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Clinical Trials/EUCTR2009-016635-36-DE
EUCTR2009-016635-36-DE
Active, not recruiting
Not Applicable

A phase II, open-label, randomised, multicentre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine, when given to healthy infants at 2, 4 and 12 months of age. - DTPA-HBV-IPV=HIB-MENC-TT-003

GlaxoSmithKline Biologicals0 sites468 target enrollmentJanuary 11, 2010
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ConditionsPrimary and booster immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, serogroup C meningococcal, rotavirus and pneumococcal diseases.MedDRA version: 14.0Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: PTClassification code 10043376Term: TetanusSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: PTClassification code 10067470Term: Rotavirus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: PTClassification code 10034738Term: PertussisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: PTClassification code 10013023Term: DiphtheriaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: PTClassification code 10036012Term: PoliomyelitisSystem Organ Class: 10021881 - Infections and infestations
DrugsInfanrix Hexa

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary and booster immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, serogroup C meningococcal, rotavirus and pneumococcal diseases.
Sponsor
GlaxoSmithKline Biologicals
Enrollment
468
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 11, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow\-up visits).
  • •\-A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination.
  • •\-Born after a gestation period of 36 to 42 weeks inclusive.
  • •\-Written informed consent obtained from the parent(s) LAR(s) of the subject.
  • •\-Healthy subjects as established by medical history and clinical examination before entering into the study.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •The following criteria should be checked at the time of study entry. If ANY exclusion
  • •criterion applies, the subject must not be included in the study:
  • •Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • •Chronic administration (defined as more than 14 days) of immunosuppressants or
  • •other immune\-modifying drugs since birth. For corticosteroids, this will mean
  • •prednisone \= 0\.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • •Child in care.
  • •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • •Administration of a vaccine not foreseen by the study protocol within 30 days prior
  • •to randomisation, or planned administration from randomisation to the end of the

Outcomes

Primary Outcomes

Not specified

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A phase II, open-label, randomised, multicentre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine, when given to healthy infants at 2, 4 and 12 months of age. - DTPA-HBV-IPV=HIB-MENC-TT-003Primary and booster immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, serogroup C meningococcal, rotavirus and pneumococcal diseases.MedDRA version: 12.1Level: LLTClassification code 10043376Term: TetanusMedDRA version: 12.1Level: LLTClassification code 10013023Term: DiphtheriaMedDRA version: 12.1Level: LLTClassification code 10034738Term: PertussisMedDRA version: 12.1Level: LLTClassification code 10019731Term: Hepatitis BMedDRA version: 12.1Level: LLTClassification code 10036012Term: PoliomyelitisMedDRA version: 12.1Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionMedDRA version: 12.1Level: LLTClassification code 10027274Term: Meningococcal infectionMedDRA version: 12.1Level: LLTClassification code 10067470Term: Rotavirus infectionMedDRA version: 12.1Level: LLTClassification code 10061353Term: Pneumococcal infection
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