Clinical trial NCT00362336: Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
Official title: Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to CombAct-HIB® Concomitantly Administered With Engerix B® Paediatric and OPV at 6, 10, and 14 Weeks of Age in South African 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: 2006-08-10
Enrollment: 622
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule

The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth.

The secondary Objectives are:

To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.

To describe Immunogenicity after the primary series and prior to and after a booster vaccination.


Eligibility criteria: Inclusion Criteria:

* 0 to 3 day old infants
* Mother seronegative for Human Immunodeficiency Virus (HIV)
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Apgar score \>7 at 5 or 10 minutes of life
* Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Current or planned participation in another clinical trial during the entire duration of the present trial
* Suspected congenital or acquired immunodeficiency
* Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received since birth
* Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from birth to 18 weeks of age
* Oral Poliovirus Vaccine (OPV) administration at birth
* Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C seropositivity
* Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
* History of seizures
* Febrile or acute illness on the day of inclusion.

Primary outcomes:
measure: Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
timeFrame: 1 month post-Dose 3
Secondary outcomes:
measure: Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
timeFrame: 1 month post-Dose 3
measure: Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
timeFrame: Day 42 before Dose 1 and 1 month post-Dose 3
measure: Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV
timeFrame: Day 540 pre-booster and Day 570 post-booster
measure: Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV
timeFrame: Day 540 pre-booster and Day 570, post-booster
measure: Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).
timeFrame: Day 0 up to Day 7 post each dose
measure: Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
timeFrame: Day 0 up to 7 post-booster vaccination
Other outcomes:
Locations:
city: Soweto
country: South Africa
state: Johannesburg
city: Bertsham
country: South Africa
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Madhi SA, Mitha I, Cutland C, Groome M, Santos-Lima E. Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. Pediatr Infect Dis J. 2011 Apr;30(4):e68-74. doi: 10.1097/INF.0b013e31820b93d2.