Trial Outcomes & Findings for Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants (NCT NCT00831753)
NCT ID: NCT00831753
Last Updated: 2016-05-13
Results Overview
Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
263 participants
Primary outcome timeframe
Day 150 (1 month after dose 3)
Results posted on
2016-05-13
Participant Flow
Participants were enrolled from 23 May 2008 to 18 July 2008 at 1 clinical center in Peru.
A total of 263 participants who met the inclusion and exclusion criteria were randomized and vaccinated in the study.
Participant milestones
| Measure |
DTaP-IPV-Hep B-PRP~T Group
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
|
Infanrix Hexa™ Group
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
131
|
|
Overall Study
COMPLETED
|
132
|
131
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants
Baseline characteristics by cohort
| Measure |
DTaP-IPV-Hep B-PRP~T Group
n=132 Participants
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
|
Infanrix Hexa™ Group
n=131 Participants
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
132 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
263 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
1.75 Months
STANDARD_DEVIATION 0.132 • n=99 Participants
|
1.72 Months
STANDARD_DEVIATION 0.123 • n=107 Participants
|
1.74 Months
STANDARD_DEVIATION 0.128 • n=206 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
|
Region of Enrollment
Peru
|
132 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
263 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 150 (1 month after dose 3)Population: Seroprotection against Hep B was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T Group
n=132 Participants
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
|
Infanrix Hexa™ Group
n=130 Participants
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
|
|---|---|---|
|
Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™
|
131 Participants
|
130 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 150 (1 month after dose 3)Population: Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as: Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL. Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T Group
n=132 Participants
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
|
Infanrix Hexa™ Group
n=130 Participants
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
|
|---|---|---|
|
Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anti-Hep B (Criteria 1)
|
131 Participants
|
130 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anti-Hep B (Criteria 2)
|
124 Participants
|
129 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anti-PRP (Criteria 1)
|
132 Participants
|
129 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anti-PRP (Criteria 2)
|
112 Participants
|
109 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anti-Diphtheria (Criteria 1)
|
126 Participants
|
130 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anti-Diphtheria (Criteria 2)
|
77 Participants
|
85 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 150 (1 month after dose 3)Population: Antibody GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T Group
n=132 Participants
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
|
Infanrix Hexa™ Group
n=130 Participants
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anti Hep B
|
986 Titers (1/dilutions)
Interval 764.0 to 1270.0
|
1139 Titers (1/dilutions)
Interval 961.0 to 1350.0
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anti Diphtheria
|
0.156 Titers (1/dilutions)
Interval 0.119 to 0.204
|
0.192 Titers (1/dilutions)
Interval 0.154 to 0.239
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anti PRP
|
5.22 Titers (1/dilutions)
Interval 4.04 to 6.73
|
3.93 Titers (1/dilutions)
Interval 3.17 to 4.89
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 after each injectionPopulation: Solicited reactions were assessed in all participants who received at least one dose of investigational or control vaccine, according to the vaccine actually received (Safety Analysis Population).
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia \> 39.5ºC; Vomiting ≥ 6 episodes per 24 hour 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; Irritability inconsolable.
Outcome measures
| Measure |
DTaP-IPV-Hep B-PRP~T Group
n=132 Participants
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
|
Infanrix Hexa™ Group
n=131 Participants
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Pyrexia Post Injection 3
|
18 Participants
|
18 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Gade 3 Pyrexia Post Any Injection
|
0 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Any Vomiting Post Injection 1
|
20 Participants
|
24 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Crying Post Injection 2
|
57 Participants
|
52 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Grade 3 Crying Post Any Injection
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Somnolence Post Injection 1
|
55 Participants
|
65 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Somnolence Post Injection 2
|
41 Participants
|
37 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Any Anorexia Post Injection 1
|
35 Participants
|
42 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anorexia Post Injection 2
|
24 Participants
|
22 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Anorexia Post Injection 3
|
24 Participants
|
25 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Pain Post Injection 3
|
53 Participants
|
55 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Swelling Post Injection 3
|
28 Participants
|
32 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Any Vomiting Post Injection 2
|
8 Participants
|
6 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Pyrexia Post Injection 2
|
21 Participants
|
17 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Vomiting Post Injection 3
|
6 Participants
|
10 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Grade 3 Vomiting Post Any Injection
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Crying Post Injection 1
|
81 Participants
|
68 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Grade 3 Irritability Post Any Injection
|
2 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Pain Post Injection 1
|
82 Participants
|
71 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Pain Post Injection 2
|
68 Participants
|
68 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Grade 3 Pain Post Any Injection
|
10 Participants
|
6 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Erythema Post Injection 1
|
32 Participants
|
16 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Erythema Post Injection 2
|
48 Participants
|
30 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
ErythemaPost Injection 3
|
45 Participants
|
46 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Grade 3 Erythema Post Any Injection
|
3 Participants
|
5 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Swelling Post Injection 1
|
34 Participants
|
12 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Swelling Post Injection 2
|
26 Participants
|
24 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Grade 3 Swelling Post Any Injection
|
3 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Pyrexia Post Injection 1
|
11 Participants
|
11 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Crying Post Injection 3
|
43 Participants
|
47 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Somnolence Post Injection 3
|
23 Participants
|
28 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Grade 3 Somnolence Post Any Injection
|
2 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Grade 3 Anorexia Post Any Injection
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Irritability Post Injection 1
|
85 Participants
|
81 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Irritability Post Injection 2
|
63 Participants
|
65 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Irritability Post Injection 3
|
40 Participants
|
55 Participants
Interval 0.0 to 0.0
|
Adverse Events
DTaP-IPV-Hep B-PRP~T Group
Serious events: 3 serious events
Other events: 102 other events
Deaths: 0 deaths
Infanrix Hexa™ Group
Serious events: 2 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DTaP-IPV-Hep B-PRP~T Group
n=132 participants at risk
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
|
Infanrix Hexa™ Group
n=131 participants at risk
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatic Cyst
|
0.00%
0/132 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
0.76%
1/131 • Number of events 1 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Infections and infestations
Cellulitis
|
0.76%
1/132 • Number of events 1 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
0.00%
0/131 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Infections and infestations
Pneumonia Viral
|
0.76%
1/132 • Number of events 1 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
0.00%
0/131 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.76%
1/132 • Number of events 1 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
0.76%
1/131 • Number of events 1 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
Other adverse events
| Measure |
DTaP-IPV-Hep B-PRP~T Group
n=132 participants at risk
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
|
Infanrix Hexa™ Group
n=131 participants at risk
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
28.8%
38/132 • Number of events 61 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
33.6%
44/131 • Number of events 65 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Gastrointestinal disorders
Diarrhea
|
12.9%
17/132 • Number of events 19 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
13.7%
18/131 • Number of events 21 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Gastrointestinal disorders
Vomiting
|
22.0%
29/132 • Number of events 29 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
24.4%
32/131 • Number of events 32 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
General disorders
Injection Site Hemorrhage
|
6.1%
8/132 • Number of events 9 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
3.1%
4/131 • Number of events 4 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
General disorders
Injection Site Pain
|
77.3%
102/132 • Number of events 102 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
77.1%
101/131 • Number of events 101 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
General disorders
Injection Site Erythema
|
59.1%
78/132 • Number of events 78 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
50.4%
66/131 • Number of events 66 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
General disorders
Injection Site Swelling
|
40.9%
54/132 • Number of events 54 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
39.7%
52/131 • Number of events 52 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
General disorders
Irritability
|
75.8%
100/132 • Number of events 100 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
74.8%
98/131 • Number of events 98 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
General disorders
Pyrexia
|
8.3%
11/132 • Number of events 13 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
5.3%
7/131 • Number of events 7 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Infections and infestations
Nasopharyngitis
|
47.0%
62/132 • Number of events 78 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
61.1%
80/131 • Number of events 118 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Infections and infestations
Pharyngitis
|
8.3%
11/132 • Number of events 11 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
11.5%
15/131 • Number of events 15 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Infections and infestations
Anorexia
|
40.9%
54/132 • Number of events 54 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
44.3%
58/131 • Number of events 58 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Nervous system disorders
Somnolence
|
55.3%
73/132 • Number of events 73 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
62.6%
82/131 • Number of events 82 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Psychiatric disorders
Crying
|
75.8%
100/132 • Number of events 100 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
71.0%
93/131 • Number of events 93 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
9.8%
13/132 • Number of events 14 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
9.2%
12/131 • Number of events 14 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.6%
14/132 • Number of events 16 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
13.7%
18/131 • Number of events 24 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.8%
9/132 • Number of events 9 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
4.6%
6/131 • Number of events 6 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
10.6%
14/132 • Number of events 15 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
7.6%
10/131 • Number of events 10 • Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
|
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