The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP\~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa) Primary Objective: To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP\~T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months) Secondary Objectives: * To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP\~T and Infanrix®Hexa) one month after the third dose of the primary series. * To assess the overall safety in each group one month after each dose of the primary series and through the entire study.
The present trial will involve two-month old Peruvian infants, randomly assigned to receive three doses of either the investigational or the control vaccine at 2, 4, and 6 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
263
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Lima, Peru
Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™
Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.
Time frame: Day 150 (1 month after dose 3)
Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as: Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL. Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL.
Time frame: Day 150 (1 month after dose 3)
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria.
Time frame: Day 150 (1 month after dose 3)
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia \> 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable.
Time frame: Day 0 up to Day 7 after each injection
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