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Completed

NCT Number: NCT00401531

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

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.

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Key information

Conditions

Hepatitis B Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Pertussis Picornaviridae Infections Polio Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Virus Diseases Whooping Cough

Age range

50 day–71 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

0.5 mL, IM

Other names: Prevnar®

DTaP-HB-IPV and Pneumococcal polysaccharide vaccines

Biological

0.5 mL, IM

Other names: Infanrix™-Hexa, Prevnar®

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™

    Time frame: Day 150 post-dose 1

    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 outcomes

  1. 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

    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.

  2. 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

    Anti poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Seroprotection was defined as a titer ≥ 8 1/dil

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Nov 20, 2006
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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