Clinical trial NCT00404651: Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
Official title: Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Keywords: Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Invasive Haemophilus influenzae type b.
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 1189
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP\~T vaccine is consistent.

The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP\~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.

The secondary objectives are:

* To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
* To assess the overall safety in each group one month after the third dose of the primary series.


Eligibility criteria: Inclusion Criteria :

* Two months old infants on the day of inclusion
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by one or both parents or by the guardian and two independent witnesses
* Able to attend all scheduled visits and to comply with all trial procedures
* Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.

Exclusion Criteria :

* Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency
* 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
* Blood or blood-derived products received since birth
* Any vaccination in the four weeks preceding the first trial visit
* Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
* Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
* Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
* Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of seizures
* Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Primary outcomes:
measure: Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
timeFrame: Day 150 (one month post-dose 3)
measure: Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.
timeFrame: Day 150 (one month post-dose 3)
measure: Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
timeFrame: Day 150 (one month post-dose 3)
Secondary outcomes:
measure: Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
timeFrame: Day 150 (one month post-dose 3)
measure: Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
timeFrame: Day 0 (pre-each vaccination) up to 7 days post-each dose
Other outcomes:
Locations:
city: Estado de Mexico
country: Mexico
city: Estado de Mexico
country: Mexico
city: Insurgentes Cuicuilco
country: Mexico
city: Monterrey
country: Mexico
city: Puebla
country: Mexico
city: Tlalpan
country: Mexico
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: