Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00343889
Collaborator
(none)
379
2
2
20
189.5
9.5
Study Details
Study Description
Brief Summary
The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.
The primary objective is:
- To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.
The secondary objectives are:
-
To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and
-
To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
379 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix-HepB/Hib™, Both Given Concomitantly With the Oral Polio Vaccine at 6, 10, and 14 Weeks of Age in Healthy Infants in the Philippines
Study Start Date
:
Aug 1, 2006
Actual Primary Completion Date
:
Nov 1, 2007
Actual Study Completion Date
:
Apr 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. |
Biological: DTaP-HB-PRP~T vaccine + OPV
0.5 mL, Intramuscular
Biological: Oral Polio Vaccine
Oral co-administered with study vaccine
|
| Active Comparator: Group 2: Tritanrix-HepB/Hib™ + OPV vaccine Participants received 3 doses of Tritanrix-Hep B/Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10, and 14 weeks of age. |
Biological: Tritanrix-HepB/Hib™ + OPV vaccine
0.5 mL, Intramuscular
Biological: Oral Polio Vaccine
Oral co-administered with study vaccine
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [1 month post third vaccination]
Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.
Secondary Outcome Measures
- Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [1 month post third vaccination]
Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination.
- Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV [1 month post third vaccination]
Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).
- Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [1 month post third vaccination]
Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies. Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination.
- Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV [1 month post third vaccination]
Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA). Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
- Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV [Day 0 up to Day 7 after each vaccination]
Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.
Eligibility Criteria
Criteria
Ages Eligible for Study:
42 Days
to 50 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.
-
Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
-
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
-
Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent 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
-
Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy.
-
Chronic illness at a stage that could interfere with the conduct or completion of the trial
-
Blood or blood-derived products received since birth
-
HB vaccination since birth
-
Any vaccination in the four weeks preceding the first trial vaccination
-
Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial
-
Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
-
Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
-
Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
-
History of seizures
-
Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Manila | Philippines | |||
| 2 | Quezon City | Philippines |
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:
NCT00343889
Other Study ID Numbers:
- AL203
First Posted:
Jun 23, 2006
Last Update Posted:
Dec 10, 2013
Last Verified:
Nov 1, 2013
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled and treated from 07 July 2006 to 26 September 2006 in 2 clinical centers in the Philippines. |
|---|---|
| Pre-assignment Detail | A total of 379 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. |
| Period Title: Overall Study | ||
| STARTED | 190 | 189 |
| COMPLETED | 187 | 188 |
| NOT COMPLETED | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Total |
|---|---|---|---|
| Arm/Group Description | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. | Total of all reporting groups |
| Overall Participants | 190 | 189 | 379 |
| Age (Count of Participants) | |||
| <=18 years |
190
100%
|
189
100%
|
379
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (Weeks) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Weeks] |
6.31
(0.308)
|
6.31
(0.304)
|
6.31
(0.306)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
101
53.2%
|
92
48.7%
|
193
50.9%
|
| Male |
89
46.8%
|
97
51.3%
|
186
49.1%
|
| Region of Enrollment (Number) [Number] | |||
| Philippines |
190
100%
|
189
100%
|
379
100%
|
Outcome Measures
| Title | Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
|---|---|
| Description | Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination. |
| Time Frame | 1 month post third vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Anti-Hepatitis B Responses was assessed in the per-protocol population. |
| Arm/Group Title | Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. |
| Measure Participants | 184 | 186 |
| Number [Participants] |
54
28.4%
|
97
51.3%
|
| Title | Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
|---|---|
| Description | Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination. |
| Time Frame | 1 month post third vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroprotection to hepatitis H Antigen was assessed in the per-protocol population. |
| Arm/Group Title | Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. |
| Measure Participants | 184 | 186 |
| Number [Participants] |
146
76.8%
|
167
88.4%
|
| Title | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
|---|---|
| Description | Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150). |
| Time Frame | 1 month post third vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population. |
| Arm/Group Title | Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. |
| Measure Participants | 260 | 271 |
| Anti-Hepatitis B (N = 184, 186) |
39.1
|
86.2
|
| Anti-PRP (N = 178, 185) |
2.35
|
7.82
|
| Anti-Diphtheria (N = 184, 186) |
0.018
|
0.018
|
| Anti-Tetanus (N = 184, 186) |
1.30
|
1.76
|
| Anti-Pertussis (N = 183, 184) |
5.16
|
5.84
|
| Anti-Filamentous Hemagglutinin (N = 184, 186) |
5.50
|
5.71
|
| Title | Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
|---|---|
| Description | Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies. Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination. |
| Time Frame | 1 month post third vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Anti-Hepatitis B Responses was assessed in the per-protocol population. |
| Arm/Group Title | Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. |
| Measure Participants | 184 | 186 |
| Anti-Diphtheria ≥ 0.01 IU/mL |
137
72.1%
|
134
70.9%
|
| Anti-Diphtheria ≥ 0.1 IU/mL |
13
6.8%
|
11
5.8%
|
| Anti-Tetanus ≥ 0.01 IU/mL |
184
96.8%
|
186
98.4%
|
| Anti-Tetanus ≥ 0.1 IU/mL |
184
96.8%
|
186
98.4%
|
| Title | Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
|---|---|
| Description | Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA). Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination. |
| Time Frame | 1 month post third vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroconversion for anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibodies were assessed in the per-protocol population. |
| Arm/Group Title | Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. |
| Measure Participants | 184 | 186 |
| Anti-Pertussis Toxoid (N =184, 180) |
183
96.3%
|
168
88.9%
|
| Anti-Filamentous Hemagglutinin (N = 178, 131) |
178
93.7%
|
116
61.4%
|
| Title | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV |
|---|---|
| Description | Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable. |
| Time Frame | Day 0 up to Day 7 after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety was assessed on the safety analysis (intent-to-treat) population. |
| Arm/Group Title | Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. |
| Measure Participants | 190 | 189 |
| Injection site Pain post any vaccination |
123
64.7%
|
152
80.4%
|
| Grade 3 Injection site Pain post any vaccination |
7
3.7%
|
24
12.7%
|
| Injection site Pain post-vaccination 1 |
100
52.6%
|
142
75.1%
|
| Injection site Pain post-vaccination 2 |
86
45.3%
|
109
57.7%
|
| Injection site Pain post-vaccination 3 |
62
32.6%
|
88
46.6%
|
| Injection site Erythema post any vaccination |
121
63.7%
|
148
78.3%
|
| Grade 3 Injec. site Erythema post any vaccination |
2
1.1%
|
3
1.6%
|
| Injection site Erythema post-vaccination 1 |
70
36.8%
|
89
47.1%
|
| Injection site Erythema post-vaccination 2 |
70
36.8%
|
105
55.6%
|
| Injection site Erythema post-vaccination 3 |
76
40%
|
