Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children
NCT ID: NCT01619462
Last Updated: 2014-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2011-11-30
2016-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea
NCT00219401
PCV13 in Non-pregnant Papua New Guinean Women
NCT04183322
Pneumococcal Conjugate Vaccine Followup
NCT01414504
Using Pneumococcal Vaccines in Combination for Maximum Protection From Ear and Lung Infections in First 3 Years of Life
NCT01735084
Pneumococcal Vaccination of Fiji Infants
NCT00170612
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. There is a lack of data worldwide on immunogenicity in populations with very high early onset of dense URT carriage.
2. The EPI immunisation schedule is very accelerated in PNG (ages 1,2 and 3 months).
3. There are not data on functional antibody to PCVs in PNG.
4. There are no data on NTHi Protein D antibody responses in PNG and worldwide in population with very high URT carriage rates from a young age, i.e. those most likely to benefit from a vaccine including NTHi protein carrier.
5. It is important to investigate impact of vaccine on carriage density in view of our finding of limited impact of 7vPCV on URT carriage.
6. There is no data on antibody responses following 10v or 13v PCV to booster with PPV as young as 9 months of age (which would be the most appropriate within the current PNG EPI schedule and in the many other third world countries).
7. There is no data on antibody responses (including functional assays) to 23vPPV challenge at age 2 years after 23vPPV booster at age 9 months in children primed with PCV.
8. The broad range of serotypes causing IPD in PNG necessitates continuing consideration of 23vPPV as a potential booster at age 9 months.
9. Serotype-specific B cell memory is an important aspect that we can now test to address immunological safety of PPV in children primed with PCV.
10. The Global Alliance for Vaccines and Immunisation (GAVI) and the World Health Organisation (WHO) have committed to the introduction of PCV for infants in GAVI-eligible countries (including PNG) using novel funding mechanism. In PNG, the introduction of a PCV is planned for 2013.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Synflorix or PCV10
130 children will receive Synflorix at 1-2-3 months
Prevenar 13 and Synflorix
260 children will be randomized to receive either Prevenar 13 or Synflorix at 1-2-3 months. At 9 months 65 children in the Prevenar 13 arm and 65 children in the Synflorix arm will receive booster dose of Pneumovax and at 23 months all children will receive a micro dose of Pneumovax.Blood will be collected at 1, 4, 9, 10, 23 and 24 months to determine serotype-specific antibody responses. Nasopharyngeal swabs will also be collected to measure carriage of pneumococci and non-typeable Haemophilus influenzae.
Prevenar 13
130 children will receive Prevenar 13 at 1-2-3 months
Prevenar 13 and Synflorix
260 children will be randomized to receive either Prevenar 13 or Synflorix at 1-2-3 months. At 9 months 65 children in the Prevenar 13 arm and 65 children in the Synflorix arm will receive booster dose of Pneumovax and at 23 months all children will receive a micro dose of Pneumovax.Blood will be collected at 1, 4, 9, 10, 23 and 24 months to determine serotype-specific antibody responses. Nasopharyngeal swabs will also be collected to measure carriage of pneumococci and non-typeable Haemophilus influenzae.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prevenar 13 and Synflorix
260 children will be randomized to receive either Prevenar 13 or Synflorix at 1-2-3 months. At 9 months 65 children in the Prevenar 13 arm and 65 children in the Synflorix arm will receive booster dose of Pneumovax and at 23 months all children will receive a micro dose of Pneumovax.Blood will be collected at 1, 4, 9, 10, 23 and 24 months to determine serotype-specific antibody responses. Nasopharyngeal swabs will also be collected to measure carriage of pneumococci and non-typeable Haemophilus influenzae.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Birth weigh \< 2000 g (2kg)
* Severe congenital abnormalities
* Mother or child known to be HIV positive
28 Days
35 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The University of Western Australia
OTHER
Papua New Guinea Institute of Medical Research
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William S Pomat, PhD
Role: PRINCIPAL_INVESTIGATOR
Papua New Guinea Institute of Medical Research
Deborah Lehmann, MSc
Role: PRINCIPAL_INVESTIGATOR
Telethon Institute for Child Health Research
Peter Richmond, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Western Australia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Papua New Guinea Institute of Medical Research
Goroka, Eastern Highlands Province, Papua New Guinea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Orami T, Aho C, Ford RL, Pomat WS, Greenhill A, Kirkham LA, Masiria G, Nivio B, Britton KJ, Jacoby P, Richmond PC, van den Biggelaar AHJ, Lehmann D. Pneumococcal carriage, serotype distribution, and antimicrobial susceptibility in Papua New Guinean children vaccinated with PCV10 or PCV13 in a head-to-head trial. Vaccine. 2023 Aug 23;41(37):5392-5399. doi: 10.1016/j.vaccine.2023.07.026. Epub 2023 Jul 20.
Martinovich KM, Rahman T, de Gier C, Seppanen EJ, Orami T, Granland CM, Francis J, Yoannes M, Corscadden KJ, Ford R, Jacoby P, van den Biggelaar AHJ, Bakaletz LO, Cripps AW, Lehmann D, Richmond PC, Pomat WS, Kirkham LS, Thornton RB. Differences in Pneumococcal and Haemophilus influenzae Natural Antibody Development in Papua New Guinean Children in the First Year of Life. Front Immunol. 2021 Aug 10;12:725244. doi: 10.3389/fimmu.2021.725244. eCollection 2021.
Rahman T, de Gier C, Orami T, Seppanen EJ, Granland CM, Francis JP, Michael A, Yoannes M, Corscadden KJ, Ford RL, Martinovich KM, Jacoby P, van den Biggelaar AHJ, Lehmann D, Richmond PC, Pomat WS, Thornton RB, Kirkham LS. PCV10 elicits Protein D IgG responses in Papua New Guinean children but has no impact on NTHi carriage in the first two years of life. Vaccine. 2021 Jun 11;39(26):3486-3492. doi: 10.1016/j.vaccine.2021.05.022. Epub 2021 May 21.
Pomat WS, van den Biggelaar AHJ, Wana S, Francis JP, Solomon V, Greenhill AR, Ford R, Orami T, Passey M, Jacoby P, Kirkham LA, Lehmann D, Richmond PC; 10v13v PCV Trial Team. Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in a High-risk Population: A Randomized Controlled Trial of 10-Valent and 13-Valent Pneumococcal Conjugate Vaccine in Papua New Guinean Infants. Clin Infect Dis. 2019 Apr 24;68(9):1472-1481. doi: 10.1093/cid/ciy743.
Lehmann D, Kirarock W, van den Biggelaar AHJ, Passey M, Jacoby P, Saleu G, Masiria G, Nivio B, Greenhill A, Orami T, Francis J, Ford R, Kirkham LA, Solomon V, Richmond PC, Pomat WS; 10v13v PCV trial team. Rationale and methods of a randomized controlled trial of immunogenicity, safety and impact on carriage of pneumococcal conjugate and polysaccharide vaccines in infants in Papua New Guinea. Pneumonia (Nathan). 2017 Dec 25;9:20. doi: 10.1186/s41479-017-0044-z. eCollection 2017.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PCV1103
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.