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PCV10 Reactogenicity and Immunogenicity Study - Malindi (PRISM)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028326
First Posted: December 9, 2009
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Kenya Ministry of Health
University of Oxford
University of Colorado, Denver
GlaxoSmithKline
Information provided by (Responsible Party):
KEMRI-Wellcome Trust Collaborative Research Program
  Purpose
The World Health Organization has recommended that developing countries should incorporate pneumococcal conjugate vaccine (PCV) into their routine immunization schedules. The Kenya Ministry of Health anticipates introducing a new formulation of PCV, PCV10, into the routine childhood immunization schedule in 2010. In the areas of Kenya that have been designated to monitor the impact of vaccine, a catch-up campaign will be implemented to vaccinate children aged 12-59 months. PCV10 has been found to be safe and effective in infants. It is licensed for use in children up to 2 years of age, but its use as a primary series in children over age 12 months has not been evaluated. This study will assess the immunogenicity and reactogenicity of PCV10 first administered at an age of 12-59 months.

Condition Intervention Phase
Pneumococcal Pneumonia Biological: PCV10 and DTaP Biological: hepatitis A vaccine, DTaP, PCV10 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Reactogenicity of 10-valent Pneumococcal Conjugate Vaccine (PCV10) in Children Aged 12-59 Months

Resource links provided by NLM:


Further study details as provided by KEMRI-Wellcome Trust Collaborative Research Program:

Primary Outcome Measures:
  • Serotype-specific anti-pneumococcal antibody responses to vaccination [ Time Frame: Day 0, 30, 90, 210 ]

Secondary Outcome Measures:
  • Serotype-specific NP carriage of pneumococci [ Time Frame: Day 0, 30, 60, 90, 180 ]
  • Vaccine reactogenicity [ Time Frame: Day 0, 3 ]
  • Immunological memory responses [ Time Frame: Day 0, 30, 90, 210 ]

Estimated Enrollment: 600
Study Start Date: January 2010
Estimated Study Completion Date: December 2017
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Group A of children will receive 2 doses of PCV10 vaccine, one at the time of enrolment and one 2 months later, followed by a dose of DTaP vaccine 4 months later
Biological: PCV10 and DTaP
A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 60 and a 0.5 mL intramuscular dose of DTaP on day 180.
Other Name: Synflorix
Experimental: Group B
Group B of children will receive PCV10 vaccine, followed by a dose of DTaP vaccine after 2 months, and another dose of PCV10 4 months later.
Biological: PCV10 and DTaP
A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 180 and a 0.5 mL dose of DTaP on day 60.
Other Name: Synflorix
Active Comparator: Group C
Group C of children will receive a dose of hepatitis A vaccine, followed by a dose of DTaP vaccine after 2 months, and another dose of hepatitis A 4 months later, along with a dose of PCV10.
Biological: hepatitis A vaccine, DTaP, PCV10
A nurse will administer a 0.5mL intramuscular dose of hepatitis A vaccine on day 0 and day 180; a 0.5 mL intramuscular dose of DTaP on day 60; and a 0.5 mL dose of PCV10 on day 180.
Other Name: Synflorix

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 12-59 months
  • Written informed consent

Exclusion Criteria:

  • Current febrile illness (temperature >38.5°C)
  • Previous receipt of any pneumococcal vaccine
  • Previous receipt of a DTP-containing vaccine after the 1st year of life
  • Previous receipt of hepatitis A vaccine
  • Severe malnutrition (mid upper arm circumference <11.5 cm) or other serious medical condition (e.g., malignancy, AIDS, tuberculosis)
  • Seizures within the previous 6 months or progressive neurological illness
  • Known allergies to vaccines or vaccine components
  • Resident in the Kilifi Demographic Surveillance area
  • Intention to leave the study area in the next 6 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028326


Locations
Kenya
Malindi District Hospital
Malindi, Coast, Kenya
Sponsors and Collaborators
KEMRI-Wellcome Trust Collaborative Research Program
Kenya Ministry of Health
University of Oxford
University of Colorado, Denver
GlaxoSmithKline
Investigators
Principal Investigator: Laura Hammitt, MD Oxford University, KEMRI-Wellcome Trust
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: KEMRI-Wellcome Trust Collaborative Research Program
ClinicalTrials.gov Identifier: NCT01028326     History of Changes
Other Study ID Numbers: SSC 1635
First Submitted: December 7, 2009
First Posted: December 9, 2009
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by KEMRI-Wellcome Trust Collaborative Research Program:
Pneumococcal pneumonia vaccine

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Vaccines
Immunologic Factors
Physiological Effects of Drugs