A Phase 3 interventional study of DTaP-IPV-HB-PRP~T and Tritanrix-HepB/Hib in Diphtheria, Tetanus and Pertussis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 2 sites in 2 countries. Open to participants aged 50 Days to 71 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-21.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention
To demonstrate that DTaP-IPV-HB-PRP\~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject.
To evaluate the overall safety in terms of:
Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.
Immunogenicity:
To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP\~T vaccine.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 2,133 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: DTaP-IPV-HB-PRP~T
Biological: Tritanrix-HepB/Hib
0.5 mL, Intramuscular (IM)
0.5 mL, Intramuscular
Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.
High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.
Time frame: Day 0 up to Day 7 post-injection
Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
Time frame: Day 30 post-dose 3
Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.
Time frame: Day 30 post-dose 3
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable.
Time frame: Day 0 up to Day 7 Post-injection
Participants were enrolled and treated from 17 July 2006 to 02 January 2008 in 1 clinical center in Mexico and 1 clinical center in Peru.
| Milestone | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| Started | 1422 | 711 |
| Completed | 1328 | 670 |
| Not completed | 94 | 41 |
| Withdrew: Serious adverse event | 6 | 1 |
| Withdrew: Adverse event | 2 | 3 |
| Withdrew: Protocol violation | 19 | 10 |
| Withdrew: Lost to follow-up | 27 | 14 |
| Withdrew: Withdrawal by subject | 39 | 12 |
| Withdrew: Did not meet age criteria | 1 | 1 |
High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.
| Participants | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| Post Any Dose (N = 1411, 703) | 56 | 39 (0 to 0) |
| Post Dose 1 (N = 1408, 703) | 5 | 4 (0 to 0) |
| Post Dose 2 (N = 1348, 681) | 25 | 15 (0 to 0) |
| Post Dose 3 (N = 1328, 672) | 26 | 23 (0 to 0) |
Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
| Titers | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | 1075 (891 to 1298) | 3376 (2672 to 4338) |
Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.
| Percentage of Participants | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| ≥ 10 mIU/mL | 100 | 100 (0 to 0) |
| ≥ 100 mIU/mL | 96 | 99 (0 to 0) |
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable.
| Participants | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| Any Pain Post Dose 1 (N=1410, 703) | 831 | 574 (0 to 0) |
| Severe Pain Post Dose 1 (N=1408, 703) | 175 | 193 (0 to 0) |
| Any Pain Post Dose 2 (N=1348, 681) | 744 | 506 (0 to 0) |
| Severe Pain Post Dose 2 (N=1348, 681) | 105 | 95 (0 to 0) |
| Any Pain Post Dose 3 (N=1327, 672) | 519 | 448 (0 to 0) |
| Severe Pain Post Dose 3 (N=1327, 672) | 29 | 65 (0 to 0) |
| Any Erythema Post Dose 1 (N=1408, 703) | 245 | 234 (0 to 0) |
| Severe Erythema Post Dose 1 (N=1408, 703) | 11 | 15 (0 to 0) |
| Any Erythema Post Dose 2 (N=1348, 681) | 427 | 308 (0 to 0) |
| Severe Erythema Post Dose 2 (N=1348, 681) | 6 | 16 (0 to 0) |
| Any Erythema Post Dose 3 (N=1327, 672) | 587 | 340 (0 to 0) |
| Severe Erythema Post Dose 3 (N=1327, 672) | 23 | 12 (0 to 0) |
| Any Swelling Post Dose 1 (N=1406, 703) | 151 | 188 (0 to 0) |
| Severe Swelling Post Dose 1 (N=1406, 703) | 8 | 24 (0 to 0) |
| Any Swelling Post Dose 2 (N=1348, 681) | 259 | 270 (0 to 0) |
| Severe Swelling Post Dose 2 (N=1348, 681) | 3 | 11 (0 to 0) |
| Any Swelling Post Dose 3 (N=1327, 672) | 400 | 323 (0 to 0) |
| Severe Swelling Post Dose 3 (N=1327, 672) | 3 | 7 (0 to 0) |
| Any Pyrexia Post Dose 1 (N=1408, 703) | 538 | 473 (0 to 0) |
| Severe Pyrexia Post Dose 1 (N=1408, 703) | 5 | 4 (0 to 0) |
| Any Pyrexia Post Dose 2 (N=1348, 681) | 675 | 457 (0 to 0) |
| Severe Pyrexia Post Dose 2 (N=1348, 681) | 27 | 16 (0 to 0) |
| Any Pyrexia Post Dose 3 (N=1328, 672) | 552 | 445 (0 to 0) |
| Severe Pyrexia Post Dose 3 (N=1328, 672) | 30 | 23 (0 to 0) |
| Any Vomiting Post Dose 1 (N=1408, 703) | 230 | 120 |
| Severe Vomiting Post Dose 1 (N=1408, 703) | 10 | 4 (0 to 0) |
| Any Vomiting Post Dose 2 (N=1348, 681) | 152 | 75 (0 to 0) |
| Severe Vomiting Post Dose 2 (N=1348, 681) | 2 | 4 (0 to 0) |
| Any Vomiting Post Dose 3 (N=1328, 672) | 167 | 95 (0 to 0) |
| Severe Vomiting Post Dose 3 (N=1328, 672) | 17 | 10 (0 to 0) |
| Any Crying Post Dose 1 (N=1409, 703) | 800 | 564 (0 to 0) |
| Severe Crying Post Dose 1 (N=1409, 703) | 21 | 26 (0 to 0) |
| Any Crying Post Dose 2 (N=1348, 681) | 721 | 481 (0 to 0) |
| Severe Crying Post Dose 2 (N=1348, 681) | 9 | 8 (0 to 0) |
| Any Crying Post Dose 3 (N=1327, 672) | 466 | 391 (0 to 0) |
| Severe Crying Post Dose 3 (N=1327, 672) | 9 | 8 (0 to 0) |
| Any Somnolence Post Dose 1 (N=1408, 703) | 635 | 375 (0 to 0) |
| Severe Somnolence Post Dose 1 (N=1408, 703) | 46 | 26 (0 to 0) |
| Any Somnolence Post Dose 2 (N=1348, 681) | 405 | 247 (0 to 0) |
| Severe Somnolence Post Dose 2 (N=1348, 681) | 16 | 12 (0 to 0) |
| Any Somnolence Post Dose 3 (N=1327, 672) | 272 | 204 (0 to 0) |
| Severe Somnolence Post Dose 3 (N=1327, 672) | 12 | 11 (0 to 0) |
| Any Anorexia Post Dose 1 (N=1408, 703) | 388 | 278 (0 to 0) |
| Severe Anorexia Post Dose 1 (N=1408, 703) | 11 | 14 (0 to 0) |
| Any Anorexia Post Dose 2 (N=1348, 681) | 327 | 195 (0 to 0) |
| Severe Anorexia Post Dose 2 (N=1348, 681) | 12 | 11 (0 to 0) |
| Any Anorexia Post Dose 3 (N=1327, 672) | 294 | 189 (0 to 0) |
| Severe Anorexia Post Dose 3 (N=1327, 672) | 18 | 17 (0 to 0) |
| Any Irritability Post Dose 1 (N=1408, 703) | 945 | 576 (0 to 0) |
| Severe Irritability Post Dose 1 (N=1408, 703) | 42 | 47 (0 to 0) |
| Any Irritability Post Dose 2 (N=1348, 681) | 799 | 492 (0 to 0) |
| Severe Irritability Post Dose 2 (N=1348, 681) | 41 | 25 (0 to 0) |
| Any Irritability Post Dose 3 (N=1327, 672) | 546 | 416 (0 to 0) |
| Severe Irritability Post Dose 3 (N=1327, 672) | 11 | 17 (0 to 0) |
Collected over Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection.. Non-serious events are listed at a 5.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T | — | 91/1,423 (6.4%) | 945/1,423 (66.4%) |
| Tritanrix-Hep B/Hib™ + OPV | — | 46/710 (6.5%) | 576/710 (81.1%) |
| Event | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| GastroenteritisInfections and infestations | 21/1423 | 18/710 |
| BronchopneumoniaInfections and infestations | 13/1423 | 3/710 |
| BronchiolitisInfections and infestations | 12/1423 | 6/710 |
| Bronchial ObstructionRespiratory, thoracic and mediastinal disorders | 9/1423 | 1/710 |
| PneumoniaInfections and infestations | 5/1423 | 3/710 |
| Head InjuryInjury, poisoning and procedural complications | 2/1423 | 3/710 |
| Pneumonia viralInfections and infestations | 6/1423 | 2/710 |
| Febrile ConvulsionNervous system disorders | 4/1423 | 1/710 |
| Cardio Respiratory DistressCardiac disorders | 0/1423 | 1/710 |
| Hip DysplasiaCongenital, familial and genetic disorders | 0/1423 | 1/710 |
| Event | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV |
|---|---|---|
| Solicited Irritability post-dose 1General disorders | 945/1410 | 576/703 |
| Solicited Injection Site Pain Post-dose 1General disorders | 831/1410 | 574/703 |
| Solicited Crying Post-dose 1Psychiatric disorders | 800/1411 | 564/703 |
| Solicited Pyrexia Post-dose 2General disorders | 675/1411 | 457/703 |
| Solicited Somnolence Post-dose 1Nervous system disorders | 635/1410 | 375/703 |
| NasopharyngitisInfections and infestations | 742/1411 | 353/703 |
| Solicited Injection site Erythema Post-dose 3General disorders | 587/1410 | 340/703 |
| Solicited Injection Site Swelling Post-dose 3General disorders | 400/1408 | 323/703 |
| Solicited Anorexia Post-dose 1Metabolism and nutrition disorders | 388/1410 | 278/703 |
| PharyngitisInfections and infestations | 395/1411 | 161/703 |
| Age, Categorical(Participants) | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | Total |
|---|---|---|---|
| <=18 years | 1422 | 711 | 2133 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Months) | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | Total |
|---|---|---|---|
| Age Continuous | 1.89 ± 0.195 | 1.88 ± 0.197 | 1.88 ± 0.196 |
| Sex: Female, Male(Participants) | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | Total |
|---|---|---|---|
| Female | 706 | 344 | 1050 |
| Male | 716 | 367 | 1083 |
| Region of Enrollment(Participants) | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | Total |
|---|---|---|---|
| Mexico | 712 | 355 | 1067 |
| Peru | 710 | 356 | 1066 |
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Sanofi Pasteur, a Sanofi Company