An alternative booster vaccine against meningitis and ear infections.

Phase 1

• Conditions: The study will include healthy children who have already been vaccinated with 2 doses of Prevenar 13 according to the UK routine immunisation schedule at 2 and 4 months of age. Both vaccines used in the study (Prevenar 13 and Synflorix) are licensed for protection against pneumococcal disease. We do not intend to extend the indication of these vaccines further but intend to confirm non-inferiority of a combinatory vaccine schedule compared to the standard schedule with respect to immunogenicity.

• Registration Number: EUCTR2011-005102-30-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-01
• Study Completion: 2014-10-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 178

Inclusion Criteria

• Aged 12 months (-2 weeks to +6 weeks) at time of enrolment. • Have received two doses of PCV-13 at less than 6 months of age with a gap of at least 6 weeks between the two vaccinations. • Have received all primary vaccines according to the UK routine immunisation schedule. • Available for entire study period and whose parent/legal guardian can be reached by telephone. • Healthy children as determined by medical history and physical examination, done by a study nurse (and/or study doctor if required, depending on the medical history of the participant and physical assessment), and judgment of the investigator. • Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Previous receipt of pneumococcal vaccine other than the 13-valent pneumococcal conjugate vaccine (Prevenar 13®, Pfizer). • Receipt of the routine 12-month immunisations (PCV13 (3rd dose), combined Haemophilus influenzae type b and serogroup C meningococcal glyco-conjugate vaccine (Hib-MenC) or measles, mumps and rubella vaccine (MMR)). • A previous anaphylactic reaction to any vaccine or vaccine-related component. • Contraindication to vaccination with pneumococcal conjugate vaccine. • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. • Known or suspected immune deficiency or suppression. • History of culture-proven invasive disease caused by S. pneumoniae. • Major known congenital malformation or serious chronic disorder. • Significant neurologic disorder or history of seizures including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. • Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; e.g., Synagis B). • Parents who plan to move out of the geographical area where the study would be conducted.

Study & Design

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