Trial Outcomes & Findings for Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants (NCT NCT00303316)
NCT ID: NCT00303316
Last Updated: 2013-02-22
Results Overview
Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
458 participants
Primary outcome timeframe
Day 0 (Before booster vaccination)
Results posted on
2013-02-22
Participant Flow
Participants were enrolled from 15 February 2006 to 03 October 2006 at 1 clinical center in Argentina.
A total of 458 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
DTacP-IPV-Hep B-PRP~T Group
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses 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-HepB-PRP\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
PENTAXIM™ and ENGERIX B® Group
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
|---|---|---|
|
Overall Study
STARTED
|
232
|
226
|
|
Overall Study
COMPLETED
|
230
|
223
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
DTacP-IPV-Hep B-PRP~T Group
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses 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-HepB-PRP\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
PENTAXIM™ and ENGERIX B® Group
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
Baseline characteristics by cohort
| Measure |
DTacP-IPV-Hep B-PRP~T Group
n=232 Participants
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses 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-HepB-PRP\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
PENTAXIM™ and ENGERIX B® Group
n=226 Participants
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
Total
n=458 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
232 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
17.6 Months
STANDARD_DEVIATION 0.436 • n=5 Participants
|
17.7 Months
STANDARD_DEVIATION 0.492 • n=7 Participants
|
17.6 Months
STANDARD_DEVIATION 0.465 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
232 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (Before booster vaccination)Population: Antibody Persistence was assessed in all enrolled participants with pre-booster vaccination data (Intent-to-Treat population).
Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).
Outcome measures
| Measure |
DTacP-IPV-Hep B-PRP~T Group
n=232 Participants
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses 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-HepB-PRP\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
PENTAXIM™ and ENGERIX B® Group
n=226 Participants
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
|---|---|---|
|
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Hepatitis B (N = 228, 222)
|
195 Participants
|
221 Participants
|
|
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-PRP (N = 224, 217)
|
171 Participants
|
164 Participants
|
|
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Diphtheria (N = 228, 221)
|
169 Participants
|
165 Participants
|
|
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Tetanus (N = 229, 216)
|
229 Participants
|
216 Participants
|
|
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 1 (N = 214, 205)
|
213 Participants
|
205 Participants
|
|
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 2 (N = 217, 204)
|
215 Participants
|
203 Participants
|
|
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 3 (N = 214, 203)
|
205 Participants
|
199 Participants
|
|
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Pertussis Toxoid (N= 216, 212)
|
190 Participants
|
190 Participants
|
|
Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Filamentous Hemagglutinin (N = 230, 220)
|
228 Participants
|
213 Participants
|
PRIMARY outcome
Timeframe: Day 30 Post-booster VaccinationPopulation: Booster responses were assessed in all vaccinated participants with endpoint data following the booster vaccination (Intent-to-Treat population).
Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.
Outcome measures
| Measure |
DTacP-IPV-Hep B-PRP~T Group
n=232 Participants
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses 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-HepB-PRP\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
PENTAXIM™ and ENGERIX B® Group
n=226 Participants
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
|---|---|---|
|
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-PRP (N = 223, 216)
|
220 Participants
|
215 Participants
|
|
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Diphtheria (N = 225, 221)
|
216 Participants
|
214 Participants
|
|
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Tetanus (N = 222, 219)
|
222 Participants
|
219 Participants
|
|
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 1 (N = 211, 209)
|
211 Participants
|
209 Participants
|
|
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 2 (N = 208, 210)
|
208 Participants
|
210 Participants
|
|
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 3 (N = 205, 205)
|
205 Participants
|
205 Participants
|
|
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Pertussis Toxoid (N = 226, 220)
|
226 Participants
|
220 Participants
|
|
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Pertussis Toxoid (4-Fold Rise: N = 211, 208)
|
202 Participants
|
199 Participants
|
|
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Filamentous Hemagglutinin (N = 227, 221)
|
227 Participants
|
221 Participants
|
|
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-FHA (4-Fold Rise: N = 225, 215)
|
198 Participants
|
202 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-booster) and Day 30 post-boosterPopulation: Geometric mean titers were assessed in all participants with endpoint data who received the booster vaccine (Intent-to-Treat Analysis Set for immunogenicity).
Antibody titers determination: Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay.
Outcome measures
| Measure |
DTacP-IPV-Hep B-PRP~T Group
n=232 Participants
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses 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-HepB-PRP\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
PENTAXIM™ and ENGERIX B® Group
n=226 Participants
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Hepatitis B Pre-booster (N = 228, 222)
|
87.6 Titers
Interval 69.2 to 111.0
|
197 Titers
Interval 168.0 to 230.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-PRP Pre-booster (N = 224, 217)
|
0.399 Titers
Interval 0.327 to 0.487
|
0.326 Titers
Interval 0.27 to 0.394
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-PRP Post-booster (N = 223, 216)
|
27.4 Titers
Interval 23.0 to 32.7
|
41.4 Titers
Interval 35.0 to 48.8
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Diphtheria Pre-booster (N = 228, 221)
|
0.022 Titers
Interval 0.018 to 0.027
|
0.018 Titers
Interval 0.015 to 0.022
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Diphtheria Post-booster (N = 225, 221)
|
1.92 Titers
Interval 1.58 to 2.32
|
2.11 Titers
Interval 1.74 to 2.56
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Tetanus Pre-booster (N = 229, 216)
|
0.287 Titers
Interval 0.255 to 0.325
|
0.171 Titers
Interval 0.153 to 0.192
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Tetanus Post-booster (N = 222, 219)
|
4.81 Titers
Interval 4.37 to 5.31
|
4.54 Titers
Interval 4.07 to 5.08
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 1 Pre-booster (N= 214, 205)
|
303 Titers
Interval 251.0 to 365.0
|
232 Titers
Interval 193.0 to 279.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 1 Post-booster (N = 211, 209)
|
7243 Titers
Interval 6218.0 to 8436.0
|
9996 Titers
Interval 8521.0 to 11725.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 2 Pre-booster (N = 217, 204)
|
370 Titers
Interval 300.0 to 457.0
|
292 Titers
Interval 234.0 to 366.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 2 Post-booster (N = 208, 210)
|
8512 Titers
Interval 7281.0 to 9952.0
|
11229 Titers
Interval 9574.0 to 13170.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 3 Pre-booster (N = 214, 203)
|
257 Titers
Interval 202.0 to 327.0
|
223 Titers
Interval 174.0 to 284.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-Polio 3 Post-booster (N = 205, 205)
|
10975 Titers
Interval 9066.0 to 13286.0
|
14482 Titers
Interval 12067.0 to 17380.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-PT Pre-booster (N = 216, 212)
|
10.7 Titers
Interval 9.37 to 12.3
|
12.9 Titers
Interval 11.3 to 14.7
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-PT Post-booster (N = 226, 220)
|
226 Titers
Interval 205.0 to 249.0
|
325 Titers
Interval 292.0 to 362.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-FHA Pre-booster (N = 230, 220)
|
28.2 Titers
Interval 24.5 to 32.5
|
19.0 Titers
Interval 16.7 to 21.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Anti-FHA Post-booster (N = 227, 221)
|
335 Titers
Interval 305.0 to 368.0
|
333 Titers
Interval 305.0 to 363.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 30 post-booster vaccinationPopulation: Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, Safety Analysis Set population.
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable.
Outcome measures
| Measure |
DTacP-IPV-Hep B-PRP~T Group
n=231 Participants
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses 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-HepB-PRP\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
PENTAXIM™ and ENGERIX B® Group
n=223 Participants
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Injection site Pain
|
112 Participants
|
117 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Grade 3 Injection site Pain
|
8 Participants
|
12 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Injection site Erythema
|
66 Participants
|
93 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Grade 3 Injection site Erythema
|
7 Participants
|
19 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Injection site Swelling
|
63 Participants
|
89 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Grade 3 Injection site Swelling
|
5 Participants
|
20 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Any Pyrexia
|
47 Participants
|
44 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Grade 3 Pyrexia
|
9 Participants
|
4 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Any Vomiting
|
18 Participants
|
18 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Grade 3 Vomiting
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Any Crying
|
61 Participants
|
53 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Grade 3 Crying
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Any Somnolence
|
52 Participants
|
44 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Grade 3 Somnolence
|
6 Participants
|
2 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Any Anorexia
|
59 Participants
|
52 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Grade 3 Anorexia
|
9 Participants
|
3 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Any Irritability
|
85 Participants
|
78 Participants
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Grade 3 Irritability
|
6 Participants
|
1 Participants
|
Adverse Events
DTacP-IPV-Hep B-PRP~T Group
Serious events: 3 serious events
Other events: 134 other events
Deaths: 0 deaths
PENTAXIM™ and ENGERIX B® Group
Serious events: 1 serious events
Other events: 137 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTacP-IPV-Hep B-PRP~T Group
n=231 participants at risk
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses 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-HepB-PRP\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
PENTAXIM™ and ENGERIX B® Group
n=223 participants at risk
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
|---|---|---|
|
Infections and infestations
Otitis Media Acute
|
0.43%
1/231 • Number of events 1 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
0.00%
0/223 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
Infections and infestations
Pneumonia
|
0.43%
1/231 • Number of events 1 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
0.00%
0/223 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
Nervous system disorders
Convulsion
|
0.43%
1/231 • Number of events 1 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
0.00%
0/223 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/231 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
0.45%
1/223 • Number of events 1 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
Other adverse events
| Measure |
DTacP-IPV-Hep B-PRP~T Group
n=231 participants at risk
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses 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-HepB-PRP\~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
PENTAXIM™ and ENGERIX B® Group
n=223 participants at risk
Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
7.8%
18/231 • Number of events 18 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
8.1%
18/223 • Number of events 18 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
General disorders
Solicited Injection Site Erythema
|
28.6%
66/231 • Number of events 66 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
41.7%
93/223 • Number of events 93 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
General disorders
Solicited Injection Site Pain
|
48.5%
112/231 • Number of events 112 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
52.5%
117/223 • Number of events 117 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
General disorders
Solicited Injection Site Swelling
|
27.3%
63/231 • Number of events 63 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
39.9%
89/223 • Number of events 89 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
General disorders
Irritability
|
36.8%
85/231 • Number of events 85 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
35.0%
78/223 • Number of events 78 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
General disorders
Pyrexia
|
20.3%
47/231 • Number of events 47 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
19.7%
44/223 • Number of events 44 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
Infections and infestations
Bronchitis
|
6.9%
16/231 • Number of events 16 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
3.6%
8/223 • Number of events 8 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
Infections and infestations
Rhinitis
|
6.5%
15/231 • Number of events 15 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
6.3%
14/223 • Number of events 14 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.5%
59/231 • Number of events 59 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
23.3%
52/223 • Number of events 52 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
Nervous system disorders
Somnolence
|
22.5%
52/231 • Number of events 52 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
19.7%
44/223 • Number of events 44 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
|
Psychiatric disorders
Crying
|
26.4%
61/231 • Number of events 61 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
23.8%
53/223 • Number of events 53 • Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
|
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