Trial Outcomes & Findings for Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants (NCT NCT00401531)
NCT ID: NCT00401531
Last Updated: 2014-04-01
Results Overview
Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
412 participants
Primary outcome timeframe
Day 150 post-dose 1
Results posted on
2014-04-01
Participant Flow
Participants were enrolled from 22 October 2006 to 19 November 2007 in 4 clinical centers in Thailand.
A total of 412 participants who met all the inclusion, but none of the exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
206
|
|
Overall Study
COMPLETED
|
197
|
196
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Protocol Violation
|
3
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
Baseline characteristics by cohort
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
n=206 Participants
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
n=206 Participants
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Total
n=412 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
206 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
412 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
Age Continuous
|
1.88 Months
STANDARD_DEVIATION 0.170 • n=5 Participants
|
1.90 Months
STANDARD_DEVIATION 0.187 • n=7 Participants
|
1.89 Months
STANDARD_DEVIATION 0.179 • n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
206 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 150 post-dose 1Population: Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.
Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
n=189 Participants
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
n=190 Participants
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
|---|---|---|
|
Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Hepatitis B (N = 188, 190)
|
187 Participants
|
189 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-PRP (N = 189, 190)
|
183 Participants
|
183 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 150 post-dose 1Population: Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria valuation, per-protocol population.
Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
n=189 Participants
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
n=190 Participants
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
|---|---|---|
|
Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Diphtheria
|
184 Participants
|
190 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Tetanus
|
189 Participants
|
190 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 150 post-dose 1Population: Seroprotection was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.
Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
n=187 Participants
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
n=186 Participants
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
|---|---|---|
|
Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti Polio Type 1
|
187 Participants
|
186 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti Polio Type 2
|
187 Participants
|
186 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti Polio Type 3
|
187 Participants
|
185 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 150 post-dose 1Population: Seroconversion was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation per-protocol population.
Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
n=189 Participants
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
n=190 Participants
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
|---|---|---|
|
Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-pertussis toxoid (N = 189, 189)
|
177 Participants
|
177 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Filamentous hemagglutinin (N = 187, 188)
|
177 Participants
|
179 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 150 post-dose 1Population: Antibody titers were assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, the per-protocol population.
Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
n=189 Participants
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
n=190 Participants
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Hepatitis B (N = 188, 190)
|
2477 Titers
Interval 2044.0 to 3002.0
|
2442 Titers
Interval 2096.0 to 2844.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-PRP (N = 189, 190)
|
5.07 Titers
Interval 4.05 to 6.33
|
2.41 Titers
Interval 1.95 to 2.98
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Diphtheria (N = 189, 190)
|
0.297 Titers
Interval 0.241 to 0.367
|
0.209 Titers
Interval 0.177 to 0.247
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Tetanus (N = 189, 190)
|
1.38 Titers
Interval 1.25 to 1.52
|
1.83 Titers
Interval 1.69 to 1.97
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Polio Type 1 (N = 187, 186)
|
765 Titers
Interval 649.0 to 902.0
|
1566 Titers
Interval 1326.0 to 1850.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Polio Type 2 (N = 187, 186)
|
1489 Titers
Interval 1259.0 to 1761.0
|
2277 Titers
Interval 1905.0 to 2723.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Polio Type 3 (N = 187, 186)
|
837 Titers
Interval 695.0 to 1007.0
|
2029 Titers
Interval 1646.0 to 2502.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Pertussis toxoid (N = 189, 189)
|
168 Titers
Interval 154.0 to 183.0
|
200 Titers
Interval 185.0 to 216.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anti-Filamentous hemagglutinin (N = 188, 188)
|
148 Titers
Interval 136.0 to 162.0
|
123 Titers
Interval 113.0 to 132.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited reactions were assessed in all participants that were enrolled and vaccinated, intent-to-treat population.
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3: Pyrexia, \>39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
n=206 Participants
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
n=206 Participants
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Pain Post-dose 1
|
161 Participants
|
135 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Pain Post-dose 2
|
136 Participants
|
118 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Pain Post-dose 3
|
119 Participants
|
112 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Pain Post-any dose
|
180 Participants
|
166 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Grade 3 Pain Post-any dose
|
20 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Erythema Post-dose 1
|
79 Participants
|
64 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Erythema Post-dose 2
|
93 Participants
|
91 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Erythema Post-dose 3
|
86 Participants
|
79 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Erythema Post-any dose
|
121 Participants
|
114 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Grade 3 Erythema Post-any dose
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Swelling Post-dose 1
|
59 Participants
|
34 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Swelling Post-dose 2
|
52 Participants
|
44 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Swelling Post-dose 3
|
34 Participants
|
32 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Swelling Post-any dose
|
85 Participants
|
65 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Grade 3 Swelling Post-any dose
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Pyrexia Post-dose 1
|
109 Participants
|
68 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Pyrexia Post-dose 2
|
84 Participants
|
79 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Pyrexia Post-dose 3
|
81 Participants
|
81 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Pyrexia Post-any dose
|
152 Participants
|
131 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Grade 3 Pyrexia Post-any dose
|
6 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Vomiting Post Dose 1
|
47 Participants
|
56 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Vomiting Post-dose 2
|
28 Participants
|
32 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Vomiting Post-dose 3
|
22 Participants
|
28 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Vomiting Post-any dose
|
77 Participants
|
82 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Grade 3 Vomiting Post-any dose
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Crying Post-dose 1
|
128 Participants
|
106 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Crying Post-dose 2
|
106 Participants
|
104 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Crying Post-dose 3
|
77 Participants
|
75 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Crying Post-any dose
|
167 Participants
|
153 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Grade 3 Crying Post-any dose
|
7 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Somnolence Post-dose 1
|
109 Participants
|
104 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Somnolence Post-dose 2
|
91 Participants
|
79 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Somnolence Post-dose 3
|
55 Participants
|
59 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Somnolence Post-any dose
|
141 Participants
|
125 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Grade 3 Somnolence post-any dose
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anorexia Post-dose 1
|
59 Participants
|
49 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anorexia Post-dose 2
|
44 Participants
|
40 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anorexia Post-dose 3
|
36 Participants
|
37 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Anorexia Post-any dose
|
91 Participants
|
83 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Grade 3 Anorexia Post-any dose
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Irritability Post-dose 1
|
134 Participants
|
122 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Irritability Post-dose 2
|
107 Participants
|
109 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Irritability Post-dose 3
|
90 Participants
|
88 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Irritability Post-any dose
|
162 Participants
|
159 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Grade 3 Irritability Post-any dose
|
4 Participants
|
6 Participants
|
Adverse Events
DTaP-IPV-Hep B-PRP-T + Prevnar™
Serious events: 6 serious events
Other events: 161 other events
Deaths: 0 deaths
Infanrix Hexa™ + Prevnar™
Serious events: 8 serious events
Other events: 135 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
n=206 participants at risk
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
n=206 participants at risk
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Gastrointestinal disorders
Intussusception
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Infections and infestations
Bronchiolitis
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Infections and infestations
Eczema Herpeticum
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
1.5%
3/206 • Number of events 3 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Infections and infestations
Pneumonia
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Infections and infestations
Pneumonia Viral
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Infections and infestations
Urethritis
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Infections and infestations
Urinary Tract Infection
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Angioneurotic Oedema
|
0.49%
1/206 • Number of events 1 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
0.00%
0/206 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
Other adverse events
| Measure |
DTaP-IPV-Hep B-PRP-T + Prevnar™
n=206 participants at risk
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
Infanrix Hexa™ + Prevnar™
n=206 participants at risk
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
7/206 • Number of events 7 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
6.3%
13/206 • Number of events 13 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
22.9%
47/205 • Number of events 47 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
27.2%
56/206 • Number of events 56 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
General disorders
Injection Site Pain
|
78.5%
161/205 • Number of events 161 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
65.5%
135/206 • Number of events 135 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
General disorders
Injection Erythema
|
45.1%
93/206 • Number of events 93 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
44.2%
91/206 • Number of events 91 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
General disorders
Injection Swelling
|
28.6%
59/206 • Number of events 59 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
21.4%
44/206 • Number of events 44 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
General disorders
Irritability
|
65.4%
134/205 • Number of events 134 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
59.2%
122/206 • Number of events 122 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
General disorders
Pyrexia
|
53.2%
109/205 • Number of events 109 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
33.0%
68/206 • Number of events 68 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
31/206 • Number of events 31 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
17.0%
35/206 • Number of events 35 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
21.8%
45/206 • Number of events 45 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
22.3%
46/206 • Number of events 46 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.8%
59/205 • Number of events 59 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
23.8%
49/206 • Number of events 49 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Nervous system disorders
Somnolence
|
53.2%
109/205 • Number of events 109 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
50.5%
104/206 • Number of events 104 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
|
Psychiatric disorders
Crying
|
62.1%
128/206 • Number of events 128 • Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
|
51.5%
106/206 • Number of events 106 • Adverse event data were collected following vaccination (Day 0) up to 10 months 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