EUCTR2007-004056-36-GB
Active, not recruiting
Not Applicable
A Phase IV, randomised study to evaluate the immune response of UK infants receiving DTaP/Hib/IPV, meningococcal C conjugate and pneumococcal conjugate vaccines, antibody persistence and responses to booster doses in the second year of life. (code: Sched2) - Sched2
ConditionsAll products arre vaccines and are given to healthy volunteers to induce immunological responses to provide protection against:Pediacel - tetanus, diphtheria, polio, pertussis (whooping cough), Haemophilus influenza ttype b (Hib disease)Menjugate and Nies-VacC - meningococcal C diseasePrevenar - pneumococcal diseaseMedDRA version: 9.1Level: PTClassification code 10027274Term: Meningococcal infectionMedDRA version: 9.1Level: LLTClassification code 10061353Term: Pneumococcal infectionMedDRA version: 9.1Level: LLTClassification code 10013023Term: DiphtheriaMedDRA version: 9.1Level: LLTClassification code 10043376Term: TetanusMedDRA version: 9.1Level: LLTClassification code 10034738Term: PertussisMedDRA version: 9.1Level: LLTClassification code 10018955Term: Haemophilus meningitisMedDRA version: 9.1Level: LLTClassification code 10036008Term: Polio
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- All products arre vaccines and are given to healthy volunteers to induce immunological responses to provide protection against:Pediacel - tetanus, diphtheria, polio, pertussis (whooping cough), Haemophilus influenza ttype b (Hib disease)Menjugate and Nies-VacC - meningococcal C diseasePrevenar - pneumococcal disease
- Sponsor
- Health Protection Agency
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •No contraindications to vaccination as specified in the Green Book” – Immunisation Against Infectious Disease, HMSO.
- •Written informed consent obtained from the parent or legal guardian of the infant
- •Infant aged no less than 7 weeks exactly, and no more than 11 weeks 6 days
- •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
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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