Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00313911
Collaborator
(none)
2,133
2
2
19.1
1066.5
56
Study Details
Study Description
Brief Summary
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject.
To evaluate the overall safety in terms of:
Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.
Immunogenicity:
To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP~T vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2133 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants
Study Start Date
:
Jul 1, 2006
Actual Primary Completion Date
:
Jan 1, 2008
Actual Study Completion Date
:
Feb 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: DTaP-IPV-Hep B-PRP-T
|
Biological: DTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular (IM)
|
| Active Comparator: Group 2: Tritanrix-Hep B/Hib™+OPV
|
Biological: Tritanrix-HepB/Hib
0.5 mL, Intramuscular
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. [Day 0 up to Day 7 post-injection]
High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.
Secondary Outcome Measures
- Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo [Day 30 post-dose 3]
Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
- Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo [Day 30 post-dose 3]
Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.
- Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination [Day 0 up to Day 7 Post-injection]
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; 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:
-
2 months old infants on the day of inclusion
-
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
-
Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses
-
Able to attend all scheduled visits and to comply with all trial procedures
-
Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.
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 corticosteroids therapy
-
Subjects with congenital or acquired immunodeficiency in the child's surrounding
-
Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
-
Chronic illness at a stage that could interfere with trial conduct or completion
-
Blood or blood-derived products received since birth
-
Any vaccination in the 4 weeks preceding the first trial vaccination
-
Vaccination planned in the 4 weeks following the trial vaccination
-
Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
-
Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen
-
Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)
-
Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination
-
History of seizures
-
Febrile or acute illness on the day of inclusion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mexico DF | Mexico | |||
| 2 | Lima | Peru |
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:
NCT00313911
Other Study ID Numbers:
- A3L04
First Posted:
Apr 12, 2006
Last Update Posted:
Apr 21, 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 and treated from 17 July 2006 to 02 January 2008 in 1 clinical center in Mexico and 1 clinical center in Peru. |
|---|---|
| Pre-assignment Detail | A total of 2133 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. |
| Period Title: Overall Study | ||
| STARTED | 1422 | 711 |
| COMPLETED | 1328 | 670 |
| NOT COMPLETED | 94 | 41 |
Baseline Characteristics
| Arm/Group Title | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | Total |
|---|---|---|---|
| Arm/Group Description | Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Total of all reporting groups |
| Overall Participants | 1422 | 711 | 2133 |
| Age (Count of Participants) | |||
| <=18 years |
1422
100%
|
711
100%
|
2133
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 |
1.89
(0.195)
|
1.88
