PCV10 Reactogenicity and Immunogenicity Study - Malindi

Pneumococcal Pneumonia Clinical Trial

— PRISM  

Official title:

Immunogenicity and Reactogenicity of 10-valent Pneumococcal Conjugate Vaccine (PCV10) in Children Aged 12-59 Months

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01028326
• Other study ID #: SSC 1635
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 7, 2009
• Last updated: February 22, 2018
• Start date: January 2010
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: KEMRI-Wellcome Trust Collaborative Research Program
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 2018
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Pneumonia
• Pneumonia
• Pneumonia, Pneumococcal

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Kenya	Malindi District Hospital	Malindi	Coast

Sponsors (5)

Lead Sponsor	Collaborator
KEMRI-Wellcome Trust Collaborative Research Program	GlaxoSmithKline, Kenya Ministry of Health, University of Colorado, Denver, University of Oxford

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serotype-specific anti-pneumococcal antibody responses to vaccination		Day 0, 30, 90, 210
Secondary	Serotype-specific NP carriage of pneumococci		Day 0, 30, 60, 90, 180
Secondary	Vaccine reactogenicity		Day 0, 3
Secondary	Immunological memory responses		Day 0, 30, 90, 210