A phase IV, single group study to evaluate the magnitude of antibody response, its persistence and avidity maturation following meningococcal serogroup C conjugate booster vaccination in older children up to ten years after receipt of three doses in infancy and a booster in the second year of life - Nava booster

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001638-34-GB

Enrollment

Registered

2005-08-24

Start date

2006-09-28

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Group C Disease

Interventions

Trade Name: Neis Vac-C Product Name: Neis Vac-C Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: No contraindications to vaccination as specified in the “Green Book” – Immunisation Against Infectious Disease, HMSO. Written informed consent obtained from the child and their parent or legal guardian Child originally enrolled in the primary immunisation study and completed the booster phase in the second year of life 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

Exclusion criteria: Current (to be checked prior to each vaccination): Generalised acute systemic illness on the day of immunisation Oral temperature >38oC on the day of immunisation

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the immunological responses of children over time when vaccinated with MCC-TT up to ten years after completion of vaccination with MCC-TT at 2, 3 and 4 months of age and further MCC or MACP vaccination in the second year of life: ; Secondary Objective: To measure the pre- to post-vaccination mean fold rise in SBA titre and the proportion of subjects with 4 fold rises between these samples. To assess avidity indices of meningococccal group C To assess the cell mediated immune responses ; Primary end point(s): Blood will be tested for responses to the following, in order of priority: 1. Meningococcal serogroup C serum bactericidal antibody titres and IgG concentration 2. Meningococcal serogroup C avidity indices 3. Peripheral blood mononuclear cells (PBMC’s) will be isolated from fresh blood taken into heparinised tubes in order to permit the assessment of memory B cells by flow cytometry Safety data will be collected by subjects using a 7 day health diary 1) local reactions (redness, swelling, tenderness) 2) daily temperature. 3) systemic symptoms. 4) visits to a doctor – hospital or GP	—

Measure

Time frame

Main Objective: To evaluate the immunological responses of children over time when vaccinated with MCC-TT up to ten years after completion of vaccination with MCC-TT at 2, 3 and 4 months of age and further MCC or MACP vaccination in the second year of life: ; Secondary Objective: To measure the pre- to post-vaccination mean fold rise in SBA titre and the proportion of subjects with 4 fold rises between these samples. To assess avidity indices of meningococccal group C To assess the cell mediated immune responses ; Primary end point(s): Blood will be tested for responses to the following, in order of priority: 1. Meningococcal serogroup C serum bactericidal antibody titres and IgG concentration 2. Meningococcal serogroup C avidity indices 3. Peripheral blood mononuclear cells (PBMC’s) will be isolated from fresh blood taken into heparinised tubes in order to permit the assessment of memory B cells by flow cytometry Safety data will be collected by subjects using a 7 day health diary 1) local reactions (redness, swelling, tenderness) 2) daily temperature. 3) systemic symptoms. 4) visits to a doctor – hospital or GP

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026