Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00404651
Collaborator
(none)
1,189
6
4
20
198.2
9.9
Study Details
Study Description
Brief Summary
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.
The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.
The secondary objectives are:
-
To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
-
To assess the overall safety in each group one month after the third dose of the primary series.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1189 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants
Study Start Date
:
Nov 1, 2006
Actual Primary Completion Date
:
Apr 1, 2008
Actual Study Completion Date
:
Jul 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 Participants receive vaccine Batch A |
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, intramuscular (IM)
|
| Experimental: Group 2 Participants receive vaccine Batch B |
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
|
| Experimental: Group 3 Participants receive vaccine Batch C |
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
|
| Active Comparator: Group 4 Participants receive Infanrix hexa™ |
Biological: DTaP-HBV-IPV vaccine
0.5 mL, IM
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine [Day 150 (one month post-dose 3)]
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
- Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. [Day 150 (one month post-dose 3)]
Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.
- Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine [Day 150 (one month post-dose 3)]
Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).
Secondary Outcome Measures
- Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine [Day 150 (one month post-dose 3)]
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).
- Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine [Day 0 (pre-each vaccination) up to 7 days post-each dose]
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Months
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria :
-
Two months old infants on the day of inclusion
-
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
-
Informed consent form signed by one or both parents or by the guardian and two independent witnesses
-
Able to attend all scheduled visits and to comply with all trial procedures
-
Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.
Exclusion Criteria :
-
Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
-
Planned participation in another clinical trial during the present trial period
-
Congenital or acquired immunodeficiency
-
Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
-
Chronic illness at a stage that could interfere with trial conduct or completion
-
Blood or blood-derived products received since birth
-
Any vaccination in the four weeks preceding the first trial visit
-
Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
-
Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
-
Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
-
Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
-
Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
-
History of seizures
-
Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Estado de Mexico | Mexico | 56613 | ||
| 2 | Estado de Mexico | Mexico | |||
| 3 | Insurgentes Cuicuilco | Mexico | |||
| 4 | Monterrey | Mexico | |||
| 5 | Puebla | Mexico | |||
| 6 | Tlalpan | Mexico | 14050 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00404651
Other Study ID Numbers:
- A3L11
First Posted:
Nov 29, 2006
Last Update Posted:
May 9, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled from 14 November 2006 to 13 July 2007 in 6 clinical centers in Mexico. |
|---|---|
