Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00401531
First received: November 16, 2006
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth.

Primary Objective:

To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar®

Secondary Objectives:

Immunogenicity:

To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series.

Safety:

To describe the overall safety after each injection.


Condition Intervention Phase
Hepatitis B
Polio
Diphtheria
Pertussis
Haemophilus Influenzae Type b
Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity Study of a DTaP IPV Hep B PRP T Combined Vaccine in Comparison to Infanrix Hexa™, Both Concomitantly Administered With Prevnar™ at 2, 4, and 6 Months of Age in Thai Infants

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Achieving Seroprotection Against Hepatitis B and Haemophilus Influenzae Type b Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [ Time Frame: Day 150 post-dose 1 ] [ Designated as safety issue: No ]
    Anti-Hepatitis B antibodies were measured using chemiluminescence detection technology; seroprotection was defined as a titer ≥ 10 mIU/mL. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay; seroprotection was defined as a titer ≥ 0.15 µg/mL.


Secondary Outcome Measures:
  • Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [ Time Frame: Day 150 post-dose 1 ] [ Designated as safety issue: No ]
    Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by an indirect enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined for both as a titer ≥ 0.01 IU/mL.

  • Number of Participants With Seroprotection Against Poliovirus Types 1, 2, and 3 Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [ Time Frame: Day 150 post-dose 1 ] [ Designated as safety issue: No ]
    Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil

  • Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [ Time Frame: Day 150 post-dose 1 ] [ Designated as safety issue: No ]
    Anti pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as ≥ 4 fold increase over baseline.

  • Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [ Time Frame: Day 150 post-dose 1 ] [ Designated as safety issue: No ]
    Anti-hepatitis B antibodies were measured using chemiluminescence detection technology. Anti-Haemophilus influenzae type b (anti-PRP) antibodies were measured by radioimmunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus and anti-Pertussis by enzyme-linked immunosorbent assay (ELISA), and anti-Polio by neutralization assay.

  • Number of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™ [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]

    Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm.

    Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.



Enrollment: 412
Study Start Date: October 2006
Study Completion Date: August 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: DTaP IPV Hep B PRP T + Prevnar™ Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
0.5 mL, IM
Other Name: Prevnar®
Active Comparator: Group 2: Infanrix hexa™ + Prevnar™ Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
0.5 mL, IM
Other Names:
  • Infanrix™-Hexa
  • Prevnar®

  Eligibility

Ages Eligible for Study:   50 Days to 71 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Two month old infant (50 to 71 days old) on the day of inclusion, of either gender.
  • Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kg.
  • Hepatitis B vaccination since birth.
  • Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria :

  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • 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.
  • Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy.
  • 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 4 weeks preceding the first trial vaccination.
  • Any planned vaccination (except trial vaccinations) during the trial.
  • Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically).
  • Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae.
  • Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity.
  • Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
  • History of seizures.
  • Febrile (rectal equivalent temperature >= 38.0°C) or acute illness on the day of inclusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401531

Locations
Thailand
Bangkok, Thailand
Khonkaen, Thailand
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00401531     History of Changes
Other Study ID Numbers: A3L12
Study First Received: November 16, 2006
Results First Received: February 14, 2014
Last Updated: February 14, 2014
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Sanofi:
Hepatitis B
Polio
Diphtheria
Pertussis
H. influenzae type b

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis B
Actinomycetales Infections
Bacterial Infections
Corynebacterium Infections
Digestive System Diseases
DNA Virus Infections
Gram-Positive Bacterial Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014