PCV10 Reactogenicity and Immunogenicity Study - Malindi

Study Overview
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Brief Summary
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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.

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

Conditions
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Pneumococcal Pneumonia

Intervention / Treatment
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* Biological: PCV10 and DTaP
* Biological: PCV10 and DTaP
* Biological: hepatitis A vaccine, DTaP, PCV10


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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<br>* 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.<br>* Other names: Synflorix;|
| Experimental: Group B<br>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<br>* 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.<br>* Other names: Synflorix;|
| Active Comparator: Group C<br>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<br>* 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.<br>* Other names: Synflorix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific anti-pneumococcal antibody responses to vaccination |  | Day 0, 30, 90, 210 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific NP carriage of pneumococci |  | Day 0, 30, 60, 90, 180 | 
| Vaccine reactogenicity |  | Day 0, 3 | 
| Immunological memory responses |  | Day 0, 30, 90, 210 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal pneumonia vaccine