Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

NCT00831311 | Completed Phase 2 Results

• 1 other identifier: A3L02
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP\~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series. Secondary Objectives:
• To describe in each group the immunogenicity parameters one month after the three-dose primary series.
• To describe safety profile after each vaccination in both groups.

Conditions

Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b; Poliomyelitis

Keywords

Diphtheria; Tetanus; Pertussis; Whooping cough; Hepatitis B; Poliomyelitis; Haemophilus influenzae type b

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®

  Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.

  1 month post last vaccination

• Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®

  Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.

  Day 150 (1 month post-vaccination 3)

• Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®

  Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).

  Day 150 (1 month post-vaccination 3)

• Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®

  Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).

  Day 150 (1 month post-vaccination 3)

Secondary Outcomes (3)

• Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™

  Day 0 up to Day 7 post-vaccination

• Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®

  Day 0 up to Day 7 post-vaccination

• Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®

  Day 0 up to Day 7 post-vaccination

Study Arms (2)

1

EXPERIMENTAL

DTaP IPV HB-PRP\~T vaccine group

Biological: DTaP-IPV-HB-PRP~T

2

ACTIVE COMPARATOR

PENTAXIM™ and ENGERIX B® vaccines group

Biological: DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine

Interventions

DTaP-IPV-HB-PRP~T BIOLOGICAL

0.5 mL, Intramuscular

1

DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine BIOLOGICAL

0.5 mL, Intramuscular (right and left thighs, respectively)

Also known as: PENTAXIM™, ENGERIX B® PEDIATRICO

2

Eligibility Criteria

• Age: 50 Days - 70 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infant of either gender, aged 50 to 70 days inclusive
• Mother is negative for HBsAg
• Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
• Written informed consent form signed by at least one parent or by another legal representative and an independent witness
• Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.

You may not qualify if:

• Current or planned enrolment in another clinical trial during the clinical trial period
• Known mother's history of Human Immunodeficiency Virus (HIV) infection
• Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)
• Receipt of blood-derived products since birth
• Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial
• Occurrence of seizures since birth
• Hypersensitivity to any of the vaccine components
• Coagulopathy contraindicating intramuscular injection
• History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases
• History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections
• Vaccination within the last 4 weeks.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Córdoba, Argentina

Location

Related Publications (1)

• Tregnaghi MW, Zambrano B, Santos-Lima E. Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. Pediatr Infect Dis J. 2011 Jun;30(6):e88-96. doi: 10.1097/INF.0b013e318212eb80.

  PMID: 21372751 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Haemophilus Infections; Poliomyelitis; Hepatitis B

Interventions

DTaP-IPV-HB-PRP-T vaccine; Pentavac

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; Pasteurellaceae Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Monitor

  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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: October 1, 2004
• Primary Completion: November 1, 2005
• Study Completion: March 1, 2007
• Last Updated: December 17, 2013
• Results First Posted: November 21, 2013

Record last verified: 2013-11

Locations

AR (1)