Clinical trial NCT00654901: Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
Official title: Immunogenicity Study of the Antibody Persistence and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Haemophilus Influenzae Type B Infection
Keywords: Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Invasive Haemophilus influenzae type b.
Haemophilus Influenzae Type B Infection
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-09
Enrollment: 881
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a follow-up of Study A3L11 (NCT00404651).

Immunogenicity

* To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP\~T or Infanrix hexa™.
* To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP\~T in a subset of subjects.

Safety

- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP\~T.


Eligibility criteria: Inclusion Criteria:

* Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age
* Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
* Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the booster vaccination.
* Planned participation in another clinical trial during the present trial period.
* 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 a vaccine containing the same substances.
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received in the last 3 months.
* Any vaccination in the 4 weeks preceding the booster vaccination.
* Any vaccination planned until the next visit.
* History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or microbiologically).
* Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or hepatitis B infection(s) since the end of participation in Study A3L11.
* Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
* Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or Hepatitis C seropositivity.
* Subjects with any related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11.
* History of seizures.
* Febrile (temperature ≥38.0°C) or acute illness on the day of inclusion
* Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; Temperature \>40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for \>3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.

Primary outcomes:
measure: Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
timeFrame: Day 0 (pre-booster) and Day 30 (one month post-booster)
measure: Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
timeFrame: Day 0 (pre-booster) and Day 30 (one month post-booster)
measure: Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
timeFrame: Days 0 up to 7 after any injection
Secondary outcomes:
Other outcomes:
Locations:
city: Estado de Mexico
country: Mexico
city: Insurgentes Cuicuilco
country: Mexico
city: Monterrey
country: Mexico
city: Puebla
country: Mexico
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References: