Clinical trial NCT01028326: PCV10 Reactogenicity and Immunogenicity Study - Malindi
Official title: Immunogenicity and Reactogenicity of 10-valent Pneumococcal Conjugate Vaccine (PCV10) in Children Aged 12-59 Months
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pneumococcal Pneumonia
Keywords: Pneumococcal pneumonia vaccine
Lead sponsor: KEMRI-Wellcome Trust Collaborative Research Program
Sponsor class: OTHER
Collaborators: name: Kenya Ministry of Health
name: University of Oxford
name: University of Colorado, Denver
name: GlaxoSmithKline
First posted: 2009-12-09
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serotype-specific anti-pneumococcal antibody responses to vaccination
timeFrame: Day 0, 30, 90, 210
Secondary outcomes:
measure: Serotype-specific NP carriage of pneumococci
timeFrame: Day 0, 30, 60, 90, 180
measure: Vaccine reactogenicity
timeFrame: Day 0, 3
measure: Immunological memory responses
timeFrame: Day 0, 30, 90, 210
Other outcomes:
Locations:
city: Malindi
country: Kenya
facility: Malindi District Hospital
state: Coast
Study officials:
affiliation: Oxford University, KEMRI-Wellcome Trust
name: Laura Hammitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feazel LM, Santorico SA, Robertson CE, Bashraheil M, Scott JA, Frank DN, Hammitt LL. Effects of Vaccination with 10-Valent Pneumococcal Non-Typeable Haemophilus influenza Protein D Conjugate Vaccine (PHiD-CV) on the Nasopharyngeal Microbiome of Kenyan Toddlers. PLoS One. 2015 Jun 17;10(6):e0128064. doi: 10.1371/journal.pone.0128064. eCollection 2015.
citation: Hammitt LL, Ojal J, Bashraheil M, Morpeth SC, Karani A, Habib A, Borys D, Goldblatt D, Scott JA. Immunogenicity, impact on carriage and reactogenicity of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Kenyan children aged 1-4 years: a randomized controlled trial. PLoS One. 2014 Jan 21;9(1):e85459. doi: 10.1371/journal.pone.0085459. eCollection 2014.