A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01177722
Collaborator
(none)
1,375
2
4
16
687.5
43
Study Details
Study Description
Brief Summary
The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines.
Primary Objectives:
-
To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses.
-
To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.
Secondary Objectives:
-
To describe in each group the immunogenicity parameters for all antigens for each vaccine
-
To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6 months of age and Rotarix™ at 2 and 4 months of age.
All participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1375 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, 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 Latin American Infants Concomitantly With Prevenar™ and Rotarix™
Study Start Date
:
Aug 1, 2010
Actual Primary Completion Date
:
Oct 1, 2011
Actual Study Completion Date
:
Dec 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: DTaP-IPV-Hep B-PRP-T (Lot A)
|
Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
|
| Experimental: Group 2: DTaP-IPV-Hep B-PRP-T (Lot B)
|
Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
|
| Experimental: Group 3: DTaP-IPV-Hep B-PRP-T (Lot C)
|
Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
|
| Active Comparator: Group 4: Active Control
|
Biological: DTaP-Hep B-IPV vaccine
0.5 mL, Intramuscular
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™ [Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination]
Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.
- Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine [30 Days post-dose 3]
Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).
Secondary Outcome Measures
- Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine [Day 0 (pre-vaccination) and 30 days post-dose 3]
Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).
- Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine [Day 0 up to 7 after each dose]
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.
- Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine [Day 0 up to 7 post each vaccination]
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Days
to 65 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria :
-
Two month old infants (55 to 65 days old) 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 legally acceptable representative as per local requirements.
-
Able to attend all scheduled visits and to comply with all trial procedures.
-
Received Hepatitis B and Bacille de Calmette-Guérin (BCG) vaccines between birth and one month of life in agreement with the national immunization calendar.
Exclusion Criteria :
-
Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
-
Planned participation in another clinical trial during the present trial period.
-
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroid therapy.
-
Known 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, in the opinion of the Investigator.
-
Blood or blood-derived products received since birth that might interfere with the assessment of the immune response.
-
Any vaccination before trial vaccination (except Hepatitis B and Bacille de Calmette Guérin given at birth).
-
Any planned vaccination until 1 month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines).
-
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 pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infections.
-
Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C seropositivity.
