Trial Outcomes & Findings for Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants (NCT NCT00348881)

Last Updated: 2013-10-22

Results Overview

Seroprotection 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. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2133 participants

Primary outcome timeframe

1 month post third vaccination

Results posted on

2013-10-22

Participant Flow

Participants were enrolled and treated from 17 May 2006 to 26 September 2006 in 1 clinic center in the Philippines.

A total of 2133 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	Group 1: DTaP-Hep B-PRP~T + OPV Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.	Group 2: Tritanrix-Hep B/ Hib™ + OPV Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
Overall Study STARTED	1424	709
Overall Study COMPLETED	1407	697
Overall Study NOT COMPLETED	17	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: DTaP-Hep B-PRP~T + OPV Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.	Group 2: Tritanrix-Hep B/ Hib™ + OPV Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
Overall Study Lost to Follow-up	12	6
Overall Study Withdrawal by Subject	3	4
Overall Study Adverse Event	2	0
Overall Study Serious Adverse Event	0	2

Baseline Characteristics

Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: DTaP-Hep B-PRP~T + OPV n=1424 Participants Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.	Group 2: Tritanrix-Hep B/ Hib™ + OPV n=709 Participants Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.	Total n=2133 Participants Total of all reporting groups
Age, Categorical <=18 years	1424 Participants n=5 Participants	709 Participants n=7 Participants	2133 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	6.27 Weeks STANDARD_DEVIATION 0.280 • n=5 Participants	6.30 Weeks STANDARD_DEVIATION 0.310 • n=7 Participants	6.28 Weeks STANDARD_DEVIATION 0.291 • n=5 Participants
Sex: Female, Male Female	718 Participants n=5 Participants	356 Participants n=7 Participants	1074 Participants n=5 Participants
Sex: Female, Male Male	706 Participants n=5 Participants	353 Participants n=7 Participants	1059 Participants n=5 Participants
Region of Enrollment Philippines	1424 Participants n=5 Participants	709 Participants n=7 Participants	2133 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month post third vaccination

Population: Seroprotection was assessed in a subset of participants available for the endpoint, the per-protocol population.

Outcome measures

Outcome measures
Measure	Group 1: DTaP-Hep B-PRP~T + OPV n=246 Participants Participants received 3 doses of the DTaP-Hep B-PRP\~T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.	Group 2: Tritanrix-Hep B/ Hib™ + OPV n=123 Participants Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with OPV vaccines at 6, 10 and 14 weeks of age.
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anti-Hep Bs (N = 246, 122)	239 Participants	119 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anti-PRP (N = 218, 122)	210 Participants	121 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anti-Diphtheria (N = 246, 123)	217 Participants	109 Participants Interval 0.0 to 0.0
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anti-Tetanus (N = 246,123)	246 Participants	123 Participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Day 0 to Day 7 post-vaccination

Population: Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received and with the total number (N) available for the endpoint at each time-point.

Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.

Outcome measures

Outcome measures
Measure	Group 1: DTaP-Hep B-PRP~T + OPV n=1425 Participants Participants received 3 doses of the DTaP-Hep B-PRP\~T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.	Group 2: Tritanrix-Hep B/ Hib™ + OPV n=708 Participants Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with OPV vaccines at 6, 10 and 14 weeks of age.
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. Post-any Vaccination (N = 1419, 705)	5 Participants	8 Participants Interval 0.0 to 0.0
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. Post-vaccination 1 (N = 1419, 705)	3 Participants	1 Participants Interval 0.0 to 0.0
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. Post-vaccination 2 (N = 1408, 698)	1 Participants	3 Participants Interval 0.0 to 0.0
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. Post-vaccination 3 (N = 1405, 698)	1 Participants	4 Participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 1 month post third vaccination

Population: GMTs were assessed in a subset 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; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.

Outcome measures

Outcome measures
Measure	Group 1: DTaP-Hep B-PRP~T + OPV n=246 Participants Participants received 3 doses of the DTaP-Hep B-PRP\~T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.	Group 2: Tritanrix-Hep B/ Hib™ + OPV n=123 Participants Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with OPV vaccines at 6, 10 and 14 weeks of age.
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anti-Filamentous Hemagglutinin (N = 205, 94)	86.7 Titers Interval 80.0 to 93.9	9.17 Titers Interval 7.33 to 11.5
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anti-Hep Bs (N = 246, 122)	464 Titers Interval 380.0 to 567.0	343 Titers Interval 265.0 to 444.0
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anti-PRP (N = 218, 121)	3.02 Titers Interval 2.47 to 3.69	10.3 Titers Interval 8.3 to 12.8
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anti-Diphtheria (N = 246, 123)	0.025 Titers Interval 0.022 to 0.028	0.023 Titers Interval 0.019 to 0.028
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anti-Tetanus (N = 246, 123)	1.05 Titers Interval 0.958 to 1.14	1.31 Titers Interval 1.14 to 1.49
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anti-Pertusiss (N = 245, 108)	139 Titers Interval 127.0 to 152.0	81.5 Titers Interval 57.3 to 116.0

SECONDARY outcome

Timeframe: Day 0 to Day 7 after vaccination

Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (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 ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for \>3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.

Outcome measures

Outcome measures
Measure	Group 1: DTaP-Hep B-PRP~T + OPV n=1425 Participants Participants received 3 doses of the DTaP-Hep B-PRP\~T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.	Group 2: Tritanrix-Hep B/ Hib™ + OPV n=708 Participants Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with OPV vaccines at 6, 10 and 14 weeks of age.
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Somnolence post any vaccination	673 Participants	360 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Grade 3 Somnolence post any vaccination	43 Participants	35 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Somnolence post-vaccination 1	527 Participants	282 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Somnolence post-vaccination 2	368 Participants	216 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Somnolence post-vaccination 3	255 Participants	150 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anorexia post any vaccination	396 Participants	250 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Grade 3 Anorexia post any vaccination	10 Participants	8 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anorexia post-vaccination 1	235 Participants	159 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anorexia post-vaccination 2	201 Participants	118 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Anorexia post-vaccination 3	130 Participants	97 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Irritability post any vaccination	945 Participants	539 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Grade 3 Irritability post any vaccination	33 Participants	32 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Irritability post-vaccination 1	823 Participants	471 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Irritability post-vaccination 2	499 Participants	331 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Irritability post-vaccination 3	369 Participants	266 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Pain post any vaccination	1092 Participants	636 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Grade 3 Injection site Pain post any vaccination	344 Participants	295 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Pain Post-vaccination 1	958 Participants	573 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Pain Post-vaccination 2	751 Participants	463 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Pain Post-vaccination 3	616 Participants	407 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Erythema Post any vaccination	794 Participants	497 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Grade 3 Inject. site Erythema Post any vaccination	16 Participants	16 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Vomiting Post-vaccination 2	105 Participants	83 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Vomiting Post any vaccination	266 Participants	172 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Grade 3 Vomiting Post any vaccination	2 Participants	3 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Vomiting Post-vaccination 1	193 Participants	118 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Erythema Post-vaccination 1	543 Participants	353 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Erythema Post-vaccination 2	448 Participants	320 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Erythema Post-vaccination 3	408 Participants	283 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Swelling Post any vaccination	719 Participants	503 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Grade 3 Inject. site Swelling Post any vaccination	15 Participants	35 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Swelling Post-vaccination 1	576 Participants	423 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Swelling Post-vaccination 2	438 Participants	343 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Injection site Swelling Post-vaccination 3	365 Participants	288 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Fever Post any vaccination	523 Participants	394 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Grade 3 Fever Post any vaccination	5 Participants	8 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Fever Post-vaccination 1	282 Participants	248 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Fever Post-vaccination 2	222 Participants	165 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Fever Post-vaccination 3	187 Participants	156 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Vomiting Post-vaccination 3	72 Participants	52 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Crying post any vaccination	567 Participants	381 Participants Interval 0.0 to 0.0
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Grade 3 Crying post any vaccination	5 Participants	0 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Crying post-vaccination 1	431 Participants	301 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Crying post-vaccination 2	275 Participants	193 Participants
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV Crying post-vaccination 3	205 Participants	152 Participants

Adverse Events

Group 1: DTaP-Hep B-PRP~T + OPV

Serious events: 31 serious events

Other events: 1092 other events

Deaths: 0 deaths

Group 2: Tritanrix-Hep B/ Hib™ + OPV

Serious events: 12 serious events

Other events: 636 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: DTaP-Hep B-PRP~T + OPV n=1425 participants at risk Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.	Group 2: Tritanrix-Hep B/ Hib™ + OPV n=708 participants at risk Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
General disorders Solicited injection site Pain	67.2% 958/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	80.9% 573/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
General disorders Solicited injection site Erythema	38.1% 543/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	49.9% 353/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
General disorders Solicited injection site Swelling	40.4% 576/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	59.7% 423/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
General disorders Pyrexia	19.8% 282/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	35.0% 248/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Gastrointestinal disorders Vomiting	13.5% 193/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	16.7% 118/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Psychiatric disorders Crying	30.2% 431/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	42.5% 301/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Metabolism and nutrition disorders Anorexia	16.5% 235/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	22.5% 159/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Nervous system disorders Somnolence	37.0% 527/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	39.8% 282/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Upper respiratory tract infection	33.8% 481/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	29.7% 210/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Psychiatric disorders Irritability	57.8% 823/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	66.5% 471/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Rhinitis	6.5% 93/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	6.2% 44/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

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

Measure	Group 1: DTaP-Hep B-PRP~T + OPV n=1425 participants at risk Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.	Group 2: Tritanrix-Hep B/ Hib™ + OPV n=708 participants at risk Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
General disorders Pyrexia	0.07% 1/1425 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Blood and lymphatic system disorders Idiopathic thrombocytopenia purpura	0.07% 1/1425 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Cardiac disorders Cardiac disorder	0.07% 1/1425 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Amoebic dysentery	0.14% 2/1425 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Bronchitis	0.14% 2/1425 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Bronchopneumonia	0.07% 1/1425 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.28% 2/708 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Diarrhoea infectious	0.07% 1/1425 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Gastroenteritis	0.63% 9/1425 • Number of events 9 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.42% 3/708 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Meningitis	0.07% 1/1425 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Pneumonia	0.91% 13/1425 • Number of events 13 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.71% 5/708 • Number of events 5 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Pneumonia primary atypical	0.07% 1/1425 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Sepsis	0.07% 1/1425 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Sepsis neonatal	0.00% 0/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.14% 1/708 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Infections and infestations Urinary tract infection	0.07% 1/1425 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Injury, poisoning and procedural complications Thermal burn	0.07% 1/1425 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.00% 0/708 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Nervous system disorders Convlusion	0.00% 0/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.14% 1/708 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Nervous system disorders Febrile convulsion	0.00% 0/1425 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.	0.14% 1/708 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.