Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
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| ClinicalTrials.gov Identifier: NCT00313911 |
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Recruitment Status :
Completed
First Posted : April 12, 2006
Results First Posted : November 19, 2012
Last Update Posted : April 21, 2014
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diphtheria Tetanus Pertussis Haemophilus Influenzae Type b Hepatitis B | Biological: DTaP-IPV-HB-PRP~T Biological: Tritanrix-HepB/Hib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2133 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants |
| Study Start Date : | July 2006 |
| Actual Primary Completion Date : | January 2008 |
| Actual Study Completion Date : | February 2008 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Group 1: DTaP-IPV-Hep B-PRP-T |
Biological: DTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular (IM) |
| Active Comparator: Group 2: Tritanrix-Hep B/Hib™+OPV |
Biological: Tritanrix-HepB/Hib
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. [ Time Frame: Day 0 up to Day 7 post-injection ]High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.
- 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 [ Time Frame: Day 30 post-dose 3 ]Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
- Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo [ Time Frame: Day 30 post-dose 3 ]
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.
- Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination [ Time Frame: Day 0 up to Day 7 Post-injection ]
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.
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| Ages Eligible for Study: | 50 Days to 71 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 2 months old infants on the day of inclusion
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses
- Able to attend all scheduled visits and to comply with all trial procedures
- Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.
Exclusion Criteria:
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Subjects with congenital or acquired immunodeficiency in the child's surrounding
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received since birth
- Any vaccination in the 4 weeks preceding the first trial vaccination
- Vaccination planned in the 4 weeks following the trial vaccination
- Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen
- Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)
- Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination
- History of seizures
- Febrile or acute illness on the day of inclusion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313911
| Mexico | |
| Mexico DF, Mexico | |
| Peru | |
| Lima, Peru | |
| Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Publications of Results:
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00313911 |
| Other Study ID Numbers: |
A3L04 |
| First Posted: | April 12, 2006 Key Record Dates |
| Results First Posted: | November 19, 2012 |
| Last Update Posted: | April 21, 2014 |
| Last Verified: | April 2014 |
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Diphtheria Tetanus Pertussis Recombinant Hepatitis B |
Poliomyelitis Haemophilus influenzae type b Tetanus protein |
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Whooping Cough Tetanus Diphtheria Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Hepadnaviridae Infections DNA Virus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Infection Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections |