Meningococcal Infection
Conditions
Keywords
Meningococcal vaccine, Immunization, secondary, vaccines conjugated, Meningococcal disease
Brief 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.
Detailed description
Children 14 to 18 months of life, previously vaccinated with 2 doses of tetanus toxoid conjugated polysaccharide men C vaccine or three doses of the CRM197 conjugated polysaccharide men C vaccine before 7 months of age, are randomized to receive any of the two vaccines. Serum antibody activity against meningococcus C will be measured inmediately before and 4 weeks after the booster dose. Children will also be vaccinated with a combined vaccine containing DTaP+IPV+Hib.
Interventions
BIOLOGICALconjugated polysaccharide menC vaccine
Booster vaccine dose at 14 to 18 months.
Sponsors
Centro Superior de Investigación en Salud Publica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Months to 19 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Bactericidal Activity Against MenC | One month after booster dose |
| Serum Antibody Titers Against Haemophilus Influenzae Type b. | One year |
Countries
Spain
Participant flow
Recruitment details
Recruitment was done in primary care pediatric clinics, between january and may 2007.
Participants by arm
| Arm | Count |
|---|---|
| MENC-CRM/MENC-CRM Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine | 104 |
| MENC-CRM/MENC-TT Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT | 109 |
| MENC-TT/MENC-CRM Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine | 89 |
| MENC-TT/MENC-TT Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine | 87 |
| Total | 389 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 1 | 2 |
| Overall Study | Unable to withdraw blood | 3 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | MENC-CRM/MENC-TT | MENC-TT/MENC-CRM | MENC-CRM/MENC-CRM | MENC-TT/MENC-TT | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 109 Participants | 89 Participants | 104 Participants | 87 Participants | 389 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 1.38 years STANDARD_DEVIATION 0.13 | 1.43 years STANDARD_DEVIATION 0.23 | 1.37 years STANDARD_DEVIATION 0.23 | 1.46 years STANDARD_DEVIATION 0.09 | 1.4 years STANDARD_DEVIATION 0.15 |
| Region of Enrollment Spain | 109 participants | 89 participants | 104 participants | 87 participants | 389 participants |
| Sex: Female, Male Female | 53 Participants | 46 Participants | 58 Participants | 45 Participants | 202 Participants |
| Sex: Female, Male Male | 56 Participants | 43 Participants | 46 Participants | 42 Participants | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 87 | 1 / 89 | 6 / 109 | 5 / 104 |
| serious Total, serious adverse events | 3 / 87 | 5 / 89 | 2 / 109 | 2 / 104 |
Outcome results
Primary
Serum Antibody Titers Against Haemophilus Influenzae Type b.
Time frame: One year
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MENC-TT/MENC-TT | Serum Antibody Titers Against Haemophilus Influenzae Type b. | 23.8 GMCs |
| MENC-TT/MENC-CRM | Serum Antibody Titers Against Haemophilus Influenzae Type b. | 30.8 GMCs |
| MENC-CRM/MENC-TT | Serum Antibody Titers Against Haemophilus Influenzae Type b. | 30.5 GMCs |
| MENC-CRM/MENC-CRM | Serum Antibody Titers Against Haemophilus Influenzae Type b. | 26.0 GMCs |
Primary
Serum Bactericidal Activity Against MenC
Time frame: One month after booster dose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MENC-TT/MENC-TT | Serum Bactericidal Activity Against MenC | 6786 GMTs |
| MENC-TT/MENC-CRM | Serum Bactericidal Activity Against MenC | 6278 GMTs |
| MENC-CRM/MENC-TT | Serum Bactericidal Activity Against MenC | 2061 GMTs |
| MENC-CRM/MENC-CRM | Serum Bactericidal Activity Against MenC | 1746 GMTs |