PCV10 Reactogenicity and Immunogenicity Study - Malindi (PRISM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Kenya Ministry of Health
University of Oxford
University of Colorado, Denver
GlaxoSmithKline
Information provided by (Responsible Party):
KEMRI-Wellcome Trust Collaborative Research Program
ClinicalTrials.gov Identifier:
NCT01028326
First received: December 7, 2009
Last updated: December 4, 2015
Last verified: December 2015
  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: December 2016
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   (Child)
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
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: 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 
Study First Received: December 7, 2009
Last Updated: December 4, 2015
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2016