None listed
Conditions
Interventions
Group 1 Type of group
133 infants who will receive three doses of the DTaP-IPV-HB-PRP-T vaccine under investigation at 2, 4 and 6 months of age.
Group name:Group 2 Type of group
133 infants who will receive three doses of Infanrix * Hexa control vaccine at 2, 4 and 6 months of age
Sponsors
SANOFI PASTEUR S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Occurrence, nature, duration, severity and relationship with the vaccination of any unsolicited adverse systemic event reported within 30 minutes of each injection. Measure:Occurrence, nature, duration, severity and relationship with the vaccination of any unsolicited adverse systemic event reported within 30 minutes of each injection. Timepoints:30 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:listed in the CRF and in the diary of the subject Measure:Occurrence, time to onset, number of days of presence and severity of reactions at the injection site and systemic reactions requested (listed in the CRF and in the diary of the subject) that occur up to 7 days after each injection. Timepoints:7 days ; Outcome name:Occurrence, nature, time to onset, duration, intensity and relationship to vaccination (only in the case of systemic adverse events) of unsolicited adverse events (reported spontaneously) occurred up to 30 days after each injection. Measure:Occurrence, nature, time to onset, duration, intensity and relationship to vaccination (only in the case of systemic adverse events) of unsolicited adverse events (reported spontaneously) occurred up to 30 days after each injection. Timepoints:30 days ; Outcome name:Serious adverse events (SAE) occurred during the study (including the 6-month follow-up period). Measure:Serious adverse events (SAE) Timepoints:6 months | — |
Countries
Peru
Contacts
Public ContactLucero Nuñez
MDS PHARMA SERVICES PERU S.A.C
Outcome results
None listed