Trial Outcomes & Findings for Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL® (NCT NCT00258895)

NCT ID: NCT00258895

Last Updated: 2016-04-14

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

649 participants

Primary outcome timeframe

0 to 7 days Post-Dose 5

Results posted on

2016-04-14

Participant Flow

Participants were enrolled from 30 March 2005 to 02 March 2006 at 22 US sites.

A total of 649 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	DAPTACEL®-Primed Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.	Pentacel®-Primed Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Overall Study STARTED	487	162
Overall Study COMPLETED	477	159
Overall Study NOT COMPLETED	10	3

Reasons for withdrawal

Reasons for withdrawal
Measure	DAPTACEL®-Primed Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.	Pentacel®-Primed Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Overall Study Lost to Follow-up	3	1
Overall Study Protocol Violation	6	2
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DAPTACEL®-Primed n=487 Participants Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.	Pentacel®-Primed n=162 Participants Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.	Total n=649 Participants Total of all reporting groups
Age, Categorical <=18 years	487 Participants n=5 Participants	162 Participants n=7 Participants	649 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	4.1 Years STANDARD_DEVIATION 0.14 • n=5 Participants	4.1 Years STANDARD_DEVIATION 0.16 • n=7 Participants	4.1 Years STANDARD_DEVIATION 0.14 • n=5 Participants
Sex: Female, Male Female	244 Participants n=5 Participants	83 Participants n=7 Participants	327 Participants n=5 Participants
Sex: Female, Male Male	243 Participants n=5 Participants	79 Participants n=7 Participants	322 Participants n=5 Participants
Region of Enrollment United States	487 participants n=5 Participants	162 participants n=7 Participants	649 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 7 days Post-Dose 5

Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.

Outcome measures

Outcome measures
Measure	DAPTACEL®-Primed n=485 Participants Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.	Pentacel®-Primed n=162 Participants Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Solicited Local Reaction - Dose 5	75 Percentage of Participants	70 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Redness (> 5 mm)	36 Percentage of Participants	24 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Redness (> 50 mm)	16 Percentage of Participants	9 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Swelling (> 5 mm)	24 Percentage of Participants	14 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Swelling (> 50 mm)	8 Percentage of Participants	1 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Tenderness	62 Percentage of Participants	55 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Tenderness (Incapacitating)	2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Change in Limb Circumference (> 5 mm)	39 Percentage of Participants	32 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Change in Limb Circumference (> 40 mm)	2 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Functional Impairment	20 Percentage of Participants	12 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Functional Impairment (Incapacitating)	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Solicited Systemic Reaction - Dose 5	55 Percentage of Participants	45 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Fever (≥ 38.0 ºC)	8 Percentage of Participants	6 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Fever (> 39.5 ºC)	0 Percentage of Participants	1 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Irritability	36 Percentage of Participants	28 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Irritability (Incapacitating)	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Crying	15 Percentage of Participants	11 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Crying (Incapacitating)	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Lethargy	22 Percentage of Participants	17 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Lethargy (Incapacitating)	1 Percentage of Participants	1 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Anorexia	16 Percentage of Participants	14 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Anorexia (skipped 2 meals)	1 Percentage of Participants	1 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Vomiting (per 24 hours)	4 Percentage of Participants	4 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Vomiting (≥ 3 episodes)	1 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Diarrhea (per 24 hours)	8 Percentage of Participants	6 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Grade 3 Diarrhea (> 5 diarrhea stools)	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination Any Rash	10 Percentage of Participants	5 Percentage of Participants

PRIMARY outcome

Timeframe: Day 28 to 48 Post-dose 5

Population: The anti-Pertussis 4-fold rises were evaluated in the per-protocol immunology population.

Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.

Outcome measures

Outcome measures
Measure	DAPTACEL®-Primed n=251 Participants Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.	Pentacel®-Primed n=80 Participants Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination Anti-Pertussis (EU/mL)	92 Percentage of Participants	98 Percentage of Participants
Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination Anti-Filamentous Haemagglutinin (EU/mL)	89 Percentage of Participants	89 Percentage of Participants
Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination Anti-Fimbriae Types 2 and 3 (EU/mL)	90 Percentage of Participants	96 Percentage of Participants
Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination Anti-Pertactin (EU/mL)	94 Percentage of Participants	95 Percentage of Participants

PRIMARY outcome

Timeframe: Day 28 to 48 Post-Dose 5

Population: The anti-pertussis booster response was assessed in the per-protocol immunogenicity population.

Booster response calculation: If pre-Dose 5 titer \< 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.

Outcome measures

Outcome measures
Measure	DAPTACEL®-Primed n=251 Participants Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.	Pentacel®-Primed n=80 Participants Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination Anti-Pertussis (EU/mL)	96 Percentage of Participants	99 Percentage of Participants
Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination Anti-Fillamentous Haemagglutinin (EU/mL)	93 Percentage of Participants	96 Percentage of Participants
Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination Anti-Fimbriae Types 2 and 3 (EU/mL)	96 Percentage of Participants	99 Percentage of Participants
Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination Anti-Pertactin (EU/mL)	97 Percentage of Participants	96 Percentage of Participants

PRIMARY outcome

Timeframe: Day 0 and between Days 28-48 Post-dose 5

Population: Antibody responses were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.

Outcome measures

Outcome measures
Measure	DAPTACEL®-Primed n=251 Participants Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.	Pentacel®-Primed n=81 Participants Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. Anti-Diphtheria (IU/mL) ≥ 0.01 Pre-dose 5	99 Percentage of Participants	99 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. Anti-Diphtheria (IU/mL) ≥ 0.1 Pre-dose 5	47 Percentage of Participants	50 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. Anti-Diptheria (IU/mL) ≥ 1.0 Pre-dose 5	1 Percentage of Participants	1 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. Anti-Diphtheria (IU/mL) ≥ 0.1 Post-dose 5	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. Anti-Diphtheria (IU/mL) ≥ 1.0 Post-dose 5	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. Anti-Tetanus (IU/mL) ≥ 0.01 Pre-dose 5	100 Percentage of Participants	99 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. Anti-Tetanus (IU/mL) ≥ 0.1 Pre-dose 5	85 Percentage of Participants	82 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. Anti-Tetanus (IU/mL) ≥ 1.0 Pre-dose 5	20 Percentage of Participants	12 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. Anti-Tetanus (IU/mL) ≥ 0.1 Post-dose 5	100 Percentage of Participants	100 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. Anti-Tetanus (IU/mL) ≥ 1.0 Post-dose 5	99 Percentage of Participants	98 Percentage of Participants

PRIMARY outcome

Timeframe: Day 0 and between Days 28-48 post-dose 5

Population: GMTs were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.

Outcome measures

Outcome measures
Measure	DAPTACEL®-Primed n=255 Participants Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.	Pentacel®-Primed n=81 Participants Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Diphtheria (IU/mL) Post-dose	19.59 All units Interval 17.06 to 22.51	22.56 All units Interval 17.78 to 28.62
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Pertussis (EU/mL) Pre-Dose	7.67 All units Interval 6.66 to 8.84	9.80 All units Interval 7.81 to 12.29
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Pertussis (EU/mL) Post-Dose	154.32 All units Interval 139.58 to 170.62	180.77 All units Interval 150.33 to 217.38
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Filamentous Haemagglutinin (EU/mL) Pre-Dose	5.03 All units Interval 4.25 to 5.96	7.52 All units Interval 5.45 to 10.39
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Filamentous Haemagglutinin (EU/mL) Post-Dose	82.11 All units Interval 73.39 to 91.88	120.03 All units Interval 98.1 to 146.86
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Fimbriae Types 2 and 3 (EU/mL) Pre-dose	24.45 All units Interval 21.22 to 28.16	34.50 All units Interval 27.0 to 44.09
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Fimbriae Types 2 and 3 (EU/mL) Post-dose	450.56 All units Interval 407.4 to 498.3	649.86 All units Interval 551.73 to 765.45
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Pertactin (EU/mL) Pre-dose	15.62 All units Interval 13.72 to 17.78	9.16 All units Interval 7.1 to 11.81
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Pertactin (EU/mL) Post-dose	229.59 All units Interval 207.45 to 254.08	148.80 All units Interval 120.63 to 183.55
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Diphtheria (IU/mL) Pre-dose	0.11 All units Interval 0.09 to 0.12	0.11 All units Interval 0.08 to 0.14
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Tetanus (IU/mL) Pre-dose	0.38 All units Interval 0.33 to 0.43	0.27 All units Interval 0.21 to 0.34
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination Anti-Tetanus (IU/mL) Post-dose	6.21 All units Interval 5.59 to 6.89	4.47 All units Interval 3.75 to 5.34

Adverse Events

DAPTACEL®-Primed

Serious events: 5 serious events

Other events: 62 other events

Deaths: 0 deaths

Pentacel®-Primed

Serious events: 3 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DAPTACEL®-Primed n=487 participants at risk Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.	Pentacel®-Primed n=162 participants at risk Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.00% 0/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.62% 1/162 • Number of events 1 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Cardiac disorders Supraventricular tachycardia	0.00% 0/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.62% 1/162 • Number of events 1 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Infections and infestations Gastroenteritis NOS	0.00% 0/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	1.2% 2/162 • Number of events 2 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Infections and infestations Otitis media NOS	0.21% 1/487 • Number of events 1 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.00% 0/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Infections and infestations Pneumonia respiratory syncytial viral	0.21% 1/487 • Number of events 1 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.00% 0/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Injury, poisoning and procedural complications Head injury	0.21% 1/487 • Number of events 1 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.00% 0/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Injury, poisoning and procedural complications Skull fracture NOS	0.21% 1/487 • Number of events 1 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.00% 0/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Metabolism and nutrition disorders Dehydration	0.00% 0/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.62% 1/162 • Number of events 1 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Psychiatric disorders Staring	0.21% 1/487 • Number of events 1 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.00% 0/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Skin and subcutaneous tissue disorders Asthma NOS	0.41% 2/487 • Number of events 2 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.00% 0/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.21% 1/487 • Number of events 1 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.00% 0/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Bronchospasm NOS	0.21% 1/487 • Number of events 1 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	0.00% 0/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.

Other adverse events

Other adverse events
Measure	DAPTACEL®-Primed n=487 participants at risk Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.	Pentacel®-Primed n=162 participants at risk Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
General disorders Injection site redness	7.4% 36/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	14.8% 24/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
General disorders Injection site swelling	4.9% 24/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	8.6% 14/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
General disorders Injection site tenderness	12.7% 62/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	34.0% 55/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Psychiatric disorders Irritability	7.4% 36/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	17.3% 28/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Psychiatric disorders Crying	3.1% 15/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	6.8% 11/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Musculoskeletal and connective tissue disorders Anorexia	3.3% 16/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	8.6% 14/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Gastrointestinal disorders Lethargy	4.5% 22/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	10.5% 17/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Infections and infestations Otitis media NOS	4.9% 24/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	5.6% 9/162 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Infections and infestations Upper respiratory tract infection NOS	7.0% 34/487 • Adverse events data were collected from the day of vaccination for 6 months post-vaccination.	4.3% 7/162 • Adverse events data were collected from the day of vaccination for 6 months post-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