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Status unknownNCT01028326PRISMUpdated Feb 23, 2018

PCV10 Reactogenicity and Immunogenicity Study - Malindi

A Phase 4 interventional study of PCV10 and DTaP and PCV10 and DTaP in Pneumococcal Pneumonia, sponsored by KEMRI-Wellcome Trust Collaborative Research Program. Status unknown at 1 site in Kenya. Open to participants aged 12 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by KEMRI-Wellcome Trust Collaborative Research Program · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
12 Months to 59 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Pneumococcal Pneumonia

Keywords

  • Pneumococcal pneumonia vaccine
03

Who can participate

Ages eligible
12 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 12-59 months
  • Written informed consent

Exclusion criteria

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
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    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

    Biological: PCV10 and DTaP

  • Experimental
    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.

    Biological: PCV10 and DTaP

  • Active comparator
    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.

    Biological: hepatitis A vaccine, DTaP, PCV10

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.

    Also known as: Synflorix

  • BiologicalPCV10 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.

    Also known as: Synflorix

  • 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.

    Also known as: Synflorix

05

What researchers measure

Primary outcomes

  1. Serotype-specific anti-pneumococcal antibody responses to vaccination

    Time frame: Day 0, 30, 90, 210

Secondary outcomes

  1. Serotype-specific NP carriage of pneumococci

    Time frame: Day 0, 30, 60, 90, 180

  2. Vaccine reactogenicity

    Time frame: Day 0, 3

  3. Immunological memory responses

    Time frame: Day 0, 30, 90, 210

06

Study locations

1 site
  • Malindi District Hospital
    Malindi, Coast, Kenya
07

References and documents

Publications

  • 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. PubMed 26083474 ↗
  • 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. PubMed 24465570 ↗
08

Registry details

Key details

Study ID
NCT01028326
Lead sponsor
KEMRI-Wellcome Trust Collaborative Research Program
Collaborators
Kenya Ministry of Health, University of Oxford, University of Colorado, Denver, GlaxoSmithKline
Responsible party
Sponsor
First posted
Dec 9, 2009
Start date
Jan 2010
Primary completion
Sep 2010
Completion
Dec 2018 (estimated)
Last update
Feb 23, 2018

Study contacts

Laura Hammitt, MD
principal investigator · Oxford University, KEMRI-Wellcome Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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