PCV10 Reactogenicity and Immunogenicity Study - Malindi

Phase 4

• Conditions: Pneumococcal Pneumonia
• Interventions: Biological: hepatitis A vaccine, DTaP, PCV10; Biological: PCV10 and DTaP

• Registration Number: NCT01028326
• Lead Sponsor: KEMRI-Wellcome Trust Collaborative Research Program

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-07
• Study First Posted: 2009-12-09
• Study Start: 2010-01
• Primary Completion: 2010-09
• Status Verified: 2017-07
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-23
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	hepatitis A vaccine, DTaP, PCV10	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.
Group A	PCV10 and DTaP	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
Group B	PCV10 and DTaP	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.

Primary Outcome Measures

Name	Time	Method
Serotype-specific anti-pneumococcal antibody responses to vaccination	Day 0, 30, 90, 210

Secondary Outcome Measures

Name	Time	Method
Immunological memory responses	Day 0, 30, 90, 210
Serotype-specific NP carriage of pneumococci	Day 0, 30, 60, 90, 180
Vaccine reactogenicity	Day 0, 3

Trial Locations

Locations (1)

Malindi District Hospital; 🇰🇪 Malindi, Coast, Kenya