Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00401531
Collaborator
(none)
412
2
2
22
206
9.4
Study Details
Study Description
Brief Summary
The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth.
Primary Objective:
To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar®
Secondary Objectives:
Immunogenicity:
To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series.
Safety:
To describe the overall safety after each injection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
412 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Immunogenicity Study of a DTaP IPV Hep B PRP T Combined Vaccine in Comparison to Infanrix Hexa™, Both Concomitantly Administered With Prevnar™ at 2, 4, and 6 Months of Age in Thai Infants
Study Start Date
:
Oct 1, 2006
Actual Primary Completion Date
:
Nov 1, 2007
Actual Study Completion Date
:
Aug 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: DTaP IPV Hep B PRP T + Prevnar™
|
Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
0.5 mL, IM
Other Names:
|
| Active Comparator: Group 2: Infanrix hexa™ + Prevnar™
|
Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
0.5 mL, IM
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [Day 150 post-dose 1]
Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.
Secondary Outcome Measures
- Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [Day 150 post-dose 1]
Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.
- Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [Day 150 post-dose 1]
Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil
- Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [Day 150 post-dose 1]
Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.
- Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [Day 150 post-dose 1]
Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [Day 0 up to Day 7 post-vaccination]
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Days
to 71 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria :
-
Two month old infant (50 to 71 days old) on the day of inclusion, of either gender.
-
Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kg.
-
Hepatitis B vaccination since birth.
-
Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
-
Able to attend all scheduled visits and to comply with all trial procedures.
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.
-
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.
-
Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy.
-
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 4 weeks preceding the first trial vaccination.
-
Any planned vaccination (except trial vaccinations) during the trial.
-
Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically).
-
Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae.
-
Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity.
-
Known thrombocytopenia or bleeding disorder contraindicating IM 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 | Bangkok | Thailand | |||
| 2 | Khonkaen | Thailand |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Monitor, 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:
NCT00401531
Other Study ID Numbers:
- A3L12
First Posted:
Nov 20, 2006
Last Update Posted:
Apr 1, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled from 22 October 2006 to 19 November 2007 in 4 clinical centers in Thailand. |
|---|---|
| Pre-assignment Detail | A total of 412 participants who met all the inclusion, but none of the exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ |
|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. |
| Period Title: Overall Study | ||
| STARTED | 206 | 206 |
| COMPLETED | 197 | 196 |
| NOT COMPLETED | 9 | 10 |
Baseline Characteristics
| Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ | Total |
|---|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Total of all reporting groups |
| Overall Participants | 206 | 206 | 412 |
| Age (Count of Participants) | |||
| <=18 years |
206
100%
|
206
100%
|
412
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (Months) [Mean (Standard Deviation) ] | |||
| Age Continuous |
1.88
(0.170)
|
1.90
(0.187)
|
1.89
(0.179)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
94
45.6%
|
111
53.9%
|
205
49.8%
|
| Male |
112
54.4%
|
95
46.1%
|
207
50.2%
|
| Region of Enrollment (Number) [Number] | |||
| Thailand |
206
100%
|
206
100%
|
412
100%
|
Outcome Measures
| Title | Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ |
|---|---|
| Description | Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL. |
| Time Frame | Day 150 post-dose 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ |
|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. |
| Measure Participants | 189 | 190 |
| Anti-Hepatitis B (N = 188, 190) |
187
90.8%
|
189
91.7%
|
| Anti-PRP (N = 189, 190) |
183
88.8%
|
183
88.8%
|
| Title | Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ |
|---|---|
| Description | Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL. |
| Time Frame | Day 150 post-dose 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria valuation, per-protocol population. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ |
|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. |
| Measure Participants | 189 | 190 |
| Anti-Diphtheria |
184
89.3%
|
190
92.2%
|
| Anti-Tetanus |
189
91.7%
|
190
92.2%
|
| Title | Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ |
|---|---|
| Description | Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil |
| Time Frame | Day 150 post-dose 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroprotection was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ |
|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. |
| Measure Participants | 187 | 186 |
| Anti Polio Type 1 |
187
90.8%
|
186
90.3%
|
| Anti Polio Type 2 |
187
90.8%
|
186
90.3%
|
| Anti Polio Type 3 |
187
90.8%
|
185
89.8%
|
| Title | Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ |
|---|---|
| Description | Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline. |
| Time Frame | Day 150 post-dose 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroconversion was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation per-protocol population. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ |
|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. |
| Measure Participants | 189 | 190 |
| Anti-pertussis toxoid (N = 189, 189) |
177
85.9%
|
177
85.9%
|
| Anti-Filamentous hemagglutinin (N = 187, 188) |
177
85.9%
|
179
86.9%
|
| Title | Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ |
|---|---|
| Description | Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay. |
| Time Frame | Day 150 post-dose 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Antibody titers were assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, the per-protocol population. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ |
|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. |
| Measure Participants | 189 | 190 |
| Anti-Hepatitis B (N = 188, 190) |
2477
|
2442
|
| Anti-PRP (N = 189, 190) |
5.07
|
2.41
|
| Anti-Diphtheria (N = 189, 190) |
0.297
|
0.209
|
| Anti-Tetanus (N = 189, 190) |
1.38
|
1.83
|
| Anti-Polio Type 1 (N = 187, 186) |
765
|
1566
|
| Anti-Polio Type 2 (N = 187, 186) |
1489
|
2277
|
| Anti-Polio Type 3 (N = 187, 186) |
837
|
2029
|
| Anti-Pertussis toxoid (N = 189, 189) |
168
|
200
|
| Anti-Filamentous hemagglutinin (N = 188, 188) |
148
|
123
|
| Title | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ |
|---|---|
| Description | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable. |
| Time Frame | Day 0 up to Day 7 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited reactions were assessed in all participants that were enrolled and vaccinated, intent-to-treat population. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ |
|---|---|---|
| Arm/Group Description | Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. |
| Measure Participants | 206 | 206 |
| Pain Post-dose 1 |
161
78.2%
|
135
65.5%
|
| Pain Post-dose 2 |
136
66%
|
118
57.3%
|
| Pain Post-dose 3 |
119
57.8%
|
112
54.4%
|
| Pain Post-any dose |
180
87.4%
|
166
80.6%
|
| Grade 3 Pain Post-any dose |
20
9.7%
|
12
5.8%
|
| Erythema Post-dose 1 |
79
38.3%
|
64
31.1%
|
| Erythema Post-dose 2 |
93
45.1%
|
91
44.2%
|
| Erythema Post-dose 3 |
86
41.7%
|
79
38.3%
|
| Erythema Post-any dose |
121
58.7%
|
114
55.3%
|
| Grade 3 Erythema Post-any dose |
3
1.5%
|
2
1%
|
| Swelling Post-dose 1 |
59
28.6%
|
34
16.5%
|
| Swelling Post-dose 2 |
52
25.2%
|
44
21.4%
|
| Swelling Post-dose 3 |
34
16.5%
|
32
15.5%
|
| Swelling Post-any dose |
85
41.3%
|
65
31.6%
|
| Grade 3 Swelling Post-any dose |
1
0.5%
|
1
0.5%
|
| Pyrexia Post-dose 1 |
109
52.9%
|
68
33%
|
| Pyrexia Post-dose 2 |
84
40.8%
|
79
38.3%
|
| Pyrexia Post-dose 3 |
81
39.3%
|
81
39.3%
|
| Pyrexia Post-any dose |
152
73.8%
|
131
63.6%
|
| Grade 3 Pyrexia Post-any dose |
6
2.9%
|
7
3.4%
|
| Vomiting Post Dose 1 |
47
22.8%
|
56
27.2%
|
| Vomiting Post-dose 2 |
28
13.6%
|
32
15.5%
|
| Vomiting Post-dose 3 |
22
10.7%
|
28
13.6%
|
| Vomiting Post-any dose |
77
37.4%
|
82
39.8%
|
| Grade 3 Vomiting Post-any dose |
1
0.5%
|
3
1.5%
|
| Crying Post-dose 1 |
128
62.1%
|
106
51.5%
|
| Crying Post-dose 2 |
106
51.5%
|
104
50.5%
|
| Crying Post-dose 3 |
77
37.4%
|
75
36.4%
|
| Crying Post-any dose |
167
81.1%
|
153
74.3%
|
| Grade 3 Crying Post-any dose |
7
3.4%
|
5
2.4%
|
| Somnolence Post-dose 1 |
109
52.9%
|
104
50.5%
|
| Somnolence Post-dose 2 |
91
44.2%
|
79
38.3%
|
| Somnolence Post-dose 3 |
55
26.7%
|
59
28.6%
|
| Somnolence Post-any dose |
141
68.4%
|
125
60.7%
|
| Grade 3 Somnolence post-any dose |
4
1.9%
|
0
0%
|
| Anorexia Post-dose 1 |
59
28.6%
|
49
23.8%
|
| Anorexia Post-dose 2 |
44
21.4%
|
40
19.4%
|
| Anorexia Post-dose 3 |
36
17.5%
|
37
18%
|
| Anorexia Post-any dose |
91
44.2%
|
83
40.3%
|
| Grade 3 Anorexia Post-any dose |
0
0%
|
0
0%
|
| Irritability Post-dose 1 |
134
65%
|
122
59.2%
|
| Irritability Post-dose 2 |
107
51.9%
|
109
52.9%
|
| Irritability Post-dose 3 |
90
43.7%
|
88
42.7%
|
| Irritability Post-any dose |
162
78.6%
|
159
77.2%
|
| Grade 3 Irritability Post-any dose |
4
1.9%
|
6
2.9%
|
Adverse Events
| Time Frame | Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ | ||
| Arm/Group Description | Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. | ||
All Cause Mortality |
||||
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/206 (2.9%) | 8/206 (3.9%) | ||
| Congenital, familial and genetic disorders | ||||
| Cryptorchism | 1/206 (0.5%) | 1 | 0/206 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 1/206 (0.5%) | 1 | 0/206 (0%) | 0 |
| Intussusception | 1/206 (0.5%) | 1 | 0/206 (0%) | 0 |
| Infections and infestations | ||||
| Bronchiolitis | 1/206 (0.5%) | 1 | 0/206 (0%) | 0 |
| Eczema Herpeticum | 0/206 (0%) | 0 | 1/206 (0.5%) | 1 |
| Gastroenteritis | 0/206 (0%) | 0 | 3/206 (1.5%) | 3 |
| Gastroenteritis Viral | 0/206 (0%) | 0 | 1/206 (0.5%) | 1 |
| Pneumonia | 1/206 (0.5%) | 1 | 0/206 (0%) | 0 |
| Pneumonia Viral | 1/206 (0.5%) | 1 | 0/206 (0%) | 0 |
| Urethritis | 0/206 (0%) | 0 | 1/206 (0.5%) | 1 |
| Urinary Tract Infection | 1/206 (0.5%) | 1 | 1/206 (0.5%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Thermal Burn | 0/206 (0%) | 0 | 1/206 (0.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Angioneurotic Oedema | 1/206 (0.5%) | 1 | 0/206 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| DTaP-IPV-Hep B-PRP-T + Prevnar™ | Infanrix Hexa™ + Prevnar™ | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 161/206 (78.2%) | 135/206 (65.5%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 7/206 (3.4%) | 7 | 13/206 (6.3%) | 13 |
| Vomiting | 47/205 (22.9%) | 47 | 56/206 (27.2%) | 56 |
| General disorders | ||||
| Injection Site Pain | 161/205 (78.5%) | 161 | 135/206 (65.5%) | 135 |
| Injection Erythema | 93/206 (45.1%) | 93 | 91/206 (44.2%) | 91 |
| Injection Swelling | 59/206 (28.6%) | 59 | 44/206 (21.4%) | 44 |
| Irritability | 134/205 (65.4%) | 134 | 122/206 (59.2%) | 122 |
| Pyrexia | 109/205 (53.2%) | 109 | 68/206 (33%) | 68 |
| Infections and infestations | ||||
| Nasopharyngitis | 31/206 (15%) | 31 | 35/206 (17%) | 35 |
| Upper Respiratory Tract Infection | 45/206 (21.8%) | 45 | 46/206 (22.3%) | 46 |
| Metabolism and nutrition disorders | ||||
| Anorexia | 59/205 (28.8%) | 59 | 49/206 (23.8%) | 49 |
| Nervous system disorders | ||||
| Somnolence | 109/205 (53.2%) | 109 | 104/206 (50.5%) | 104 |
| Psychiatric disorders | ||||
| Crying | 128/206 (62.1%) | 128 | 106/206 (51.5%) | 106 |
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:
NCT00401531
Other Study ID Numbers:
- A3L12
First Posted:
Nov 20, 2006
Last Update Posted:
Apr 1, 2014
Last Verified:
Feb 1, 2014