A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Aug 6, 2010

Keywords

ClinConnect Summary

Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6 months of age and Rotarix™ at 2 and 4 months of age.

All participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.

Gender

ALL

Eligibility criteria

• Inclusion Criteria :
• • Two month old infants (55 to 65 days old) 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 as per local requirements.
• • Able to attend all scheduled visits and to comply with all trial procedures.
• • Received Hepatitis B and Bacille de Calmette-Guérin (BCG) vaccines between birth and one month of life in agreement with the national immunization calendar.
• 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.
• • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroid therapy.
• • Known 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, in the opinion of the Investigator.
• • Blood or blood-derived products received since birth that might interfere with the assessment of the immune response.
• • Any vaccination before trial vaccination (except Hepatitis B and Bacille de Calmette Guérin given at birth).
• • Any planned vaccination until 1 month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines).
• • Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or Hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
• • Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infections.
• • Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C seropositivity.
• • Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intramuscular (IM) vaccination.
• • History of seizures or encephalopathy.
• • Febrile illness (temperature ≥ 38.0°C), or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment.