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Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

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ClinicalTrials.gov Identifier: NCT01444781
Recruitment Status : Completed
First Posted : October 3, 2011
Results First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliomyelitis
Interventions Biological: DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide
Biological: DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide
Biological: DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
Enrollment 1106
Recruitment Details The study participants were enrolled from 26 September 2011 through 19 July 2012 at 2 clinic centers in Colombia and Costa Rica.
Pre-assignment Details A total of 1106 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster
Hide Arm/Group Description Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7) Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7. Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
Period Title: Overall Study
Started 416 415 275
Completed 413 411 272
Not Completed 3 4 3
Reason Not Completed
Lost to Follow-up             0             3             1
Withdrawal by Subject             3             1             2
Arm/Group Title DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster Group. Total
Hide Arm/Group Description Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7) Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7. Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7 Total of all reporting groups
Overall Number of Baseline Participants 416 415 275 1106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 416 participants 415 participants 275 participants 1106 participants
<=18 years
416
 100.0%
415
 100.0%
275
 100.0%
1106
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 416 participants 415 participants 275 participants 1106 participants
17.6  (3.25) 17.6  (3.34) 17.8  (3.26) 17.7  (3.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 416 participants 415 participants 275 participants 1106 participants
Female
203
  48.8%
186
  44.8%
128
  46.5%
517
  46.7%
Male
213
  51.2%
229
  55.2%
147
  53.5%
589
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 416 participants 415 participants 275 participants 1106 participants
Colombia 266 266 172 704
Costa Rica 150 149 103 402
1.Primary Outcome
Title Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine
Hide Description

Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination.

Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers

Time Frame Day 140 (Primary series) and Day 0 (Pre-booster)
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses were assessed in the Per Protocol Analysis Set, which includes all persons who did not have any protocol deviations.
Arm/Group Title Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
Overall Number of Participants Analyzed 396 393 260
Measure Type: Number
Unit of Measure: Participants
Anti-Diphtheria Day140 ≥0.01 IU/mL (N=392,391,259) 392 391 259
Anti-Diphtheria Day 140 ≥0.1 IU/mL (N=392,391,259) 308 290 197
Anti-Diphtheria Day 0 ≥0.01 IU/mL (N=390,390,257) 382 378 246
Anti-Diphtheria Day 0 ≥0.1 IU/mL (N=390,390,257) 156 153 70
Anti-Diphtheria Day 30 ≥0.01 IU/mL (N=393,387,254) 393 387 254
Anti-Diphtheria Day 30 ≥0.1 IU/mL (N=393,387,254) 393 386 254
Anti-Tetanus Day 140 ≥0.01 IU/mL (N=392,391,258) 392 391 258
Anti-Tetanus Day 140 ≥0.1 IU/mL (N=392,391,258) 392 390 258
Anti-Tetanus Day 0 ≥0.01 IU/mL (N=389,387,255) 389 386 255
Anti-Tetanus Day 0 ≥0.1 IU/mL (N=389,387,255) 289 286 196
Anti-Tetanus Day 30 ≥0.01 IU/mL (N=392,385,254) 392 385 254
Anti-Tetanus Day 30 ≥0.1 IU/mL (N=392,385,254) 391 385 254
2.Primary Outcome
Title Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Hide Description

Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations < LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2.

Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.

Time Frame Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses were assessed in the Per-protocol Analysis Set.
Arm/Group Title Group 1: DTaP-IPV Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
Overall Number of Participants Analyzed 396 393 260
Measure Type: Number
Unit of Measure: Participants
Anti-PT Day 140 ≥2 EU/mL (N=393,391,259) 393 391 259
Anti-PT Day 0 ≥2 EU/mL (N=385,382,257) 344 349 225
A-PT Day 30 ≥ 2 EU/mL (N=391,383,254) 391 383 254
Anti-PT 4-fold increase (N=380,374,252) 353 351 234
Anti-PT booster response (N=380,374,252) 375 365 245
Anti-FHA Day 140 ≥2 EU/mL (N=391,390,259) 391 390 259
Anti-FHA Day 0 ≥2 EU/mL (N=389,384,255) 389 384 253
Anti-FHA Day 30 ≥2 EU/mL (N=390,385,254) 390 385 254
Anti-FHA 4-fold increase (N=384,376,252) 336 334 235
Anti-FHA booster response (N=384,376,252) 370 367 249
3.Primary Outcome
Title Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Hide Description

Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30.

Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.

Time Frame Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses were assessed in the Per Protocol Analysis Set.
Arm/Group Title Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
Overall Number of Participants Analyzed 396 393 260
Measure Type: Number
Unit of Measure: Participants
Anti-Polio 1 Day 140 (N = 338,329,214) 338 329 214
Anti-Polio 1 Day 0 (N = 338,326,213) 334 320 210
Anti-Polio 1 Day 30 (N = 339,327,212) 339 327 212
Anti-Polio 2 Day 140 (N = 338,327,214) 338 327 214
Anti-Polio 2 Day 0(N = 337,328,213) 335 328 213
Anti-Polio 2 Day 30 (N = 340,327,212) 340 327 212
Anti-Polio 3 Day 140 (N = 338,328,214) 338 328 214
Anti-Polio 3 Day 0 (N = 338,326,213) 324 309 211
Anti-Polio 3 Day 30 (N = 340,326,212) 340 326 212
4.Primary Outcome
Title Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Hide Description

Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30.

Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.

Time Frame Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses were assessed in the Per Protocol Analysis Set.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
Overall Number of Participants Analyzed 396 393 260
Measure Type: Number
Unit of Measure: Participants
Anti-Hep B Day 140 ≥10 mIU/mL (N = 393,392,260) 391 391 260
Anti-Hep B Day 140 ≥100 mIU/mL (N = 393,392,260) 389 387 259
Anti-Hep B Day 0 ≥10 mIU/mL (N = 396,391,259) 386 382 257
Anti-Hep B Day 0 ≥100 mIU/mL (N = 396,391,259) 327 333 213
Anti-Hep B Day 30 ≥10 mIU/mL (N = 395,393,259) 394 391 259
Anti-Hep B Day 30 ≥100 mIU/mL (N = 395,393,259) 386 384 257
Anti-PRP Day 140 ≥0.15 µg/mL (N = 393,392,260) 370 375 246
Anti-PRP Day 140 ≥1.0 µg/mL (N = 393,392,260) 297 305 188
Anti-PRP Day 0 ≥0.15 µg/mL (N = 395,391,258) 290 304 197
Anti-PRP Day 0 ≥1.0 µg/mL (N = 395,391,258) 110 129 73
Anti-PRP Day 30 ≥0.15 µg/mL (N = 396,391,258) 395 391 258
Anti-PRP Day 30 ≥1.0 µg/mL (N = 396,391,258) 391 387 258
5.Secondary Outcome
Title Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.
Hide Description

Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, anti-PT, and anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-PRP antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker).

Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.

