9.2%
49/532 • Number of events 102 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
9.4%
50/533 • Number of events 59 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
8.0%
43/538 • Number of events 77 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
9.0%
49/543 • Number of events 71 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
General disorders
Injection site pain
|
64.3%
342/532 • Number of events 1406 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
58.2%
310/533 • Number of events 545 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
55.9%
301/538 • Number of events 967 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
57.1%
310/543 • Number of events 542 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
General disorders
Fever
|
41.2%
219/531 • Number of events 300 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
37.3%
199/533 • Number of events 254 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
41.2%
221/537 • Number of events 304 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
38.3%
208/543 • Number of events 268 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
128/532 • Number of events 169 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
22.3%
119/533 • Number of events 153 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
24.3%
131/538 • Number of events 174 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
21.9%
119/543 • Number of events 150 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Psychiatric disorders
Anbormal crying
|
53.9%
287/532 • Number of events 495 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
52.9%
282/533 • Number of events 446 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
51.0%
275/539 • Number of events 452 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
52.5%
285/543 • Number of events 442 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
General disorders
Lethargy
|
50.9%
271/532 • Number of events 456 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
51.6%
275/533 • Number of events 415 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
48.7%
262/538 • Number of events 415 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
44.0%
239/543 • Number of events 369 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Metabolism and nutrition disorders
Appetite Decreased
|
40.2%
214/532 • Number of events 295 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
35.8%
191/533 • Number of events 253 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
35.7%
192/538 • Number of events 267 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
32.0%
174/543 • Number of events 251 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
|
Psychiatric disorders
Irritability
|
75.0%
399/532 • Number of events 820 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
73.9%
394/533 • Number of events 795 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
78.1%
421/539 • Number of events 820 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
76.2%
414/543 • Number of events 800 • Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
|
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