Trial Outcomes & Findings for Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (NCT NCT00802867)

Last Updated: 2016-04-14

Results Overview

Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function. Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

989 participants

Primary outcome timeframe

0 to 3 days post-dose 5 vaccination

Results posted on

2016-04-14

Participant Flow

Participants were enrolled from 05 February through 30 November 2004 at 19 US sites.

A total of 989 participants were enrolled and vaccinated with DAPTACEL as the fifth dose after receiving 4 doses of Pentacel vaccine in previous studies.

Participant milestones

Participant milestones
Measure	DAPTACEL® Vaccine Group Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Overall Study STARTED	989
Overall Study COMPLETED	976
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	DAPTACEL® Vaccine Group Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Overall Study Lost to Follow-up	6
Overall Study Protocol Violation	6
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DAPTACEL® Vaccine Group n=989 Participants Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Age, Categorical <=18 years	989 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	4.2 Years STANDARD_DEVIATION 0.15 • n=5 Participants
Sex: Female, Male Female	514 Participants n=5 Participants
Sex: Female, Male Male	475 Participants n=5 Participants
Region of Enrollment United States	989 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 3 days post-dose 5 vaccination

Population: Safety analysis was on all enrolled and vaccinated participants intend-to-treat population.

Outcome measures

Outcome measures
Measure	DAPTACEL® Vaccine Group n=982 Participants Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Solicited Systemic Reaction Post-dose 5	37 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Redness (> 5 mm)	20 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Redness (> 50 mm)	7 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Swelling (> 5 mm)	12 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Swelling (> 50 mm)	3 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Tenderness	50 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Tenderness (Incapacitating)	0 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Change in Limb Circumference (> 5 mm)	29 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Change in Limb Circumference (> 40 mm)	1 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Functional Impairment	9 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Functional Impairment (Incapacitating)	0 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Fever (≥ 38 ºC)	5 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Fever (> 39.5 ºC)	0 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Irritability	23 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Irritability (Incapacitating)	1 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Crying	7 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Crying (Incapacitating)	0 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Lethargy	13 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Lethargy (Incapacitating)	0 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Anorexia	11 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Anorexia (Skips 2 meals)	1 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Vomiting	3 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Vomiting (≥ 3 episodes)	1 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Any Diarrhea	4 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Grade 3 Diarrhea (> 5 diarrhea stools)	0 Percentage of Participants
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® Rash Present	5 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28 to 48 Post-dose 5

Population: The vaccine antibody responses were evaluated in a subset of the per-protocol population for immunogenicity.

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® Vaccine Group n=228 Participants Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. Anti-Pertussis (EU/mL) ≥ 4-Fold Rise	94 Percentage of Participants
Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. Anti-Filamentous Haemagglutinin ≥ 4-Fold Rise	91 Percentage of Participants
Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. Anti-Fimbriae Types 2 and 3 ≥ 4-Fold Rise	91 Percentage of Participants
Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. Anti-Pertactin (EU/mL) ≥ 4-Fold Rise	90 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28 to 48 Post-dose 5

Population: The anti-Pertussis Booster response was evaluated in a subset of the per-protocol population for immunogenicity.

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® Vaccine Group n=228 Participants Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Pertussis (EU/mL)	98 Percentage of participants
Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Filamentous Haemagglutinin	97 Percentage of participants
Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Fimbriae Types 2 and 3	96 Percentage of participants
Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Pertactin (EU/mL)	95 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 28 to 48 Post-dose 5

Population: The anti-Diphtheria and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.

Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination

Outcome measures

Outcome measures
Measure	DAPTACEL® Vaccine Group n=228 Participants Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Diphtheria (IU/mL) ≥0.01 Pre-dose 5	100 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Diphtheria (IU/mL) ≥0.1 Pre-dose 5	77 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Diphtheria (IU/mL) ≥1.0 Pre-dose 5	9 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Diphtheria (IU/mL) ≥0.1 Post-dose 5	100 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Diphtheria (IU/mL) ≥1.0 Post-dose 5	100 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Tetanus (IU/mL) ≥0.01 Pre-dose 5	100 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Tetanus (IU/mL) ≥0.1 Pre-dose 5	92 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Tetanus (IU/mL) ≥1.0 Pre-dose 5	13 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Tetanus (IU/mL) ≥0.1 Post-dose 5	100 Percentage of Participants
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Tetanus (IU/mL) ≥1.0 Post-dose 5	96 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose 5 and Day 28 to 48 Post-dose 5

Population: The GMTs of anti-Pertussis, anti-Diphtheria, and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.

Outcome measures

Outcome measures
Measure	DAPTACEL® Vaccine Group n=228 Participants Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Pertussis (EU/mL) - Pre-dose 5	12.73 Titers Interval 10.85 to 14.94
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Pertussis (EU/mL) - Post-dose 5	309.64 Titers Interval 276.16 to 347.18
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Filamentous Haemagglutinin (EU/mL) Pre-dose 5	9.90 Titers Interval 8.49 to 11.55
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Filamentous Haemagglutinin (EU/mL) Post-dose5	158.27 Titers Interval 144.26 to 173.63
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Fimbriae Types 2 and 3 (EU/mL) Pre-dose 5	40.62 Titers Interval 35.13 to 46.98
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Fimbriae Types 2 and 3 (EU/mL) Post-dose 5	659.28 Titers Interval 595.32 to 730.12
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Pertactin (EU/mL) Pre-dose 5	10.36 Titers Interval 8.92 to 12.02
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Pertactin (EU/mL) Post-dose 5	140.86 Titers Interval 122.24 to 162.31
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Diphtheria (IU/mL) Pre-dose 5	0.25 Titers Interval 0.22 to 0.28
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Diphtheria (IU/mL) Post-dose 5	18.98 Titers Interval 17.1 to 21.07
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Tetanus (IU/mL) Pre-dose 5	0.38 Titers Interval 0.33 to 0.42
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose Anti-Tetanus (IU/mL) Post-dose 5	4.30 Titers Interval 3.86 to 4.79

Adverse Events

DAPTACEL® Vaccine Group

Serious events: 10 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DAPTACEL® Vaccine Group n=989 participants at risk Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.10% 1/989 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination.
Infections and infestations Appendicitis	0.10% 1/989 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination.
Infections and infestations Cellulitis	0.10% 1/989 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination.
Infections and infestations Gastroenteritis nos	0.10% 1/989 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination.
Infections and infestations Pneumonia nos	0.10% 1/989 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination.
Metabolism and nutrition disorders Dehydration	0.20% 2/989 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination.
Nervous system disorders Febrile convulsion	0.10% 1/989 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination.
Nervous system disorders Obstructive sleep apnoea syndrome	0.10% 1/989 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Asthma nos	0.20% 2/989 • Number of events 2 • Adverse event data were collected for 6 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.10% 1/989 • Number of events 1 • Adverse event data were collected for 6 months post-vaccination.

Other adverse events

Other adverse events
Measure	DAPTACEL® Vaccine Group n=989 participants at risk Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Infections and infestations Upper respiratory tract infection NOS	5.0% 49/989 • Number of events 49 • Adverse event data were collected 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
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