-
Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intramuscular (IM) vaccination.
-
History of seizures or encephalopathy.
-
Febrile illness (temperature ≥ 38.0°C), or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cali | Colombia | |||
| 2 | San José de Costa Rica | Costa Rica |
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:
NCT01177722
Other Study ID Numbers:
- A3L24
- UTN: U1111-1111-5801
First Posted:
Aug 9, 2010
Last Update Posted:
May 5, 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 03 August 2010 to 23 November 2010 in 2 clinical centers in Columbia and 1 clinical center in Costa Rica. |
|---|---|
| Pre-assignment Detail | A total of 1375 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa |
|---|---|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. |
| Period Title: Overall Study | ||||
| STARTED | 344 | 344 | 342 | 345 |
| COMPLETED | 331 | 334 | 333 | 338 |
| NOT COMPLETED | 13 | 10 | 9 | 7 |
Baseline Characteristics
| Arm/Group Title | DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Total of all reporting groups |
| Overall Participants | 344 | 344 | 342 | 345 | 1375 |
| Age (Count of Participants) | |||||
| <=18 years |
344
100%
|
344
100%
|
342
100%
|
345
100%
|
1375
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 (Days) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Days] |
58.8
(3.49)
|
58.7
(3.25)
|
58.5
(3.16)
|
58.7
(3.31)
|
58.7
(3.30)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
161
46.8%
|
165
48%
|
152
44.4%
|
156
45.2%
|
634
46.1%
|
| Male |
183
53.2%
|
179
52%
|
190
55.6%
|
189
54.8%
|
741
53.9%
|
| Region of Enrollment (Number) [Number] | |||||
| Colombia |
233
67.7%
|
234
68%
|
233
68.1%
|
233
67.5%
|
933
67.9%
|
| Costa Rica |
111
32.3%
|
110
32%
|
109
31.9%
|
112
32.5%
|
442
32.1%
|
Outcome Measures
| Title | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™ |
|---|---|
| Description | Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection. |
| Time Frame | Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per-Protocol Population). |
| Arm/Group Title | DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa |
|---|---|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. |
| Measure Participants | 312 | 310 | 313 | 316 |
| Anti-Hep B Pre-dose 1 |
4.02
|
4.07
|
4.93
|
4.30
|
| Anti-Hep B Post-dose 3 |
3048
|
2801
|
3202
|
2766
|
| Title | Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine |
|---|---|
| Description | Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ). |
| Time Frame | 30 Days post-dose 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroprotection and vaccine response were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population). |
| Arm/Group Title | DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa |
|---|---|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. |
| Measure Participants | 312 | 310 | 313 | 316 |
| Anti-Diphtheria (N = 310, 310, 312, 315) |
310
90.1%
|
310
90.1%
|
312
91.2%
|
315
91.3%
|
| Anti-Tetanus (N = 311, 310, 311, 314) |
311
90.4%
|
310
90.1%
|
311
90.9%
|
314
91%
|
| Anti-PT (N = 308, 309, 308, 312) |
304
88.4%
|
299
86.9%
|
299
87.4%
|
307
89%
|
| Anti-FHA (N = 306, 306, 304, 311) |
306
89%
|
305
88.7%
|
303
88.6%
|
309
89.6%
|
| Anti-Polio 1 (N = 310, 309, 308, 311) |
310
90.1%
|
309
89.8%
|
308
90.1%
|
311
90.1%
|
| Anti-Polio 2 (N = 309, 309, 307, 312) |
309
89.8%
|
309
89.8%
|
307
89.8%
|
312
90.4%
|
| Anti-Polio 3 (N = 310, 309, 307, 312) |
