Trial Outcomes & Findings for Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™ (NCT NCT00772928)

NCT ID: NCT00772928

Last Updated: 2012-02-01

Results Overview

Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1167 participants
• Primary outcome timeframe: 28 to 48 days post-3rd vaccination
• Results posted on: 2012-02-01

Participant Flow

Study participants were enrolled from 30 October 2003 to 29 March 2004 in 23 medical clinics in the US.

A total of 1167 subjects that met the inclusion and exclusion criteria were enrolled, 1166 were vaccinated.

Participant milestones

Measure	Pentacel™ Concurrently With Prevnar® Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine	Pentacel™ Staggered Schedule With Prevnar® Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Overall Study STARTED	587	579
Overall Study COMPLETED	543	538
Overall Study NOT COMPLETED	44	41

Reasons for withdrawal

Measure	Pentacel™ Concurrently With Prevnar® Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine	Pentacel™ Staggered Schedule With Prevnar® Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Overall Study Lost to Follow-up	9	6
Overall Study Protocol Violation	10	12
Overall Study Withdrawal by Subject	25	22
Overall Study Did not receive vaccine	0	1

Baseline Characteristics

Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™

Baseline characteristics by cohort

Measure	Pentacel™ Concurrently With Prevnar® n=587 Participants Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine	Pentacel™ Staggered Schedule With Prevnar® n=579 Participants Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).	Total n=1166 Participants Total of all reporting groups
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	2.2 Months STANDARD_DEVIATION 0.29 • n=5 Participants	2.1 Months STANDARD_DEVIATION 0.28 • n=7 Participants	2.1 Months STANDARD_DEVIATION 0.29 • n=5 Participants
Sex: Female, Male Female	278 Participants n=5 Participants	259 Participants n=7 Participants	537 Participants n=5 Participants
Sex: Female, Male Male	309 Participants n=5 Participants	320 Participants n=7 Participants	629 Participants n=5 Participants
Region of Enrollment United States	587 participants n=5 Participants	579 participants n=7 Participants	1166 participants n=5 Participants
Age, Categorical <=18 years	587 Participants n=5 Participants	579 Participants n=7 Participants	1166 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 to 48 days post-3rd vaccination

Population: Analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population.

Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.

Outcome measures

Measure	Pentacel™ Concurrently With Prevnar® n=447 Participants Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine	Pentacel™ Staggered Schedule With Prevnar® n=438 Participants Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Poliovirus Polyribosyl. P Tetanus, PRP ≥0.15 μg/mL	96 Percentage of Participants	95 Percentage of Participants
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Pertussis Toxoid (PT) EU/mL	90 Percentage of Participants	90 Percentage of Participants
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Filamentous Haemagglutinin (FHA) EU/mL	82 Percentage of Participants	82 Percentage of Participants
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Fimbriae Types 2 and 3 (FIM 2&3) EU/mL	88 Percentage of Participants	88 Percentage of Participants
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Pertactin (PRN) EU/mL	74 Percentage of Participants	72 Percentage of Participants
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Poliovirus Polyribosyl. P Tetanus, PRP ≥0.10 μg/mL	77 Percentage of Participants	80 Percentage of Participants

PRIMARY outcome

Timeframe: 60 Days Post-dose 3

Population: Geometric mean titer analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population

Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.

Outcome measures

Measure	Pentacel™ Concurrently With Prevnar® n=447 Participants Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine	Pentacel™ Staggered Schedule With Prevnar® n=439 Participants Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Poliovirus Polyribosylribitol P Tetanus(PRP) μg/mL	3.32 All Units Interval 2.85 to 3.87	3.60 All Units Interval 3.09 to 4.2
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Diphtheria (IU/mL)	0.59 All Units Interval 0.53 to 0.64	1.32 All Units Interval 1.22 to 1.42
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Tetanus (IU/mL)	1.27 All Units Interval 1.18 to 1.35	1.30 All Units Interval 1.21 to 1.39
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Polio 1 (1/dil)	543.52 All Units Interval 480.61 to 614.67	593.09 All Units Interval 515.54 to 682.31
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Polio 2 (1/dil)	846.36 All Units Interval 752.37 to 952.08	949.06 All Units Interval 847.95 to 1062.22
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Polio 3 (1/dil)	1025.73 All Units Interval 899.05 to 1170.26	1104.05 All Units Interval 969.8 to 1256.88
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Pertussis Toxoid (PT) EU/mL	103.58 All Units Interval 97.87 to 109.63	102.78 All Units Interval 96.86 to 109.06
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Filamentous Haemagglutinin (FHA) EU/mL	82.41 All Units Interval 77.4 to 87.75	77.80 All Units Interval 72.62 to 83.35
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Fimbriae Types 2 and 3 (FIM) EU/mL	272.47 All Units Interval 251.39 to 295.32	280.97 All Units Interval 258.02 to 305.97
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) Pertactin (PRN) EU/mL	45.7 All Units Interval 41.59 to 50.23	44.28 All Units Interval 40.11 to 48.89

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-3 days post- vaccination and entire study period

Population: Analysis was on all enrolled and vaccinated subjects, intend-to-treat population.

Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.

Outcome measures

Measure	Pentacel™ Concurrently With Prevnar® n=587 Participants Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine	Pentacel™ Staggered Schedule With Prevnar® n=579 Participants Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Redness Post-dose 1	5 Percentage of Participants	3 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Swelling, > 50 mm Post-dose 3	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Fever > 39.5°C Post-dose 1	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Diarrhea Post-dose 1	11 Percentage of Participants	9 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Irritability Post-dose 1	53 Percentage of Participants	52 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Irritability, >3 hours Post-dose 1	3 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Diarrhea Post-dose 2	9 Percentage of Participants	7 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Fever Post-dose 3	20 Percentage of Participants	16 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Fever > 39.5°C Post-dose 3	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Lethargy Post-dose 3	18 Percentage of Participants	8 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Vomiting Post-dose 3	4 Percentage of Participants	5 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Solicited Systemic Reaction, All doses	87 Percentage of Participants	78 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Fever All doses	35 Percentage of Participants	32 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Diarrhea, > 5 stools All doses	1 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Solicited Local Reaction Post-dose 1	31 Percentage of Participants	26 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Redness, > 50 mm Post-dose 1	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Swelling Post-Dose 1	4 Percentage of Participants	4 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Swelling, > 50 mm Post-dose 1	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Tenderness Post-dose 1	28 Percentage of Participants	24 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grd 3 Tenderness Cries when limb is moved Post-d 1	1 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Solicited Local Reaction Post-dose 2	24 Percentage of Participants	15 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Redness Post-dose 2	4 Percentage of Participants	4 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Redness, > 50 mm Post-dose 2	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Swelling Post-Dose 2	2 Percentage of Participants	2 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Swelling, > 50 mm Post-dose 2	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Tenderness Post-dose 2	22 Percentage of Participants	12 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grd 3 Tenderness Cries when limb is moved Post-d 2	1 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Solicited Local Reaction, Post-dose 3	20 Percentage of Participants	9 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Redness Post-dose 3	6 Percentage of Participants	3 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Redness, > 50 mm Post-dose 3	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Swelling Post-Dose 3	2 Percentage of Participants	2 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Tenderness Post-dose 3	17 Percentage of Participants	7 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grd 3 Tenderness Cries when limb is moved Post-d 3	1 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Solicited Local Reaction All doses	46 Percentage of Participants	38 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Redness All doses	12 Percentage of Participants	8 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Redness, > 50 mm All doses	0 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Swelling All doses	7 Percentage of Participants	7 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Swelling, > 50 mm All doses	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Tenderness All doses	41 Percentage of Participants	33 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grd3 Tenderness Cries when limb is moved All doses	2 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Solicited Systemic Reaction Post-dose 1	69 Percentage of Participants	64 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Fever Post-dose 1	8 Percentage of Participants	11 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Lethargy Post-dose 1	33 Percentage of Participants	28 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grd3 Lethargy not interested in usual day activity	2 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Vomiting Post-dose 1	9 Percentage of Participants	8 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Vomiting, ≥ 3 episodes Post-dose 1	0 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Diarrhea, > 5 stools Post-dose 1	1 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Crying Post-dose 1	31 Percentage of Participants	29 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Crying, > 3 hours Post-dose 1	1 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Appetite Decreased Post-dose 1	18 Percentage of Participants	11 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-d1	1 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Solicited Systemic Reaction, Post-dose 2	63 Percentage of Participants	45 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Fever Post-dose 2	19 Percentage of Participants	16 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Fever > 39.5°C Post-dose 2	1 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Lethargy Post-dose 2	21 Percentage of Participants	11 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Vomiting Post-dose 2	9 Percentage of Participants	3 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Vomiting, ≥ 3 episodes Post-dose 2	1 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Diarrhea, > 5 stools Post-dose 2	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Crying Post-dose 2	25 Percentage of Participants	14 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Crying, > 3 hours Post-dose 2	1 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Irritability Post-dose 2	47 Percentage of Participants	34 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Irritability, > 3 hours Post-dose 2	4 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Appetite Decreased Post-dose 2	15 Percentage of Participants	8 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-D2	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Solicited Systemic Reaction, Post-dose 3	54 Percentage of Participants	34 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Vomiting, ≥ 3 episodes Post-dose 3	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Diarrhea Post-dose 3	6 Percentage of Participants	4 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Diarrhea, > 5 stools Post-dose 3	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Crying Post-dose 3	18 Percentage of Participants	9 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Crying, > 3 hours Post-dose 3	0 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Irritability Post-dose 3	40 Percentage of Participants	26 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Irritability, > 3 hours Post-dose 3	2 Percentage of Participants	2 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Appetite Decreased Post-dose 3	11 Percentage of Participants	7 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-D3	1 Percentage of Participants	0 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Fever > 39.5°C, All doses	1 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Lethargy All doses	46 Percentage of Participants	36 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Vomiting All doses	18 Percentage of Participants	14 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Vomiting, ≥ 3 episodes All doses	1 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Diarrhea All doses	21 Percentage of Participants	18 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Crying All doses	48 Percentage of Participants	39 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Crying, > 3 hours All doses	1 Percentage of Participants	1 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Irritability All doses	74 Percentage of Participants	68 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grade 3 Irritability, > 3 hours All doses	7 Percentage of Participants	4 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Any Appetite Decreased All doses	33 Percentage of Participants	21 Percentage of Participants
Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ Grd 3 Appetite Decreased, Refuses ≥ 3 feeds All D	2 Percentage of Participants	1 Percentage of Participants

Adverse Events

Pentacel™ Concurrently With Prevnar®

Serious events: 32 serious events

Other events: 475 other events

Deaths: 0 deaths

Pentacel™ Staggered Schedule With Prevnar®

Serious events: 15 serious events

Other events: 481 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pentacel™ Concurrently With Prevnar® n=587 participants at risk Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine	Pentacel™ Staggered Schedule With Prevnar® n=579 participants at risk Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Blood and lymphatic system disorders Lymphadenitis nos	0.00% 0/587 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Blood and lymphatic system disorders Lymphadenopathy	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Congenital, familial and genetic disorders Gastrointestinal malformation nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Congenital, familial and genetic disorders Lymphangioma	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Gastrointestinal disorders Acquired pyloric stenosis	0.00% 0/587 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Gastrointestinal disorders Diarrhoea nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Gastrointestinal disorders Gastric ulcers	0.00% 0/587 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Gastrointestinal disorders Gastrooesophageal reflux disease	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Gastrointestinal disorders Small intestinal obstruction nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
General disorders Developmental delay nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
General disorders Pyrexia	0.51% 3/587 • Number of events 3 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Immune system disorders Anaphylactic reaction	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Bronchiolitis	1.9% 11/587 • Number of events 11 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	1.7% 10/579 • Number of events 10 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Candidal infection nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Cellulitis	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Croup infectious	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Gastroenteritis rotavirus	0.51% 3/587 • Number of events 3 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Influenza	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Otitis media nos	0.34% 2/587 • Number of events 2 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Pneumonia nos	0.00% 0/587 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.35% 2/579 • Number of events 2 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Pyelonephritis nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Respiratory syncytial virus infection nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Roseola	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Skin and subcutaneous tissue abscess nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Upper respiratory tract infection viral nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Urinary tract infection nos	0.51% 3/587 • Number of events 3 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/587 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Injury, poisoning and procedural complications Skull fracture nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Metabolism and nutrition disorders Dehydration	0.68% 4/587 • Number of events 4 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Metabolism and nutrition disorders Failure to thrive	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Nervous system disorders Convulsions nos	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Nervous system disorders Dystonia	0.00% 0/587 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Metabolism and nutrition disorders Febrile convulsion	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Renal and urinary disorders Vesico-ureteric reflux	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Respiratory, thoracic and mediastinal disorders Apnoeic attack	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Respiratory, thoracic and mediastinal disorders Hypoxia	0.17% 1/587 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.00% 0/579 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/587 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	0.17% 1/579 • Number of events 1 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1

Other adverse events

Measure	Pentacel™ Concurrently With Prevnar® n=587 participants at risk Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine	Pentacel™ Staggered Schedule With Prevnar® n=579 participants at risk Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Eye disorders Conjunctivitis	10.2% 60/587 • Number of events 65 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	10.2% 59/579 • Number of events 67 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Gastrointestinal disorders Constipation	5.1% 30/587 • Number of events 34 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	6.0% 35/579 • Number of events 40 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Gastrointestinal disorders Diarrhoea NOS	4.8% 28/587 • Number of events 28 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	7.1% 41/579 • Number of events 43 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Gastrointestinal disorders Flatulence	7.2% 42/587 • Number of events 51 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	7.1% 41/579 • Number of events 48 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Gastrointestinal disorders Gastrooesophageal reflux disease	5.8% 34/587 • Number of events 34 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	6.0% 35/579 • Number of events 35 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Gastrointestinal disorders Teething	15.5% 91/587 • Number of events 104 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	21.9% 127/579 • Number of events 154 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
General disorders Pyrexia	7.7% 45/587 • Number of events 55 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	5.0% 29/579 • Number of events 35 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Bronchiolitis	11.2% 66/587 • Number of events 70 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	13.0% 75/579 • Number of events 86 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Candidal infection NOS	6.1% 36/587 • Number of events 41 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	6.7% 39/579 • Number of events 43 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Gastroenteritis NOS	6.0% 35/587 • Number of events 40 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	7.1% 41/579 • Number of events 44 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Nasopharyngitis	7.0% 41/587 • Number of events 43 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	8.1% 47/579 • Number of events 55 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Otitis media NOS	27.6% 162/587 • Number of events 226 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	28.0% 162/579 • Number of events 244 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Otitis media serous acute NOS	6.3% 37/587 • Number of events 44 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	4.5% 26/579 • Number of events 33 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Upper respiratory tract infection NOS	44.0% 258/587 • Number of events 352 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	45.6% 264/579 • Number of events 368 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Upper respiratory tract infection viral NOS	4.1% 24/587 • Number of events 29 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	6.0% 35/579 • Number of events 35 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Infections and infestations Viral infection NOS	7.8% 46/587 • Number of events 50 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	8.6% 50/579 • Number of events 55 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Respiratory, thoracic and mediastinal disorders Cough	8.9% 52/587 • Number of events 56 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	11.1% 64/579 • Number of events 75 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.2% 48/587 • Number of events 50 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	9.5% 55/579 • Number of events 65 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	3.7% 22/587 • Number of events 24 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	5.0% 29/579 • Number of events 35 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.4% 14/587 • Number of events 14 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	5.9% 34/579 • Number of events 39 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Skin and subcutaneous tissue disorders Dermatitis diaper	3.9% 23/587 • Number of events 25 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	5.2% 30/579 • Number of events 31 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Skin and subcutaneous tissue disorders Eczema	7.0% 41/587 • Number of events 41 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1	5.7% 33/579 • Number of events 33 • Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: RegistryContactUs@sanofipasteur.com

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