Trial Outcomes & Findings for Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™ (NCT NCT00654901)
NCT ID: NCT00654901
Last Updated: 2016-05-13
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 by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). 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 ELISA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
881 participants
Primary outcome timeframe
Day 0 (pre-booster) and Day 30 (one month post-booster)
Results posted on
2016-05-13
Participant Flow
Participants were enrolled from 25 March 2008 to 28 November 2008 at 5 clinical centers in Mexico.
A total of 881 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
DTaP-IPV-Hep B-PRP~T Batch 1
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 2
Participants had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 3
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
Infanrix Hexa™
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP\~T at Day 0 in the present study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
254
|
262
|
252
|
113
|
|
Overall Study
COMPLETED
|
250
|
262
|
250
|
113
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
DTaP-IPV-Hep B-PRP~T Batch 1
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 2
Participants had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 3
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
Infanrix Hexa™
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP\~T at Day 0 in the present study.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
1
|
0
|
Baseline Characteristics
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
Baseline characteristics by cohort
| Measure |
DTaP-IPV-Hep B-PRP~T Batch 1
n=254 Participants
Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 2
n=262 Participants
Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 3
n=252 Participants
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
Infanrix Hexa™
n=113 Participants
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP\~T at Day 0 in the present study.
|
Total
n=881 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
254 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
881 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
|
17.3 Months
STANDARD_DEVIATION 1.51 • n=5 Participants
|
17.2 Months
STANDARD_DEVIATION 1.47 • n=7 Participants
|
17.4 Months
STANDARD_DEVIATION 1.42 • n=5 Participants
|
17.1 Months
STANDARD_DEVIATION 1.51 • n=4 Participants
|
17.3 Months
STANDARD_DEVIATION 1.47 • n=21 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
438 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
443 Participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
254 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
881 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-booster) and Day 30 (one month post-booster)Population: Geometric mean titers were assessed in a subset of 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 by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). 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 ELISA.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T Batch 1
n=58 Participants
Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 2
n=61 Participants
Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 3
n=58 Participants
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
Infanrix Hexa™
n=65 Participants
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP\~T at Day 0 in the present study.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Hep B Pre-booster (N = 58, 60, 58, 65)
|
91.1 Titers
Interval 56.8 to 146.0
|
127 Titers
Interval 83.9 to 193.0
|
69.2 Titers
Interval 42.3 to 113.0
|
127 Titers
Interval 86.2 to 186.0
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti PT Post-booster (N = 58, 61, 58, 64)
|
186 Titers
Interval 151.0 to 230.0
|
200 Titers
Interval 166.0 to 241.0
|
171 Titers
Interval 137.0 to 212.0
|
162 Titers
Interval 131.0 to 200.0
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Hep B Post-booster (N = 58, 61, 58, 65)
|
2167 Titers
Interval 1314.0 to 3573.0
|
3998 Titers
Interval 2510.0 to 6368.0
|
1877 Titers
Interval 1152.0 to 3058.0
|
4757 Titers
Interval 3124.0 to 7243.0
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti PRP Pre-booster (N = 58, 60, 57, 65)
|
1.09 Titers
Interval 0.644 to 1.86
|
1.32 Titers
Interval 0.937 to 1.87
|
0.880 Titers
Interval 0.51 to 1.52
|
1.33 Titers
Interval 0.839 to 2.1
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti PRP Post-booster (N = 58, 61, 58, 65)
|
64.0 Titers
Interval 47.4 to 86.6
|
94.8 Titers
Interval 71.6 to 125.0
|
49.7 Titers
Interval 30.6 to 80.6
|
102 Titers
Interval 72.8 to 144.0
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Diphtheria Pre-booster (N = 58, 60, 57, 64)
|
0.116 Titers
Interval 0.072 to 0.187
|
0.190 Titers
Interval 0.126 to 0.287
|
0.101 Titers
Interval 0.062 to 0.164
|
0.081 Titers
Interval 0.055 to 0.119
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Diphtheria Post-booster (N = 58, 61, 58, 65)
|
7.78 Titers
Interval 4.88 to 12.4
|
15.2 Titers
Interval 10.1 to 23.1
|
9.31 Titers
Interval 5.8 to 14.9
|
6.01 Titers
Interval 3.99 to 9.06
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Tetanus Pre-booster (N = 58, 60, 57, 65)
|
0.330 Titers
Interval 0.236 to 0.462
|
0.331 Titers
Interval 0.256 to 0.427
|
0.231 Titers
Interval 0.167 to 0.318
|
0.297 Titers
Interval 0.229 to 0.385
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Tetanus Post-booster (N = 58, 61, 58, 65)
|
5.26 Titers
Interval 3.97 to 6.96
|
8.49 Titers
Interval 6.5 to 11.1
|
5.55 Titers
Interval 4.2 to 7.33
|
6.98 Titers
Interval 5.26 to 9.26
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Polio 1 Pre-booster (N = 57, 59, 57, 65)
|
614 Titers
Interval 382.0 to 988.0
|
663 Titers
Interval 458.0 to 959.0
|
551 Titers
Interval 356.0 to 853.0
|
887 Titers
Interval 571.0 to 1378.0
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Polio 1 Post-booster (N = 57, 61, 58, 64)
|
7037 Titers
Interval 4977.0 to 9949.0
|
9938 Titers
Interval 7418.0 to 13313.0
|
8907 Titers
Interval 6474.0 to 12254.0
|
10173 Titers
Interval 7909.0 to 13086.0
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Polio 2 Pre-booster (N = 58, 59, 56, 65)
|
936 Titers
Interval 584.0 to 1501.0
|
839 Titers
Interval 530.0 to 1326.0
|
531 Titers
Interval 309.0 to 913.0
|
1267 Titers
Interval 747.0 to 2152.0
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Polio 2 Post-booster (N = 56, 61, 58, 64)
|
10756 Titers
Interval 7636.0 to 15151.0
|
10224 Titers
Interval 7476.0 to 13981.0
|
9232 Titers
Interval 6549.0 to 13014.0
|
13482 Titers
Interval 10245.0 to 17742.0
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Polio 3 Pre-booster (N = 58, 59, 56, 65)
|
428 Titers
Interval 255.0 to 719.0
|
373 Titers
Interval 224.0 to 619.0
|
241 Titers
Interval 130.0 to 446.0
|
896 Titers
Interval 508.0 to 1580.0
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti Polio 3 Post-booster (N = 56, 60, 58, 64)
|
6597 Titers
Interval 4281.0 to 10164.0
|
9575 Titers
Interval 6859.0 to 13365.0
|
5296 Titers
Interval 3503.0 to 8007.0
|
13337 Titers
Interval 9619.0 to 18491.0
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti PT Pre-booster (N = 57, 59, 55, 64)
|
15.6 Titers
Interval 11.6 to 20.9
|
14.7 Titers
Interval 11.8 to 18.4
|
14.5 Titers
Interval 11.3 to 18.6
|
15.3 Titers
Interval 11.6 to 20.2
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti FHA Pre-booster (N = 58, 60, 56, 64)
|
42.1 Titers
Interval 30.6 to 57.9
|
33.7 Titers
Interval 26.0 to 43.8
|
28.3 Titers
Interval 21.5 to 37.3
|
25.9 Titers
Interval 19.6 to 34.2
|
|
Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Anti FHA Post-booster (N = 58, 60, 58, 65)
|
410 Titers
Interval 336.0 to 499.0
|
455 Titers
Interval 387.0 to 536.0
|
346 Titers
Interval 284.0 to 421.0
|
291 Titers
Interval 242.0 to 349.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-booster) and Day 30 (one month post-booster)Population: Antibody persistence and immunogenicity response 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 persistence and immunogenicity response: Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T Batch 1
n=58 Participants
Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 2
n=61 Participants
Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 3
n=58 Participants
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
Infanrix Hexa™
n=65 Participants
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP\~T at Day 0 in the present study.
