Trial Outcomes & Findings for Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants (NCT NCT00619502)

NCT ID: NCT00619502

Last Updated: 2016-05-13

Results Overview

Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

254 participants

Primary outcome timeframe

Day 0 before and Day 30 Post-booster vaccination

Results posted on

2016-05-13

Participant Flow

Participants were enrolled from 14 December 2007 to 07 January 2008 at 1 clinical center in Turkey.

A total of 254 participants who met all inclusion, but no exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	DTaP-IPV-HepB-PRP~T All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study.	Pentaxim™ + Engerix B™ All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study.
Overall Study STARTED	130	124
Overall Study COMPLETED	122	114
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	DTaP-IPV-HepB-PRP~T All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study.	Pentaxim™ + Engerix B™ All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study.
Overall Study Lost to Follow-up	8	10

Baseline Characteristics

Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTaP-IPV-HepB-PRP~T n=130 Participants All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study.	Pentaxim™ + Engerix B™ n=124 Participants All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study.	Total n=254 Participants Total of all reporting groups
Age, Categorical <=18 years	130 Participants n=93 Participants	124 Participants n=4 Participants	254 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	17.6 Months STANDARD_DEVIATION 0.198 • n=93 Participants	17.6 Months STANDARD_DEVIATION 0.279 • n=4 Participants	17.6 Months STANDARD_DEVIATION 0.241 • n=27 Participants
Sex: Female, Male Female	56 Participants n=93 Participants	54 Participants n=4 Participants	110 Participants n=27 Participants
Sex: Female, Male Male	74 Participants n=93 Participants	70 Participants n=4 Participants	144 Participants n=27 Participants
Region of Enrollment Turkey	130 Participants n=93 Participants	124 Participants n=4 Participants	254 Participants n=27 Participants

PRIMARY outcome

Timeframe: Day 0 before and Day 30 Post-booster vaccination

Population: Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation.

Outcome measures

Outcome measures
Measure	DTaP-IPV-HepB-PRP~T n=114 Participants All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study.	Pentaxim™ + Engerix B™ n=103 Participants All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study.
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Tetanus Post-booster (N = 109, 96)	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Polio 1 Pre-booster (N = 88, 86)	99 Percentage of Participants	99 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Polio 1 Post-booster (N = 105, 87)	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Polio 2 Post-booster (N = 101, 83)	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Polio 3 Pre-booster (N = 88,86)	85 Percentage of Participants	97 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-PT Post-booster (N = 86, 79)	97 Percentage of Participants	96 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-FHA Post-booster (N = 73,77)	92 Percentage of Participants	97 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Polio 2 Pre-booster (N = 84, 87)	100 Percentage of Participants	98 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Polio 3 Post-booster (N = 102, 84)	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Hep B Pre-booster (N = 109, 103)	81 Percentage of Participants	99 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Hep B Post-booster (N = 111, 103)	97 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-PRP Pre-booster (N = 113,102)	85 Percentage of Participants	83 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-PRP Post-booster (N = 114, 103)	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Diphtheria Pre-booster (N = 104, 94)	90 Percentage of Participants	88 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Diphtheria Post-booster (N = 112, 98)	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ Anti-Tetanus Pre-booster (N = 97, 90)	100 Percentage of Participants	100 Percentage of Participants

PRIMARY outcome

Timeframe: Day 0 before and Day 30 post-booster vaccination

Population: GMTs were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per Protocol Population).

Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).

Outcome measures

Outcome measures
Measure	DTaP-IPV-HepB-PRP~T n=114 Participants All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study.	Pentaxim™ + Engerix B™ n=103 Participants All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study.
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Hep B Pre-booster (N = 109, 103)	44.2 Titers Interval 32.3 to 60.7	223 Titers Interval 176.0 to 282.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-PRP Pre-booster (N = 113, 102)	0.724 Titers Interval 0.541 to 0.968	0.612 Titers Interval 0.443 to 0.844
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-PRP Post-booster (N = 114, 103)	72.5 Titers Interval 55.8 to 94.3	86.9 Titers Interval 69.8 to 108.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Diphtheria Pre-booster (N = 104, 94)	0.028 Titers Interval 0.022 to 0.035	0.032 Titers Interval 0.024 to 0.041
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Diphtheria Post-booster (N = 112, 98)	5.09 Titers Interval 3.89 to 6.66	10.2 Titers Interval 7.59 to 13.8
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Polio 1 Pre-booster (N= 88, 86)	110 Titers Interval 81.6 to 148.0	114 Titers Interval 82.4 to 157.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Polio 2 Pre-booster (N = 84, 87)	114 Titers Interval 84.9 to 153.0	131 Titers Interval 95.3 to 179.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-FHA Post-booster (N = 111, 97)	222 Titers Interval 194.0 to 254.0	234 Titers Interval 201.0 to 272.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Hep B Post-booster (N = 111, 103)	1379 Titers Interval 916.0 to 2078.0	26189 Titers Interval 19133.0 to 35846.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Tetanus Pre-booster (N = 97, 90)	0.244 Titers Interval 0.204 to 0.292	0.194 Titers Interval 0.158 to 0.238
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Tetanus Post-booster (N = 109, 96)	8.98 Titers Interval 7.52 to 10.7	13.1 Titers Interval 10.8 to 15.8
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Polio 1 Post-booster (N = 105, 87)	5477 Titers Interval 4401.0 to 6814.0	9050 Titers Interval 7134.0 to 11480.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Polio 2 Post-booster (N = 101, 83)	6099 Titers Interval 4916.0 to 7566.0	9170 Titers Interval 7170.0 to 11727.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Polio 3 Pre-booster (N = 88, 86)	47.1 Titers Interval 33.1 to 67.1	101 Titers Interval 73.0 to 141.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-Polio 3 Post-booster (N = 102, 84)	5542 Titers Interval 4156.0 to 7392.0	10152 Titers Interval 7806.0 to 13205.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-PT Pre-booster (N = 86, 87)	6.08 Titers Interval 4.74 to 7.79	7.49 Titers Interval 5.97 to 9.41
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-PT Post-booster (N = 113, 95)	160 Titers Interval 137.0 to 187.0	237 Titers Interval 202.0 to 278.0
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anti-FHA Pre-booster (N = 74, 81)	12.5 Titers Interval 9.59 to 16.4	8.18 Titers Interval 6.49 to 10.3

PRIMARY outcome

Timeframe: Day 0 up to Day 7 post-booster vaccination

Population: Solicited reactions were assessed in all participants who received a booster dose of DTaP-IPV-Hep B-PRP\~T according to the primary series received (Safety Analysis Population).

Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying \> 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable.

Outcome measures

Outcome measures
Measure	DTaP-IPV-HepB-PRP~T n=121 Participants All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study.	Pentaxim™ + Engerix B™ n=111 Participants All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study.
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Grade 3 Anorexia	9 Participants	8 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Pain	56 Participants	67 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Grade 3 Pain	4 Participants	2 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Erythema	35 Participants	50 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Grade 3 Erythema	3 Participants	4 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Swelling	26 Participants	36 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Grade 3 Swelling	2 Participants	3 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Extensive Swelling of Vaccinated Limb	0 Participants	0 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Pyrexia	29 Participants	36 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Grade 3 Pyrexia	1 Participants	0 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vomiting	13 Participants	11 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Grade 3 Vomiting	2 Participants	2 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Crying	29 Participants	35 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Grade 3 Crying	3 Participants	4 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Somnolence	24 Participants	25 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Grade 3 Somnolence	2 Participants	3 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Anorexia	40 Participants	43 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Irritability	51 Participants	61 Participants
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Grade 3 Irritability	5 Participants	7 Participants

Adverse Events

DTaP-IPV-HepB-PRP~T

Serious events: 4 serious events

Other events: 56 other events

Deaths: 0 deaths

Pentaxim™ + Engerix B™

Serious events: 2 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DTaP-IPV-HepB-PRP~T n=130 participants at risk All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study.	Pentaxim™ + Engerix B™ n=124 participants at risk All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study.
Gastrointestinal disorders Gastroesophageal reflux disease	0.77% 1/130 • Number of events 1 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	0.00% 0/124 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
Infections and infestations Bronchitis	0.77% 1/130 • Number of events 1 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	0.00% 0/124 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
Infections and infestations Gastroenteritis	0.77% 1/130 • Number of events 1 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	0.81% 1/124 • Number of events 1 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/130 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	0.81% 1/124 • Number of events 1 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
Injury, poisoning and procedural complications Poisoning	0.77% 1/130 • Number of events 1 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	0.00% 0/124 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.

Other adverse events

Other adverse events
Measure	DTaP-IPV-HepB-PRP~T n=130 participants at risk All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study.	Pentaxim™ + Engerix B™ n=124 participants at risk All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study.
Gastrointestinal disorders Vomiting	10.0% 13/130 • Number of events 13 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	8.9% 11/124 • Number of events 11 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
General disorders Injection site erythema	26.9% 35/130 • Number of events 35 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	40.3% 50/124 • Number of events 50 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
General disorders Injection site pain	43.1% 56/130 • Number of events 56 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	54.0% 67/124 • Number of events 67 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
General disorders Injection site swelling	20.0% 26/130 • Number of events 26 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	29.0% 36/124 • Number of events 36 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
General disorders Irritability	39.2% 51/130 • Number of events 51 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	49.2% 61/124 • Number of events 61 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
General disorders Pyrexia	22.3% 29/130 • Number of events 29 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	29.0% 36/124 • Number of events 36 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
Metabolism and nutrition disorders Anorexia	30.8% 40/130 • Number of events 40 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	34.7% 43/124 • Number of events 43 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
Nervous system disorders Somnolence	18.5% 24/130 • Number of events 24 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	20.2% 25/124 • Number of events 25 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.
Psychiatric disorders Crying	22.3% 29/130 • Number of events 29 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.	28.2% 35/124 • Number of events 35 • Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.

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