PCV10 Reactogenicity and Immunogenicity Study - Malindi

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01028326

Acronym

PRISM

Enrollment

600

Registered

2009-12-09

Start date

2010-01-31

Completion date

2018-12-31

Last updated

2018-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Pneumonia

Keywords

Pneumococcal pneumonia vaccine

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.

Interventions

BIOLOGICALPCV10 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.

BIOLOGICALhepatitis 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Months to 59 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026