(0.197)
|
1.88
(0.196)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
706
49.6%
|
344
48.4%
|
1050
49.2%
|
| Male |
716
50.4%
|
367
51.6%
|
1083
50.8%
|
| Region of Enrollment (Number) [Number] | |||
| Mexico |
712
50.1%
|
355
49.9%
|
1067
50%
|
| Peru |
710
49.9%
|
356
50.1%
|
1066
50%
|
Outcome Measures
| Title | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. |
|---|---|
| Description | High fever was defined as rectal temperature equivalent to ≥ 39.6ºC. |
| Time Frame | Day 0 up to Day 7 post-injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| The occurrence of high fever was assessed for all enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants in each group adjusted for the participant that got a vaccine assigned for the other group. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. |
| Measure Participants | 1423 | 710 |
| Post Any Dose (N = 1411, 703) |
56
3.9%
|
39
5.5%
|
| Post Dose 1 (N = 1408, 703) |
5
0.4%
|
4
0.6%
|
| Post Dose 2 (N = 1348, 681) |
25
1.8%
|
15
2.1%
|
| Post Dose 3 (N = 1328, 672) |
26
1.8%
|
23
3.2%
|
| Title | Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo |
|---|---|
| Description | Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. |
| Time Frame | Day 30 post-dose 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. |
| Measure Participants | 184 | 95 |
| Geometric Mean (95% Confidence Interval) [Titers] |
1075
|
3376
|
| Title | Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo |
|---|---|
| Description | Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively. |
| Time Frame | Day 30 post-dose 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. |
| Measure Participants | 184 | 95 |
| ≥ 10 mIU/mL |
100
7%
|
100
14.1%
|
| ≥ 100 mIU/mL |
96
6.8%
|
99
13.9%
|
| Title | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination |
|---|---|
| Description | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable. |
| Time Frame | Day 0 up to Day 7 Post-injection |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants (N) in each group adjusted for the participant that got a vaccine assigned for the other group. |
| Arm/Group Title | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| Arm/Group Description | Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. |
| Measure Participants | 1423 | 710 |
| Any Pain Post Dose 1 (N=1410, 703) |
831
58.4%
|
574
80.7%
|
| Severe Pain Post Dose 1 (N=1408, 703) |
175
12.3%
|
193
27.1%
|
| Any Pain Post Dose 2 (N=1348, 681) |
744
52.3%
|
506
71.2%
|
| Severe Pain Post Dose 2 (N=1348, 681) |
105
7.4%
|
95
13.4%
|
| Any Pain Post Dose 3 (N=1327, 672) |
519
36.5%
|
448
63%
|
| Severe Pain Post Dose 3 (N=1327, 672) |
29
2%
|
65
9.1%
|
| Any Erythema Post Dose 1 (N=1408, 703) |
245
17.2%
|
234
32.9%
|
| Severe Erythema Post Dose 1 (N=1408, 703) |
11
0.8%
|
15
2.1%
|
| Any Erythema Post Dose 2 (N=1348, 681) |
427
30%
|
308
43.3%
|
| Severe Erythema Post Dose 2 (N=1348, 681) |
6
0.4%
|
16
2.3%
|
| Any Erythema Post Dose 3 (N=1327, 672) |
587
41.3%
|
340
47.8%
|
| Severe Erythema Post Dose 3 (N=1327, 672) |
23
1.6%
|
12
1.7%
|
| Any Swelling Post Dose 1 (N=1406, 703) |
151
10.6%
|
188
26.4%
|
| Severe Swelling Post Dose 1 (N=1406, 703) |
8
0.6%
|
24
3.4%
|
| Any Swelling Post Dose 2 (N=1348, 681) |
259
18.2%
|
270
38%
|
| Severe Swelling Post Dose 2 (N=1348, 681) |
3
0.2%
|
11
1.5%
|
| Any Swelling Post Dose 3 (N=1327, 672) |
400
28.1%
|
323
45.4%
|
| Severe Swelling Post Dose 3 (N=1327, 672) |
3
0.2%
|
7
1%
|
| Any Pyrexia Post Dose 1 (N=1408, 703) |
538
37.8%
|
473
66.5%
|
| Severe Pyrexia Post Dose 1 (N=1408, 703) |
5
0.4%
|
4
0.6%
|
| Any Pyrexia Post Dose 2 (N=1348, 681) |
675
47.5%
|
457
64.3%
|
| Severe Pyrexia Post Dose 2 (N=1348, 681) |
27
1.9%
|
16
2.3%
|
| Any Pyrexia Post Dose 3 (N=1328, 672) |
552
38.8%
|
445
62.6%
|
| Severe Pyrexia Post Dose 3 (N=1328, 672) |
30
2.1%
|
23
3.2%
|
| Any Vomiting Post Dose 1 (N=1408, 703) |
230
16.2%
|
120
16.9%
|
| Severe Vomiting Post Dose 1 (N=1408, 703) |
10
0.7%
|
4
0.6%
|
| Any Vomiting Post Dose 2 (N=1348, 681) |
152
10.7%
|
75
10.5%
|
| Severe Vomiting Post Dose 2 (N=1348, 681) |
2
0.1%
|
4
0.6%
|
| Any Vomiting Post Dose 3 (N=1328, 672) |
167
11.7%
|
95
13.4%
|
| Severe Vomiting Post Dose 3 (N=1328, 672) |
17
1.2%
|
10
1.4%
|
| Any Crying Post Dose 1 (N=1409, 703) |
800
56.3%
|
564
79.3%
|
| Severe Crying Post Dose 1 (N=1409, 703) |
21
1.5%
|
26
3.7%
|
| Any Crying Post Dose 2 (N=1348, 681) |
721
50.7%
|
481
67.7%
|
| Severe Crying Post Dose 2 (N=1348, 681) |
9
0.6%
|
8
1.1%
|
| Any Crying Post Dose 3 (N=1327, 672) |
466
32.8%
|
391
55%
|
| Severe Crying Post Dose 3 (N=1327, 672) |
9
0.6%
|
8
1.1%
|
| Any Somnolence Post Dose 1 (N=1408, 703) |
635
44.7%
|
375
52.7%
|
| Severe Somnolence Post Dose 1 (N=1408, 703) |
46
3.2%
|
26
3.7%
|
| Any Somnolence Post Dose 2 (N=1348, 681) |
405
28.5%
|
247
34.7%
|
| Severe Somnolence Post Dose 2 (N=1348, 681) |
16
1.1%
|
12
1.7%
|
| Any Somnolence Post Dose 3 (N=1327, 672) |
272
19.1%
|
204
28.7%
|
| Severe Somnolence Post Dose 3 (N=1327, 672) |
12
0.8%
|
11
1.5%
|
| Any Anorexia Post Dose 1 (N=1408, 703) |
388
27.3%
|
278
39.1%
|
| Severe Anorexia Post Dose 1 (N=1408, 703) |
11
0.8%
|
14
2%
|
| Any Anorexia Post Dose 2 (N=1348, 681) |
327
23%
|
195
27.4%
|
| Severe Anorexia Post Dose 2 (N=1348, 681) |
12
0.8%
|
11
1.5%
|
| Any Anorexia Post Dose 3 (N=1327, 672) |
294
20.7%
|
189
26.6%
|
| Severe Anorexia Post Dose 3 (N=1327, 672) |
18
1.3%
|
17
2.4%
|
| Any Irritability Post Dose 1 (N=1408, 703) |
945
66.5%
|
576
81%
|
| Severe Irritability Post Dose 1 (N=1408, 703) |
42
3%
|
47
6.6%
|
| Any Irritability Post Dose 2 (N=1348, 681) |
799
56.2%
|
492
69.2%
|
| Severe Irritability Post Dose 2 (N=1348, 681) |
41
2.9%
|
25
3.5%
|
| Any Irritability Post Dose 3 (N=1327, 672) |
546
38.4%
|
416
58.5%
|
| Severe Irritability Post Dose 3 (N=1327, 672) |
11
0.8%
|
17
2.4%
|
Adverse Events
| Time Frame | Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data. | |||
| Arm/Group Title | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | ||
| Arm/Group Description | Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | ||
All Cause Mortality |
||||
| DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 91/1423 (6.4%) | 46/710 (6.5%) | ||
| Cardiac disorders | ||||
| Cardio Respiratory Distress | 0/1423 (0%) | 0 | 1/710 (0.1%) | 1 |
| Congenital, familial and genetic disorders | ||||
| Hip Dysplasia | 0/1423 (0%) | 0 | 1/710 (0.1%) | 1 |
| Gastrointestinal disorders | ||||
| Intussusception | 0/1423 (0%) | 0 | 1/710 (0.1%) | 1 |
| Diarrhoea | 2/1423 (0.1%) | 2 | 0/710 (0%) | 0 |
| Gastric Haemorrhage | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Gastrooesophageal reflux disease | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Inguinal Hernia, Obstructive | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| General disorders | ||||
| Pyrexia | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Choledochal Cyst | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Infections and infestations | ||||
| Abscess Neck | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Bronchiolitis | 12/1423 (0.8%) | 12 | 6/710 (0.8%) | 6 |
| Bronchopneumonia | 13/1423 (0.9%) | 13 | 3/710 (0.4%) | 3 |
| Encephalitis viral | 0/1423 (0%) | 0 | 1/710 (0.1%) | 1 |
| Gastroenteritis | 21/1423 (1.5%) | 21 | 18/710 (2.5%) | 18 |
| Gastroenteritis rotavirus | 1/1423 (0.1%) | 1 | 1/710 (0.1%) | 1 |
