Condition category
Infections and Infestations
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
30/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.onderzoekminoes.nl

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 measures

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

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

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes