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

Study Overview
=================
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.

Official Title
-----------------
Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants

Conditions
-----------------
Diphtheria, Tetanus, Pertussis, Hepatitis B, Influenza

Intervention / Treatment
-----------------
* Biological: DTaP-HB-PRP T combined vaccine
* Biological: Tritanrix-HepB/Hib™ vaccine
* Biological: Oral poliomyelitis vaccine (OPV)


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Six weeks of age Received a dose of Hepatitis B (HB) in the first three days of life Able to attend all scheduled visits and to comply with all trial procedures. 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.

Ages Eligible for Study
-----------------
Minimum Age: 42 Days
Maximum Age: 50 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: DTaP-Hep B-PRP-T + OPV vaccine<br>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. | Biological: DTaP-HB-PRP T combined vaccine<br>* 0.5 mL, Intramuscular<br>Biological: Oral poliomyelitis vaccine (OPV)<br>* Oral co-administered with study vaccine.<br>|
| Active Comparator: Group 2: Tritanrix-HepB/Hib™ + OPV vaccine<br>Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age. | Biological: Tritanrix-HepB/Hib™ vaccine<br>* 0.5 mL, Intramuscular<br>Biological: Oral poliomyelitis vaccine (OPV)<br>* Oral co-administered with study vaccine.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 1 month post 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. | Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections. | Day 0 to Day 7 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 1 month post third vaccination | 
| 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 | 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. | Day 0 to Day 7 after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b