Effect of Two Versus Three Pneumococcal Conjugate Vaccinations
MNOES
Effect of 2 Versus 3 Pneumococcal Conjugate Vaccinations Prevnar on Nasopharyngeal Carriage, Transmission and Herd-immunity;a Randomized, Controlled Study
2 other identifiers
interventional
1,005
0 countries
N/A
Brief Summary
Two( 2) or three (3) instead of four vaccinations before the age of 6 months with pneumococcal conjugate vaccine are presumed to protect children against invasive pneumococcal disease like meningitis, at least on the short term till 18-24 months of age. The current hypothesis in this study is 2 or 3 vaccinations will protect against IPD but will not alter pneumococcal nasopharyngeal carriage in infants, and consequently not change pneumococcal transmission and induce no herd-immunity. Furthermore, antibody development and memory may benefit from carriage of vaccine type S. pneumoniae
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedAugust 22, 2011
August 1, 2011
2.7 years
September 9, 2005
August 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Nasopharyngeal bacterial (pneumococcal) colonization at 6 weeks, 6, 12, 18 and 24 months in infants and at 12 and 24 months of family members
duration of study, 23 months per subject
transmission to family members( sib, caregiver)
at infants age of 12 and 24 months
Secondary Outcomes (2)
anti-pneumococcal antibody levels at 12 and 24 months of age
23 months
antibody levels and B-memory cells after vaccination at 24 months
23 months
Study Arms (3)
2-dose
EXPERIMENTALPCV7 at age 2 and 4 months
2+1-dose
EXPERIMENTALPCV7 at age 2, 4 and 11 months
Control
NO INTERVENTIONControl group
Interventions
Eligibility Criteria
You may qualify if:
- Newborn infants eligible for participation in the national infant vaccination program in the Netherlands
You may not qualify if:
- a medical condition requiring treatment that can interfere with the effect of vaccinations
- known or suspected allergy to components of the pneumococcal conjugate vaccine
- known or suspected immunodeficiency disease
- previous treatment with plasma or immunoglobulins
- previous vaccinations other than hepatitis B vaccinations
- coagulation disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Netherlands: Ministry of Health, Welfare and Sportscollaborator
- Netherlands Vaccine Institutecollaborator
Related Publications (8)
Biesbroek G, Tsivtsivadze E, Sanders EA, Montijn R, Veenhoven RH, Keijser BJ, Bogaert D. Early respiratory microbiota composition determines bacterial succession patterns and respiratory health in children. Am J Respir Crit Care Med. 2014 Dec 1;190(11):1283-92. doi: 10.1164/rccm.201407-1240OC.
PMID: 25329446DERIVEDBiesbroek G, Bosch AA, Wang X, Keijser BJ, Veenhoven RH, Sanders EA, Bogaert D. The impact of breastfeeding on nasopharyngeal microbial communities in infants. Am J Respir Crit Care Med. 2014 Aug 1;190(3):298-308. doi: 10.1164/rccm.201401-0073OC.
PMID: 24921688DERIVEDBiesbroek G, Wang X, Keijser BJ, Eijkemans RM, Trzcinski K, Rots NY, Veenhoven RH, Sanders EA, Bogaert D. Seven-valent pneumococcal conjugate vaccine and nasopharyngeal microbiota in healthy children. Emerg Infect Dis. 2014 Feb;20(2):201-10. doi: 10.3201/eid2002.131220.
PMID: 24447437DERIVEDvan Westen E, Rodenburg GD, van Gils EJ, Tcherniaeva I, Berbers GA, Cowell L, Goldblatt D, Rots NY, van den Dobbelsteen GP, Sanders EA. Levels and functionality of antibodies after pneumococcal conjugate vaccine in schedules with different timing of the booster dose. Vaccine. 2013 Dec 2;31(49):5834-42. doi: 10.1016/j.vaccine.2013.09.073. Epub 2013 Oct 10.
PMID: 24120678DERIVEDRodenburg GD, van Gils EJ, Veenhoven RH, Bogaert D, van den Dobbelsteen GP, Berbers GA, Sanders EA. Lower immunoglobulin G antibody responses to pneumococcal conjugate vaccination at the age of 2 years after previous nasopharyngeal carriage of Streptococcus pneumoniae. J Pediatr. 2011 Dec;159(6):965-70.e1. doi: 10.1016/j.jpeds.2011.06.011. Epub 2011 Aug 2.
PMID: 21813135DERIVEDvan Gils EJ, Hak E, Veenhoven RH, Rodenburg GD, Bogaert D, Bruin JP, van Alphen L, Sanders EA. Effect of seven-valent pneumococcal conjugate vaccine on Staphylococcus aureus colonisation in a randomised controlled trial. PLoS One. 2011;6(6):e20229. doi: 10.1371/journal.pone.0020229. Epub 2011 Jun 10.
PMID: 21695210DERIVEDvan Gils EJ, Veenhoven RH, Hak E, Rodenburg GD, Keijzers WC, Bogaert D, Trzcinski K, Bruin JP, van Alphen L, van der Ende A, Sanders EA. Pneumococcal conjugate vaccination and nasopharyngeal acquisition of pneumococcal serotype 19A strains. JAMA. 2010 Sep 8;304(10):1099-106. doi: 10.1001/jama.2010.1290.
PMID: 20823436DERIVEDvan Gils EJ, Veenhoven RH, Hak E, Rodenburg GD, Bogaert D, Ijzerman EP, Bruin JP, van Alphen L, Sanders EA. Effect of reduced-dose schedules with 7-valent pneumococcal conjugate vaccine on nasopharyngeal pneumococcal carriage in children: a randomized controlled trial. JAMA. 2009 Jul 8;302(2):159-67. doi: 10.1001/jama.2009.975.
PMID: 19584345DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elisabeth A. M. Sanders, MD, PhD
UMC Utrecht
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. dr.
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
June 1, 2005
Primary Completion
February 1, 2008
Last Updated
August 22, 2011
Record last verified: 2011-08