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

December 7, 2009
August 23, 2010
January 2010
September 2010   (final data collection date for primary outcome measure)
Serotype-specific anti-pneumococcal antibody responses to vaccination [ Time Frame: Day 0, 30, 90, 210 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028326 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
PCV10 Reactogenicity and Immunogenicity Study - Malindi
Immunogenicity and Reactogenicity of 10-valent Pneumococcal Conjugate Vaccine (PCV10) in Children Aged 12-59 Months

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Pneumococcal Pneumonia
  • 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
  • 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
  • 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
  • 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
    Intervention: Biological: PCV10 and DTaP
  • 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.
    Intervention: Biological: PCV10 and DTaP
  • 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.
    Intervention: Biological: hepatitis A vaccine, DTaP, PCV10
Hammitt LL, Ojal J, Bashraheil M, Morpeth SC, Karani A, Habib A, Borys D, Goldblatt D, Scott JA. Immunogenicity, impact on carriage and reactogenicity of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Kenyan children aged 1-4 years: a randomized controlled trial. PLoS One. 2014 Jan 21;9(1):e85459. doi: 10.1371/journal.pone.0085459. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
March 2011
September 2010   (final data collection date for primary outcome measure)

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
Both
12 Months to 59 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01028326
SSC 1635
No
Dr. Laura Hammitt, University of Oxford, KEMRI-Wellcome Trust Research Programme
KEMRI-Wellcome Trust Collaborative Research Program
  • Kenya Ministry of Health
  • University of Oxford
  • University of Colorado, Denver
  • GlaxoSmithKline
Principal Investigator: Laura Hammitt, MD Oxford University, KEMRI-Wellcome Trust
KEMRI-Wellcome Trust Collaborative Research Program
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP