To demonstrate that DTaP-IPV-HB-PRP\~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject. To evaluate the overall safety in terms of: Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial. Immunogenicity: To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP\~T vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,133
0.5 mL, Intramuscular (IM)
0.5 mL, Intramuscular
Unnamed facility
Mexico City, Mexico
Unnamed facility
Lima, Peru
Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.
High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.
Time frame: Day 0 up to Day 7 post-injection
Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
Time frame: Day 30 post-dose 3
Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.
Time frame: Day 30 post-dose 3
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable.
Time frame: Day 0 up to Day 7 Post-injection
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