Overview

This trial is active, not recruiting.

Condition pneumococcal pneumonia
Treatments pcv10 and dtap, hepatitis a vaccine, dtap, pcv10
Phase phase 4
Sponsor KEMRI-Wellcome Trust Collaborative Research Program
Collaborator Kenya Ministry of Health
Start date January 2010
End date September 2010
Trial size 600 participants
Trial identifier NCT01028326, SSC 1635

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Experimental)
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
pcv10 and dtap Synflorix
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.
(Experimental)
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.
pcv10 and dtap Synflorix
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.
(Active Comparator)
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.
hepatitis a vaccine, dtap, pcv10 Synflorix
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.

Primary Outcomes

Measure
Serotype-specific anti-pneumococcal antibody responses to vaccination
time frame: Day 0, 30, 90, 210

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 12 months up to 59 months old.

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

Additional Information

Official title Immunogenicity and Reactogenicity of 10-valent Pneumococcal Conjugate Vaccine (PCV10) in Children Aged 12-59 Months
Principal investigator Laura Hammitt, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by KEMRI-Wellcome Trust Collaborative Research Program.