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Trial record 2 of 2 for:    A3L11

Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00404651
Recruitment Status : Completed
First Posted : November 29, 2006
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Biological: DTaP-IPV-HB-PRP~T vaccine Biological: DTaP-HBV-IPV vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : November 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : July 2008


Arm Intervention/treatment
Experimental: Group 1
Participants receive vaccine Batch A
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, intramuscular (IM)

Experimental: Group 2
Participants receive vaccine Batch B
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM

Experimental: Group 3
Participants receive vaccine Batch C
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM

Active Comparator: Group 4
Participants receive Infanrix hexa™
Biological: DTaP-HBV-IPV vaccine
0.5 mL, IM
Other Name: INFANRIX®HEXA




Primary Outcome Measures :
  1. 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 [ Time Frame: Day 150 (one month post-dose 3) ]
    Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.

  2. 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. [ Time Frame: Day 150 (one month post-dose 3) ]
    Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.

  3. 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 [ Time Frame: Day 150 (one month post-dose 3) ]
    Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).


Secondary Outcome Measures :
  1. Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine [ Time Frame: Day 150 (one month post-dose 3) ]
    Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).

  2. 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 [ Time Frame: Day 0 (pre-each vaccination) up to 7 days post-each dose ]
    Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability



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Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404651


Locations
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Mexico
Estado de Mexico, Mexico, 56613
Estado de Mexico, Mexico
Insurgentes Cuicuilco, Mexico
Monterrey, Mexico
Puebla, Mexico
Tlalpan, Mexico, 14050
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00404651     History of Changes
Other Study ID Numbers: A3L11
First Posted: November 29, 2006    Key Record Dates
Results First Posted: May 9, 2014
Last Update Posted: May 9, 2014
Last Verified: April 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Invasive Haemophilus influenzae type b.

Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Hepatitis B
Poliomyelitis
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases