Pneumococcal InfectionPhase 4FPCVNCT03489018
The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants
A Phase 4 study testing PCV10 and PCV13 in people with Pneumococcal Infection and Streptococcus Pneumoniae Infection, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
Trial summary
Before the introduction of pneumonia vaccines in 2000, between 700,000 - 1 million children died each year as a result of infection with the bacteria Streptococcus pneumoniae and the resulting diseases, namely, meningitis, sepsis and pneumonia. Most of the deaths were in Africa and Asia. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection, Streptococcus Pneumoniae Infection, Invasive Pneumococcal Disease, Protection Against
- What is being tested?
- PCV10 and PCV13
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 1 siteKenya
- Study dates
- 21 Mar 2019to 1 Nov 2024
- 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 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants aged 6-8 weeks of age (HIV positive or negative but with no symptoms of current clinical immunosuppression i.e. HIV infection at WHO clinical stage 1);
- Parents are willing to provide informed consent for their child to participate in the study
- Parents and infant are likely to remain in the study area until the infant is 18 months of age and comply with study requirements including the requirement to return to the same health facility to obtain all other childhood vaccines.
Who cannot join
- Infants >8 weeks of age at time of enrolment
- Signs or symptoms of immunosuppression or HIV infection clinical stage 2 or above.
- Acute illness (e.g. febrile disease) on the day of vaccination
- Contraindications precluding vaccination (e.g. hypersensitivity to any component of the vaccine, including diphtheria toxoid)
- Previous PCV vaccination
- Family are planning to migrate out of the study areas before the end of the study follow-up
- Family are planning to obtain the subsequent vaccine doses of the routine immunisation schedule elsewhere and therefore their child may receive a full dose under the routine vaccination programme.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines (PCV10 and PCV13) on Immunogenicity and Vaccine-serotype Carriage in Kenyan Infants
Before the introduction of pneumonia vaccines in 2000, between 700,000 - 1 million children died each year as a result of infection with the bacteria Streptococcus pneumoniae and the resulting diseases, namely, meningitis, sepsis and pneumonia. Most of the deaths were in Africa and Asia. Where the vaccines have been introduced, they have been highly effective and have already reduced disease. However, at 10 USD per child, they are not affordable to most low-income countries without financial support from Gavi, the Vaccine Alliance.
This project aims to assess whether lower doses of the two commercially available pneumonia vaccines can protect Kenyan infants as well as the full dose. The results could be used to increase the affordability of the pneumonia vaccine, and enable delivery of the vaccine to continue in the absence of Gavi support.
Read the detailed description
Background:
PCV is currently the most expensive vaccine in the routine immunisation schedule in Gavi-supported countries. This study aims to provide evidence which may enable a substantial decrease in the cost of PCV programmes, therefore increasing the sustainability of PCV programmes in low and middle income countries (LMICs). We propose to assess whether fractional (20% and 40%) doses of pneumococcal conjugate vaccine (PCV10 and PCV13) in a 2p+1 schedule (2 primary doses followed by a booster dose) induce non-inferior immunogenicity and effects on vaccine-serotype carriage when compared to the full dose. These lower doses could convert new 4-dose vials of PCVs into 10- or 20-dose vials, ready for immediate implementation in LMIC programmes.
Primary objective:
Non-inferior immunogenicity at 1-month post-boost (10 months of age). Non-inferiority will be reached if the lower CI around the ratio of geometric mean concentrations (GMC) of IgG (fractional/full dose) is >0.5 (i.e. the 2-fold criterion).
Secondary objectives:
Non-inferior immunogenicity at 1-month post-primary series (18 weeks of age). Non-inferiority will be achieved if the lower limit of the 95% confidence interval (CI) around the difference in the proportion of 'responders', children with IgG>=0.35 mcg/ml, (fractional dose group - full dose group) is >-10% for at least 8 of the 10 vaccine types in the PCV10 arms and at least 10 of the 13 vaccine types in the PCV13 arms.
The opsonophagocytic activity of the antibody response to 7 serotypes after full/ fractional doses at the 1-month post-boost time point.
The direct vaccine effectiveness of full/fractional doses of PCV13 against carriage of serotypes 6A and 19A, with primary analyses at 18 months of age and secondary analyses at 9 months of age.
The proportion of children with evidence of vaccine-serotype carriage by trial arm at 9 and 18 months of age.
The geometric mean concentration (GMC) of serotype-specific IgG after the primary series of the 2p+1 schedule, prior to boost, at 9 months of age.
The geometric mean concentration (GMC) of serotype-specific IgG after three doses of vaccine in a 2p+1 schedule at 18 months of age.
The carriage prevalence at 9 and 18 months of age and IgG concentrations at 4 weeks after the primary series after full dose of PCV10 in a 3p+0 schedule, and full/ fractional doses of PCV10/13 in a 2p+1 schedule.
Trial design:
A phase IV individually-randomised controlled trial of full or fractional (20% or 40%) doses of PCV10/ PCV13, given as a 3-dose schedule to infants: 2 doses at 6 and 14 weeks of age and a booster dose at 9 months (the 2p+1 schedule) or 3 full doses at 6, 10 and 14 weeks of age (the 3p+0 schedule).
At 6-8 weeks of age, 300 infants will be enrolled at random into each of the seven trial arms and followed until 18 months of age.
The seven trial arms:
- Full dose PCV13 vaccination in a 2p+1 schedule. B. 40% fractional dose PCV13 vaccination in a 2p+1 schedule. C. 20% fractional dose PCV13 vaccination in a 2p+1 schedule. D. Full dose PCV10 vaccination in a 2p+1 schedule. E. 40% fractional dose PCV10 vaccination in a 2p+1 schedule. F. 20% fractional dose PCV10 vaccination in a 2p+1 schedule. G. Full dose PCV10 vaccination in a 3p+0 schedule. This arm would represent the current vaccine and schedule in the Kenyan routine immunisation programme and would act as an additional comparison arm.
Study procedures:
No study procedures will be conducted without prior parental informed consent. Participants in trial arms A-F will provide 3 or 5 blood samples in the course of the trial at enrolment, 4 weeks post-primary series (approximately 18 weeks of age) and 4 weeks post-boost (approximately 10 months of age); additionally a random selection of half the participants will contribute blood samples pre-boost (9 months of age) and at the last study visit (18 months of age).
Participants in trial arm G will provide 2 blood samples (at enrolment and at 4 weeks post-primary series (approximately 18 weeks of age).
All participants will provide 2 nasopharyngeal swabs at approximately 9 and 18 months of age and contribute safety data.
- Conditions
- Pneumococcal Infection, Streptococcus Pneumoniae Infection, Invasive Pneumococcal Disease, Protection Against
- Being tested
- PCV10, PCV13
- Keywords
- Pneumococcal Vaccines;, Immunogenicity, Vaccine, 10-valent pneumococcal vaccine, 13-valent pneumococcal vaccine, Schedule, Pneumococcal Infection, Kenya, Infant, Vaccines, Conjugate, Humans, Immunization schedule, Streptococcus pneumoniae, vaccine, Dose-Response Relationship, immunologic, Equivalence Trial as Topic
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV10Biological
Also called Synflorix (GlaxoSmithKline plc.), 10-valent pneumococcal conjugate vaccine
Experimental arms will receive a lower dose of the intervention than the marketed dose.
PCV13Biological
Also called Prevnar 13 (Pfizer Inc.), 13-valent pneumococcal conjugate vaccine, Prevnar13
Experimental arms will receive a lower dose of the intervention than the marketed dose.
| Study group | Role | What they receive |
|---|---|---|
| Full dose PCV13 (2p+1 schedule) | Active comparator | Full dose PCV13 administration in 2p+1 schedule Receives: Biological: PCV13 |
| 40% dose PCV13 (2p+1 schedule) | Experimental | Fractional (40%) dose PCV13 administration in 2p+1 schedule Receives: Biological: PCV13 |
| 20% dose PCV13 (2p+1 schedule) | Experimental | Fractional (20%) dose PCV13 administration in 2p+1 schedule Receives: Biological: PCV13 |
| Full dose PCV10 (2p+1 schedule) | Active comparator | Full dose PCV10 administration in 2p+1 schedule Receives: Biological: PCV10 |
| 40% dose PCV10 (2p+1 schedule) | Experimental | Fractional (40%) dose PCV10 administration in 2p+1 schedule Receives: Biological: PCV10 |
| 20% dose PCV10 (2p+1 schedule) | Experimental | Fractional (20%) dose PCV10 administration in 2p+1 schedule Receives: Biological: PCV10 |
| Full dose PCV10 (3p+0 schedule) | Active comparator | The current vaccine (PCV10) and schedule (3p+0) in use in the Kenyan routine immunisation programme as an additional comparison arm. Receives: Biological: PCV10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: The ratio of IgG GMCs at 1-month post boost
The ratio of the geometric mean concentrations of IgG after vaccination with 3 full or fractional doses of PCV
Measured: 4-weeks post-boost (approximately 10 months of age)
Secondary outcomes (5)
Immunogenicity: the proportion of children who 'seroconvert' to vaccine-serotypes after vaccination
The proportion of children with vaccine-serotype specific IgG antibody concentrations more than or equal to 0.35 mcg/ml after vaccination
Measured: 4-weeks post-primary series (approximately 18 weeks of age)
The proportion of children with evidence of vaccine-serotype carriage
Vaccine-type carriage prevalence across arms
Measured: Approximately 18 months of age
The proportion of children with evidence of vaccine-serotype carriage
Vaccine-type carriage prevalents across arms
Measured: Approximately 9 months of age
The direct vaccine effectiveness of full/fractional doses of PCV13 against carriage of serotypes 6A and 19A
The direct effectiveness of full/fractional doses of PCV13 in preventing carriage of serotypes 6A and 19A compared to that of full dose PCV10
Measured: Approximately 18 months of age
Opsonophagocytic activity of vaccine-induced antibody to 4 serotypes
Functionality of the antibody response
Measured: Approximately 18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start21 Mar 2019
- Primary completion30 Sep 2022
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Participants will be randomised to one of seven groups for the duration of the study: A. Full dose PCV13 vaccination in a 2p+1 schedule; B. 40% fractional dose PCV13 vaccination in a 2p+1 schedule; C. 20% fractional dose PCV13 vaccination in a 2p+1 schedule; D. Full dose PCV10 vaccination in a 2p+1 schedule; E. 40% fractional dose PCV10 vaccination in a 2p+1 schedule; F. 20% fractional dose PCV10 vaccination in a 2p+1 schedule; G. Full dose PCV10 vaccination in a 3p+0 schedule.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, KEMRI-Wellcome Trust Collaborative Research Program, Bill and Melinda Gates Foundation, National Institute of Health Research (NIHR) Mucosal Pathogens Research Unit (MPRU), Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- J. Anthony G Scott, DTMH FMedSci, Principal investigator, London School of Hygiene & Tropical Medicine, Keppel Street, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489018
- Sponsor's protocol ID
- QA1075
- Acronym
- FPCV
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2018
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be open access and held in the LSHTM data repository (http://datacompass.lshtm.ac.uk/cgi/request\_doc?docid=1); Data access will be granted upon reasonable request after the primary analyses of the trial, as specified, are published.
Publications
Gallagher KE, Lucinde R, Bottomley C, Kaniu M, Suaad B, Mutahi M, Mwalekwa L, Ragab S, Twi-Yeboah L, Berkley JA, Hamaluba M, Karani A, Shangala J, Otiende M, Gardiner E, Mugo D, Smith PG, Tabu C, Were F, Goldblatt D, Scott JAG. Fractional Doses of Pneumococcal Conjugate Vaccine - A Noninferiority Trial. N Engl J Med. 2024 Nov 28;391(21):2003-2013. doi: 10.1056/NEJMoa2314620. Epub 2024 Sep 26.
PubMed 39330966
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines (PCV10 and PCV13) on Immunogenicity and Vaccine-serotype Carriage in Kenyan Infants
- ClinicalTrials.gov ID
- NCT03489018
- Acronym / sponsor ID
- FPCV / QA1075
- Conditions
- Pneumococcal Infection, Streptococcus Pneumoniae Infection, Invasive Pneumococcal Disease, Protection Against
- Keywords
- Pneumococcal Vaccines;, Immunogenicity, Vaccine, 10-valent pneumococcal vaccine, 13-valent pneumococcal vaccine, Schedule, Pneumococcal Infection, Kenya, Infant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,100 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University College, London, KEMRI-Wellcome Trust Collaborative Research Program, Bill and Melinda Gates Foundation, National Institute of Health Research (NIHR) Mucosal Pathogens Research Unit (MPRU), Wellcome Trust
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Before the introduction of pneumonia vaccines in 2000, between 700,000 - 1 million children died each year as a result of infection with the bacteria Streptococcus pneumoniae and the resulting diseases, namely, meningitis, sepsis and pneumonia. Most of the deaths were in Africa and Asia. Where the vaccines have been introduced, they have been highly effective and have already reduced disease. However, at 10 USD per child, they are not affordable to most low-income countries without financial support from Gavi, the Vaccine Alliance.
This project aims to assess whether lower doses of the two commercially available pneumonia vaccines can protect Kenyan infants as well as the full dose. The results could be used to increase the affordability of the pneumonia vaccine, and enable delivery of the vaccine to continue in the absence of Gavi support.
Detailed description
Background:
PCV is currently the most expensive vaccine in the routine immunisation schedule in Gavi-supported countries. This study aims to provide evidence which may enable a substantial decrease in the cost of PCV programmes, therefore increasing the sustainability of PCV programmes in low and middle income countries (LMICs). We propose to assess whether fractional (20% and 40%) doses of pneumococcal conjugate vaccine (PCV10 and PCV13) in a 2p+1 schedule (2 primary doses followed by a booster dose) induce non-inferior immunogenicity and effects on vaccine-serotype carriage when compared to the full dose. These lower doses could convert new 4-dose vials of PCVs into 10- or 20-dose vials, ready for immediate implementation in LMIC programmes.
Primary objective:
Non-inferior immunogenicity at 1-month post-boost (10 months of age). Non-inferiority will be reached if the lower CI around the ratio of geometric mean concentrations (GMC) of IgG (fractional/full dose) is >0.5 (i.e. the 2-fold criterion).
Secondary objectives:
Non-inferior immunogenicity at 1-month post-primary series (18 weeks of age). Non-inferiority will be achieved if the lower limit of the 95% confidence interval (CI) around the difference in the proportion of 'responders', children with IgG>=0.35 mcg/ml, (fractional dose group - full dose group) is >-10% for at least 8 of the 10 vaccine types in the PCV10 arms and at least 10 of the 13 vaccine types in the PCV13 arms.
The opsonophagocytic activity of the antibody response to 7 serotypes after full/ fractional doses at the 1-month post-boost time point.
The direct vaccine effectiveness of full/fractional doses of PCV13 against carriage of serotypes 6A and 19A, with primary analyses at 18 months of age and secondary analyses at 9 months of age.
The proportion of children with evidence of vaccine-serotype carriage by trial arm at 9 and 18 months of age.
The geometric mean concentration (GMC) of serotype-specific IgG after the primary series of the 2p+1 schedule, prior to boost, at 9 months of age.
The geometric mean concentration (GMC) of serotype-specific IgG after three doses of vaccine in a 2p+1 schedule at 18 months of age.
The carriage prevalence at 9 and 18 months of age and IgG concentrations at 4 weeks after the primary series after full dose of PCV10 in a 3p+0 schedule, and full/ fractional doses of PCV10/13 in a 2p+1 schedule.
Trial design:
A phase IV individually-randomised controlled trial of full or fractional (20% or 40%) doses of PCV10/ PCV13, given as a 3-dose schedule to infants: 2 doses at 6 and 14 weeks of age and a booster dose at 9 months (the 2p+1 schedule) or 3 full doses at 6, 10 and 14 weeks of age (the 3p+0 schedule).
At 6-8 weeks of age, 300 infants will be enrolled at random into each of the seven trial arms and followed until 18 months of age.
The seven trial arms:
- Full dose PCV13 vaccination in a 2p+1 schedule. B. 40% fractional dose PCV13 vaccination in a 2p+1 schedule. C. 20% fractional dose PCV13 vaccination in a 2p+1 schedule. D. Full dose PCV10 vaccination in a 2p+1 schedule. E. 40% fractional dose PCV10 vaccination in a 2p+1 schedule. F. 20% fractional dose PCV10 vaccination in a 2p+1 schedule. G. Full dose PCV10 vaccination in a 3p+0 schedule. This arm would represent the current vaccine and schedule in the Kenyan routine immunisation programme and would act as an additional comparison arm.
Study procedures:
No study procedures will be conducted without prior parental informed consent. Participants in trial arms A-F will provide 3 or 5 blood samples in the course of the trial at enrolment, 4 weeks post-primary series (approximately 18 weeks of age) and 4 weeks post-boost (approximately 10 months of age); additionally a random selection of half the participants will contribute blood samples pre-boost (9 months of age) and at the last study visit (18 months of age).
Participants in trial arm G will provide 2 blood samples (at enrolment and at 4 weeks post-primary series (approximately 18 weeks of age).
All participants will provide 2 nasopharyngeal swabs at approximately 9 and 18 months of age and contribute safety data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Participants will be randomised to one of seven groups for the duration of the study: A. Full dose PCV13 vaccination in a 2p+1 schedule; B. 40% fractional dose PCV13 vaccination in a 2p+1 schedule; C. 20% fractional dose PCV13 vaccination in a 2p+1 schedule; D. Full dose PCV10 vaccination in a 2p+1 schedule; E. 40% fractional dose PCV10 vaccination in a 2p+1 schedule; F. 20% fractional dose PCV10 vaccination in a 2p+1 schedule; G. Full dose PCV10 vaccination in a 3p+0 schedule.
| Arm | Type | Receives |
|---|---|---|
| Full dose PCV13 (2p+1 schedule) | Active comparator | Biological: PCV13Full dose PCV13 administration in 2p+1 schedule |
| 40% dose PCV13 (2p+1 schedule) | Experimental | Biological: PCV13Fractional (40%) dose PCV13 administration in 2p+1 schedule |
| 20% dose PCV13 (2p+1 schedule) | Experimental | Biological: PCV13Fractional (20%) dose PCV13 administration in 2p+1 schedule |
| Full dose PCV10 (2p+1 schedule) | Active comparator | Biological: PCV10Full dose PCV10 administration in 2p+1 schedule |
| 40% dose PCV10 (2p+1 schedule) | Experimental | Biological: PCV10Fractional (40%) dose PCV10 administration in 2p+1 schedule |
| 20% dose PCV10 (2p+1 schedule) | Experimental | Biological: PCV10Fractional (20%) dose PCV10 administration in 2p+1 schedule |
| Full dose PCV10 (3p+0 schedule) | Active comparator | Biological: PCV10The current vaccine (PCV10) and schedule (3p+0) in use in the Kenyan routine immunisation programme as an additional comparison arm. |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants aged 6-8 weeks of age (HIV positive or negative but with no symptoms of current clinical immunosuppression i.e. HIV infection at WHO clinical stage 1);
- Parents are willing to provide informed consent for their child to participate in the study
- Parents and infant are likely to remain in the study area until the infant is 18 months of age and comply with study requirements including the requirement to return to the same health facility to obtain all other childhood vaccines.
Key exclusion criteria (7 listed)
- Infants >8 weeks of age at time of enrolment
- Signs or symptoms of immunosuppression or HIV infection clinical stage 2 or above.
- Acute illness (e.g. febrile disease) on the day of vaccination
- Contraindications precluding vaccination (e.g. hypersensitivity to any component of the vaccine, including diphtheria toxoid)
- Previous PCV vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCV10Also: Synflorix (GlaxoSmithKline plc.), 10-valent pneumococcal conjugate vaccineExperimental arms will receive a lower dose of the intervention than the marketed dose. | Biological | 20% dose PCV10 (2p+1 schedule), 40% dose PCV10 (2p+1 schedule), Full dose PCV10 (2p+1 schedule), Full dose PCV10 (3p+0 schedule) |
| PCV13Also: Prevnar 13 (Pfizer Inc.), 13-valent pneumococcal conjugate vaccine, Prevnar13Experimental arms will receive a lower dose of the intervention than the marketed dose. | Biological | 20% dose PCV13 (2p+1 schedule), 40% dose PCV13 (2p+1 schedule), Full dose PCV13 (2p+1 schedule) |
Primary outcome
Immunogenicity: The ratio of IgG GMCs at 1-month post boost
Time frame: 4-weeks post-boost (approximately 10 months of age)
The ratio of the geometric mean concentrations of IgG after vaccination with 3 full or fractional doses of PCV
5 secondary outcomes
Immunogenicity: the proportion of children who 'seroconvert' to vaccine-serotypes after vaccination
Time frame: 4-weeks post-primary series (approximately 18 weeks of age)
The proportion of children with evidence of vaccine-serotype carriage
Time frame: Approximately 18 months of age
The proportion of children with evidence of vaccine-serotype carriage
Time frame: Approximately 9 months of age
The direct vaccine effectiveness of full/fractional doses of PCV13 against carriage of serotypes 6A and 19A
Time frame: Approximately 18 months of age
Opsonophagocytic activity of vaccine-induced antibody to 4 serotypes
Time frame: Approximately 18 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 39330966Gallagher KE, Lucinde R, Bottomley C, Kaniu M, Suaad B, Mutahi M, Mwalekwa L, Ragab S, Twi-Yeboah L, Berkley JA, Hamaluba M, Karani A, Shangala J, Otiende M, Gardiner E, Mugo D, Smith PG, Tabu C, Were F, Goldblatt D, Scott JAG. Fractional Doses of Pneumococcal Conjugate Vaccine - A Noninferiority Trial. N Engl J Med. 2024 Nov 28;391(21):2003-2013. doi: 10.1056/NEJMoa2314620. Epub 2024 Sep 26.
- Individual participant dataSharing planned: Yes. The data will be open access and held in the LSHTM data repository (http://datacompass.lshtm.ac.uk/cgi/request_doc?docid=1); Data access will be granted upon reasonable request after the primary analyses of the trial, as specified, are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Anthony G Scott, DTMH FMedSci principal investigator
London School of Hygiene & Tropical Medicine, Keppel Street, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCV10 and PCV13 in people with Pneumococcal Infection and Streptococcus Pneumoniae Infection, run by London School of Hygiene and Tropical Medicine 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 12 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immunogenicity: The ratio of IgG GMCs at 1-month post boost (time frame: 4-weeks post-boost (approximately 10 months of age)). 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 NCT03489018, which also lists 1 linked publication.
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 12 Nov 2024.