Trial record 1 of 1 for:
E2I43
Immunogenicity and Safety of Pentaxim in South African Infants
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| ClinicalTrials.gov Identifier: NCT00254969 |
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Recruitment Status :
Completed
First Posted : November 17, 2005
Last Update Posted : April 17, 2012
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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Brief Summary:
The present clinical study will assess the immunogenicity and reactogenicity of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diphtheria Tetanus Haemophilus Infections Pertussis Poliomyelitis | Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 212 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Study Start Date : | October 2005 |
| Actual Primary Completion Date : | May 2008 |
| Actual Study Completion Date : | January 2010 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, Im
Other Name: PENTAXIM™ |
Primary Outcome Measures :
- To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine. [ Time Frame: 1 month post-vaccination ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 24 Hours and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Aged < 24 hours on the day of inclusion
Exclusion Criteria:
- At visit 01 (screening)
- Illness at a stage that could interfere with trial conduct or completion.
- Any vaccination preceding the trial participation (except Bacille Calmette-Guerin [BCG])
- Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
- Planned participation in another clinical trial during the present trial period
- Blood or blood-derived products received since birth.
- Mother known as seropositive to HIV or hepatitis B.
- Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of/current seizures at visit 02 (first study vaccination)
- Participation in another clinical trial preceding the first trial vaccination
- Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy.
- 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.
- Any vaccination preceding the first trial vaccination (except BCG)
- History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.
- Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination
Information from the National Library of Medicine
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): NCT00254969
Locations
| South Africa | |
| Soweto, South Africa | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00254969 |
| Other Study ID Numbers: |
E2I43 |
| First Posted: | November 17, 2005 Key Record Dates |
| Last Update Posted: | April 17, 2012 |
| Last Verified: | April 2012 |
Keywords provided by Sanofi:
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Diphteria tetanus haemophilus influenzae type b poliomyelitis pertussis |
Additional relevant MeSH terms:
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Whooping Cough Tetanus Diphtheria Poliomyelitis Haemophilus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Respiratory Tract Infections Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections |
Nervous System Diseases Corynebacterium Infections Actinomycetales Infections Myelitis Central Nervous System Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases Central Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Pasteurellaceae Infections |