Clinical trial NCT00348881: Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Influenza
Keywords: Diphtheria
Tetanus
Pertussis
Hepatitis B Hansenula (HB)
Haemophilus influenzae type b
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 2133
Sex: ALL
Minimum age (years): 42
Maximum age (years): 50
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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
timeFrame: 1 month post third vaccination
measure: 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.
timeFrame: Day 0 to Day 7 post-vaccination
Secondary outcomes:
measure: 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
timeFrame: 1 month post third vaccination
measure: 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
timeFrame: Day 0 to Day 7 after vaccination
Other outcomes:
Locations:
city: Alabang
country: Philippines
state: Muntinlupa City
city: Putatan,
country: Philippines
state: Muntinlupa City
city: Tunasan,
country: Philippines
state: Muntinlupa City
city: Corporate City
country: Philippines
facility: Filinvest
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: