Pneumococcal Infections Clinical Trial
— sched1Official title:
Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
| NCT number | NCT00197808 |
| Other study ID # | sched1 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | April 2005 |
| Est. completion date | January 2010 |
| Verified date | August 2018 |
| Source | Public Health England |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.
| Status | Completed |
| Enrollment | 392 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 7 Weeks to 11 Weeks |
| Eligibility |
Inclusion Criteria: - Written informed consent obtained from parent or legal guardian of infant - Age 7-11 weeks at first dose Exclusion Criteria: - Any contraindications to vaccination as specified in the UK Handbook "Immunisation Against Infectious Disease" (Ed 1996) - < 7 weeks or > 11 weeks at first dose |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Gloucestershire Primary Care Trusts | Gloucester | |
| United Kingdom | Hertfordshire Primary Care Trusts | Welwyn Garden City | Hertfordshire |
| Lead Sponsor | Collaborator |
|---|---|
| Public Health England |
United Kingdom,
Goldblatt D, Southern J, Ashton L, Richmond P, Burbidge P, Tasevska J, Crowley-Luke A, Andrews N, Morris R, Borrow R, Cartwright K, Miller E. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and to — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Immunogenicity | SBA men C responses | 3 months after last sample |
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