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

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ClinicalTrials.gov Identifier: NCT00772928
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : February 12, 2010
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Haemophilus Infection
Pertussis
Polio
Intervention Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
Enrollment 1167
Recruitment Details Study participants were enrolled from 30 October 2003 to 29 March 2004 in 23 medical clinics in the US.
Pre-assignment Details A total of 1167 subjects that met the inclusion and exclusion criteria were enrolled, 1166 were vaccinated.
Arm/Group Title Pentacel™ Concurrently With Prevnar® Pentacel™ Staggered Schedule With Prevnar®
Hide Arm/Group Description Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Period Title: Overall Study
Started 587 579
Completed 543 538
Not Completed 44 41
Reason Not Completed
Lost to Follow-up             9             6
Protocol Violation             10             12
Withdrawal by Subject             25             22
Did not receive vaccine             0             1
Arm/Group Title Pentacel™ Concurrently With Prevnar® Pentacel™ Staggered Schedule With Prevnar® Total
Hide Arm/Group Description Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule). Total of all reporting groups
Overall Number of Baseline Participants 587 579 1166
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 587 participants 579 participants 1166 participants
<=18 years
587
 100.0%
579
 100.0%
1166
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 587 participants 579 participants 1166 participants
2.2  (0.29) 2.1  (0.28) 2.1  (0.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 587 participants 579 participants 1166 participants
Female
278
  47.4%
259
  44.7%
537
  46.1%
Male
309
  52.6%
320
  55.3%
629
  53.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 587 participants 579 participants 1166 participants
587 579 1166
1.Primary Outcome
Title 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®)
Hide Description 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.
Time Frame 28 to 48 days post-3rd vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population.
Arm/Group Title Pentacel™ Concurrently With Prevnar® Pentacel™ Staggered Schedule With Prevnar®
Hide Arm/Group Description:
Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Overall Number of Participants Analyzed 447 438
Measure Type: Number
Unit of Measure: Percentage of Participants
Pertussis Toxoid (PT) EU/mL 90 90
Filamentous Haemagglutinin (FHA) EU/mL 82 82
Fimbriae Types 2 and 3 (FIM 2&3) EU/mL 88 88
Pertactin (PRN) EU/mL 74 72
Poliovirus Polyribosyl. P Tetanus, PRP ≥0.15 μg/mL 96 95
Poliovirus Polyribosyl. P Tetanus, PRP ≥0.10 μg/mL 77 80
2.Primary Outcome
Title 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®)
Hide Description Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.
Time Frame 60 Days Post-dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population
Arm/Group Title Pentacel™ Concurrently With Prevnar® Pentacel™ Staggered Schedule With Prevnar®
Hide Arm/Group Description:
Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Overall Number of Participants Analyzed 447 439
Geometric Mean (95% Confidence Interval)
Unit of Measure: All Units
Pertussis Toxoid (PT) EU/mL
103.58
(97.87 to 109.63)
102.78
(96.86 to 109.06)
Filamentous Haemagglutinin (FHA) EU/mL
82.41
(77.40 to 87.75)
77.80
(72.62 to 83.35)
Fimbriae Types 2 and 3 (FIM) EU/mL
272.47
(251.39 to 295.32)
280.97
(258.02 to 305.97)
Pertactin (PRN) EU/mL
45.7
(41.59 to 50.23)
44.28
(40.11 to 48.89)
Poliovirus Polyribosylribitol P Tetanus(PRP) μg/mL
3.32
(2.85 to 3.87)
3.60
(3.09 to 4.20)
Diphtheria (IU/mL)
0.59
(0.53 to 0.64)
1.32
(1.22 to 1.42)
Tetanus (IU/mL)
1.27
(1.18 to 1.35)
1.30
(1.21 to 1.39)
Polio 1 (1/dil)
543.52
(480.61 to 614.67)
593.09
(515.54 to 682.31)
Polio 2 (1/dil)
846.36
(752.37 to 952.08)
949.06
(847.95 to 1062.22)
Polio 3 (1/dil)
1025.73
(899.05 to 1170.26)
1104.05
(969.80 to 1256.88)
3.Other Pre-specified Outcome
Title Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™
Hide Description Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.
Time Frame 0-3 days post- vaccination and entire study period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was on all enrolled and vaccinated subjects, intend-to-treat population.
Arm/Group Title Pentacel™ Concurrently With Prevnar® Pentacel™ Staggered Schedule With Prevnar®
Hide Arm/Group Description:
Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine
Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
Overall Number of Participants Analyzed 587 579
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Local Reaction Post-dose 1 31 26
Any Redness Post-dose 1 5 3
Grade 3 Redness, > 50 mm Post-dose 1 0 0
Any Swelling Post-Dose 1 4 4
Grade 3 Swelling, > 50 mm Post-dose 1 0 0
Any Tenderness Post-dose 1 28 24
Grd 3 Tenderness Cries when limb is moved Post-d 1 1 1
Any Solicited Local Reaction Post-dose 2 24 15
Any Redness Post-dose 2 4 4
Grade 3 Redness, > 50 mm Post-dose 2 0 0
Any Swelling Post-Dose 2 2 2
Grade 3 Swelling, > 50 mm Post-dose 2 0 0
Any Tenderness Post-dose 2 22 12
Grd 3 Tenderness Cries when limb is moved Post-d 2 1 0
Any Solicited Local Reaction, Post-dose 3 20 9
Any Redness Post-dose 3 6 3
Grade 3 Redness, > 50 mm Post-dose 3 0 0
Any Swelling Post-Dose 3 2 2
Grade 3 Swelling, > 50 mm Post-dose 3 0 0
Any Tenderness Post-dose 3 17 7
Grd 3 Tenderness Cries when limb is moved Post-d 3 1 0
Any Solicited Local Reaction All doses 46 38
Any Redness All doses 12 8
Grade 3 Redness, > 50 mm All doses 0 1
Any Swelling All doses 7 7
Grade 3 Swelling, > 50 mm All doses 0 0
Any Tenderness All doses 41 33
Grd3 Tenderness Cries when limb is moved All doses 2 1
Any Solicited Systemic Reaction Post-dose 1 69 64
Any Fever Post-dose 1 8 11
Grade 3 Fever > 39.5°C Post-dose 1 0 0
Any Lethargy Post-dose 1 33 28
Grd3 Lethargy not interested in usual day activity 1 0
Any Vomiting Post-dose 1 9 8
Grade 3 Vomiting, ≥ 3 episodes Post-dose 1 0 1
Any Diarrhea Post-dose 1 11 9
Grade 3 Diarrhea, > 5 stools Post-dose 1 1 0
Any Crying Post-dose 1 31 29
Grade 3 Crying, > 3 hours Post-dose 1 1 0
Any Irritability Post-dose 1 53 52
Grade 3 Irritability, >3 hours Post-dose 1 3 1
Any Appetite Decreased Post-dose 1 18 11
Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-d1 1 0
Any Solicited Systemic Reaction, Post-dose 2 63 45
Any Fever Post-dose 2 19 16
Grade 3 Fever > 39.5°C Post-dose 2 1 0
Any Lethargy Post-dose 2 21 11
Grd3 Lethargy not interested in usual day activity 1 0
Any Vomiting Post-dose 2 9 3
Grade 3 Vomiting, ≥ 3 episodes Post-dose 2 1 0
Any Diarrhea Post-dose 2 9 7
Grade 3 Diarrhea, > 5 stools Post-dose 2 0 0
Any Crying Post-dose 2 25 14
Grade 3 Crying, > 3 hours Post-dose 2 1 1
Any Irritability Post-dose 2 47 34
Grade 3 Irritability, > 3 hours Post-dose 2 4 1
Any Appetite Decreased Post-dose 2 15 8
Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-D2 0 0
Any Solicited Systemic Reaction, Post-dose 3 54 34
Any Fever Post-dose 3 20 16
Grade 3 Fever > 39.5°C Post-dose 3 0 0
Any Lethargy Post-dose 3 18 8
Grd3 Lethargy not interested in usual day activity 1 0
Any Vomiting Post-dose 3 4 5
Grade 3 Vomiting, ≥ 3 episodes Post-dose 3 0 0
Any Diarrhea Post-dose 3 6 4
Grade 3 Diarrhea, > 5 stools Post-dose 3 0 0
Any Crying Post-dose 3 18 9
Grade 3 Crying, > 3 hours Post-dose 3 0 0
Any Irritability Post-dose 3 40 26
Grade 3 Irritability, > 3 hours Post-dose 3 2 2
Any Appetite Decreased Post-dose 3 11 7
Grd 3 Appetite Decreased, Refuses ≥3 feeds Post-D3 1 0
Any Solicited Systemic Reaction, All doses 87 78
Any Fever All doses 35 32
Grade 3 Fever > 39.5°C, All doses 1 1
Any Lethargy All doses 46 36
Grd3 Lethargy not interested in usual day activity 2 1
Any Vomiting All doses 18 14
Grade 3 Vomiting, ≥ 3 episodes All doses 1 1
Any Diarrhea All doses 21 18
Grade 3 Diarrhea, > 5 stools All doses 1 1
Any Crying All doses 48 39
Grade 3 Crying, > 3 hours All doses 1 1
Any Irritability All doses 74 68
Grade 3 Irritability, > 3 hours All doses 7 4
Any Appetite Decreased All doses 33 21
Grd 3 Appetite Decreased, Refuses ≥ 3 feeds All D 2 1
Time Frame Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pentacel™ Concurrently With Prevnar® Pentacel™ Staggered Schedule With Prevnar®
Hide Arm/Group Description Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule).
All-Cause Mortality
Pentacel™ Concurrently With Prevnar® Pentacel™ Staggered Schedule With Prevnar®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pentacel™ Concurrently With Prevnar® Pentacel™ Staggered Schedule With Prevnar®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/587 (5.45%)      15/579 (2.59%)    
Blood and lymphatic system disorders     
Lymphadenitis nos * 1  0/587 (0.00%)  0 1/579 (0.17%)  1
Lymphadenopathy * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Congenital, familial and genetic disorders     
Gastrointestinal malformation nos * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Lymphangioma * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Gastrointestinal disorders     
Acquired pyloric stenosis * 1  0/587 (0.00%)  0 1/579 (0.17%)  1
Diarrhoea nos * 1  1/587 (0.17%)  1 1/579 (0.17%)  1
Gastric ulcers * 1  0/587 (0.00%)  0 1/579 (0.17%)  1
Gastrooesophageal reflux disease * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Small intestinal obstruction nos * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
General disorders     
Developmental delay nos * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Pyrexia * 1  3/587 (0.51%)  3 1/579 (0.17%)  1
Immune system disorders     
Anaphylactic reaction * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Infections and infestations     
Bronchiolitis * 1  11/587 (1.87%)  11 10/579 (1.73%)  10
Candidal infection nos * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Cellulitis * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Croup infectious * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Gastroenteritis rotavirus * 1  3/587 (0.51%)  3 0/579 (0.00%)  0
Influenza * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Otitis media nos * 1  2/587 (0.34%)  2 1/579 (0.17%)  1
Pneumonia nos * 1  0/587 (0.00%)  0 2/579 (0.35%)  2
Pyelonephritis nos * 1  1/587 (0.17%)  1 1/579 (0.17%)  1
Respiratory syncytial virus infection nos * 1  1/587 (0.17%)  1 1/579 (0.17%)  1
Roseola * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Skin and subcutaneous tissue abscess nos * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Upper respiratory tract infection viral nos * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Urinary tract infection nos * 1  3/587 (0.51%)  3 0/579 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental overdose * 1  0/587 (0.00%)  0 1/579 (0.17%)  1
Skull fracture nos * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  4/587 (0.68%)  4 0/579 (0.00%)  0
Failure to thrive * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Febrile convulsion * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Nervous system disorders     
Convulsions nos * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Dystonia * 1  0/587 (0.00%)  0 1/579 (0.17%)  1
Renal and urinary disorders     
Vesico-ureteric reflux * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Apnoeic attack * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Hypoxia * 1  1/587 (0.17%)  1 0/579 (0.00%)  0
Respiratory distress * 1  0/587 (0.00%)  0 1/579 (0.17%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pentacel™ Concurrently With Prevnar® Pentacel™ Staggered Schedule With Prevnar®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   475/587 (80.92%)      481/579 (83.07%)    
Eye disorders     
Conjunctivitis * 1  60/587 (10.22%)  65 59/579 (10.19%)  67
Gastrointestinal disorders     
Constipation * 1  30/587 (5.11%)  34 35/579 (6.04%)  40
Diarrhoea NOS * 1  28/587 (4.77%)  28 41/579 (7.08%)  43
Flatulence * 1  42/587 (7.16%)  51 41/579 (7.08%)  48
Gastrooesophageal reflux disease * 1  34/587 (5.79%)  34 35/579 (6.04%)  35
Teething * 1  91/587 (15.50%)  104 127/579 (21.93%)  154
General disorders     
Pyrexia * 1  45/587 (7.67%)  55 29/579 (5.01%)  35
Infections and infestations     
Bronchiolitis * 1  66/587 (11.24%)  70 75/579 (12.95%)  86
Candidal infection NOS * 1  36/587 (6.13%)  41 39/579 (6.74%)  43
Gastroenteritis NOS * 1  35/587 (5.96%)  40 41/579 (7.08%)  44
Nasopharyngitis * 1  41/587 (6.98%)  43 47/579 (8.12%)  55
Otitis media NOS * 1  162/587 (27.60%)  226 162/579 (27.98%)  244
Otitis media serous acute NOS * 1  37/587 (6.30%)  44 26/579 (4.49%)  33
Upper respiratory tract infection NOS * 1  258/587 (43.95%)  352 264/579 (45.60%)  368
Upper respiratory tract infection viral NOS * 1  24/587 (4.09%)  29 35/579 (6.04%)  35
Viral infection NOS * 1  46/587 (7.84%)  50 50/579 (8.64%)  55
Respiratory, thoracic and mediastinal disorders     
Cough * 1  52/587 (8.86%)  56 64/579 (11.05%)  75
Nasal congestion * 1  48/587 (8.18%)  50 55/579 (9.50%)  65
Respiratory tract congestion * 1  22/587 (3.75%)  24 29/579 (5.01%)  35
Rhinorrhoea * 1  14/587 (2.39%)  14 34/579 (5.87%)  39
Skin and subcutaneous tissue disorders     
Dermatitis diaper * 1  23/587 (3.92%)  25 30/579 (5.18%)  31
Eczema * 1  41/587 (6.98%)  41 33/579 (5.70%)  33
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00772928     History of Changes
Other Study ID Numbers: M5A07
First Submitted: October 13, 2008
First Posted: October 15, 2008
Results First Submitted: September 23, 2009
Results First Posted: February 12, 2010
Last Update Posted: February 1, 2012