Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

NCT00348881 | Completed Phase 3 Results DMC

• 1 other identifier: AL201
• Study Type: interventional
• Target: 2,133
• Locations: 1 country
• Sites: 4

Brief Summary

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP\~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Conditions

Diphtheria; Tetanus; Pertussis; Hepatitis B; Influenza

Keywords

Diphtheria; Tetanus; Pertussis; Hepatitis B Hansenula (HB); Haemophilus influenzae type b

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV

  Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.

  1 month post third vaccination

• Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.

  Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.

  Day 0 to Day 7 post-vaccination

Secondary Outcomes (2)

• Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV

  1 month post third vaccination

• Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV

  Day 0 to Day 7 after vaccination

Study Arms (2)

Group 1: DTaP-Hep B-PRP-T + OPV vaccine

EXPERIMENTAL

Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.

Biological: DTaP-HB-PRP~T combined vaccine; Biological: Oral poliomyelitis vaccine (OPV)

Group 2: Tritanrix-HepB/Hib™ + OPV vaccine

ACTIVE COMPARATOR

Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.

Biological: Tritanrix-HepB/Hib™ vaccine; Biological: Oral poliomyelitis vaccine (OPV)

Interventions

DTaP-HB-PRP~T combined vaccine BIOLOGICAL

0.5 mL, Intramuscular

Group 1: DTaP-Hep B-PRP-T + OPV vaccine

Tritanrix-HepB/Hib™ vaccine BIOLOGICAL

0.5 mL, Intramuscular

Group 2: Tritanrix-HepB/Hib™ + OPV vaccine

Oral poliomyelitis vaccine (OPV) BIOLOGICAL

Oral co-administered with study vaccine.

Group 1: DTaP-Hep B-PRP-T + OPV vaccine; Group 2: Tritanrix-HepB/Hib™ + OPV vaccine

Eligibility Criteria

• Age: 42 Days - 50 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• At Screening:
• to 3 day old infants
• Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
• Apgar score ≥ 7 at three minutes after birth
• Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
• Six weeks of age
• Received a dose of Hepatitis B (HB) in the first three days of life
• Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• At Screening:
• Illness at a stage that could interfere with trial conduct or completion
• Any vaccination before HB vaccination (except bacille Calmette-Guérin \[BCG\] given at birth)
• Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
• Acute illness on the day of screening.
• Blood or blood-derived products received since birth
• Planned participation in another clinical trial during the present trial period
• Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
• Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
• Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)
• Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
• Participation in another clinical trial before the first trial vaccination
• Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (4)

Unknown Facility

Alabang, Muntinlupa City, Philippines

Location

Unknown Facility

Putatan, Muntinlupa City, Philippines

Location

Unknown Facility

Tunasan, Muntinlupa City, Philippines

Location

Filinvest

Corporate City, Philippines

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Influenza, Human; Haemophilus Infections

Interventions

Poliovirus Vaccine, Oral

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; Orthomyxoviridae Infections; RNA Virus Infections; Pasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Poliovirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 6, 2006
• Study Start: June 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: June 1, 2008
• Last Updated: October 22, 2013
• Results First Posted: October 22, 2013

Record last verified: 2013-08

Locations

PH (4)