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Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants

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ClinicalTrials.gov Identifier: NCT00303316
Recruitment Status : Completed
First Posted : March 16, 2006
Results First Posted : February 22, 2013
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Poliomyelitis
Hepatitis B
Intervention Biological: DTaP-IPV//PRP~T combined vaccine
Enrollment 458
Recruitment Details Participants were enrolled from 15 February 2006 to 03 October 2006 at 1 clinical center in Argentina.
Pre-assignment Details A total of 458 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title DTacP-IPV-Hep B-PRP~T Group PENTAXIM™ and ENGERIX B® Group
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 232 226
Completed 230 223
Not Completed 2 3
Reason Not Completed
Protocol Violation             1             0
Lost to Follow-up             0             1
Withdrawal by Subject             1             2
Arm/Group Title DTacP-IPV-Hep B-PRP~T Group PENTAXIM™ and ENGERIX B® Group Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 232 226 458
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants 226 participants 458 participants
<=18 years
232
 100.0%
226
 100.0%
458
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 232 participants 226 participants 458 participants
17.6  (0.436) 17.7  (0.492) 17.6  (0.465)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants 226 participants 458 participants
Female
107
  46.1%
107
  47.3%
214
  46.7%
Male
125
  53.9%
119
  52.7%
244
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Argentina Number Analyzed 232 participants 226 participants 458 participants
232 226 458
1.Primary Outcome
Title 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.
Hide Description 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).
Time Frame Day 0 (Before booster vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody Persistence was assessed in all enrolled participants with pre-booster vaccination data (Intent-to-Treat population).
Arm/Group Title DTacP-IPV-Hep B-PRP~T Group PENTAXIM™ and ENGERIX B® Group
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 232 226
Measure Type: Number
Unit of Measure: Participants
Anti-Hepatitis B (N = 228, 222) 195 221
Anti-PRP (N = 224, 217) 171 164
Anti-Diphtheria (N = 228, 221) 169 165
Anti-Tetanus (N = 229, 216) 229 216
Anti-Polio 1 (N = 214, 205) 213 205
Anti-Polio 2 (N = 217, 204) 215 203
Anti-Polio 3 (N = 214, 203) 205 199
Anti-Pertussis Toxoid (N= 216, 212) 190 190
Anti-Filamentous Hemagglutinin (N = 230, 220) 228 213
2.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Day 30 Post-booster Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster responses were assessed in all vaccinated participants with endpoint data following the booster vaccination (Intent-to-Treat population).
Arm/Group Title DTacP-IPV-Hep B-PRP~T Group PENTAXIM™ and ENGERIX B® Group
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 232 226
Measure Type: Number
Unit of Measure: Participants
Anti-PRP (N = 223, 216) 220 215
Anti-Diphtheria (N = 225, 221) 216 214
Anti-Tetanus (N = 222, 219) 222 219
Anti-Polio 1 (N = 211, 209) 211 209
Anti-Polio 2 (N = 208, 210) 208 210
Anti-Polio 3 (N = 205, 205) 205 205
Anti-Pertussis Toxoid (N = 226, 220) 226 220
Anti-Pertussis Toxoid (4-Fold Rise: N = 211, 208) 202 199
Anti-Filamentous Hemagglutinin (N = 227, 221) 227 221
Anti-FHA (4-Fold Rise: N = 225, 215) 198 202
3.Primary Outcome
Title 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.
Hide Description

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.
Time Frame Day 0 (pre-booster) and Day 30 post-booster
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in all participants with endpoint data who received the booster vaccine (Intent-to-Treat Analysis Set for immunogenicity).
Arm/Group Title DTacP-IPV-Hep B-PRP~T Group PENTAXIM™ and ENGERIX B® Group
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 232 226
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Hepatitis B Pre-booster (N = 228, 222)
87.6
(69.2 to 111)
197
(168 to 230)
Anti-PRP Pre-booster (N = 224, 217)
0.399
(0.327 to 0.487)
0.326
(0.270 to 0.394)
Anti-PRP Post-booster (N = 223, 216)
27.4
(23.0 to 32.7)
41.4
(35.0 to 48.8)
Anti-Diphtheria Pre-booster (N = 228, 221)
0.022
(0.018 to 0.027)
0.018
(0.015 to 0.022)
Anti-Diphtheria Post-booster (N = 225, 221)
1.92
(1.58 to 2.32)
2.11
(1.74 to 2.56)
Anti-Tetanus Pre-booster (N = 229, 216)
0.287
(0.255 to 0.325)
0.171
(0.153 to 0.192)
Anti-Tetanus Post-booster (N = 222, 219)
4.81
(4.37 to 5.31)
4.54
(4.07 to 5.08)
Anti-Polio 1 Pre-booster (N= 214, 205)
303
(251 to 365)
232
(193 to 279)
Anti-Polio 1 Post-booster (N = 211, 209)
7243
(6218 to 8436)
9996
(8521 to 11725)
Anti-Polio 2 Pre-booster (N = 217, 204)
370
(300 to 457)
292
(234 to 366)
Anti-Polio 2 Post-booster (N = 208, 210)
8512
(7281 to 9952)
11229
(9574 to 13170)
Anti-Polio 3 Pre-booster (N = 214, 203)
257
(202 to 327)
223
(174 to 284)
Anti-Polio 3 Post-booster (N = 205, 205)
10975
(9066 to 13286)
14482
(12067 to 17380)
Anti-PT Pre-booster (N = 216, 212)
10.7
(9.37 to 12.3)
12.9
(11.3 to 14.7)
Anti-PT Post-booster (N = 226, 220)
226
(205 to 249)
325
(292 to 362)
Anti-FHA Pre-booster (N = 230, 220)
28.2
(24.5 to 32.5)
19.0
(16.7 to 21.6)
Anti-FHA Post-booster (N = 227, 221)
335
(305 to 368)
333
(305 to 363)
4.Secondary Outcome
Title Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Hide Description

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.
Time Frame Day 0 up to Day 30 post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, Safety Analysis Set population.
Arm/Group Title DTacP-IPV-Hep B-PRP~T Group PENTAXIM™ and ENGERIX B® Group
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 231 223
Measure Type: Number
Unit of Measure: Participants
Injection site Pain 112 117
Grade 3 Injection site Pain 8 12
Injection site Erythema 66 93
Grade 3 Injection site Erythema 7 19
Injection site Swelling 63 89
Grade 3 Injection site Swelling 5 20
Any Pyrexia 47 44
Grade 3 Pyrexia 9 4
Any Vomiting 18 18
Grade 3 Vomiting 0 0
Any Crying 61 53
Grade 3 Crying 3 2
Any Somnolence 52 44
Grade 3 Somnolence 6 2
Any Anorexia 59 52
Grade 3 Anorexia 9 3
Any Irritability 85 78
Grade 3 Irritability 6 1
Time Frame Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
Adverse Event Reporting Description 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.
 
Arm/Group Title DTacP-IPV-Hep B-PRP~T Group PENTAXIM™ and ENGERIX B® Group
Hide Arm/Group Description 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). 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).
All-Cause Mortality
DTacP-IPV-Hep B-PRP~T Group PENTAXIM™ and ENGERIX B® Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
DTacP-IPV-Hep B-PRP~T Group PENTAXIM™ and ENGERIX B® Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/231 (1.30%)      1/223 (0.45%)    
Infections and infestations     
Otitis Media Acute * 1  1/231 (0.43%)  1 0/223 (0.00%)  0
Pneumonia * 1  1/231 (0.43%)  1 0/223 (0.00%)  0
Nervous system disorders     
Convulsion * 1  1/231 (0.43%)  1 0/223 (0.00%)  0
Febrile Convulsion * 1  0/231 (0.00%)  0 1/223 (0.45%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
DTacP-IPV-Hep B-PRP~T Group PENTAXIM™ and ENGERIX B® Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   134/231 (58.01%)      137/223 (61.43%)    
Gastrointestinal disorders     
Vomiting † 1  18/231 (7.79%)  18 18/223 (8.07%)  18
General disorders     
Solicited Injection Site Erythema † 1  66/231 (28.57%)  66 93/223 (41.70%)  93
Solicited Injection Site Pain † 1  112/231 (48.48%)  112 117/223 (52.47%)  117
Solicited Injection Site Swelling † 1  63/231 (27.27%)  63 89/223 (39.91%)  89
Irritability † 1  85/231 (36.80%)  85 78/223 (34.98%)  78
Pyrexia † 1  47/231 (20.35%)  47 44/223 (19.73%)  44
Infections and infestations     
Bronchitis * 1  16/231 (6.93%)  16 8/223 (3.59%)  8
Rhinitis * 1  15/231 (6.49%)  15 14/223 (6.28%)  14
Metabolism and nutrition disorders     
Anorexia † 1  59/231 (25.54%)  59 52/223 (23.32%)  52
Nervous system disorders     
Somnolence † 1  52/231 (22.51%)  52 44/223 (19.73%)  44
Psychiatric disorders     
Crying † 1  61/231 (26.41%)  61 53/223 (23.77%)  53
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Publications of Results:
Tregnaghi M, Zambrano B, Santos-Lima E. Antibody persistence after a primary series of a new DTaP-IPV-Hep B-PRP-T combined vaccine or separate DTaP-IPV//PRP-T and hepatitis B vaccines at 2, 4, and 6 months of age and the effect of a subsequent DTaP-IPV//PRP-T booster vaccination at 18 months of age in healthy Argentinean infants. Pediatr Infect Dis J. 2012 Jan;31(1):e24-30. doi: 10.1097/INF.0b013e318242460a.
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00303316    
Other Study ID Numbers: A3L16
First Submitted: March 13, 2006
First Posted: March 16, 2006
Results First Submitted: December 11, 2012
Results First Posted: February 22, 2013
Last Update Posted: February 22, 2013