| Kawasaki's disease | 0/1423 (0%) | 0 | 1/710 (0.1%) | 1 |
| Laryngotracheitis | 2/1423 (0.1%) | 2 | 0/710 (0%) | 0 |
| Lymphangitis | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Periorbital Cellulitis | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Pharyngitis | 2/1423 (0.1%) | 2 | 0/710 (0%) | 0 |
| Pneumonia | 5/1423 (0.4%) | 5 | 3/710 (0.4%) | 3 |
| Pneumonia viral | 6/1423 (0.4%) | 6 | 2/710 (0.3%) | 2 |
| Postoperative Wound Infection | 0/1423 (0%) | 0 | 1/710 (0.1%) | 1 |
| Pyoderma | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Pyoderma Streptococcal | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Urinary Tract Infection | 1/1423 (0.1%) | 1 | 1/710 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Head Injury | 2/1423 (0.1%) | 2 | 3/710 (0.4%) | 3 |
| Nervous system disorders | ||||
| Encephalitis | 1/1423 (0.1%) | 1 | 1/710 (0.1%) | 1 |
| Epilepsy | 1/1423 (0.1%) | 1 | 1/710 (0.1%) | 1 |
| Febrile Convulsion | 4/1423 (0.3%) | 4 | 1/710 (0.1%) | 1 |
| Hypotonic Hyporesponsive Episode | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Subarachnoid Haemorrhage | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchial Hyperactivity | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Bronchial Obstruction | 9/1423 (0.6%) | 9 | 1/710 (0.1%) | 1 |
| Bronchospasm | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Foreign Body Aspiration | 1/1423 (0.1%) | 1 | 0/710 (0%) | 0 |
| Obstructive Airways Disorder | 0/1423 (0%) | 0 | 1/710 (0.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Purpura | 0/1423 (0%) | 0 | 1/710 (0.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 945/1423 (66.4%) | 576/710 (81.1%) | ||
| Gastrointestinal disorders | ||||
| Abdominal Pain | 131/1411 (9.3%) | 131 | 70/703 (10%) | 70 |
| Diarrhoea | 264/1411 (18.7%) | 264 | 123/703 (17.5%) | 123 |
| Solicited Vomiting Post-dose 1 | 230/1410 (16.3%) | 230 | 120/703 (17.1%) | 120 |
| General disorders | ||||
| Solicited Injection site Erythema Post-dose 3 | 587/1410 (41.6%) | 587 | 340/703 (48.4%) | 340 |
| Injection Site Haemorrhage | 39/1411 (2.8%) | 39 | 63/703 (9%) | 63 |
| Injection Site Nodule | 81/1411 (5.7%) | 81 | 79/703 (11.2%) | 79 |
| Solicited Injection Site Pain Post-dose 1 | 831/1410 (58.9%) | 831 | 574/703 (81.7%) | 574 |
| Solicited Injection Site Swelling Post-dose 3 | 400/1408 (28.4%) | 400 | 323/703 (45.9%) | 323 |
| Solicited Irritability post-dose 1 | 945/1410 (67%) | 945 | 576/703 (81.9%) | 576 |
| Solicited Pyrexia Post-dose 2 | 675/1411 (47.8%) | 675 | 457/703 (65%) | 457 |
| Infections and infestations | ||||
| Gastroenteritis | 101/1411 (7.2%) | 101 | 40/703 (5.7%) | 40 |
| Nasopharyngitis | 742/1411 (52.6%) | 742 | 353/703 (50.2%) | 353 |
| Pharyngitis | 395/1411 (28%) | 395 | 161/703 (22.9%) | 161 |
| Rhinitis | 136/1411 (9.6%) | 136 | 56/703 (8%) | 56 |
| Metabolism and nutrition disorders | ||||
| Solicited Anorexia Post-dose 1 | 388/1410 (27.5%) | 388 | 278/703 (39.5%) | 278 |
| Nervous system disorders | ||||
| Solicited Somnolence Post-dose 1 | 635/1410 (45%) | 635 | 375/703 (53.3%) | 375 |
| Psychiatric disorders | ||||
| Solicited Crying Post-dose 1 | 800/1411 (56.7%) | 800 | 564/703 (80.2%) | 564 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchospasm | 163/1411 (11.6%) | 163 | 74/703 (10.5%) | 74 |
| Rhinitis Allergic | 75/1411 (5.3%) | 75 | 36/703 (5.1%) | 36 |
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis Diaper | 160/1411 (11.3%) | 160 | 54/703 (7.7%) | 54 |
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:
NCT00313911
Other Study ID Numbers:
- A3L04
First Posted:
Apr 12, 2006
Last Update Posted:
Apr 21, 2014
Last Verified:
Apr 1, 2014