Trial Outcomes & Findings for Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants (NCT NCT00514709)
NCT ID: NCT00514709
Last Updated: 2016-08-02
Results Overview
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) 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; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1843 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and Day 28 post-booster vaccination
Results posted on
2016-08-02
Participant Flow
Participants were randomized and enrolled from 06 August 2007 to 29 July 2008 in 2 clinic centers in the Philippines.
A total of 1843 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 a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) 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 AL201 (NCT00348881).
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
|
|---|---|---|
|
Overall Study
STARTED
|
1230
|
613
|
|
Overall Study
COMPLETED
|
1230
|
613
|
|
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 in Filipino Infants
Baseline characteristics by cohort
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=1230 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) 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 AL201.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=613 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
|
Total
n=1843 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1230 Participants
n=5 Participants
|
613 Participants
n=7 Participants
|
1843 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
|
15.1 Months
STANDARD_DEVIATION 1.96 • n=5 Participants
|
15.1 Months
STANDARD_DEVIATION 1.95 • n=7 Participants
|
15.1 Months
STANDARD_DEVIATION 1.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
629 Participants
n=5 Participants
|
302 Participants
n=7 Participants
|
931 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
601 Participants
n=5 Participants
|
311 Participants
n=7 Participants
|
912 Participants
n=5 Participants
|
|
Region of Enrollment
Philippines
|
1230 Participants
n=5 Participants
|
613 Participants
n=7 Participants
|
1843 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-booster 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-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) 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; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.
Outcome measures
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=93 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) 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 AL201.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=105 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
|
|---|---|---|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-Hep B Pre-booster (N = 93, 103)
|
81 Participants
|
80 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-Hep B Post-booster (N = 93, 105)
|
91 Participants
|
103 Participants
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-PRP Pre-booster (N = 93, 105)
|
78 Participants
|
105 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-PRP Post-booster (N = 93, 105)
|
93 Participants
|
105 Participants
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-Diphtheria Pre-booster (N = 93, 105)
|
72 Participants
|
68 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-Diphtheria Post-booster (N = 93, 105)
|
93 Participants
|
103 Participants
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-Tetanus Pre-booster (N = 93, 105)
|
93 Participants
|
105 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-Tetanus Post-booster (N = 93, 105)
|
93 Participants
|
105 Participants
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-Pertussis 4-Fold increase (N = 89, 101)
|
85 Participants
|
100 Participants
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-Pertussis booster response (N = 89, 101)
|
87 Participants
|
101 Participants
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-FHA 4-Fold increase (N = 91, 103)
|
80 Participants
|
102 Participants
|
|
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Anti-FHA booster response (N = 91, 103)
|
89 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: GMTs were assessed in a sub-set of the 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-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.
Outcome measures
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=93 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) 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 AL201.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=105 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-Tetanus post-booster (N = 93, 105)
|
11.6 Titers
Interval 9.71 to 13.9
|
24.7 Titers
Interval 21.9 to 27.7
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-FHA Post-booster (N = 91,103)
|
204 Titers
Interval 179.0 to 233.0
|
158 Titers
Interval 135.0 to 185.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-Hep B Pre-booster (N = 93, 103)
|
71.6 Titers
Interval 51.1 to 100.0
|
42.2 Titers
Interval 30.5 to 58.5
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-Hep Bs Post-booster (N = 93, 105)
|
4224 Titers
Interval 2760.0 to 6464.0
|
3673 Titers
Interval 2441.0 to 5527.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-PRP Pre-booster (N = 93, 105)
|
0.889 Titers
Interval 0.602 to 1.31
|
5.32 Titers
Interval 4.13 to 6.84
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-PRP Post-booster (N = 93, 105)
|
58.1 Titers
Interval 40.4 to 83.4
|
242 Titers
Interval 195.0 to 299.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-Diphtheria Pre-booster (N = 93, 105)
|
0.016 Titers
Interval 0.013 to 0.021
|
0.014 Titers
Interval 0.011 to 0.018
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-Diphtheria Post-booster (N = 93, 105)
|
1.36 Titers
Interval 1.05 to 1.77
|
1.43 Titers
Interval 1.06 to 1.93
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-Tetanus pre-booster (N = 93, 105)
|
0.364 Titers
Interval 0.308 to 0.431
|
0.504 Titers
Interval 0.438 to 0.581
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-Pertusiss pre-booster (N = 89, 101)
|
7.34 Titers
Interval 6.22 to 8.64
|
6.82 Titers
Interval 5.3 to 8.76
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-Pertusiss post-booster (N = 93, 105)
|
128 Titers
Interval 107.0 to 153.0
|
185 Titers
Interval 149.0 to 229.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anti-FHA Pre-booster (N = 91,103)
|
14.0 Titers
Interval 11.3 to 17.3
|
2.21 Titers
Interval 1.83 to 2.67
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 after vaccinationPopulation: Safety was assessed on the safety analysis (intent-to-treat) population.
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal 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=1230 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) 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 AL201.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=613 Participants
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Injection site Swelling post-vaccination
|
211 Participants
|
120 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Vomiting post-vaccination
|
53 Participants
|
33 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Grade 3 Vomiting post-vaccination
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Grade 3 Crying post-vaccination
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Anorexia post-vaccination
|
97 Participants
|
53 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Injection site Pain post-vaccination
|
411 Participants
|
216 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Grade 3 Injection site Pain post-vaccination
|
10 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Injection site Erythema post-vaccination
|
272 Participants
|
136 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Grade 3 Injection site Erythema post-vaccination
|
7 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Grade 3 Injection site Swelling post-vaccination
|
7 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Extensive swelling of vaccinated limb
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Pyrexia post-vaccination
|
137 Participants
|
70 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Grade 3 Pyrexia post-vaccination
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Crying post-vaccination
|
98 Participants
|
58 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Somnolence post-vaccination
|
114 Participants
|
73 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Grade 3 Somnolence post-vaccination
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Grade 3 Anorexia post-vaccination
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Irritability post-vaccination
|
224 Participants
|
114 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Grade 3 Irritability post-vaccination
|
1 Participants
|
0 Participants
|
Adverse Events
Group 1: DTaP-Hep B-PRP~T + OPV
Serious events: 3 serious events
Other events: 411 other events
Deaths: 0 deaths
Group 2: Tritanrix-Hep B/ Hib™ + OPV
Serious events: 0 serious events
Other events: 216 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=1230 participants at risk
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) 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 AL201.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=613 participants at risk
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.16%
2/1230 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
0.00%
0/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Infections and infestations
Meningitis tuberculous
|
0.08%
1/1230 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
0.00%
0/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
Other adverse events
| Measure |
Group 1: DTaP-Hep B-PRP~T + OPV
n=1230 participants at risk
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) 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 AL201.
|
Group 2: Tritanrix-Hep B/ Hib™ + OPV
n=613 participants at risk
Participants received a booster dose of the DTaP-Hep B-PRP\~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
|
|---|---|---|
|
General disorders
Solicited injection site Pain
|
33.4%
411/1230 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
35.2%
216/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
General disorders
Solicited injection site Erythema
|
22.1%
272/1230 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
22.2%
136/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
General disorders
Solicited injection site Swelling
|
17.2%
211/1230 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
19.6%
120/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
General disorders
Pyrexia
|
11.1%
137/1230 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
11.4%
70/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
53/1230 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
5.4%
33/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Psychiatric disorders
Crying
|
8.0%
98/1230 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
9.5%
58/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.9%
97/1230 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
8.6%
53/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Nervous system disorders
Somnolence
|
9.3%
114/1230 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
11.9%
73/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
69/1230 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
6.2%
38/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
|
Psychiatric disorders
Irritability
|
18.2%
224/1230 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
|
18.6%
114/613 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 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