Trial Outcomes & Findings for Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ (NCT NCT00534833)
NCT ID: NCT00534833
Last Updated: 2013-11-21
Results Overview
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
362 participants
Primary outcome timeframe
28 Days post-vaccination
Results posted on
2013-11-21
Participant Flow
Participants were randomized and enrolled from 21 September 2007 to 03 December 2007 in 2 clinical centers in the Philippines.
A total of 362 participants who met the inclusion but not the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
Participants received a booster dose of DTaP-Hep B-PRP\~T concomitantly with OPV at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP\~T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with OPV at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
|
|---|---|---|
|
Overall Study
STARTED
|
182
|
180
|
|
Overall Study
COMPLETED
|
182
|
180
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
Baseline characteristics by cohort
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=182 Participants
Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=180 Participants
Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
|
Total
n=362 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
182 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
362 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
15.9 Months
STANDARD_DEVIATION 0.946 • n=5 Participants
|
15.9 Months
STANDARD_DEVIATION 0.942 • n=7 Participants
|
15.9 Months
STANDARD_DEVIATION 0.945 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
182 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
362 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 Days post-vaccinationPopulation: Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio.
Outcome measures
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=98 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP\~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=98 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203
|
|---|---|---|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Hep B, Pre-booster (N = 98, 98)
|
36 Participants
|
58 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Hep B, Post-booster (N = 98, 98)
|
81 Participants
|
94 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-PRP, Pre-booster (N = 98, 98)
|
82 Participants
|
97 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-PRP, Post-booster (N = 98, 98)
|
97 Participants
|
98 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Diphtheria, Pre-booster (N = 98, 98)
|
67 Participants
|
59 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Diphtheria, Post-booster (N = 98, 98)
|
97 Participants
|
97 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Tetanus, Pre-booster (N = 98, 97)
|
98 Participants
|
97 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Tetanus, Post-booster (N = 98, 98)
|
98 Participants
|
98 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Pertussis, 4-Fold Increase (N = 96, 92)
|
94 Participants
|
83 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Pertussis, Booster response (N = 96, 92)
|
95 Participants
|
85 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-FHA, 4-Fold Increase (N = 94, 93)
|
89 Participants
|
92 Participants
|
|
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-FHA, Booster response (N = 94, 93)
|
93 Participants
|
93 Participants
|
PRIMARY outcome
Timeframe: Day 28 post-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 28 days after the Booster vaccination
Outcome measures
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=98 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP\~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=98 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Hepatitis B Pre-booster (N = 98, 98)
|
6.75 Titers
Interval 5.17 to 8.81
|
17.5 Titers
Interval 12.7 to 24.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Hepatitis B Post-booster (N = 98, 98)
|
119 Titers
Interval 75.3 to 188.0
|
1352 Titers
Interval 883.0 to 2071.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-PRP Pre-booster (N = 98, 98)
|
0.908 Titers
Interval 0.631 to 1.31
|
3.76 Titers
Interval 2.76 to 5.13
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-PRP Post-booster (N = 98, 98)
|
64.4 Titers
Interval 47.1 to 88.2
|
103 Titers
Interval 82.8 to 129.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Diphtheria Pre-booster (N = 98, 98)
|
0.016 Titers
Interval 0.012 to 0.021
|
0.013 Titers
Interval 0.01 to 0.018
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Diphtheria Post-booster (N = 98, 98)
|
2.81 Titers
Interval 2.01 to 3.92
|
1.15 Titers
Interval 0.779 to 1.7
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Tetanus Pre-booster (N = 98, 98)
|
0.382 Titers
Interval 0.32 to 0.455
|
0.500 Titers
Interval 0.429 to 0.584
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Tetanus Post-booster (N = 98, 98)
|
15.8 Titers
Interval 13.2 to 18.9
|
14.7 Titers
Interval 13.1 to 16.4
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Pertussis Pre-booster (N = 96, 92)
|
9.11 Titers
Interval 7.77 to 10.7
|
6.94 Titers
Interval 5.2 to 9.25
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Pertussis Post-booster (N = 98, 98)
|
199 Titers
Interval 174.0 to 228.0
|
105 Titers
Interval 76.9 to 144.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-FHA Pre-booster (N = 95, 93)
|
15.0 Titers
Interval 12.4 to 18.2
|
2.10 Titers
Interval 1.76 to 2.51
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-FHA Post-booster (N = 97, 98)
|
233 Titers
Interval 206.0 to 263.0
|
117 Titers
Interval 101.0 to 135.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-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 are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; 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=182 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP\~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=180 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203
|
|---|---|---|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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
|
65 Participants
|
124 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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
|
1 Participants
|
9 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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
|
71 Participants
|
90 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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 Erythema
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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
|
21 Participants
|
47 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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 Swelling
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Extensive swelling of vaccinated limb
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Pyrexia
|
39 Participants
|
46 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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
|
0 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Vomiting
|
16 Participants
|
15 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Crying
|
23 Participants
|
42 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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-vaccination
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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
|
22 Participants
|
41 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anorexia
|
24 Participants
|
39 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Irritability
|
38 Participants
|
71 Participants
|
|
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster 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
|
0 Participants
|
1 Participants
|
Adverse Events
Group 1: DTaP-Hep B-PRP~T + OPV
Serious events: 14 serious events
Other events: 101 other events
Deaths: 0 deaths
Group 2: Tritanrix-Hep B/ Hib™ + OPV
Serious events: 7 serious events
Other events: 142 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=182 participants at risk
Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=180 participants at risk
Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
|
|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.55%
1/182 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
6/182 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
1.7%
3/180 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
1.1%
2/180 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.56%
1/180 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Infections and infestations
Urinary tract infections
|
0.55%
1/182 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Nervous system disorders
Convulsion
|
0.55%
1/182 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Nervous system disorders
Febrile convulsion
|
1.6%
3/182 • Number of events 4 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
2/182 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.00%
0/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
0.56%
1/180 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
Other adverse events
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=182 participants at risk
Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=180 participants at risk
Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
8.8%
16/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
8.3%
15/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Injection site pain
|
35.7%
65/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
68.9%
124/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Injection site erythemia
|
39.0%
71/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
50.0%
90/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Injection site swelling
|
11.5%
21/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
26.1%
47/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
General disorders
Pyrexia
|
21.4%
39/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
25.6%
46/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.2%
24/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
21.7%
39/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Nervous system disorders
Somnolence
|
12.1%
22/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
22.8%
41/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
23.6%
43/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
23.9%
43/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Metabolism and nutrition disorders
Rhinitis
|
8.8%
16/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
8.9%
16/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Psychiatric disorders
Crying
|
12.6%
23/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
23.3%
42/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
|
Psychiatric disorders
Irritability
|
20.9%
38/182 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
39.4%
71/180 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
|
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