PCV10 Reactogenicity and Immunogenicity Study - Malindi (PRISM)

KEMRI-Wellcome Trust

Status and phase: Unknown; Phase 4

Conditions: Pneumococcal Pneumonia

Treatments: Biological: PCV10 and DTaP; Biological: hepatitis A vaccine, DTaP, PCV10

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01028326

SSC 1635

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 12 to 59 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 3 patient groups

Group A

Experimental group

Description:

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

Treatment:

Biological: PCV10 and DTaP

Group B

Experimental group

Description:

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.

Treatment:

Biological: PCV10 and DTaP

Group C

Active Comparator group

Description:

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.

Treatment:

Biological: hepatitis A vaccine, DTaP, PCV10