Time Frame Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers against vaccine antibodies were assessed in the Per Protocol Analysis Set.
Arm/Group Title Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
Overall Number of Participants Analyzed 396 393 260
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Diphtheria Day 140 (N=392,391,259)
0.265
(0.237 to 0.295)
0.254
(0.227 to 0.285)
0.251
(0.220 to 0.286)
Anti-Diphtheria Day 0 (N=390,390,257)
0.077
(0.069 to 0.086)
0.074
(0.066 to 0.083)
0.059
(0.051 to 0.068)
Anti-Diphtheria Day 30 (N=393,387,254)
5.55
(5.07 to 6.08)
4.40
(3.99 to 4.86)
6.05
(5.41 to 6.76)
Anti-Tetanus Day 140 (N=392,391,258)
1.50
(1.39 to 1.61)
1.54
(1.44 to 1.65)
1.80
(1.68 to 1.93)
Anti-Tetanus Day 0 (N=389,387,255)
0.208
(0.188 to 0.231)
0.224
(0.200 to 0.251)
0.201
(0.180 to 0.225)
Anti-Tetanus Day 30 (N=392,385,254)
5.72
(5.21 to 6.27)
5.21
(4.78 to 5.68)
7.52
(6.63 to 8.52)
Anti-PT Day 140 (N=393,391,259)
99.6
(94.0 to 106)
102
(96.6 to 108)
97.0
(90.1 to 105)
Anti-PT Day 0 (N=385,382,257)
7.43
(6.63 to 8.32)
8.47
(7.52 to 9.56)
7.41
(6.38 to 8.61)
Anti PT D30 (N=391,383,254)
154
(143 to 166)
191
(178 to 206)
140
(127 to 153)
Anti-FHA Day 140 (N=391,390,259)
179
(169 to 190)
187
(176 to 199)
120
(112 to 129)
Anti-FHA Day 0 (N=389,384,255)
21.2
(18.9 to 23.8)
23.4
(20.8 to 26.3)
14.4
(12.5 to 16.8)
Anti-FHA Day 30 (N=390,385,254)
316
(293 to 342)
418
(386 to 454)
260
(231 to 293)
Anti-Polio 1 Day 140 (N=338,329,214)
656
(587 to 734)
705
(625 to 796)
1276
(1098 to 1484)
Anti-Polio 1 Day 0 (N=338,326,213)
132
(116 to 150)
134
(116 to 154)
224
(188 to 267)
Anti-Polio 1 Day 30 (N=339,327,212)
2140
(1937 to 2364)
2633
(2363 to 2933)
2978
(2592 to 3421)
Anti-Polio 2 Day 140 (N=338,327,214)
1152
(1035 to 1282)
1241
(1101 to 1398)
1945
(1676 to 2256)
Anti-Polio 2 Day 0 (N=337,328,213)
251
(214 to 294)
289
(245 to 341)
380
(313 to 461)
Anti-Polio 2 Day 30 (N=340,327,212)
4232
(3821 to 4688)
4887
(4372 to 5463)
6369
(5569 to 7283)
Anti-Polio 3 Day 140 (N=338,328,214)
1169
(1025 to 1332)
1108
(979 to 1255)
1948
(1647 to 2304)
Anti-Polio 3 Day 0 (N=338,326,213)
128
(109 to 149)
126
(106 to 150)
207
(173 to 248)
Anti-Polio 3 Day 30 (N=340,326,212)
3569
(3164 to 4027)
3322
(2939 to 3755)
6015
(5244 to 6898)
Anti-Hepatitis B Day 140 (N=393,392,260)
3050
(2715 to 3427)
3180
(2834 to 3568)
2910
(2556 to 3313)
Anti-Hepatitis B Day 0 (N=396,391,259)
386
(332 to 449)
406
(349 to 472)
336
(284 to 397)
Anti-Hepatitis B Day 30 (N=395,393,259)
8462
(7154 to 10010)
11218
(9482 to 13272)
9688
(7940 to 11821)
Anti-PRP Day 140 (N=393,392,260)
3.19
(2.69 to 3.78)
3.60
(3.05 to 4.25)
2.13
(1.78 to 2.54)
Ant-PRP Day 0 (N=395,391,258)
0.482
(0.406 to 0.573)
0.556
(0.472 to 0.656)
0.455
(0.375 to 0.553)
Anti-PRP Day 30 (N=396,391,258)
42.4
(37.0 to 48.6)
41.5
(36.6 to 47.0)
56.5
(48.4 to 65.9)
6.Secondary Outcome
Title Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Hide Description Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Booster response to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F was defined as antibody titers ≥0.35 µg/mL at Day 30.
Time Frame Day 30 after final booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses against Prevenar vaccine serotypes were assessed in the Per-protocol Analysis Set.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
Overall Number of Participants Analyzed 396 393 260
Measure Type: Number
Unit of Measure: Participants
Anti-Pneumococcal 4 (N=161,147,94) 160 146 94
Anti-Pneumococcal 6B (N=160,146,94) 155 145 93
Anti-Pneumococcal 9V (N=161,147,94) 161 147 94
Anti-Pneumococcal 14 (N=161,147,94) 161 147 94
Anti-Pneumococcal 18C (N=161,147,94) 160 147 94
Anti-Pneumococcal 19F (N=161,147,94) 161 144 94
Anti-Pneumococcal 23F (N=158,145,93) 158 144 93
7.Secondary Outcome
Title Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Hide Description Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA.
Time Frame Day 30 after final booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers against Prevenar vaccine serotypes were assessed in the Per Protocol Analysis Set.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
Overall Number of Participants Analyzed 396 393 260
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Pneumococcal 4 (N=161,147,94)
2.79
(2.47 to 3.15)
3.03
(2.64 to 3.47)
3.58
(3.07 to 4.17)
Anti-Pneumococcal 6B (N=160,146,94)
6.87
(5.68 to 8.31)
8.98
(7.86 to 10.3)
9.34
(7.76 to 11.2)
Anti-Pneumococcal 9V (N=161,147,94)
2.51
(2.22 to 2.85)
2.86
(2.57 to 3.19)
2.92
(2.50 to 3.42)
Anti-Pneumococcal 14 (N=161,147,94)
11.6
(10.2 to 13.2)
13.2
(11.5 to 15.2)
12.3
(10.2 to 14.7)
Anti-Pneumococcal 18C (N=161,147,94)
2.37
(2.10 to 2.67)
2.63
(2.35 to 2.95)
3.40
(2.92 to 3.94)
Anti-Pneumococcal 19F (N=161,147,94)
3.01
(2.62 to 3.47)
3.74
(3.19 to 4.38)
3.72
(3.19 to 4.32)
Anti-Pneumococcal 23F (N=158,145,93)
6.98
(6.14 to 7.94)
7.20
(6.23 to 8.33)
9.30
(7.79 to 11.1)
8.Secondary Outcome
Title Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata
Hide Description Anti-PT and anti-FHA antibodies were measured by ELISA.
Time Frame Day 0 (pre-vaccination) and Day 30 after final booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Booster responses to vaccine antigens were assessed in the Per Protocol Analysis Set.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
Overall Number of Participants Analyzed 396 393 260
Measure Type: Number
Unit of Measure: Participants
Anti-PT ≥12 to <15 month Day 0 (N=104,105,61) 100 104 61
Anti-PT ≥12 to <15 moth Day 30 4-fold N=103,102,60 87 92 53
Anti-PT ≥12 to <15 months Booster (N=103,102,60) 100 99 56
Anti-PT ≥15 to <19 month Day 0 (N=142,128,96) 133 118 86
Anti-PT ≥15 to <19 moth Day 30 4-fold N=140,126,95 132 121 89
Anti-PT ≥15 to <19 month Booster (N=140,126,95) 138 125 94
Anti-PT ≥19 to ≤24 months Day 0 (N=139,149,100) 111 127 78
AntiPT ≥19 to ≤24 month Day 30 4 fold N=137,146,97 134 138 92
Anti-PT ≥19 to ≤24 months Booster (N=137,146,97) 136 141 95
Anti-FHA ≥12 to <15 months Day 0 (N=103,105,59) 103 105 59
Anti-FHA ≥12 to <15 mos Day 30 4-fold N=103,101,58 76 78 53
Anti-FHA ≥12 to <15 months Booster (N=103,101,58) 96 99 58
Anti-FHA ≥15 to <19 month Day 0 (N=143,130,96) 143 130 95
Anti-FHA ≥15 to <19 mos Day 30 4-fold N=140,128,96 127 118 88
Anti-FHA ≥15 to <19 months Booster (N=140,128,96) 136 124 94
Anti-FHA ≥19 to ≤24 month Day 0 (N=143,149,100) 143 149 99
Anti-FHA ≥19 to ≤24 mos Day 30 4-fold N=141,147,98 133 138 94
Anti-FHA ≥19 to ≤ 24 months Booster (N=141,147,98) 138 144 97
9.Secondary Outcome
Title Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata
Hide Description Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.
Time Frame Day 30 after final booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to vaccine antigens were assessed in the Per Protocol Analysis Set.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
Overall Number of Participants Analyzed 396 393 260
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Diphtheria ≥12 to <15 months (N=103,107,59)
3.20
(2.72 to 3.76)
2.73
(2.30 to 3.24)
3.82
(3.01 to 4.84)
Anti-Diphtheria ≥15 to <19 months (N=144,129,95)
6.39
(5.56 to 7.34)
4.77
(3.98 to 5.72)
6.56
(5.43 to 7.92)
Anti-Diphtheria ≥19 to ≤24 months (N=146,151,100)
7.14
(6.17 to 8.26)
5.77
(5.00 to 6.66)
7.34
(6.30 to 8.56)
