PCV10 Reactogenicity and Immunogenicity Study - Malindi (PRISM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by KEMRI-Wellcome Trust Collaborative Research Program.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Kenya Ministry of Health
University of Oxford
University of Colorado, Denver
GlaxoSmithKline
Information provided by:
KEMRI-Wellcome Trust Collaborative Research Program
ClinicalTrials.gov Identifier:
NCT01028326
First received: December 7, 2009
Last updated: August 23, 2010
Last verified: August 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serotype-specific NP carriage of pneumococci [ Time Frame: Day 0, 30, 60, 90, 180 ] [ Designated as safety issue: No ]
  • Vaccine reactogenicity [ Time Frame: Day 0, 3 ] [ Designated as safety issue: Yes ]
  • Immunological memory responses [ Time Frame: Day 0, 30, 90, 210 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2010
Estimated Study Completion Date: March 2011
Estimated 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

Ages Eligible for Study:   12 Months to 59 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Laura Hammitt, University of Oxford, KEMRI-Wellcome Trust Research Programme
ClinicalTrials.gov Identifier: NCT01028326     History of Changes
Other Study ID Numbers: SSC 1635
Study First Received: December 7, 2009
Last Updated: August 23, 2010
Health Authority: Kenya: Ethical Review Committee
Kenya: Pharmacy and Poisons Board
United Kingdom: Oxford Tropical Research Ethics Committee

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

ClinicalTrials.gov processed this record on April 23, 2014