Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof E.A.M. Sanders
ORCID ID
Contact details
University Medical Center Utrecht
Department of Pediatric Immunology
HP 06.063.0
P.O. Box 85090
Lundlaan 6
Utrecht
3508 AB
Netherlands
+31 (0)30 2504000
l.sanders@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MINOES 01, STEG R05 008
Study information
Scientific title
Acronym
MINOES
Study hypothesis
Study hypotheses amended as of 22/05/2007:
1. Two vaccinations with 7-valent conjugate vaccine before six months of age will protect against invasive pneumococcal disease in the first 18 to 24 months of life
2. Two vaccinations at 2 and 4 months of age without a booster vaccination at 11 months will have less effect on vaccine-type pneumococcal carriage reduction and therefore also herd-immunity and respiratory tract infections but also less pneumococcal replacement by non-vaccine types and other potentially pathogenic bacteria
3. Anti-pneumococcal antibody development after two vacinations with 7-valent conjugate vacine before six months of age and revaccination at 24 months of age will be equal or better compared with antibody development after two vaccination before six months of age followed by booster vaccination at 11 and 24 months of age. Later vaccination will improve long term protection
Previous study hypothesis:
1. Two vaccinations before the age of 6 months with the pneumococcal conjugate vaccine Prevnar in infants will protect the children against invasive pneumococcal disease.
2. Two vaccinations at 2 and 4 months of age without a booster vaccination at 11 months will have less effect on vaccine-type pneumococcal carriage reduction and therefore also herd-immunity and respiratory tract infections but also less pneumococcal replacement by non-vaccine types and other potentially pathogenic bacteria.
Ethics approval
Approval received from the local medical ethics board (Stichting Therapeutische Evaluatie Geneesmiddelen [STEG], acknowledged by the Centrale Commissie Mensgebonden Onderzoek [CCMO], The Netherlands) on the 21st June 2005 (ref: STEG R05.008, version 6).
First and second amendment (collection of saliva for immunological analysis and extension microbiology research of collected nasopharyngeal swabs in subgroups of children) approved on the 11th September 2006.
Third amendment (addition of booster vaccination at 24 months and blood sampling) approved on the 2nd March 2007 (ref: STEG R05-008, MINOES version 8 dd february 2007).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Invasive pneumococcal disease, Respiratory tract infection.
Added as of 22/05/2007:
Change in: nasopharyngeal carriage after reduced doses 7-valent conjugate vaccine, antipneumococcal antibody development, family transmission of pneumococci
Intervention
Three groups of each 333 newborns:
Group I: Prevnar at age 2 and 4 months
Group II: Prevnar at age 2, 4 and 11 months
Group III: Prevnar at age 24 months
Amendment made as of 22/05/2007:
Groups I and II will receive booster vaccination 7-valent conjugate vaccine at 24 months of age.
Intervention type
Drug
Phase
Not Specified
Drug names
Pneumococcal conjugate vaccine Prevnar
Primary outcome measure
Pneumococcal nasopharyngeal carriage before 2 months of age, and at 6, 12, 18 and 24 months of age in vaccinated children (groups I and II) and controls (group III), and NP pneumococcal carriage of siblings and parents/caregivers when the baby is 12 and 24 months of age (herd immunity).
Secondary outcome measures
1. Determination of pneumococcal (vaccine and non-vaccine serotypes) colonization of infants in the Netherlands before introduction of Prevnar in the National Vaccination Program (group III)
2. Evaluation of replacing pneumococcal serotypes after Prevnar vaccinations
3. Influence of Prevnar vaccinations on other colonizing bacterial species like Staphylococcus, H. influenzae, M. catarrhalis and Streptococcus
4. Anti pneumococcal antibody levels at 12 and 24 months after 2 doses as compared to 2+1 Prevnar vaccinations
5. Relation between invasive pneumococcal disease and pneumococcal colonization in the Netherlands
6. Evaluation of potential reduction of physician-diagnosed acute otitis media and lower respiratory tract infections after pneumococcal conjugate vaccinations
Added as of 22/05/2007:
7. Comparison of anti-pneumococcal antibody levels after vaccinations at 2, 4 and 24 months, at 2, 4, 11 and 24 months and after primo-vaccination at 24 months of age in subgroups of 80 children of groups I, II and III
8. Comparison of B-memory cells after vaccination at 24 months of age after vaccination schemes of groups I, II and III
Overall trial start date
20/06/2005
Overall trial end date
01/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1000 healthy newborns (and family members) who will receive childhood vaccinations according to the national vaccination program, starting at 2 months of age.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
1000
Participant exclusion criteria
Exclusion from the national vaccination program because of the presence of a medical condition requiring treatment that can interfere with the results of vaccinations, known of suspected allergy to components of the vaccine, known or suspected immunodeficiency disease other than IgA or IgG-subclass deficiency, previous treatment with plasma or immunoglobulins, previous vaccinations other than hepatitis B vaccinations, coagulations disorders
Recruitment start date
20/06/2005
Recruitment end date
01/03/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 AB
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
PO Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
The Netherlands Ministry of Health, Welfare and Sport (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list