Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

Phase 3

Completed

Interventions: Biological: DTaP-HB-PRP~T combined vaccine
Biological: Tritanrix-HepB/Hib™ vaccine
Biological: Oral poliomyelitis vaccine (OPV)

Brief Summary: This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP\~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Recruitment & Eligibility

Inclusion Criteria

At Screening:

0 to 3 day old infants
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
Apgar score ≥ 7 at three minutes after birth
Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)

At Inclusion:

Exclusion Criteria

At Screening:

Illness at a stage that could interfere with trial conduct or completion
Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth)
Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
Acute illness on the day of screening.

At Screening and at Inclusion:

Blood or blood-derived products received since birth
Planned participation in another clinical trial during the present trial period
Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)

At Inclusion:

Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
Participation in another clinical trial before the first trial vaccination
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
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
Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
History of seizures
Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Arm && Interventions

Group	Intervention	Description
Group 1: DTaP-Hep B-PRP-T + OPV vaccine	DTaP-HB-PRP~T combined vaccine	Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
Group 2: Tritanrix-HepB/Hib™ + OPV vaccine	Tritanrix-HepB/Hib™ vaccine	Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
Group 2: Tritanrix-HepB/Hib™ + OPV vaccine	Oral poliomyelitis vaccine (OPV)	Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
Group 1: DTaP-Hep B-PRP-T + OPV vaccine	Oral poliomyelitis vaccine (OPV)	Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV	1 month post third vaccination	Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.	Day 0 to Day 7 post-vaccination	Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV	Day 0 to Day 7 after vaccination	Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for \>3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV	1 month post third vaccination	Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.