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Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants

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ClinicalTrials.gov Identifier: NCT00401531
Recruitment Status : Completed
First Posted : November 20, 2006
Results First Posted : April 1, 2014
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Hepatitis B
Polio
Diphtheria
Pertussis
Haemophilus Influenzae Type b
Interventions Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Enrollment 412
Recruitment Details Participants were enrolled from 22 October 2006 to 19 November 2007 in 4 clinical centers in Thailand.
Pre-assignment Details A total of 412 participants who met all the inclusion, but none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Hide Arm/Group Description Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Period Title: Overall Study
Started 206 206
Completed 197 196
Not Completed 9 10
Reason Not Completed
Adverse Event             2             0
Protocol Violation             3             7
Lost to Follow-up             1             1
Withdrawal by Subject             3             2
Arm/Group Title DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™ Total
Hide Arm/Group Description Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. Total of all reporting groups
Overall Number of Baseline Participants 206 206 412
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 206 participants 412 participants
<=18 years
206
 100.0%
206
 100.0%
412
 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
Age Continuous Number Analyzed 206 participants 206 participants 412 participants
1.88  (0.170) 1.90  (0.187) 1.89  (0.179)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 206 participants 412 participants
Female
94
  45.6%
111
  53.9%
205
  49.8%
Male
112
  54.4%
95
  46.1%
207
  50.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 206 participants 206 participants 412 participants
206 206 412
1.Primary Outcome
Title Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Hide Description Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.
Time Frame Day 150 post-dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.
Arm/Group Title DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Hide Arm/Group Description:
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Overall Number of Participants Analyzed 189 190
Measure Type: Number
Unit of Measure: Participants
Anti-Hepatitis B (N = 188, 190) 187 189
Anti-PRP (N = 189, 190) 183 183
2.Secondary Outcome
Title Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Hide Description Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.
Time Frame Day 150 post-dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in the participants who had not committed any protocol violation that could have interfered with the primary criteria valuation, per-protocol population.
Arm/Group Title DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Hide Arm/Group Description:
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Overall Number of Participants Analyzed 189 190
Measure Type: Number
Unit of Measure: Participants
Anti-Diphtheria 184 190
Anti-Tetanus 189 190
3.Secondary Outcome
Title Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Hide Description Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil
Time Frame Day 150 post-dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, per-protocol population.
Arm/Group Title DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Hide Arm/Group Description:
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Overall Number of Participants Analyzed 187 186
Measure Type: Number
Unit of Measure: Participants
Anti Polio Type 1 187 186
Anti Polio Type 2 187 186
Anti Polio Type 3 187 185
4.Secondary Outcome
Title Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Hide Description Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.
Time Frame Day 150 post-dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation per-protocol population.
Arm/Group Title DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Hide Arm/Group Description:
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Overall Number of Participants Analyzed 189 190
Measure Type: Number
Unit of Measure: Participants
Anti-pertussis toxoid (N = 189, 189) 177 177
Anti-Filamentous hemagglutinin (N = 187, 188) 177 179
5.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Hide Description Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.
Time Frame Day 150 post-dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in participants who had not committed any protocol violation that could have interfered with the primary criteria evaluation, the per-protocol population.
Arm/Group Title DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Hide Arm/Group Description:
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Overall Number of Participants Analyzed 189 190
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Hepatitis B (N = 188, 190)
2477
(2044 to 3002)
2442
(2096 to 2844)
Anti-PRP (N = 189, 190)
5.07
(4.05 to 6.33)
2.41
(1.95 to 2.98)
Anti-Diphtheria (N = 189, 190)
0.297
(0.241 to 0.367)
0.209
(0.177 to 0.247)
Anti-Tetanus (N = 189, 190)
1.38
(1.25 to 1.52)
1.83
(1.69 to 1.97)
Anti-Polio Type 1 (N = 187, 186)
765
(649 to 902)
1566
(1326 to 1850)
Anti-Polio Type 2 (N = 187, 186)
1489
(1259 to 1761)
2277
(1905 to 2723)
Anti-Polio Type 3 (N = 187, 186)
837
(695 to 1007)
2029
(1646 to 2502)
Anti-Pertussis toxoid (N = 189, 189)
168
(154 to 183)
200
(185 to 216)
Anti-Filamentous hemagglutinin (N = 188, 188)
148
(136 to 162)
123
(113 to 132)
6.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
Hide Description

Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm.

Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.

Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited reactions were assessed in all participants that were enrolled and vaccinated, intent-to-treat population.
Arm/Group Title DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Hide Arm/Group Description:
Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
Overall Number of Participants Analyzed 206 206
Measure Type: Number
Unit of Measure: Participants
Pain Post-dose 1 161 135
Pain Post-dose 2 136 118
Pain Post-dose 3 119 112
Pain Post-any dose 180 166
Grade 3 Pain Post-any dose 20 12
Erythema Post-dose 1 79 64
Erythema Post-dose 2 93 91
Erythema Post-dose 3 86 79
Erythema Post-any dose 121 114
Grade 3 Erythema Post-any dose 3 2
Swelling Post-dose 1 59 34
Swelling Post-dose 2 52 44
Swelling Post-dose 3 34 32
Swelling Post-any dose 85 65
Grade 3 Swelling Post-any dose 1 1
Pyrexia Post-dose 1 109 68
Pyrexia Post-dose 2 84 79
Pyrexia Post-dose 3 81 81
Pyrexia Post-any dose 152 131
Grade 3 Pyrexia Post-any dose 6 7
Vomiting Post Dose 1 47 56
Vomiting Post-dose 2 28 32
Vomiting Post-dose 3 22 28
Vomiting Post-any dose 77 82
Grade 3 Vomiting Post-any dose 1 3
Crying Post-dose 1 128 106
Crying Post-dose 2 106 104
Crying Post-dose 3 77 75
Crying Post-any dose 167 153
Grade 3 Crying Post-any dose 7 5
Somnolence Post-dose 1 109 104
Somnolence Post-dose 2 91 79
Somnolence Post-dose 3 55 59
Somnolence Post-any dose 141 125
Grade 3 Somnolence post-any dose 4 0
Anorexia Post-dose 1 59 49
Anorexia Post-dose 2 44 40
Anorexia Post-dose 3 36 37
Anorexia Post-any dose 91 83
Grade 3 Anorexia Post-any dose 0 0
Irritability Post-dose 1 134 122
Irritability Post-dose 2 107 109
Irritability Post-dose 3 90 88
Irritability Post-any dose 162 159
Grade 3 Irritability Post-any dose 4 6
Time Frame Adverse event data were collected following vaccination (Day 0) up to 10 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Hide Arm/Group Description Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth. Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
All-Cause Mortality
DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/206 (2.91%)      8/206 (3.88%)    
Congenital, familial and genetic disorders     
Cryptorchism * 1  1/206 (0.49%)  1 0/206 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea * 1  1/206 (0.49%)  1 0/206 (0.00%)  0
Intussusception * 1  1/206 (0.49%)  1 0/206 (0.00%)  0
Infections and infestations     
Bronchiolitis * 1  1/206 (0.49%)  1 0/206 (0.00%)  0
Eczema Herpeticum * 1  0/206 (0.00%)  0 1/206 (0.49%)  1
Gastroenteritis * 1  0/206 (0.00%)  0 3/206 (1.46%)  3
Gastroenteritis Viral * 1  0/206 (0.00%)  0 1/206 (0.49%)  1
Pneumonia * 1  1/206 (0.49%)  1 0/206 (0.00%)  0
Pneumonia Viral * 1  1/206 (0.49%)  1 0/206 (0.00%)  0
Urethritis * 1  0/206 (0.00%)  0 1/206 (0.49%)  1
Urinary Tract Infection * 1  1/206 (0.49%)  1 1/206 (0.49%)  1
Injury, poisoning and procedural complications     
Thermal Burn * 1  0/206 (0.00%)  0 1/206 (0.49%)  1
Skin and subcutaneous tissue disorders     
Angioneurotic Oedema * 1  1/206 (0.49%)  1 0/206 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
DTaP-IPV-Hep B-PRP-T + Prevnar™ Infanrix Hexa™ + Prevnar™
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   161/206 (78.16%)      135/206 (65.53%)    
Gastrointestinal disorders     
Diarrhoea * 1  7/206 (3.40%)  7 13/206 (6.31%)  13
Vomiting  1  47/205 (22.93%)  47 56/206 (27.18%)  56
General disorders     
Injection Site Pain  1  161/205 (78.54%)  161 135/206 (65.53%)  135
Injection Erythema  1  93/206 (45.15%)  93 91/206 (44.17%)  91
Injection Swelling  1  59/206 (28.64%)  59 44/206 (21.36%)  44
Irritability  1  134/205 (65.37%)  134 122/206 (59.22%)  122
Pyrexia  1  109/205 (53.17%)  109 68/206 (33.01%)  68
Infections and infestations     
Nasopharyngitis * 1  31/206 (15.05%)  31 35/206 (16.99%)  35
Upper Respiratory Tract Infection * 1  45/206 (21.84%)  45 46/206 (22.33%)  46
Metabolism and nutrition disorders     
Anorexia  1  59/205 (28.78%)  59 49/206 (23.79%)  49
Nervous system disorders     
Somnolence  1  109/205 (53.17%)  109 104/206 (50.49%)  104
Psychiatric disorders     
Crying  1  128/206 (62.14%)  128 106/206 (51.46%)  106
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00401531     History of Changes
Other Study ID Numbers: A3L12
First Submitted: November 16, 2006
First Posted: November 20, 2006
Results First Submitted: February 14, 2014
Results First Posted: April 1, 2014
Last Update Posted: April 1, 2014