Clinical trial NCT00401531: Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
Official title: Immunogenicity Study of a DTaP IPV Hep B PRP T Combined Vaccine in Comparison to Infanrix Hexa™, Both Concomitantly Administered With Prevnar™ at 2, 4, and 6 Months of Age in Thai Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Polio
Diphtheria
Pertussis
Haemophilus Influenzae Type b
Keywords: Hepatitis B
Polio
Diphtheria
Pertussis
H. influenzae type b
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 412
Sex: ALL
Minimum age (years): 50
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth.

Primary Objective:

To demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar®

Secondary Objectives:

Immunogenicity:

To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP\~T and Infanrix™-Hexa) one month after the third dose of the primary series.

Safety:

To describe the overall safety after each injection.


Eligibility criteria: Inclusion Criteria :

* Two month old infant (50 to 71 days old) on the day of inclusion, of either gender.
* Born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 2.5 kg.
* Hepatitis B vaccination since birth.
* Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
* 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 first trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* 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.
* Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy.
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received since birth.
* Any vaccination in the 4 weeks preceding the first trial vaccination.
* Any planned vaccination (except trial vaccinations) during the trial.
* Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically).
* Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae.
* Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity.
* Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
* History of seizures.
* Febrile (rectal equivalent temperature \>= 38.0°C) or acute illness on the day of inclusion.

Primary outcomes:
measure: Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
timeFrame: Day 150 post-dose 1
Secondary outcomes:
measure: Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
timeFrame: Day 150 post-dose 1
measure: Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
timeFrame: Day 150 post-dose 1
measure: Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
timeFrame: Day 150 post-dose 1
measure: Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
timeFrame: Day 150 post-dose 1
measure: Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™
timeFrame: Day 0 up to Day 7 post-vaccination
Other outcomes:
Locations:
city: Bangkok
country: Thailand
city: Khonkaen
country: Thailand
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kosalaraksa P, Thisyakorn U, Benjaponpitak S, Chokephaibulkit K, Santos-Lima E. Immunogenicity and safety study of a new DTaP-IPV-Hep B-PRP-T combined vaccine compared to a licensed DTaP-IPV-Hep B//PRP-T comparator, both concomitantly administered with a 7-valent pneumococcal conjugate vaccine at 2, 4, and 6 months of age in Thai infants. Int J Infect Dis. 2011 Apr;15(4):e249-56. doi: 10.1016/j.ijid.2010.12.004. Epub 2011 Feb 18.