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Pneumococcal PneumoniaPhase 4PRISMNCT01028326

PCV10 Reactogenicity and Immunogenicity Study - Malindi

A Phase 4 study testing PCV10 and DTaP and hepatitis A vaccine, DTaP, PCV10 in people with Pneumococcal Pneumonia, run by KEMRI-Wellcome Trust Collaborative Research Program at 1 site in Kenya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 59 monthsHealthy volunteers can take part
Conditions the study is for
Pneumococcal Pneumonia
What is being tested?
PCV10 and DTaP and hepatitis A vaccine, DTaP, PCV10
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteKenya
Study dates
Jan 2010to Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 59 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age 12-59 months
  • Written informed consent

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Malindi District Hospital

    Malindi, Coast

Other trials in Kenya

About this study

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

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.

Being tested
PCV10 and DTaP, hepatitis A vaccine, DTaP, PCV10
Keywords
Pneumococcal pneumonia vaccine
Medical subject headings
Pneumonia, Pneumococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCV10 and DTaPBiological

    Also called Synflorix

    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.

  • PCV10 and DTaPBiological

    Also called Synflorix

    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.

  • hepatitis A vaccine, DTaP, PCV10Biological

    Also called Synflorix

    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 groups in NCT01028326
Study groupRoleWhat they receive
Group AExperimentalGroup 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
Receives: Biological: PCV10 and DTaP
Group BExperimentalGroup 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.
Receives: Biological: PCV10 and DTaP
Group CActive comparatorGroup 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.
Receives: Biological: hepatitis A vaccine, DTaP, PCV10

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 0, 30, 90, 210

Secondary outcomes (3)

  1. Serotype-specific NP carriage of pneumococci

    Measured: Day 0, 30, 60, 90, 180

  2. Vaccine reactogenicity

    Measured: Day 0, 3

  3. Immunological memory responses

    Measured: Day 0, 30, 90, 210

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionSep 2010
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01028326
Sponsor's protocol ID
SSC 1635
Acronym
PRISM
Status last verified
Jul 2017
First submitted
7 Dec 2009
Last updated
23 Feb 2018
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PCV10 and DTaP and hepatitis A vaccine, DTaP, PCV10 in people with Pneumococcal Pneumonia, run by KEMRI-Wellcome Trust Collaborative Research Program at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serotype-specific anti-pneumococcal antibody responses to vaccination (time frame: Day 0, 30, 90, 210). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01028326, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.

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