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

NCT00401531 | Completed Phase 3 Results DMC

• 1 other identifier: A3L12
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hepatitis B; Polio; Diphtheria; Pertussis; Haemophilus Influenzae Type b

Keywords

Hepatitis B; Polio; Diphtheria; Pertussis; H. influenzae type b

Outcome Measures

Primary Outcomes (1)

• 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™

  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.

  Day 150 post-dose 1

Secondary Outcomes (5)

• Number of Participants With Seroprotection Against Diphtheria and Tetanus Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™

  Day 150 post-dose 1

• 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™

  Day 150 post-dose 1

• Number of Participants With Seroconversion Against Pertussis Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™

  Day 150 post-dose 1

• Geometric Mean Titers (GMTs) of Vaccine Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T + Prevnar™ or Infanrix Hexa™ + Prevnar™

  Day 150 post-dose 1

• 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™

  Day 0 up to Day 7 post-vaccination

Study Arms (2)

Group 1: DTaP IPV Hep B PRP T + Prevnar™

EXPERIMENTAL

Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines

Group 2: Infanrix hexa™ + Prevnar™

ACTIVE COMPARATOR

Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines

Interventions

DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines BIOLOGICAL

0.5 mL, IM

Also known as: Prevnar®

Group 1: DTaP IPV Hep B PRP T + Prevnar™

DTaP-HB-IPV and Pneumococcal polysaccharide vaccines BIOLOGICAL

0.5 mL, IM

Also known as: Infanrix™-Hexa, Prevnar®

Group 2: Infanrix hexa™ + Prevnar™

Eligibility Criteria

• Age: 50 Days - 71 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Khonkaen, Thailand

Location

Related Publications (1)

• Kosalaraksa P, Thisyakorn U, Benjaponpitak S, Chokephaibulkit K, Santos-Lima E. Immunogenicity and safety study of a new DTaP-IPV-Hep B-PRP-T combined vaccine compared to a licensed DTaP-IPV-Hep B//PRP-T comparator, both concomitantly administered with a 7-valent pneumococcal conjugate vaccine at 2, 4, and 6 months of age in Thai infants. Int J Infect Dis. 2011 Apr;15(4):e249-56. doi: 10.1016/j.ijid.2010.12.004. Epub 2011 Feb 18.

  PMID: 21334243 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

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

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; 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; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

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 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 16, 2006
• First Posted: November 20, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: August 1, 2008
• Last Updated: April 1, 2014
• Results First Posted: April 1, 2014

Record last verified: 2014-02

Locations

TH (2)