Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants
- Conditions
- -Z278 Need for immunisation against other combinations of infectious diseasesNeed for immunisation against other combinations of infectious diseasesZ278
- Registration Number
- PER-120-07
- Lead Sponsor
- SANOFI PASTEUR S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Infants two months of age (OS at 71 days of age) on the day of inclusion, of both sexes.
• Born at term (> 37 weeks) and with a birth weight> 2.5 kg.
• Negative mother for hepatitis B surface antigen (HBsAg) in the last trimester of pregnancy (from> 29 weeks of amenorrhea) or in the 4 weeks after delivery.
• Informed consent form signed by both parents. If one or both parents are under 18 years of age, the subject´s grandparents must also sign. You must also sign an independent witness if the parents / grandparents are illiterate.
• Ability to attend all scheduled visits and complete all study procedures.
• Have received the BCG vaccine between birth and month of life, according to the national immunization schedule.
• Participation in another clinical study in the 4 weeks prior to the first vaccination of the study.
• Planned participation in another clinical study during the period of this study.
• Known systemic hypersensitivity to any component of the vaccine, or a history of life-threatening reactions by administration of the study vaccine or a vaccine containing the same substances.
• Congenital or acquired immunodeficiency, or immunosuppressive therapies such as therapy with long-term systemic corticosteroids (more than 2 weeks) in the last four weeks
• Chronic disease in a stage that could interfere with the completion or completion of the study.
• Administration of blood or blood products from birth.
• Any vaccination applied in the 4 weeks prior to the first vaccination of the study.
• Any planned vaccination during the study (up to V06), except for study vaccines, rotavirus vaccine and conjugated pneumococcal vaccines.
• Documented history of infections due to pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b (clinically, serologically or microbiologically confirmed).
• Prevaccination against pertussis, tetanus, diphtheria, polio, hepatitis B or Haemophilus influenzae type b infections.
• Personal or mother´s known background of seropositive status to human immunodeficiency virus, hepatitis B or hepatitis C.
• Known thrombocytopenia or bleeding disorder for which an FM application is contraindicated.
• History of seizures.
• Febrile illness (temperature> 38.0 ° C) or acute on the day of inclusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Occurrence, nature, duration, severity and relationship with the vaccination of any unsolicited adverse systemic event reported within 30 minutes of each injection.<br>Measure:Occurrence, nature, duration, severity and relationship with the vaccination of any unsolicited adverse systemic event reported within 30 minutes of each injection.<br>Timepoints:30 minutes<br>
- Secondary Outcome Measures
Name Time Method