310
90.1%
|
309
89.8%
|
307
89.8%
|
311
90.1%
|
| Anti-Hep B (N = 312, 310, 312, 316) |
311
90.4%
|
310
90.1%
|
310
90.6%
|
316
91.6%
|
| Anti-PRP (N = 312, 310, 312, 316) |
299
86.9%
|
298
86.6%
|
287
83.9%
|
303
87.8%
|
| Title | Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine |
|---|---|
| Description | Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP). |
| Time Frame | Day 0 (pre-vaccination) and 30 days post-dose 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population). |
| Arm/Group Title | DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa™ |
|---|---|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. |
| Measure Participants | 312 | 310 | 313 | 316 |
| Anti-Diphtheria Pre-dose 1 (N= 312, 308, 311, 315) |
0.599
|
0.596
|
0.641
|
0.630
|
| Anti-Diphtheria Post-dose 3 (N=310, 310, 312, 315) |
0.252
|
0.279
|
0.228
|
0.240
|
| Anti-Tetanus Post-dose 3 (N = 311, 310, 311, 314) |
1.66
|
1.55
|
1.45
|
1.80
|
| Anti-PT Pre-dose 1 (N = 308, 309, 310, 314) |
3.02
|
3.50
|
3.54
|
3.11
|
| Anti-PT Post-dose 3 (N = 312, 310, 311, 314) |
102
|
103
|
102
|
98.9
|
| Anti-FHA Pre-dose 1(N = 307, 307, 307, 312) |
5.36
|
5.66
|
5.76
|
5.13
|
| Anti-FHA Post-dose 3 (N=311, 309, 310, 315) |
186
|
175
|
183
|
118
|
| Anti-Polio 1 Post-dose 3 (N = 310, 309, 308, 311) |
755
|
655
|
636
|
1298
|
| Anti-Polio 2 Post-dose 3 (N = 309, 309, 307, 312) |
1190
|
1232
|
1120
|
1981
|
| Anti-Polio 3 Post-dose 3 (N = 310, 309, 307, 312) |
1102
|
1119
|
1097
|
1944
|
| Anti-PRP Post-dose 3 (N = 312, 310, 312, 316) |
3.37
|
4.02
|
3.33
|
2.24
|
| Title | Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine |
|---|---|
| Description | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable. |
| Time Frame | Day 0 up to 7 after each dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set). |
| Arm/Group Title | DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa |
|---|---|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. |
| Measure Participants | 345 | 343 | 342 | 345 |
| Pain Post-dose 1 (N = 338, 341, 340, 344) |
199
57.8%
|
194
56.4%
|
216
63.2%
|
185
53.6%
|
| Pain Post-dose 2 (N = 333, 337, 335, 340) |
180
52.3%
|
196
57%
|
203
59.4%
|
188
54.5%
|
| Pain Post-dose 3 (N = 331, 331, 334, 337) |
168
48.8%
|
163
47.4%
|
162
47.4%
|
147
42.6%
|
| Grade 3 Pain Post Dose 1 (N = 338, 341, 344, 344) |
21
6.1%
|
22
6.4%
|
22
6.4%
|
7
2%
|
| Grade 3 Pain Post Dose 3 (N=331, 331, 334, 338) |
10
2.9%
|
9
2.6%
|
8
2.3%
|
8
2.3%
|
| Erythema Post-dose 1 (N = 338, 341, 340, 344 |
72
20.9%
|
63
18.3%
|
82
24%
|
52
15.1%
|
| Erythema Post-dose 2 (N = 333, 337, 335, 340 |
87
25.3%
|
78
22.7%
|
80
23.4%
|
67
19.4%
|
| Erythema Post-dose 3 (N = 331, 331, 334, 337) |
85
24.7%
|
79
23%
|
96
28.1%
|
68
19.7%
|
| Grade 3 Erythema Post-dose 1(N=338, 341, 340, 344) |
2
0.6%
|
3
0.9%
|
2
0.6%
|
0
0%
|
| Grade 3 Erythema Post-dose 3(N=331, 331, 334, 337) |
0
0%
|
0
0%
|
1
0.3%
|
0
0%
|
| Swelling Post dose 1 (N = 338, 341, 340, 344) |
47
13.7%
|
30
8.7%
|
47
13.7%
|
33
9.6%
|
| Swelling Post dose 2 (N = 333, 337, 335, 340) |
44
12.8%
|
35
10.2%
|
45
13.2%
|
44
12.8%
|
| Swelling Post dose 3 (N = 331, 331, 334, 337) |
43
12.5%
|
34
9.9%
|
48
14%
|
42
12.2%
|
| Grade 3 Swelling Post-dose 1(N=338, 341, 340, 344) |
2
0.6%
|
3
0.9%
|
2
0.6%
|
0
0%
|
| Grade 3 Swelling post-dose 3(N=331, 331, 340, 338) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Pyrexia Post dose 1 (N = 338, 341, 340, 344) |
46
13.4%
|
42
12.2%
|
68
19.9%
|
46
13.3%
|
| Pyrexia Post dose 2 (N = 333, 337, 335, 340) |
70
20.3%
|
68
19.8%
|
68
19.9%
|
70
20.3%
|
| Pyrexia Post dose 3 (N = 331, 331, 333, 337) |
67
19.5%
|
63
18.3%
|
72
21.1%
|
65
18.8%
|
| Grade 3 Pyrexia Post-dose 1 (N=338, 341, 340, 344) |
2
0.6%
|
0
0%
|
0
0%
|
0
0%
|
| Grade 3 Pyrexia Post-dose 3 (N=331, 331, 333, 337) |
4
1.2%
|
1
0.3%
|
1
0.3%
|
2
0.6%
|
| Vomiting Post dose 1 (N = 338, 341, 340, 344) |
85
24.7%
|
90
26.2%
|
86
25.1%
|
94
27.2%
|
| Vomiting Post dose 2 (N = 333, 337, 335, 340) |
58
16.9%
|
80
23.3%
|
64
18.7%
|
62
18%
|
| Vomiting Post dose 3 (N = 331, 331, 334, 337) |
32
9.3%
|
58
16.9%
|
46
13.5%
|
39
11.3%
|
| Grade 3 Vomiting Post-dose 1(N=338, 341, 340, 344) |
4
1.2%
|
5
1.5%
|
6
1.8%
|
5
1.4%
|
| Grade 3 Vomiting post-dose 3(N=331, 331, 334, 337) |
3
0.9%
|
1
0.3%
|
2
0.6%
|
2
0.6%
|
| Crying Post dose 1 (N = 338, 341, 340, 344) |
198
57.6%
|
186
54.1%
|
189
55.3%
|
161
46.7%
|
| Crying Post dose 2 (N = 333, 337, 335, 340) |
163
47.4%
|
179
52%
|
169
49.4%
|
161
46.7%
|
| Crying Post dose 3 (N = 331, 331, 334, 337) |
141
41%
|
145
42.2%
|
142
41.5%
|
120
34.8%
|
| Grade 3 Crying Post-dose 1 (N =338, 341, 340, 344) |
15
4.4%
|
10
2.9%
|
23
6.7%
|
9
2.6%
|
| Grade 3 Crying Post-dose 3 (N =331, 331, 334, 337) |
8
2.3%
|
6
1.7%
|
10
2.9%
|
6
1.7%
|
| Somnolence Post dose 1 (N = 338, 341, 341, 344) |
159
46.2%
|
146
42.4%
|
160
46.8%
|
147
42.6%
|
| Somnolence Post dose 2 (N = 333, 337, 335, 340) |
109
31.7%
|
108
31.4%
|
110
32.2%
|
111
32.2%
|
| Somnolence Post dose 3 (N = 331, 331, 334, 337) |
85
24.7%
|
99
28.8%
|
96
28.1%
|
81
23.5%
|
| Grad 3 Somnolence Post-dose 1 N=338, 341, 341, 344 |
3
0.9%
|
14
4.1%
|
19
5.6%
|
9
2.6%
|
| Grad 3 Somnolence Post-dose 3 N=331, 331, 334, 337 |
5
1.5%
|
2
0.6%
|
4
1.2%
|
4
1.2%
|
| Anorexia Post dose 1 (N = 338, 341, 341, 344) |
78
22.7%
|
97
28.2%
|
96
28.1%
|
75
21.7%
|
| Anorexia Post dose 2 (N = 333, 337, 335, 340) |
75
21.8%
|
93
27%
|
86
25.1%
|
74
21.4%
|
| Anorexia Post dose 3 (N = 331, 331, 334, 337) |
63
18.3%
|
64
18.6%
|
60
17.5%
|
54
15.7%
|
| Grade 3 Anorexia Post-dose 1(N=338, 341, 341, 344) |
3
0.9%
|
4
1.2%
|
8
2.3%
|
3
0.9%
|
| Grade 3 Anorexia Post-dose 3(N=331, 331, 334, 337) |
4
1.2%
|
7
2%
|
4
1.2%
|
3
0.9%
|
| Irritability Post dose 1 (N = 338, 341, 341, 344) |
208
60.5%
|
206
59.9%
|
208
60.8%
|
180
52.2%
|
| Irritability Post dose 2 (N = 333, 337, 335, 340) |
193
56.1%
|
199
57.8%
|
191
55.8%
|
193
55.9%
|
| Irritability Post dose 3 (N = 331, 332, 334, 337) |
155
45.1%
|
161
46.8%
|
154
45%
|
144
41.7%
|
| Grd 3 Irritability Post-dose 1N=338, 341, 341, 344 |
15
4.4%
|
17
4.9%
|
20
5.8%
|
8
2.3%
|
| Grd 3 Irritability Post-dose 3N=331, 332, 334, 337 |
11
3.2%
|
13
3.8%
|
12
3.5%
|
5
1.4%
|
| Title | Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine |
|---|---|
| Description | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable. |
| Time Frame | Day 0 up to 7 post each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set). |
| Arm/Group Title | DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa |
|---|---|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. |
| Measure Participants | 345 | 341 | 342 | 345 |
| Pain Post-dose 1 (N = 338, 341, 340, 344) |
171
49.7%
|
173
50.3%
|
184
53.8%
|
169
49%
|
| Grade 3 Pain Post-dose 1 (N = 338, 341, 340, 344) |
15
4.4%
|
15
4.4%
|
16
4.7%
|
8
2.3%
|
| Pain Post-dose 2 (N = 333, 337, 335, 340) |
160
46.5%
|
183
53.2%
|
180
52.6%
|
174
50.4%
|
| Grade 3 Pain Post-dose 2 (N = 333, 337, 335, 340) |
14
4.1%
|
17
4.9%
|
16
4.7%
|
13
3.8%
|
| Pain Post-dose 3 (N =331, 331, 334, 337) |
146
42.4%
|
105
30.5%
|
146
42.7%
|
125
36.2%
|
| Grade 3 Pain Post-dose 3 (N = 331, 331, 334, 337) |
8
2.3%
|
9
2.6%
|
10
2.9%
|
7
2%
|
| Erythema Post-dose 1 (N = 338, 341, 340, 344) |
47
13.7%
|
48
14%
|
55
16.1%
|
42
12.2%
|
| Grade 3 Erythema Post-dose 1 (N=338, 341, 340, 344 |
0
0%
|
1
0.3%
|
2
0.6%
|
0
0%
|
| Erythema Post-dose 2 (N = 333, 337, 335, 340) |
65
18.9%
|
55
16%
|
62
18.1%
|
53
15.4%
|
| Grade 3 Erythema Post-dose 2 (N=333, 337, 335, 340 |
1
0.3%
|
0
0%
|
0
0%
|
0
0%
|
| Erythema Post-dose 3 (N = 331, 331, 334, 337) |
63
18.3%
|
57
16.6%
|
69
20.2%
|
49
14.2%
|
| Grade 3 Erythema Post-dose 3 (N=331, 331, 334, 337 |
1
0.3%
|
1
0.3%
|
0
0%
|
0
0%
|
| Swelling Post-dose 1 (N = 338, 341, 340, 344) |
34
9.9%
|
21
6.1%
|
33
9.6%
|
31
9%
|
| Grade 3 Swelling Post-dose 1 (N=338, 341, 340, 344 |
0
0%
|
0
0%
|
2
0.6%
|
1
0.3%
|
| Swelling Post-dose 2 (N = 333, 337, 335, 340) |
32
9.3%
|
28
8.1%
|
36
10.5%
|
32
9.3%
|
| Grade 3 Swelling Post-dose 2 (N=333, 337, 335, 340 |
0
0%
|
0
0%
|
1
0.3%
|
0
0%
|
| Swelling Post-dose 3 (N = 331, 331, 334, 337) |
27
7.8%
|
29
8.4%
|
36
10.5%
|
29
8.4%
|
| Grade 3 Swelling Post-dose 3 (N=331, 331, 334, 337 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event. | |||||||
| Arm/Group Title | DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa | ||||
| Arm/Group Description | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age. | ||||
All Cause Mortality |
||||||||
| DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | 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-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/345 (2.9%) | 14/343 (4.1%) | 16/342 (4.7%) | 10/345 (2.9%) | ||||
| Cardiac disorders | ||||||||
| Cardiac Failure | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||
| Cerebral Atrophy Congenital | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal strangulated hernia | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 0/342 (0%) | 0 | 1/345 (0.3%) | 1 |
| Diarrhoea | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 0/342 (0%) | 0 | 1/345 (0.3%) | 1 |
| Enteritis | 0/345 (0%) | 0 | 1/343 (0.3%) | 1 | 0/342 (0%) | 0 | 1/345 (0.3%) | 1 |
| Intussusception | 0/345 (0%) | 0 | 1/343 (0.3%) | 1 | 0/342 (0%) | 0 | 1/345 (0.3%) | 1 |
| Stomatitis | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Vomiting | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| General disorders | ||||||||
| Pyrexia | 1/345 (0.3%) | 1 | 1/343 (0.3%) | 1 | 0/342 (0%) | 0 | 0/345 (0%) | 0 |
| Sudden Infant Death Syndrome | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Infections and infestations | ||||||||
| Bronchiolitis | 5/345 (1.4%) | 5 | 6/343 (1.7%) | 6 | 9/342 (2.6%) | 10 | 8/345 (2.3%) | 8 |
| Bronchopneumonia | 1/345 (0.3%) | 1 | 0/343 (0%) | 0 | 0/342 (0%) | 0 | 0/345 (0%) | 0 |
| Dengue Fever | 1/345 (0.3%) | 1 | 0/343 (0%) | 0 | 0/342 (0%) | 0 | 1/345 (0.3%) | 1 |
| Exanthema Subitum | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Gastroenteritis | 1/345 (0.3%) | 1 | 0/343 (0%) | 0 | 0/342 (0%) | 0 | 0/345 (0%) | 0 |
| Gastroenteritis bacterial | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 0/342 (0%) | 0 | 1/345 (0.3%) | 1 |
| Kawasaki's Disease | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Otitis Media Acute | 0/345 (0%) | 0 | 1/343 (0.3%) | 1 | 0/342 (0%) | 0 | 0/345 (0%) | 0 |
| Periorbital Cellulitis | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 0/342 (0%) | 0 | 1/345 (0.3%) | 1 |
| Pneumonia | 4/345 (1.2%) | 4 | 5/343 (1.5%) | 6 | 11/342 (3.2%) | 11 | 5/345 (1.4%) | 7 |
| Pneumonia Primary Atypical | 0/345 (0%) | 0 | 1/343 (0.3%) | 1 | 0/342 (0%) | 0 | 1/345 (0.3%) | 1 |
| Pneumonia Viral | 1/345 (0.3%) | 1 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Pyelonephritis Acute | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Urinary Tract Infection | 3/345 (0.9%) | 3 | 2/343 (0.6%) | 3 | 2/342 (0.6%) | 2 | 3/345 (0.9%) | 3 |
| Viral Diarrhoea | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Viral Infection | 0/345 (0%) | 0 | 1/343 (0.3%) | 1 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Thermal Burn | 0/345 (0%) | 0 | 1/343 (0.3%) | 1 | 0/342 (0%) | 0 | 0/345 (0%) | 0 |
| Nervous system disorders | ||||||||
| Convulsion | 0/345 (0%) | 0 | 2/343 (0.6%) | 2 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Epilepsy | 1/345 (0.3%) | 1 | 0/343 (0%) | 0 | 0/342 (0%) | 0 | 0/345 (0%) | 0 |
| Febrile Convulsion | 2/345 (0.6%) | 3 | 1/343 (0.3%) | 1 | 0/342 (0%) | 0 | 1/345 (0.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 1/342 (0.3%) | 1 | 0/345 (0%) | 0 |
| Asthmatic Crisis | 0/345 (0%) | 0 | 1/343 (0.3%) | 1 | 0/342 (0%) | 0 | 0/345 (0%) | 0 |
| Diaphragmatic Hernia | 1/345 (0.3%) | 1 | 0/343 (0%) | 0 | 0/342 (0%) | 0 | 0/345 (0%) | 0 |
| Foreign Body Aspiration | 0/345 (0%) | 0 | 0/343 (0%) | 0 | 0/342 (0%) | 0 | 1/345 (0.3%) | 1 |
| Urticaria | 0/345 (0%) | 0 | 1/343 (0.3%) | 1 | 0/342 (0%) | 0 | 0/345 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| DTap-IPV-Hep B-PRP~T Batch A | DTaP-IPV-Hep B-PRP~T Batch B | DTaP-IPV-Hep B-PRP~T Batch C | Infanrix Hexa | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 208/345 (60.3%) | 206/343 (60.1%) | 216/342 (63.2%) | 193/345 (55.9%) | ||||
| Gastrointestinal disorders | ||||||||
| Vomiting | 85/338 (25.1%) | 85 | 90/341 (26.4%) | 90 | 86/340 (25.3%) | 86 | 94/344 (27.3%) | 94 |
| General disorders | ||||||||
| Injection Site Erythema | 87/338 (25.7%) | 87 | 79/341 (23.2%) | 79 | 96/340 (28.2%) | 96 | 68/344 (19.8%) | 68 |
| Injection Site Pain | 199/338 (58.9%) | 199 | 196/341 (57.5%) | 196 | 216/340 (63.5%) | 216 | 188/344 (54.7%) | 188 |
| Injection Site Swelling | 47/338 (13.9%) | 47 | 35/341 (10.3%) | 35 | 48/340 (14.1%) | 48 | 44/344 (12.8%) | 44 |
| Irritability | 208/338 (61.5%) | 208 | 206/341 (60.4%) | 206 | 208/341 (61%) | 208 | 193/344 (56.1%) | 193 |
| Pyrexia | 70/338 (20.7%) | 70 | 68/341 (19.9%) | 68 | 72/340 (21.2%) | 72 | 70/344 (20.3%) | 70 |
| Infections and infestations | ||||||||
| Nasopharyngitis | 99/345 (28.7%) | 125 | 96/343 (28%) | 132 | 90/342 (26.3%) | 116 | 87/345 (25.2%) | 105 |
| Metabolism and nutrition disorders | ||||||||
| Anorexia | 75/338 (22.2%) | 75 | 97/341 (28.4%) | 97 | 96/341 (28.2%) | 96 | 75/344 (21.8%) | 75 |
| Nervous system disorders | ||||||||
| Somnolence | 159/338 (47%) | 159 | 146/341 (42.8%) | 146 | 160/341 (46.9%) | 160 | 147/344 (42.7%) | 147 |
| Psychiatric disorders | ||||||||
| Crying | 198/338 (58.6%) | 198 | 186/341 (54.5%) | 186 | 189/340 (55.6%) | 189 | 161/344 (46.8%) | 161 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 21/345 (6.1%) | 24 | 17/343 (5%) | 17 | 23/342 (6.7%) | 25 | 17/345 (4.9%) | 18 |
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:
NCT01177722
Other Study ID Numbers:
- A3L24
- UTN: U1111-1111-5801
First Posted:
Aug 9, 2010
Last Update Posted:
May 5, 2014
Last Verified:
Apr 1, 2014