Status:
COMPLETED
Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neisseria Meningitidis
Haemophilus Influenzae Type b
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose p...
Detailed Description
This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.
Eligibility Criteria
Inclusion
- All subjects must satisfy the following criteria at study entry:
- A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Born after 36 to 42 weeks of gestation.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, \>= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- 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 vaccination, or planned administration during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
- History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- • Current febrile illness or axillary temperature ≥37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration
Key Trial Info
Start Date :
June 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2010
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT00871338
Start Date
June 24 2009
End Date
December 9 2010
Last Update
June 6 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Ely, Cambridgeshire, United Kingdom, CB7 4HF
2
GSK Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
3
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
4
GSK Investigational Site
Bristol, United Kingdom, BS2 8AE