Trial Outcomes & Findings for Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine (NCT NCT00343889)
NCT ID: NCT00343889
Last Updated: 2013-12-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
379 participants
Primary outcome timeframe
1 month post third vaccination
Results posted on
2013-12-10
Participant Flow
Participants were enrolled and treated from 07 July 2006 to 26 September 2006 in 2 clinical centers in the Philippines.
A total of 379 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
|---|---|---|
|
Overall Study
STARTED
|
190
|
189
|
|
Overall Study
COMPLETED
|
187
|
188
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
Baseline characteristics by cohort
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=190 Participants
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=189 Participants
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
Total
n=379 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
190 Participants
n=93 Participants
|
189 Participants
n=4 Participants
|
379 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
6.31 Weeks
STANDARD_DEVIATION 0.308 • n=93 Participants
|
6.31 Weeks
STANDARD_DEVIATION 0.304 • n=4 Participants
|
6.31 Weeks
STANDARD_DEVIATION 0.306 • n=27 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
193 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
186 Participants
n=27 Participants
|
|
Region of Enrollment
Philippines
|
190 Participants
n=93 Participants
|
189 Participants
n=4 Participants
|
379 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 month post third vaccinationPopulation: Seroprotection to hepatitis H Antigen was assessed in the per-protocol population.
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.
Outcome measures
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=184 Participants
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=186 Participants
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
|---|---|---|
|
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
|
146 Participants
|
167 Participants
|
SECONDARY outcome
Timeframe: 1 month post third vaccinationPopulation: Anti-Hepatitis B Responses was assessed in the per-protocol population.
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.
Outcome measures
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=184 Participants
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=186 Participants
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
|---|---|---|
|
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
|
54 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: 1 month post third vaccinationPopulation: Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.
Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).
Outcome measures
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=260 Participants
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=271 Participants
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
|---|---|---|
|
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
Anti-PRP (N = 178, 185)
|
2.35 Titers
Interval 1.83 to 3.01
|
7.82 Titers
Interval 6.45 to 9.48
|
|
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
Anti-Hepatitis B (N = 184, 186)
|
39.1 Titers
Interval 31.0 to 49.2
|
86.2 Titers
Interval 68.0 to 109.0
|
|
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
Anti-Diphtheria (N = 184, 186)
|
0.018 Titers
Interval 0.015 to 0.022
|
0.018 Titers
Interval 0.014 to 0.021
|
|
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
Anti-Tetanus (N = 184, 186)
|
1.30 Titers
Interval 1.16 to 1.46
|
1.76 Titers
Interval 1.58 to 1.97
|
|
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
Anti-Pertussis (N = 183, 184)
|
5.16 Titers
Interval 4.36 to 6.11
|
5.84 Titers
Interval 4.81 to 7.09
|
|
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
Anti-Filamentous Hemagglutinin (N = 184, 186)
|
5.50 Titers
Interval 4.68 to 6.48
|
5.71 Titers
Interval 4.85 to 6.71
|
SECONDARY outcome
Timeframe: 1 month post third vaccinationPopulation: Anti-Hepatitis B Responses was assessed in the per-protocol population.
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.
Outcome measures
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=184 Participants
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=186 Participants
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
|---|---|---|
|
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
Anti-Diphtheria ≥ 0.01 IU/mL
|
137 Participants
|
134 Participants
|
|
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
Anti-Diphtheria ≥ 0.1 IU/mL
|
13 Participants
|
11 Participants
|
|
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
Anti-Tetanus ≥ 0.01 IU/mL
|
184 Participants
|
186 Participants
|
|
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
Anti-Tetanus ≥ 0.1 IU/mL
|
184 Participants
|
186 Participants
|
SECONDARY outcome
Timeframe: 1 month post third vaccinationPopulation: Seroconversion for anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibodies were assessed in the per-protocol population.
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.
Outcome measures
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=184 Participants
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=186 Participants
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
|---|---|---|
|
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
Anti-Filamentous Hemagglutinin (N = 178, 131)
|
178 Participants
|
116 Participants
Interval 0.0 to 0.0
|
|
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
Anti-Pertussis Toxoid (N =184, 180)
|
183 Participants
|
168 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 after each vaccinationPopulation: Safety was assessed on the safety analysis (intent-to-treat) population.
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.
Outcome measures
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=190 Participants
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=189 Participants
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
|---|---|---|
|
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
Grade 3 Injec. site Swelling post any vaccination
|
4 Participants
|
7 Participants
Interval 0.0 to 0.0
|
|
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
Vomiting post any vaccination
|
43 Participants
|
61 Participants
Interval 0.0 to 0.0
|
|
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
Vomiting post-vaccination 2
|
16 Participants
|
24 Participants
Interval 0.0 to 0.0
|
|
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
Vomiting post-vaccination 3
|
9 Participants
|
13 Participants
|
|
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
Crying post-vaccination 3
|
16 Participants
|
34 Participants
|
|
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
Crying post any vaccination
|
56 Participants
|
97 Participants
|
|
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
Grade 3 Crying post any vaccination
|
0 Participants
|
0 Participants
|
|
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
Crying post-vaccination 1
|
41 Participants
|
71 Participants
|
|
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
Crying post-vaccination 2
|
29 Participants
|
42 Participants
|
|
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
Somnolence post any vaccination
|
52 Participants
|
63 Participants
|
|
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
Injection site Pain post any vaccination
|
123 Participants
|
152 Participants
Interval 0.0 to 0.0
|
|
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
Grade 3 Injection site Pain post any vaccination
|
7 Participants
|
24 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Pain post-vaccination 1
|
100 Participants
|
142 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Pain post-vaccination 2
|
86 Participants
|
109 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Pain post-vaccination 3
|
62 Participants
|
88 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Erythema post any vaccination
|
121 Participants
|
148 Participants
Interval 0.0 to 0.0
|
|
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
Grade 3 Injec. site Erythema post any vaccination
|
2 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Erythema post-vaccination 1
|
70 Participants
|
89 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Erythema post-vaccination 2
|
70 Participants
|
105 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Erythema post-vaccination 3
|
76 Participants
|
104 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Swelling post any vaccination
|
60 Participants
|
107 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Swelling post-vaccination 1
|
41 Participants
|
89 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Swelling post-vaccination 2
|
28 Participants
|
57 Participants
Interval 0.0 to 0.0
|
|
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
Injection site Swelling post-vaccination 3
|
24 Participants
|
49 Participants
Interval 0.0 to 0.0
|
|
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
Pyrexia post any vaccination
|
85 Participants
|
129 Participants
Interval 0.0 to 0.0
|
|
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
Grade 3 Pyrexia post any vaccination
|
1 Participants
|
4 Participants
Interval 0.0 to 0.0
|
|
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
Pyrexia post-vaccination 1
|
59 Participants
|
106 Participants
Interval 0.0 to 0.0
|
|
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
Pyrexia post-vaccination 2
|
40 Participants
|
54 Participants
Interval 0.0 to 0.0
|
|
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
Pyrexia post-vaccination 3
|
22 Participants
|
51 Participants
Interval 0.0 to 0.0
|
|
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
Grade 3 Vomiting post any vaccination
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
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
Vomiting post-vaccination 1
|
37 Participants
|
40 Participants
Interval 0.0 to 0.0
|
|
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
Grade 3 Somnolence post any vaccination
|
2 Participants
|
2 Participants
|
|
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
Somnolence post-vaccination 1
|
43 Participants
|
49 Participants
|
|
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
Somnolence post-vaccination 2
|
24 Participants
|
26 Participants
|
|
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
Somnolence post-vaccination 3
|
10 Participants
|
18 Participants
|
|
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
Anorexia post any vaccination
|
48 Participants
|
67 Participants
|
|
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
Grade 3 Anorexia post any vaccination
|
1 Participants
|
1 Participants
|
|
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
Anorexia post-vaccination 1
|
32 Participants
|
50 Participants
|
|
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
Anorexia post-vaccination 2
|
20 Participants
|
25 Participants
|
|
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
Anorexia post-vaccination 3
|
16 Participants
|
27 Participants
|
|
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
Irritability post any vaccination
|
102 Participants
|
128 Participants
|
|
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
Grade 3 Irritability post any vaccination
|
4 Participants
|
7 Participants
|
|
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
Irritability post-vaccination 1
|
90 Participants
|
116 Participants
|
|
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
Irritability post-vaccination 2
|
48 Participants
|
71 Participants
|
|
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
Irritability post-vaccination 3
|
32 Participants
|
56 Participants
|
Adverse Events
Group 1: DTaP-Hep B-PRP~T + OPV
Serious events: 17 serious events
Other events: 123 other events
Deaths: 0 deaths
Group 2: Tritanrix-Hep B/ Hib™ + OPV
Serious events: 10 serious events
Other events: 152 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=190 participants at risk
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=189 participants at risk
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
|---|---|---|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/190 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
0.53%
1/189 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Infections and infestations
Bronchopneumonia
|
0.53%
1/190 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
0.00%
0/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Infections and infestations
Bronchitis
|
0.53%
1/190 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
0.00%
0/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Infections and infestations
Bullus impetigo
|
0.53%
1/190 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
0.00%
0/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Infections and infestations
Diarrhoea infectious
|
0.53%
1/190 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
0.00%
0/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Infections and infestations
Exanthema subitum
|
0.53%
1/190 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
0.00%
0/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Infections and infestations
Gastroenteritis
|
4.2%
8/190 • Number of events 8 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
2.1%
4/189 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Infections and infestations
Pneumonia
|
1.6%
3/190 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
2.6%
5/189 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Infections and infestations
Sepsis
|
0.53%
1/190 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
0.00%
0/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/190 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
0.53%
1/189 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
Other adverse events
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=190 participants at risk
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.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=189 participants at risk
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
22.8%
43/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
32.3%
61/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Gastrointestinal disorders
Injection site pain
|
65.1%
123/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
80.4%
152/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
General disorders
Injection site erythemia
|
64.0%
121/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
78.3%
148/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
General disorders
Injection site swelling
|
31.7%
60/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
56.6%
107/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
General disorders
Pyrexia
|
3.7%
7/190 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
9.0%
17/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.4%
48/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
35.4%
67/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Nervous system disorders
Somnolence
|
27.5%
52/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
33.3%
63/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Infections and infestations
Upper respiratory tract infection
|
46.8%
89/190 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
59.8%
113/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Metabolism and nutrition disorders
Rhinitis
|
7.4%
14/190 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
8.5%
16/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Psychiatric disorders
Crying
|
29.6%
56/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
51.3%
97/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
|
Psychiatric disorders
Irritability
|
54.0%
102/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
67.7%
128/189 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER