Trial Outcomes & Findings for Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants (NCT NCT00404651)
NCT ID: NCT00404651
Last Updated: 2014-05-09
Results Overview
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1189 participants
Primary outcome timeframe
Day 150 (one month post-dose 3)
Results posted on
2014-05-09
Participant Flow
Participants were enrolled from 14 November 2006 to 13 July 2007 in 6 clinical centers in Mexico.
A total of 1189 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
DTaP-IPV-HB-PRP~T Batch 1
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 2
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 3
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
Infanrix Hexa™
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
340
|
343
|
339
|
167
|
|
Overall Study
COMPLETED
|
301
|
315
|
294
|
146
|
|
Overall Study
NOT COMPLETED
|
39
|
28
|
45
|
21
|
Reasons for withdrawal
| Measure |
DTaP-IPV-HB-PRP~T Batch 1
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 2
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 3
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
Infanrix Hexa™
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
|
|---|---|---|---|---|
|
Overall Study
Serious Adverse Event
|
0
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
10
|
5
|
14
|
5
|
|
Overall Study
Lost to Follow-up
|
15
|
11
|
13
|
10
|
|
Overall Study
Withdrawal by Subject
|
14
|
12
|
16
|
6
|
Baseline Characteristics
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
Baseline characteristics by cohort
| Measure |
DTaP-IPV-HB-PRP~T Batch 1
n=340 Participants
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 2
n=343 Participants
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 3
n=339 Participants
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
Infanrix Hexa™
n=167 Participants
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
|
Total
n=1189 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
340 Participants
n=5 Participants
|
343 Participants
n=7 Participants
|
339 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
1189 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
|
2.00 Months
STANDARD_DEVIATION 0.200 • n=5 Participants
|
2.00 Months
STANDARD_DEVIATION 0.197 • n=7 Participants
|
2.01 Months
STANDARD_DEVIATION 0.193 • n=5 Participants
|
1.98 Months
STANDARD_DEVIATION 0.189 • n=4 Participants
|
2.00 Months
STANDARD_DEVIATION 0.195 • n=21 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
572 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
617 Participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
340 Participants
n=5 Participants
|
343 Participants
n=7 Participants
|
339 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
1189 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 150 (one month post-dose 3)Population: Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint.
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
Outcome measures
| Measure |
DTaP-IPV-HB-PRP~T Batch 1
n=231 Participants
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 2
n=236 Participants
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 3
n=228 Participants
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
Infanrix Hexa™
n=119 Participants
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
|
|---|---|---|---|---|
|
Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
Anti-Diphtheria (N = 231, 236, 228, 119)
|
220 Participants
|
228 Participants
Interval 0.0 to 0.0
|
222 Participants
Interval 0.0 to 0.0
|
118 Participants
Interval 0.0 to 0.0
|
|
Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
Anti-Hep B (N = 230, 234, 236, 119)
|
226 Participants
|
231 Participants
Interval 0.0 to 0.0
|
221 Participants
Interval 0.0 to 0.0
|
119 Participants
Interval 0.0 to 0.0
|
|
Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
Anti-PRP (N = 231, 236, 228, 119)
|
229 Participants
|
232 Participants
Interval 0.0 to 0.0
|
226 Participants
Interval 0.0 to 0.0
|
118 Participants
Interval 0.0 to 0.0
|
|
Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
Anti-Tetanus (N = 231, 236, 227, 119)
|
231 Participants
|
236 Participants
Interval 0.0 to 0.0
|
227 Participants
Interval 0.0 to 0.0
|
119 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 150 (one month post-dose 3)Population: Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.
Outcome measures
| Measure |
DTaP-IPV-HB-PRP~T Batch 1
n=231 Participants
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 2
n=236 Participants
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 3
n=228 Participants
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
Infanrix Hexa™
n=119 Participants
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
|
|---|---|---|---|---|
|
Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.
Anti-Pertussis (N= 228, 234, 223, 118)
|
223 Participants
|
226 Participants
Interval 0.0 to 0.0
|
218 Participants
Interval 0.0 to 0.0
|
113 Participants
Interval 0.0 to 0.0
|
|
Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.
Anti-FHA (N= 227, 233, 221, 115)
|
225 Participants
|
229 Participants
Interval 0.0 to 0.0
|
216 Participants
Interval 0.0 to 0.0
|
111 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 150 (one month post-dose 3)Population: Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).
Outcome measures
| Measure |
DTaP-IPV-HB-PRP~T Batch 1
n=231 Participants
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 2
n=236 Participants
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 3
n=228 Participants
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
Infanrix Hexa™
n=119 Participants
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
|
|---|---|---|---|---|
|
Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
Anti-Polio 1 (N = 231, 236, 225, 119)
|
230 Participants
|
236 Participants
Interval 0.0 to 0.0
|
225 Participants
Interval 0.0 to 0.0
|
119 Participants
Interval 0.0 to 0.0
|
|
Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
Anti-Polio 2 (N = 230, 236, 226, 118)
|
230 Participants
|
236 Participants
Interval 0.0 to 0.0
|
226 Participants
Interval 0.0 to 0.0
|
118 Participants
Interval 0.0 to 0.0
|
|
Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
Anti-Polio 3 (N = 230, 236, 226, 119)
|
229 Participants
|
235 Participants
Interval 0.0 to 0.0
|
226 Participants
Interval 0.0 to 0.0
|
117 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 150 (one month post-dose 3)Population: Geometric Mean Titers were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
DTaP-IPV-HB-PRP~T Batch 1
n=231 Participants
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 2
n=236 Participants
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 3
n=228 Participants
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
Infanrix Hexa™
n=119 Participants
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anti-FHA (N = 230, 234, 226, 118)
|
243 Titers
Interval 228.0 to 259.0
|
256 Titers
Interval 237.0 to 277.0
|
220 Titers
Interval 202.0 to 239.0
|
182 Titers
Interval 165.0 to 200.0
|
|
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anti-Hep B (N = 230, 234, 226, 119)
|
935 Titers
Interval 755.0 to 1158.0
|
1566 Titers
Interval 1288.0 to 1905.0
|
1009 Titers
Interval 814.0 to 1252.0
|
1576 Titers
Interval 1283.0 to 1934.0
|
|
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anti-PRP (N = 231, 236, 228, 119)
|
11.9 Titers
Interval 9.77 to 14.5
|
13.1 Titers
Interval 10.7 to 16.0
|
11.5 Titers
Interval 9.26 to 14.3
|
6.68 Titers
Interval 5.1 to 8.74
|
|
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anti-Diphtheria (N = 231, 236, 228, 119)
|
0.176 Titers
Interval 0.143 to 0.217
|
0.246 Titers
Interval 0.194 to 0.311
|
0.173 Titers
Interval 0.139 to 0.214
|
0.173 Titers
Interval 0.132 to 0.226
|
|
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anti-Tetanus (N = 231, 236, 227, 119)
|
1.90 Titers
Interval 1.67 to 2.15
|
1.86 Titers
Interval 1.64 to 2.1
|
1.77 Titers
Interval 1.57 to 2.01
|
2.20 Titers
Interval 1.93 to 2.52
|
|
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anti-Polio 1 (N = 231, 236, 225, 119)
|
860 Titers
Interval 725.0 to 1021.0
|
945 Titers
Interval 809.0 to 1102.0
|
843 Titers
Interval 712.0 to 999.0
|
1370 Titers
Interval 1082.0 to 1736.0
|
|
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anti-Polio 2 (N = 230, 236, 226, 118)
|
1689 Titers
Interval 1429.0 to 1996.0
|
1665 Titers
Interval 1416.0 to 1957.0
|
1612 Titers
Interval 1374.0 to 1892.0
|
2337 Titers
Interval 1878.0 to 2909.0
|
|
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anti-Polio 3 (N = 230, 235, 226, 117)
|
1198 Titers
Interval 1015.0 to 1413.0
|
1170 Titers
Interval 995.0 to 1377.0
|
962 Titers
Interval 809.0 to 1143.0
|
2186 Titers
Interval 1752.0 to 2727.0
|
|
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anti-Pertusiss toxoid (N = 230, 235, 226, 119)
|
242 Titers
Interval 226.0 to 260.0
|
238 Titers
Interval 220.0 to 258.0
|
241 Titers
Interval 222.0 to 262.0
|
228 Titers
Interval 205.0 to 254.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-each vaccination) up to 7 days post-each dosePopulation: Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two batch 1 subjects got batch 2 vaccine, and 1 batch 1 got batch 3 vaccine. Total number (N) are those with available data for the outcome
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever (\[pyrexia\] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability
Outcome measures
| Measure |
DTaP-IPV-HB-PRP~T Batch 1
n=337 Participants
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 2
n=345 Participants
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 3
n=340 Participants
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
Infanrix Hexa™
n=167 Participants
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Pain Post-dose 2 (N = 310, 319, 316, 153)
|
191 Participants
|
220 Participants
Interval 0.0 to 0.0
|
199 Participants
Interval 0.0 to 0.0
|
88 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Pain Pos-dose 3 (N = 302, 317, 306, 149)
|
188 Participants
|
209 Participants
Interval 0.0 to 0.0
|
198 Participants
Interval 0.0 to 0.0
|
87 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Swelling Post-dose 2 (N = 310, 319, 315, 153)
|
74 Participants
|
70 Participants
Interval 0.0 to 0.0
|
60 Participants
Interval 0.0 to 0.0
|
26 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Pyrexia Post-dose 1 (N = 323, 336, 329, 156)
|
63 Participants
|
77 Participants
Interval 0.0 to 0.0
|
82 Participants
Interval 0.0 to 0.0
|
17 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Crying Post-dose 3 (N=302, 317, 306, 149)
|
110 Participants
|
118 Participants
Interval 0.0 to 0.0
|
122 Participants
Interval 0.0 to 0.0
|
40 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Somnolence Post-dse 2 (N = 310, 319, 316, 153)
|
69 Participants
|
78 Participants
Interval 0.0 to 0.0
|
65 Participants
Interval 0.0 to 0.0
|
24 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anorexia Post-dose 2 (N = 310, 319, 315, 153)
|
56 Participants
|
64 Participants
Interval 0.0 to 0.0
|
65 Participants
Interval 0.0 to 0.0
|
25 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anorexia Post-dose 3 (N = 302, 317, 306, 149)
|
61 Participants
|
58 Participants
Interval 0.0 to 0.0
|
65 Participants
Interval 0.0 to 0.0
|
29 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Irritability Post-dse 3 (N = 302, 317, 306, 149)
|
158 Participants
|
167 Participants
Interval 0.0 to 0.0
|
165 Participants
Interval 0.0 to 0.0
|
69 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Pain Post-dose 1 (N = 323, 336, 329, 155)
|
220 Participants
|
237 Participants
Interval 0.0 to 0.0
|
225 Participants
Interval 0.0 to 0.0
|
95 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Erythema-Post dose 1 (N = 323, 336, 329, 156)
|
92 Participants
|
97 Participants
Interval 0.0 to 0.0
|
97 Participants
Interval 0.0 to 0.0
|
41 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Erythema Post-dose 2 (N = 310, 319, 315, 153)
|
94 Participants
|
101 Participants
Interval 0.0 to 0.0
|
96 Participants
Interval 0.0 to 0.0
|
33 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Erythema Post-dose 3 (N = 302, 317, 306, 149)
|
95 Participants
|
94 Participants
Interval 0.0 to 0.0
|
101 Participants
Interval 0.0 to 0.0
|
43 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Swelling Post-dose 1 (N = 323, 336, 329, 156)
|
67 Participants
|
86 Participants
Interval 0.0 to 0.0
|
80 Participants
Interval 0.0 to 0.0
|
35 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Swelling Post-dose 3 (N = 302, 317, 306, 149)
|
66 Participants
|
65 Participants
Interval 0.0 to 0.0
|
72 Participants
Interval 0.0 to 0.0
|
22 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Pyrexia Post-dose 2 (N = 310, 318, 315, 153)
|
75 Participants
|
84 Participants
Interval 0.0 to 0.0
|
85 Participants
Interval 0.0 to 0.0
|
32 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Pyrexia Post-dose 3 (N = 302, 317, 306, 149)
|
69 Participants
|
85 Participants
Interval 0.0 to 0.0
|
70 Participants
Interval 0.0 to 0.0
|
28 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Vomiting Post-dose 1 (N = 323, 336, 329, 156)
|
68 Participants
|
63 Participants
Interval 0.0 to 0.0
|
56 Participants
Interval 0.0 to 0.0
|
27 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Vomiting Post-dose 2 (N = 310, 319, 316, 153)
|
37 Participants
|
46 Participants
Interval 0.0 to 0.0
|
34 Participants
Interval 0.0 to 0.0
|
18 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Vomiting Post-dose 3 (N = 302, 317, 306, 149)
|
51 Participants
|
46 Participants
Interval 0.0 to 0.0
|
47 Participants
Interval 0.0 to 0.0
|
20 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Crying Post-dose 1 (N = 323, 336, 329, 156)
|
160 Participants
|
156 Participants
Interval 0.0 to 0.0
|
148 Participants
Interval 0.0 to 0.0
|
62 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Crying Post-dose 2 (N=310, 319, 316, 153)
|
133 Participants
|
145 Participants
Interval 0.0 to 0.0
|
134 Participants
Interval 0.0 to 0.0
|
59 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Somnolence Post-dose 1 (N = 323, 336, 329, 156)
|
93 Participants
|
110 Participants
Interval 0.0 to 0.0
|
102 Participants
Interval 0.0 to 0.0
|
45 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Somnolence Post-dose 3 (N = 302, 317, 306, 149)
|
56 Participants
|
57 Participants
Interval 0.0 to 0.0
|
54 Participants
Interval 0.0 to 0.0
|
20 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Anorexia Post-dose 1 (N = 323, 336, 329, 156)
|
62 Participants
|
75 Participants
Interval 0.0 to 0.0
|
70 Participants
Interval 0.0 to 0.0
|
27 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Irritability Post-dose 1 (N = 323, 336, 329, 156)
|
188 Participants
|
198 Participants
Interval 0.0 to 0.0
|
193 Participants
Interval 0.0 to 0.0
|
83 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Irritability Post-dose 2 (N = 310, 319, 316, 153)
|
158 Participants
|
192 Participants
Interval 0.0 to 0.0
|
174 Participants
Interval 0.0 to 0.0
|
72 Participants
Interval 0.0 to 0.0
|
Adverse Events
DTaP-IPV-HB-PRP~T Batch 1
Serious events: 5 serious events
Other events: 220 other events
Deaths: 0 deaths
DTaP-IPV-HB-PRP~T Batch 2
Serious events: 5 serious events
Other events: 237 other events
Deaths: 0 deaths
DTaP-IPV-HB-PRP~T Batch 3
Serious events: 12 serious events
Other events: 225 other events
Deaths: 0 deaths
Infanrix Hexa™
Serious events: 6 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTaP-IPV-HB-PRP~T Batch 1
n=337 participants at risk
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 2
n=345 participants at risk
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 3
n=340 participants at risk
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
Infanrix Hexa™
n=167 participants at risk
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Heart Disease Congenital
|
0.00%
0/337 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.29%
1/345 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/340 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/167 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/337 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/345 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.29%
1/340 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/167 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Infections and infestations
Bronchiolitis
|
0.30%
1/337 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/345 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/340 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
1.2%
2/167 • Number of events 2 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/337 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/345 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.29%
1/340 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/167 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/337 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/345 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.29%
1/340 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/167 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Infections and infestations
Gastroenteritis
|
0.59%
2/337 • Number of events 2 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.58%
2/345 • Number of events 2 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
1.5%
5/340 • Number of events 5 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
1.2%
2/167 • Number of events 2 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Infections and infestations
Pneumonia
|
0.30%
1/337 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/345 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.29%
1/340 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/167 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/337 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.29%
1/345 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/340 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/167 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/337 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.29%
1/345 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/340 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/167 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Metabolism and nutrition disorders
Food Intolerance
|
0.30%
1/337 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/345 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/340 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/167 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Nervous system disorders
Febrile Convulsion
|
0.30%
1/337 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/345 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.29%
1/340 • Number of events 2 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.60%
1/167 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Nervous system disorders
Infantile Spasms
|
0.00%
0/337 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/345 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.29%
1/340 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/167 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Nervous system disorders
Partial Seizures
|
0.00%
0/337 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/345 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/340 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.60%
1/167 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/337 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/345 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.29%
1/340 • Number of events 1 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
0.00%
0/167 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
Other adverse events
| Measure |
DTaP-IPV-HB-PRP~T Batch 1
n=337 participants at risk
Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 2
n=345 participants at risk
Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
DTaP-IPV-HB-PRP~T Batch 3
n=340 participants at risk
Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T), with one dose each at 2, 4, and 6 months of age.
|
Infanrix Hexa™
n=167 participants at risk
Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
21.1%
68/323 • Number of events 68 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
18.8%
63/336 • Number of events 63 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
17.0%
56/329 • Number of events 56 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
17.3%
27/156 • Number of events 27 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
General disorders
Injection Site Pain
|
68.1%
220/323 • Number of events 220 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
70.5%
237/336 • Number of events 237 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
68.4%
225/329 • Number of events 225 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
61.3%
95/155 • Number of events 95 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
General disorders
Injection Site Erythema
|
31.5%
95/302 • Number of events 95 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
31.7%
101/319 • Number of events 101 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
33.0%
101/306 • Number of events 101 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
28.9%
43/149 • Number of events 43 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
General disorders
Injection Site Swelling
|
23.9%
74/310 • Number of events 74 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
25.6%
86/336 • Number of events 86 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
24.3%
80/329 • Number of events 80 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
22.4%
35/156 • Number of events 35 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
General disorders
Irritability
|
58.2%
188/323 • Number of events 188 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
58.9%
198/336 • Number of events 198 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
58.7%
193/329 • Number of events 193 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
53.2%
83/156 • Number of events 83 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
General disorders
Pyrexia
|
24.2%
75/310 • Number of events 75 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
26.8%
85/317 • Number of events 85 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
27.0%
85/315 • Number of events 85 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
20.9%
32/153 • Number of events 32 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Metabolism and nutrition disorders
Anorexia
|
19.2%
62/323 • Number of events 62 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
22.3%
75/336 • Number of events 75 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
21.3%
70/329 • Number of events 70 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
19.5%
29/149 • Number of events 29 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Nervous system disorders
Somnolence
|
28.8%
93/323 • Number of events 93 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
32.7%
110/336 • Number of events 110 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
31.0%
102/329 • Number of events 102 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
28.8%
45/156 • Number of events 45 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
|
Psychiatric disorders
Crying
|
49.5%
160/323 • Number of events 160 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
46.4%
156/336 • Number of events 156 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
45.0%
148/329 • Number of events 148 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
39.7%
62/156 • Number of events 62 • Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.
Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data.
|
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