|
|---|---|---|---|---|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-Hep B Level 2 Post-booster (N=58, 61, 58, 65)
|
52 Participants
|
58 Participants
|
55 Participants
|
63 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-PRP Level 1 Post-booster (N=58, 61, 58, 65)
|
58 Participants
|
61 Participants
|
58 Participants
|
65 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-PRP Level 2 Post booster (N=58, 61, 58, 65)
|
58 Participants
|
61 Participants
|
55 Participants
|
64 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-D Level 3 Post-booster (N=58, 61, 58, 65)
|
53 Participants
|
59 Participants
|
53 Participants
|
60 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-T Level 1 Pre-booster (N=58, 60, 57, 65)
|
58 Participants
|
60 Participants
|
57 Participants
|
65 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-T Level 2 Pre-booster (N=58, 60, 57, 65)
|
48 Participants
|
52 Participants
|
41 Participants
|
54 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-T Level 1 Post-booster (N=58, 61, 58, 65)
|
58 Participants
|
61 Participants
|
58 Participants
|
65 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-T Level 2 Post-booster (N=58, 61, 58, 65)
|
58 Participants
|
61 Participants
|
58 Participants
|
64 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-Polio 2 Pre-booster (N=58, 59, 56, 65)
|
58 Participants
|
59 Participants
|
56 Participants
|
65 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-FHA Post-booster (N=58, 59, 56, 64)
|
48 Participants
|
50 Participants
|
52 Participants
|
57 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-Hep B Level 1 Pre-booster (N=58, 60, 58, 65)
|
51 Participants
|
56 Participants
|
51 Participants
|
62 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-Hep B Level 2 Pre-booster (N=58, 60, 58, 65)
|
29 Participants
|
39 Participants
|
25 Participants
|
38 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-D Level 1 Post-booster (N=58, 61, 58, 65)
|
58 Participants
|
60 Participants
|
58 Participants
|
64 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-D Level 2 Post-booster (N=58, 61, 58, 65)
|
56 Participants
|
60 Participants
|
56 Participants
|
63 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-T Level 3 Post-booster (N=58, 61, 58, 65)
|
52 Participants
|
58 Participants
|
55 Participants
|
62 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-Polio 1 Pre-booster (N=57, 59, 57, 65)
|
57 Participants
|
59 Participants
|
57 Participants
|
65 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-Polio 1 Post-booster (N=57, 61, 58, 64)
|
57 Participants
|
61 Participants
|
58 Participants
|
64 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-Hep B Level 1 Post-booster (N=58, 61, 58, 65)
|
58 Participants
|
61 Participants
|
57 Participants
|
65 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-PRP Level 1 Pre-booster (N=58, 60, 57, 65)
|
51 Participants
|
54 Participants
|
47 Participants
|
60 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-PRP Level 2 Pre-booster (N=58, 60, 57, 65)
|
27 Participants
|
36 Participants
|
25 Participants
|
32 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-D Level 1 Pre-booster (N=58, 60, 57, 64)
|
51 Participants
|
59 Participants
|
51 Participants
|
62 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-D Level 2 Pre-booster (N=58, 60, 57, 64)
|
31 Participants
|
39 Participants
|
29 Participants
|
32 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-Polio 2 Post-booster (N=56, 61, 58, 64)
|
56 Participants
|
61 Participants
|
58 Participants
|
64 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-Polio 3 Pre-booster (N=58, 59, 56, 65)
|
57 Participants
|
57 Participants
|
53 Participants
|
64 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-Polio 3 Post-booster (N=56, 60, 58, 64)
|
56 Participants
|
60 Participants
|
58 Participants
|
64 Participants
|
|
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anti-PT Post-booster (N=57, 59, 55, 63)
|
48 Participants
|
57 Participants
|
52 Participants
|
51 Participants
|
PRIMARY outcome
Timeframe: Days 0 up to 7 after any injectionPopulation: Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population).
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T Batch 1
n=254 Participants
Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 2
n=262 Participants
Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 3
n=252 Participants
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
Infanrix Hexa™
n=113 Participants
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP\~T at Day 0 in the present study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Grade 3 injection site Swelling
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Injection site Erythema
|
135 Participants
|
127 Participants
|
135 Participants
|
63 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Grade 3 injection site Erythema
|
3 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Injection site Swelling
|
51 Participants
|
69 Participants
|
58 Participants
|
35 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Extensive Swelling of Vaccinated Limb
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Grade 3 Extensive Swelling of Vaccinated Limb
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Pyrexia
|
25 Participants
|
35 Participants
|
28 Participants
|
22 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Grade 3 Irritability
|
8 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Injection site Pain
|
174 Participants
|
193 Participants
|
177 Participants
|
80 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Grade 3 injection site Pain
|
8 Participants
|
11 Participants
|
14 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Grade 3 Pyrexia
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Vomiting
|
44 Participants
|
49 Participants
|
36 Participants
|
19 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Grade 3 Vomiting
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Crying
|
91 Participants
|
91 Participants
|
87 Participants
|
42 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Grade 3 Crying
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Somnolence
|
55 Participants
|
66 Participants
|
54 Participants
|
33 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Grade 3 Somnolence
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Anorexia
|
95 Participants
|
101 Participants
|
87 Participants
|
42 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Grade 3 Anorexia
|
6 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Irritability
|
145 Participants
|
166 Participants
|
166 Participants
|
75 Participants
|
Adverse Events
DTaP-IPV-Hep B-PRP~T Batch 1
Serious events: 1 serious events
Other events: 188 other events
Deaths: 0 deaths
DTaP-IPV-Hep B-PRP~T Batch 2
Serious events: 1 serious events
Other events: 207 other events
Deaths: 0 deaths
DTaP-IPV-Hep B-PRP~T Batch 3
Serious events: 1 serious events
Other events: 197 other events
Deaths: 0 deaths
Infanrix Hexa™
Serious events: 0 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTaP-IPV-Hep B-PRP~T Batch 1
n=254 participants at risk
Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 2
n=262 participants at risk
Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 3
n=252 participants at risk
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
Infanrix Hexa™
n=113 participants at risk
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP\~T at Day 0 in the present study.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.39%
1/254 • Number of events 1 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
0.00%
0/262 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
0.00%
0/252 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
0.00%
0/113 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/254 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
0.00%
0/262 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
0.40%
1/252 • Number of events 1 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
0.00%
0/113 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/254 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
0.38%
1/262 • Number of events 1 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
0.00%
0/252 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
0.00%
0/113 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
Other adverse events
| Measure |
DTaP-IPV-Hep B-PRP~T Batch 1
n=254 participants at risk
Participants had received 3 primary doses of Batch A of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 2
n=262 participants at risk
Participants had received 3 primary doses of Batch B of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
DTaP-IPV-Hep B-PRP~T Batch 3
n=252 participants at risk
Participants had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP\~T) at Day 0 in the present study.
|
Infanrix Hexa™
n=113 participants at risk
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component \[aP\]), Hepatitis B (Hep B, \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]) (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP\~T at Day 0 in the present study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
17.3%
44/254 • Number of events 44 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
18.7%
49/262 • Number of events 49 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
14.3%
36/252 • Number of events 36 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
16.8%
19/113 • Number of events 19 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
General disorders
Solicited Injection Site Erythema
|
53.1%
135/254 • Number of events 135 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
48.5%
127/262 • Number of events 127 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
53.6%
135/252 • Number of events 135 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
55.8%
63/113 • Number of events 63 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
General disorders
Solicited Injection Site Pain
|
68.5%
174/254 • Number of events 174 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
73.7%
193/262 • Number of events 193 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
70.2%
177/252 • Number of events 177 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
70.8%
80/113 • Number of events 80 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
General disorders
Solicited Injection Site Swelling
|
20.1%
51/254 • Number of events 51 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
26.3%
69/262 • Number of events 69 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
23.0%
58/252 • Number of events 58 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
31.0%
35/113 • Number of events 35 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
Psychiatric disorders
Irritability
|
57.1%
145/254 • Number of events 145 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
63.4%
166/262 • Number of events 166 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
65.9%
166/252 • Number of events 166 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
66.4%
75/113 • Number of events 75 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
General disorders
Pyrexia
|
9.8%
25/254 • Number of events 25 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
13.4%
35/262 • Number of events 35 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
11.1%
28/252 • Number of events 28 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
19.5%
22/113 • Number of events 22 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
13/254 • Number of events 14 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
7.3%
19/262 • Number of events 19 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
5.6%
14/252 • Number of events 14 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
3.5%
4/113 • Number of events 4 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
Metabolism and nutrition disorders
Anorexia
|
37.4%
95/254 • Number of events 95 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
38.5%
101/262 • Number of events 101 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
34.5%
87/252 • Number of events 87 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
37.2%
42/113 • Number of events 42 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
Nervous system disorders
Somnolence
|
21.7%
55/254 • Number of events 55 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
25.2%
66/262 • Number of events 66 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
21.4%
54/252 • Number of events 54 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
29.2%
33/113 • Number of events 33 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
|
Psychiatric disorders
Crying
|
35.8%
91/254 • Number of events 91 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
34.7%
91/262 • Number of events 91 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
34.5%
87/252 • Number of events 87 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
37.2%
42/113 • Number of events 42 • Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.
|
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