| Pre-assignment Detail | A total of 1189 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
| Period Title: Overall Study | ||||
| STARTED | 340 | 343 | 339 | 167 |
| COMPLETED | 301 | 315 | 294 | 146 |
| NOT COMPLETED | 39 | 28 | 45 | 21 |
Baseline Characteristics
| Arm/Group Title | DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. | Total of all reporting groups |
| Overall Participants | 340 | 343 | 339 | 167 | 1189 |
| Age (Count of Participants) | |||||
| <=18 years |
340
100%
|
343
100%
|
339
100%
|
167
100%
|
1189
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (Months) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Months] |
2.00
(0.200)
|
2.00
(0.197)
|
2.01
(0.193)
|
1.98
(0.189)
|
2.00
(0.195)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
160
47.1%
|
163
47.5%
|
167
49.3%
|
82
49.1%
|
572
48.1%
|
| Male |
180
52.9%
|
180
52.5%
|
172
50.7%
|
85
50.9%
|
617
51.9%
|
| Region of Enrollment (Number) [Number] | |||||
| Mexico |
340
100%
|
343
100%
|
339
100%
|
167
100%
|
1189
100%
|
Outcome Measures
| Title | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine |
|---|---|
| Description | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies. |
| Time Frame | Day 150 (one month post-dose 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint. |
| Arm/Group Title | DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
| Measure Participants | 231 | 236 | 228 | 119 |
| Anti-Hep B (N = 230, 234, 236, 119) |
226
66.5%
|
231
67.3%
|
221
65.2%
|
119
71.3%
|
| Anti-PRP (N = 231, 236, 228, 119) |
229
67.4%
|
232
67.6%
|
226
66.7%
|
118
70.7%
|
| Anti-Diphtheria (N = 231, 236, 228, 119) |
220
64.7%
|
228
66.5%
|
222
65.5%
|
118
70.7%
|
| Anti-Tetanus (N = 231, 236, 227, 119) |
231
67.9%
|
236
68.8%
|
227
67%
|
119
71.3%
|
| Title | Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. |
|---|---|
| Description | Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3. |
| Time Frame | Day 150 (one month post-dose 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). |
| Arm/Group Title | DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
| Measure Participants | 231 | 236 | 228 | 119 |
| Anti-Pertussis (N= 228, 234, 223, 118) |
223
65.6%
|
226
65.9%
|
218
64.3%
|
113
67.7%
|
| Anti-FHA (N= 227, 233, 221, 115) |
225
66.2%
|
229
66.8%
|
216
63.7%
|
111
66.5%
|
| Title | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine |
|---|---|
| Description | Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions). |
| Time Frame | Day 150 (one month post-dose 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). |
| Arm/Group Title | DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
| Measure Participants | 231 | 236 | 228 | 119 |
| Anti-Polio 1 (N = 231, 236, 225, 119) |
230
67.6%
|
236
68.8%
|
225
66.4%
|
119
71.3%
|
| Anti-Polio 2 (N = 230, 236, 226, 118) |
230
67.6%
|
236
68.8%
|
226
66.7%
|
118
70.7%
|
| Anti-Polio 3 (N = 230, 236, 226, 119) |
229
67.4%
|
235
68.5%
|
226
66.7%
|
117
70.1%
|
| Title | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine |
|---|---|
| Description | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). |
| Time Frame | Day 150 (one month post-dose 3) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric Mean Titers were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). |
| Arm/Group Title | DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
| Measure Participants | 231 | 236 | 228 | 119 |
| Anti-Hep B (N = 230, 234, 226, 119) |
935
|
1566
|
1009
|
1576
|
| Anti-PRP (N = 231, 236, 228, 119) |
11.9
|
13.1
|
11.5
|
6.68
|
| Anti-Diphtheria (N = 231, 236, 228, 119) |
0.176
|
0.246
|
0.173
|
0.173
|
| Anti-Tetanus (N = 231, 236, 227, 119) |
1.90
|
1.86
|
1.77
|
2.20
|
| Anti-Polio 1 (N = 231, 236, 225, 119) |
860
