Pertussis and Meningitis C Concomitant Vaccination in Adolescents

• Status: Completed
• Trial end date: 2017-03-31
• Target enrollment: 0
• Participant gender: All

Summary

The trial includes groups receiving various combinations of meningitis C and pertussis containing vaccines, to be administered concomitantly in adolescents due their school leaving booster vaccinations (as per UK routine immunisation schedule at 13-17 years of age). Immunogenicity and reactogenicity will be assessed.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Public Health England
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Participant is willing and able to give written informed consent for participation. If aged below 16 years, parent/legal guardian gives consent while the participant gives written assent for participation in the study.

• Male or female aged 13 years and 6 months (+0 day) to 17 years (+364 days) on the day of consent.

• Completed childhood meningococcal serogroup C and pertussis vaccination according to the UK (catch-up and/or routine) schedule appropriate for the participant's age

Exclusion Criteria:

-

The participant may not enter the study if ANY of the following apply:

• Any contraindication to vaccination as specified in the "Green Book"- Immunisation against Infectious Disease.

• Significant illness including progressive neurological disease or seizure disorder; confirmed or suspected immunosuppressive or immunodeficient conditions; major congenital defects; or known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time).

• Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

• History of invasive meningococcal disease or pertussis.

• Significant contact (household or intimate exposure) to an individual with culture proven Neisseria meningitis disease or pertussis in the previous 60 days.

• Received the routine teenage booster dose of tetanus/diphtheria/polio

• Pregnancy

Temporary Exclusion Criteria

• Fever (sublingual temperature ≥ 38°C)

• Received systemic antibiotic(s) (either oral or parenteral) within the past 7 days. For all visits, if allowed by the study visit window, receipt of systemic antibiotics (either oral or parenteral) will delay venepuncture until at least 7 days after cessation of antibiotics.

• Received any blood or blood products within the past 12 weeks.

• Received another investigational agent within 90 days - or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial to the end of this study.

• Possibility of pregnancy