104
55%
|
| Injection site Swelling post any vaccination |
60
31.6%
|
107
56.6%
|
| Grade 3 Injec. site Swelling post any vaccination |
4
2.1%
|
7
3.7%
|
| Injection site Swelling post-vaccination 1 |
41
21.6%
|
89
47.1%
|
| Injection site Swelling post-vaccination 2 |
28
14.7%
|
57
30.2%
|
| Injection site Swelling post-vaccination 3 |
24
12.6%
|
49
25.9%
|
| Pyrexia post any vaccination |
85
44.7%
|
129
68.3%
|
| Grade 3 Pyrexia post any vaccination |
1
0.5%
|
4
2.1%
|
| Pyrexia post-vaccination 1 |
59
31.1%
|
106
56.1%
|
| Pyrexia post-vaccination 2 |
40
21.1%
|
54
28.6%
|
| Pyrexia post-vaccination 3 |
22
11.6%
|
51
27%
|
| Vomiting post any vaccination |
43
22.6%
|
61
32.3%
|
| Grade 3 Vomiting post any vaccination |
0
0%
|
0
0%
|
| Vomiting post-vaccination 1 |
37
19.5%
|
40
21.2%
|
| Vomiting post-vaccination 2 |
16
8.4%
|
24
12.7%
|
| Vomiting post-vaccination 3 |
9
4.7%
|
13
6.9%
|
| Crying post any vaccination |
56
29.5%
|
97
51.3%
|
| Grade 3 Crying post any vaccination |
0
0%
|
0
0%
|
| Crying post-vaccination 1 |
41
21.6%
|
71
37.6%
|
| Crying post-vaccination 2 |
29
15.3%
|
42
22.2%
|
| Crying post-vaccination 3 |
16
8.4%
|
34
18%
|
| Somnolence post any vaccination |
52
27.4%
|
63
33.3%
|
| Grade 3 Somnolence post any vaccination |
2
1.1%
|
2
1.1%
|
| Somnolence post-vaccination 1 |
43
22.6%
|
49
25.9%
|
| Somnolence post-vaccination 2 |
24
12.6%
|
26
13.8%
|
| Somnolence post-vaccination 3 |
10
5.3%
|
18
9.5%
|
| Anorexia post any vaccination |
48
25.3%
|
67
35.4%
|
| Grade 3 Anorexia post any vaccination |
1
0.5%
|
1
0.5%
|
| Anorexia post-vaccination 1 |
32
16.8%
|
50
26.5%
|
| Anorexia post-vaccination 2 |
20
10.5%
|
25
13.2%
|
| Anorexia post-vaccination 3 |
16
8.4%
|
27
14.3%
|
| Irritability post any vaccination |
102
53.7%
|
128
67.7%
|
| Grade 3 Irritability post any vaccination |
4
2.1%
|
7
3.7%
|
| Irritability post-vaccination 1 |
90
47.4%
|
116
61.4%
|
| Irritability post-vaccination 2 |
48
25.3%
|
71
37.6%
|
| Irritability post-vaccination 3 |
32
16.8%
|
56
29.6%
|
Adverse Events
| Time Frame | Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The total number (N) for each adverse event indicated those with available data for the event. | |||
| Arm/Group Title | Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | ||
| Arm/Group Description | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. | ||
All Cause Mortality |
||||
| Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/190 (8.9%) | 10/189 (5.3%) | ||
| Gastrointestinal disorders | ||||
| Intussusception | 0/190 (0%) | 0 | 1/189 (0.5%) | 1 |
| Infections and infestations | ||||
| Bronchopneumonia | 1/190 (0.5%) | 1 | 0/189 (0%) | 0 |
| Bronchitis | 1/190 (0.5%) | 1 | 0/189 (0%) | 0 |
| Bullus impetigo | 1/190 (0.5%) | 1 | 0/189 (0%) | 0 |
| Diarrhoea infectious | 1/190 (0.5%) | 1 | 0/189 (0%) | 0 |
| Exanthema subitum | 1/190 (0.5%) | 1 | 0/189 (0%) | 0 |
| Gastroenteritis | 8/190 (4.2%) | 8 | 4/189 (2.1%) | 4 |
| Pneumonia | 3/190 (1.6%) | 3 | 5/189 (2.6%) | 5 |
| Sepsis | 1/190 (0.5%) | 1 | 0/189 (0%) | 0 |
| Urinary tract infection | 0/190 (0%) | 0 | 1/189 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Group 1: DTaP-Hep B-PRP~T + OPV | Group 2: Tritanrix-Hep B/ Hib™ + OPV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 123/190 (64.7%) | 152/189 (80.4%) | ||
| Gastrointestinal disorders | ||||
| Vomiting | 43/189 (22.8%) | 61/189 (32.3%) | ||
| Injection site pain | 123/189 (65.1%) | 152/189 (80.4%) | ||
| General disorders | ||||
| Injection site erythemia | 121/189 (64%) | 148/189 (78.3%) | ||
| Injection site swelling | 60/189 (31.7%) | 107/189 (56.6%) | ||
| Pyrexia | 85/189 (45%) | 129/189 (68.3%) | ||
| Pyrexia | 7/190 (3.7%) | 17/189 (9%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 89/190 (46.8%) | 113/189 (59.8%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 48/189 (25.4%) | 67/189 (35.4%) | ||
| Rhinitis | 14/190 (7.4%) | 16/189 (8.5%) | ||
| Nervous system disorders | ||||
| Somnolence | 52/189 (27.5%) | 63/189 (33.3%) | ||
| Psychiatric disorders | ||||
| Crying | 56/189 (29.6%) | 97/189 (51.3%) | ||
| Irritability | 102/189 (54%) | 128/189 (67.7%) | ||
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:
NCT00343889
Other Study ID Numbers:
- AL203
First Posted:
Jun 23, 2006
Last Update Posted:
Dec 10, 2013
Last Verified:
Nov 1, 2013