|
945
|
843
|
1370
|
| Anti-Polio 2 (N = 230, 236, 226, 118) |
1689
|
1665
|
1612
|
2337
|
| Anti-Polio 3 (N = 230, 235, 226, 117) |
1198
|
1170
|
962
|
2186
|
| Anti-Pertusiss toxoid (N = 230, 235, 226, 119) |
242
|
238
|
241
|
228
|
| Anti-FHA (N = 230, 234, 226, 118) |
243
|
256
|
220
|
182
|
| Title | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine |
|---|---|
| Description | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability |
| Time Frame | Day 0 (pre-each vaccination) up to 7 days post-each dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two batch 1 subjects got batch 2 vaccine, and 1 batch 1 got batch 3 vaccine. Total number (N) are those with available data for the outcome |
| Arm/Group Title | DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ |
|---|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. |
| Measure Participants | 337 | 345 | 340 | 167 |
| Pain Post-dose 1 (N = 323, 336, 329, 155) |
220
64.7%
|
237
69.1%
|
225
66.4%
|
95
56.9%
|
| Pain Post-dose 2 (N = 310, 319, 316, 153) |
191
56.2%
|
220
64.1%
|
199
58.7%
|
88
52.7%
|
| Pain Pos-dose 3 (N = 302, 317, 306, 149) |
188
55.3%
|
209
60.9%
|
198
58.4%
|
87
52.1%
|
| Erythema-Post dose 1 (N = 323, 336, 329, 156) |
92
27.1%
|
97
28.3%
|
97
28.6%
|
41
24.6%
|
| Erythema Post-dose 2 (N = 310, 319, 315, 153) |
94
27.6%
|
101
29.4%
|
96
28.3%
|
33
19.8%
|
| Erythema Post-dose 3 (N = 302, 317, 306, 149) |
95
27.9%
|
94
27.4%
|
101
29.8%
|
43
25.7%
|
| Swelling Post-dose 1 (N = 323, 336, 329, 156) |
67
19.7%
|
86
25.1%
|
80
23.6%
|
35
21%
|
| Swelling Post-dose 2 (N = 310, 319, 315, 153) |
74
21.8%
|
70
20.4%
|
60
17.7%
|
26
15.6%
|
| Swelling Post-dose 3 (N = 302, 317, 306, 149) |
66
19.4%
|
65
19%
|
72
21.2%
|
22
13.2%
|
| Pyrexia Post-dose 1 (N = 323, 336, 329, 156) |
63
18.5%
|
77
22.4%
|
82
24.2%
|
17
10.2%
|
| Pyrexia Post-dose 2 (N = 310, 318, 315, 153) |
75
22.1%
|
84
24.5%
|
85
25.1%
|
32
19.2%
|
| Pyrexia Post-dose 3 (N = 302, 317, 306, 149) |
69
20.3%
|
85
24.8%
|
70
20.6%
|
28
16.8%
|
| Vomiting Post-dose 1 (N = 323, 336, 329, 156) |
68
20%
|
63
18.4%
|
56
16.5%
|
27
16.2%
|
| Vomiting Post-dose 2 (N = 310, 319, 316, 153) |
37
10.9%
|
46
13.4%
|
34
10%
|
18
10.8%
|
| Vomiting Post-dose 3 (N = 302, 317, 306, 149) |
51
15%
|
46
13.4%
|
47
13.9%
|
20
12%
|
| Crying Post-dose 1 (N = 323, 336, 329, 156) |
160
47.1%
|
156
45.5%
|
148
43.7%
|
62
37.1%
|
| Crying Post-dose 2 (N=310, 319, 316, 153) |
133
39.1%
|
145
42.3%
|
134
39.5%
|
59
35.3%
|
| Crying Post-dose 3 (N=302, 317, 306, 149) |
110
32.4%
|
118
34.4%
|
122
36%
|
40
24%
|
| Somnolence Post-dose 1 (N = 323, 336, 329, 156) |
93
27.4%
|
110
32.1%
|
102
30.1%
|
45
26.9%
|
| Somnolence Post-dse 2 (N = 310, 319, 316, 153) |
69
20.3%
|
78
22.7%
|
65
19.2%
|
24
14.4%
|
| Somnolence Post-dose 3 (N = 302, 317, 306, 149) |
56
16.5%
|
57
16.6%
|
54
15.9%
|
20
12%
|
| Anorexia Post-dose 1 (N = 323, 336, 329, 156) |
62
18.2%
|
75
21.9%
|
70
20.6%
|
27
16.2%
|
| Anorexia Post-dose 2 (N = 310, 319, 315, 153) |
56
16.5%
|
64
18.7%
|
65
19.2%
|
25
15%
|
| Anorexia Post-dose 3 (N = 302, 317, 306, 149) |
61
17.9%
|
58
16.9%
|
65
19.2%
|
29
17.4%
|
| Irritability Post-dose 1 (N = 323, 336, 329, 156) |
188
55.3%
|
198
57.7%
|
193
56.9%
|
83
49.7%
|
| Irritability Post-dose 2 (N = 310, 319, 316, 153) |
158
46.5%
|
192
56%
|
174
51.3%
|
72
43.1%
|
| Irritability Post-dse 3 (N = 302, 317, 306, 149) |
158
46.5%
|
167
48.7%
|
165
48.7%
|
69
41.3%
|
Adverse Events
| Time Frame | Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety was assessed in all participants who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two participants randomized to Batch 1 got Batch 2 vaccine; 1 Batch 1 participant got Batch 3 vaccine. Total number (N) for each safety parameter are those with available data. | |||||||
| Arm/Group Title | DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ | ||||
| Arm/Group Description | Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age. | Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. | ||||
All Cause Mortality |
||||||||
| DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/337 (1.5%) | 5/345 (1.4%) | 12/340 (3.5%) | 6/167 (3.6%) | ||||
| Congenital, familial and genetic disorders | ||||||||
| Heart Disease Congenital | 0/337 (0%) | 0 | 1/345 (0.3%) | 1 | 0/340 (0%) | 0 | 0/167 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Intussusception | 0/337 (0%) | 0 | 0/345 (0%) | 0 | 1/340 (0.3%) | 1 | 0/167 (0%) | 0 |
| Infections and infestations | ||||||||
| Bronchiolitis | 1/337 (0.3%) | 1 | 0/345 (0%) | 0 | 0/340 (0%) | 0 | 2/167 (1.2%) | 2 |
| Bronchopneumonia | 0/337 (0%) | 0 | 0/345 (0%) | 0 | 1/340 (0.3%) | 1 | 0/167 (0%) | 0 |
| Ear Infection | 0/337 (0%) | 0 | 0/345 (0%) | 0 | 1/340 (0.3%) | 1 | 0/167 (0%) | 0 |
| Gastroenteritis | 2/337 (0.6%) | 2 | 2/345 (0.6%) | 2 | 5/340 (1.5%) | 5 | 2/167 (1.2%) | 2 |
| Pneumonia | 1/337 (0.3%) | 1 | 0/345 (0%) | 0 | 1/340 (0.3%) | 1 | 0/167 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Head Injury | 0/337 (0%) | 0 | 1/345 (0.3%) | 1 | 0/340 (0%) | 0 | 0/167 (0%) | 0 |
| Multiple Fractures | 0/337 (0%) | 0 | 1/345 (0.3%) | 1 | 0/340 (0%) | 0 | 0/167 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Food Intolerance | 1/337 (0.3%) | 1 | 0/345 (0%) | 0 | 0/340 (0%) | 0 | 0/167 (0%) | 0 |
| Nervous system disorders | ||||||||
| Febrile Convulsion | 1/337 (0.3%) | 1 | 0/345 (0%) | 0 | 1/340 (0.3%) | 2 | 1/167 (0.6%) | 1 |
| Infantile Spasms | 0/337 (0%) | 0 | 0/345 (0%) | 0 | 1/340 (0.3%) | 1 | 0/167 (0%) | 0 |
| Partial Seizures | 0/337 (0%) | 0 | 0/345 (0%) | 0 | 0/340 (0%) | 0 | 1/167 (0.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asphyxia | 0/337 (0%) | 0 | 0/345 (0%) | 0 | 1/340 (0.3%) | 1 | 0/167 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| DTaP-IPV-HB-PRP~T Batch 1 | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | Infanrix Hexa™ | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 220/337 (65.3%) | 237/345 (68.7%) | 225/340 (66.2%) | 95/167 (56.9%) | ||||
| Gastrointestinal disorders | ||||||||
| Vomiting | 68/323 (21.1%) | 68 | 63/336 (18.8%) | 63 | 56/329 (17%) | 56 | 27/156 (17.3%) | 27 |
| General disorders | ||||||||
| Injection Site Pain | 220/323 (68.1%) | 220 | 237/336 (70.5%) | 237 | 225/329 (68.4%) | 225 | 95/155 (61.3%) | 95 |
| Injection Site Erythema | 95/302 (31.5%) | 95 | 101/319 (31.7%) | 101 | 101/306 (33%) | 101 | 43/149 (28.9%) | 43 |
| Injection Site Swelling | 74/310 (23.9%) | 74 | 86/336 (25.6%) | 86 | 80/329 (24.3%) | 80 | 35/156 (22.4%) | 35 |
| Irritability | 188/323 (58.2%) | 188 | 198/336 (58.9%) | 198 | 193/329 (58.7%) | 193 | 83/156 (53.2%) | 83 |
| Pyrexia | 75/310 (24.2%) | 75 | 85/317 (26.8%) | 85 | 85/315 (27%) | 85 | 32/153 (20.9%) | 32 |
| Metabolism and nutrition disorders | ||||||||
| Anorexia | 62/323 (19.2%) | 62 | 75/336 (22.3%) | 75 | 70/329 (21.3%) | 70 | 29/149 (19.5%) | 29 |
| Nervous system disorders | ||||||||
| Somnolence | 93/323 (28.8%) | 93 | 110/336 (32.7%) | 110 | 102/329 (31%) | 102 | 45/156 (28.8%) | 45 |
| Psychiatric disorders | ||||||||
| Crying | 160/323 (49.5%) | 160 | 156/336 (46.4%) | 156 | 148/329 (45%) | 148 | 62/156 (39.7%) | 62 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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. |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00404651
Other Study ID Numbers:
- A3L11
First Posted:
Nov 29, 2006
Last Update Posted:
May 9, 2014
Last Verified:
Apr 1, 2014