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Clinical Trials/EUCTR2009-016635-36-FR
EUCTR2009-016635-36-FR
Active, not recruiting
Phase 1

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 sites480 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: 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
DrugsInfanrix Hexa

Overview

Phase
Phase 1
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
480
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 11, 2010
End Date
October 11, 2011
Last Updated
6 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

Similar Trials

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