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

• 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; MedDRA version: 9.1Level: PTClassification code 10027274Term: Meningococcal infection; MedDRA version: 9.1Level: LLTClassification code 10061353Term: Pneumococcal infection; MedDRA version: 9.1Level: LLTClassification code 10013023Term: Diphtheria; MedDRA version: 9.1Level: LLTClassification code 10043376Term: Tetanus; MedDRA version: 9.1Level: LLTClassification code 10034738Term: Pertussis; MedDRA version: 9.1Level: LLTClassification code 10018955Term: Haemophilus meningitis; MedDRA version: 9.1Level: LLTClassification code 10036008Term: Polio

• Registration Number: EUCTR2007-004056-36-GB
• Lead Sponsor: Health Protection Agency

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

None

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified