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

NCT00404651 | Completed Phase 3 Results DMC

• 1 other identifier: A3L11
• Study Type: interventional
• Target: 1,189
• Locations: 1 country
• Sites: 6

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.

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis

Keywords

Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Invasive Haemophilus influenzae type b.

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  Day 150 (one month post-dose 3)

• 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.

  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.

  Day 150 (one month post-dose 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

  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).

  Day 150 (one month post-dose 3)

Secondary Outcomes (2)

• Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine

  Day 150 (one month post-dose 3)

• 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

  Day 0 (pre-each vaccination) up to 7 days post-each dose

Study Arms (4)

Group 1

EXPERIMENTAL

Participants receive vaccine Batch A

Biological: DTaP-IPV-HB-PRP~T vaccine

Group 2

EXPERIMENTAL

Participants receive vaccine Batch B

Biological: DTaP-IPV-HB-PRP~T vaccine

Group 3

EXPERIMENTAL

Participants receive vaccine Batch C

Biological: DTaP-IPV-HB-PRP~T vaccine

Group 4

ACTIVE COMPARATOR

Participants receive Infanrix hexa™

Biological: DTaP-HBV-IPV vaccine

Interventions

DTaP-IPV-HB-PRP~T vaccine BIOLOGICAL

0.5 mL, intramuscular (IM)

Group 1

DTaP-HBV-IPV vaccine BIOLOGICAL

0.5 mL, IM

Also known as: INFANRIX®HEXA

Group 4

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (6)

Unknown Facility

Estado de México, 56613, Mexico

Location

Unknown Facility

Estado de México, Mexico

Location

Unknown Facility

Insurgentes Cuicuilco, Mexico

Location

Unknown Facility

Monterrey, Mexico

Location

Unknown Facility

Puebla City, Mexico

Location

Unknown Facility

Tlalpan, 14050, Mexico

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis

Interventions

DTaP-IPV-HB-PRP-T vaccine; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 29, 2006
• Study Start: November 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2008
• Last Updated: May 9, 2014
• Results First Posted: May 9, 2014

Record last verified: 2014-04

Locations

ME (6)