Anti-FHA ≥12 to <15 months (N=103,105,60)
235
(209 to 263)
268
(233 to 308)
197
(156 to 248)
Anti-FHA ≥15 to <19 months (N=143,130,96)
339
(294 to 392)
453
(392 to 524)
280
(236 to 331)
Anti-FHA ≥19 to ≤24 months (N=144,150,98)
365
(322 to 414)
533
(473 to 599)
287
(232 to 356)
Anti-Polio 3 ≥12 to <15 months (N=87,92,45)
2509
(1944 to 3240)
2616
(2098 to 3263)
5617
(4006 to 7876)
Anti-Polio 3 ≥15 to <19 months (N=128,114,81)
3944
(3265 to 4764)
3261
(2585 to 4113)
5409
(4359 to 6713)
Anti-Polio 3 ≥19 to ≤24 months (N=125,120,86)
4119
(3398 to 4993)
4061
(3387 to 4869)
6889
(5583 to 8499)
10.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine
Hide Description Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb; Solicited systemic reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Injection site: Pain, Cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; Extensive swelling of limb, Severe. Grade 3 Systemic reactions: Pyrexia (Temperature) >39.5˚C; Vomiting, ≥ 6 times per 24 hours or needing parenteral nutrition; Crying, >3 hours; Somnolence, Sleeping often or difficulty waking; Anorexia, refuses ≥3 meals; and Irritability, Inconsolable.
Time Frame Day 0 up to Day 7 after final booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received the study or control vaccine.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
Overall Number of Participants Analyzed 416 415 275
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (N=413,412,272) 232 205 160
Grade 3 inj. site Pain (N=413,412,272) 10 6 6
Injection site Erythema (N=413,412,272) 112 100 86
Grade 3 inj. site Erythema (N=413,412,272) 4 3 7
Injection site Swelling (N=412,412,272) 60 56 49
Grade 3 inj. site Swelling (N=412,412,272) 3 3 1
Extensive swelling of limb (N=413,412,272) 0 0 0
Grade 3 Extensive swelling of limb (N=413,412,272) 0 0 0
Pyrexia (N=413,412,272) 114 99 91
Grade 3 Pyrexia (N=413,412,272) 2 6 1
Vomiting (N=413,412,272) 34 39 19
Grade 3 Vomiting (N=413,412,272) 1 1 0
Crying (N=413,412,272) 148 139 102
Grade 3 Crying (N=413,412,272) 1 1 2
Somnolence (N=413,412,272) 124 113 85
Grade 3 Somnolence (N=413,412,272) 2 1 2
Anorexia (N=413,412,272) 118 121 90
Grade 3 Anorexia (N=413,412,272) 3 3 4
Irritability (N=413,412,272) 201 176 146
Grade 3 Irritability (N=413,412,272) 1 3 2
11.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine
Hide Description Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Grade 3 Injection site: Pain, cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; and Extensive swelling of limb, Severe.
Time Frame Day 0 up to Day 7 after final booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site reactions were assessed in the Safety Analysis Set.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~ T + Prevenar™ Primary and Booster Group 2: DTaP-IPV-HepB-PRP~Tprimary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Hide Arm/Group Description:
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
Overall Number of Participants Analyzed 416 415 275
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (N=413,412,272) 224 184 140
Grade 3 Injection site Pain (N=413,412,272) 9 9 5
Injection site Erythema (N=413,412,272) 84 77 52
Grade 3 Injection site Erythema (N=413,412,272) 0 0 0
Injection site Swelling (N=413,412,272) 51 42 33
Grade 3 Injection site Swelling (N=413,412,272) 1 1 1
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 after final booster vaccination.
Adverse Event Reporting Description The total number (N) for solicited adverse events in the table reflects those participants for which the diary cards were returned and for which data were available for the event during the period.
 
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Hide Arm/Group Description Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7) Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7. Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
All-Cause Mortality
Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/416 (3.13%)      15/415 (3.61%)      9/275 (3.27%)    
Blood and lymphatic system disorders       
Idiopathic thrombocytopenic purpura * 1  0/416 (0.00%)  0 1/415 (0.24%)  1 0/275 (0.00%)  0
General disorders       
Adverse drug reaction * 1  1/416 (0.24%)  1 0/415 (0.00%)  0 0/275 (0.00%)  0
Infections and infestations       
Acute sinusitis * 1  0/416 (0.00%)  0 1/415 (0.24%)  1 0/275 (0.00%)  0
Cellulitis * 1  1/416 (0.24%)  1 0/415 (0.00%)  0 1/275 (0.36%)  1
Gastroenteritis * 1  1/416 (0.24%)  1 0/415 (0.00%)  0 1/275 (0.36%)  1
Kawasaki's disease * 1  1/416 (0.24%)  1 0/415 (0.00%)  0 0/275 (0.00%)  0
Osteomyelitis acute * 1  0/416 (0.00%)  0 1/415 (0.24%)  1 0/275 (0.00%)  0
Pneumonia * 1  5/416 (1.20%)  5 4/415 (0.96%)  4 5/275 (1.82%)  5
Pyelonephritis acute * 1  0/416 (0.00%)  0 1/415 (0.24%)  1 0/275 (0.00%)  0
Subcutaneous abscess * 1  0/416 (0.00%)  0 0/415 (0.00%)  0 1/275 (0.36%)  1
Urinary tract infection * 1  0/416 (0.00%)  0 2/415 (0.48%)  2 0/275 (0.00%)  0
Viral infection * 1  0/416 (0.00%)  0 1/415 (0.24%)  1 0/275 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthropathy * 1  0/416 (0.00%)  0 1/415 (0.24%)  1 0/275 (0.00%)  0
Nervous system disorders       
Febrile convulsion * 1  2/416 (0.48%)  2 2/415 (0.48%)  2 1/275 (0.36%)  1
Renal and urinary disorders       
Haematuria * 1  0/416 (0.00%)  0 1/415 (0.24%)  1 0/275 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  2/416 (0.48%)  2 1/415 (0.24%)  1 0/275 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   253/416 (60.82%)      221/415 (53.25%)      168/275 (61.09%)    
Gastrointestinal disorders       
Vomiting  1  34/413 (8.23%)  34 39/412 (9.47%)  39 19/272 (6.99%)  19
General disorders       
Injection site Pain  1  232/416 (55.77%)  232 205/412 (49.76%)  205 160/272 (58.82%)  160
Injection site Erythema  1  112/413 (27.12%)  112 100/412 (24.27%)  100 86/272 (31.62%)  86
Injection site Swelling  1  60/412 (14.56%)  60 56/412 (13.59%)  56 49/272 (18.01%)  49
Pyrexia  1  114/413 (27.60%)  114 99/412 (24.03%)  99 91/272 (33.46%)  91
Infections and infestations       
Nasopharyngitis * 1  27/416 (6.49%)  27 23/415 (5.54%)  23 12/275 (4.36%)  12
Metabolism and nutrition disorders       
Anorexia  1  118/413 (28.57%)  118 121/412 (29.37%)  121 90/272 (33.09%)  90
Nervous system disorders       
Drowsiness  1  124/413 (30.02%)  124 113/412 (27.43%)  113 85/272 (31.25%)  85
Psychiatric disorders       
Crying  1  148/413 (35.84%)  148 139/412 (33.74%)  139 102/272 (37.50%)  102
Irritability  1  201/413 (48.67%)  201 176/412 (42.72%)  176 146/272 (53.68%)  146
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 12.0
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01444781     History of Changes
Other Study ID Numbers: A3L27
U1111-1112-8473 ( Other Identifier: WHO )
First Submitted: September 29, 2011
First Posted: October 3, 2011
Results First Submitted: June 12, 2014
Results First Posted: July 16, 2014
Last Update Posted: July 16, 2014