PCV10 Reactogenicity and Immunogenicity Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2018-12-31

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.

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Detailed Description

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Conditions

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Pneumococcal Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A

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 Type EXPERIMENTAL

PCV10 and DTaP

Intervention Type BIOLOGICAL

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.

Group B

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.

Group Type EXPERIMENTAL

PCV10 and DTaP

Intervention Type BIOLOGICAL

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.

Group C

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 Type ACTIVE_COMPARATOR

hepatitis A vaccine, DTaP, PCV10

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Synflorix Synflorix Synflorix

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

Minimum Eligible Age

12 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes