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Impact of the 7 Valent Pneumococcal Conjugate Vaccine (7vPCV) on Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Jordanian Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by German-Jordanian University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
German-Jordanian University
ClinicalTrials.gov Identifier:
NCT00900978
First received: March 16, 2009
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

Nasopharyngeal (NP) colonization of S. pneumoniae in infants is generally acquired at approximately 4-6 months of age. Although there are differences in the prevalence and rank order of serotypes obtained from NP specimens and from those with invasive diseases, pneumococcal nasopharyngeal isolates may reflect the strains circulating in the community and may be used as a marker to predict serotype prevalence of invasive disease and resistance patterns. The information about pneumococcal strains found in Jordanian children and NP-carriage of infants is limited and do not include children living in rural regions. Monitoring serotype distribution is essential for the appropriate application of vaccination. Vaccine use in infants proves to be highly efficacious in the prevention of invasive pneumococcal disease as well as in decreasing the carriage of vaccine serotypes in the nasopharynx of infants which impacted significantly in the long run on otitis media infection and helped decrease the infection rates among contacts of these infants. The result has been a decrease in the pneumococcal infection rate among elderly contacts of these infants and decrease colonization with pneumococci. In order to determine the pneumococcal serotypes which are prevalent among infants attending day care centers (DCCs) in Jordan, a study of these types circulating among infants will be determined over a period of 15 months in 250-300 children attending the DCCs in Ajlun-City by taking 3 NP-swabs, the first before the first vaccine injection in May 2009, the second before the third injection at 10 months of age and the third swab sample is taken at 1 year of age (2-3 months after the last injection with the 7vPCV. The aims of this study were to determine the frequency of NP-carriage and serotype distribution of the strains isolated from infants less than 2 years old, and to get an insight about the coverage of the available and future pneumococcal conjugate vaccines developed for this infectious agent. Good results of this study project would make recommendations for the Ministry of Health (MOH) to include the vaccine in the National Vaccination Program. 15000 doses of the 7v PCV (Prevenar) were donated from Wyeth Pharmaceutical company to the MOH of Jordan in September 2008. These will be vaccinated in a vaccine program (for free) over 15 months period in 2009-2010 in one city in north Jordan called Ajlun. This city has 3676 births per year (Statistics of the MOH 2007). The vaccination program will start from the 18th of May, 2009, and ending in August 2010. The way the vaccine will be given is 2 + 1 injections as recommended by the vaccination committee of the MOH.


Condition Intervention Phase
Streptococcus Pneumoniae
Biological: 7 valent pneumococcal conjugate vaccine (7v-PCV) - Prevenar
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of the 7 Valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Carriage of S. Pneumoniae in Healthy Jordanian Infants.

Resource links provided by NLM:


Further study details as provided by German-Jordanian University:

Primary Outcome Measures:
  • Decrease colonization with S. pneumoniae. [ Time Frame: 1.5 years maximum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Decrease infections related to S. pneumoniae by infants and indirectly elderly of same families and decrease use of Antibiotics and therefore the resistance [ Time Frame: 1.5 years to finish the whole trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 377
Study Start Date: May 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 7v-PCV (Prevenar)
Biological/vaccine
Biological: 7 valent pneumococcal conjugate vaccine (7v-PCV) - Prevenar
The 7v-PCV will be given to children below 2 years of age. Nasopharyngeal swabs will be taken from the children before vaccination and after finishing the vaccination. The vaccine will be given in a 2+1 scheme.
Other Name: PREVENAR

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All infants who were enrolled in the time period May 18th, 2009 to August 10th, 2010, would have the 7v PCV
  • Those infants who have no exclusion criteria

Exclusion Criteria:

  • Isolates from the same patient as duplicates will not be considered
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900978

Locations
Jordan
German Jordanian University
Amman, Jordan, 11180
Sponsors and Collaborators
German-Jordanian University
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Adnan AL-lahham, PhD German Jordanian University/ School of Applied Medical Sciences/ P.O.Box 35247 Amman/ 11180 Amman, Jordan
  More Information

No publications provided

Responsible Party: Dr Adnan Al-Lahham, German Jordanian University
ClinicalTrials.gov Identifier: NCT00900978     History of Changes
Other Study ID Numbers: 0887X1-4611, GPR01703
Study First Received: March 16, 2009
Last Updated: September 29, 2009
Health Authority: Jordan: Ethical Committee

Keywords provided by German-Jordanian University:
Streptococcus pneumoniae
carriage
Resistance
Serotype
vaccination
Colonization of S. pneumoniae

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 25, 2014