Phase 4
N=389
Immunogenicity of the Booster Dose of Two MenC Vaccines
Meningococcal Infection
Bottom Line
View on ClinicalTrials.gov: NCT00392808 ↗Enrolled (actual)
389
Serious AEs
3.1%
Results posted
Oct 2013
Primary outcome: Primary: Serum Bactericidal Activity Against MenC — 6786; 6278; 2061; 1746 GMTs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- conjugated polysaccharide menC vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Centro Superior de Investigación en Salud Publica
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Bactericidal Activity Against MenC |
6786; 6278; 2061; 1746 | — |
| PRIMARY Serum Antibody Titers Against Haemophilus Influenzae Type b. |
23.8; 30.8; 30.5; 26.0 | — |
Summary
The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to assess the interchangeability of the two different vaccines.
Eligibility Criteria
Inclusion Criteria
- Healthy toddlers of both sexes
- Toddlers of 14 to 19 months of age (including the day that the toddler is 14 and the day before he is 19 months of age)
- Children previously vaccinated with two doses of polysaccharide meningococcal C vaccine conjugated to tetanus toxoid or three doses of polysaccharide meningococcal C conjugated to CRM197 before 7 month of age.
- Informed consent signed by one or both parents who are adequately informed about the study.
Exclusion Criteria
- Toddlers with severe diseases or axilar temperature ≥ 38,0ºC at inclusion time
- Toddlers with severe chronic diseases
- Toddlers who have received any other vaccine within the last month or with a programmed vaccination within the 28 subsequent days after the administration of the vaccine of study.
- Toddlers with clinical or bacteriological diagnosis of previous meningococcal disease.
- Toddlers with hypersensitivity to any of the components of the vaccines to study or antibiotics used during the manufacturing process that could be present as non- detectable traces (streptomycin, neomycin, polymyxin B).
- Toddlers with personal history of convulsions.
- Toddlers with known bleeding disorder no controlled
- Toddlers with known congenital or acquired immunodeficiency
- Toddlers who are receiving or have been received any treatment that could change the immune response (administration of intravenous immunoglobulin, systemic corticosteroids or haemoderivates) within the 3 previous months.
- A toddler that under investigator opinion is probable to be lost during the follow-up
- A toddler that is currently included or is planned to be included in any other clinical trial.
- A toddler that under investigator opinion must not be included in the study due to other medical or social reasons.
Data sourced from ClinicalTrials.gov (NCT00392808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.