Pneumococcal InfectionsNCT04183322
PCV13 in Non-pregnant Papua New Guinean Women
An observational study of Pneumococcal Infections, run by Telethon Kids Institute at 1 site in Papua New Guinea.
Trial summary
This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- 13-valent pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- 10 May 2016to 10 Apr 2018
- Phase
- Observational
- 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 18 to 45 years
- Women only
- Adult
Study population: 50 healthy non-pregnant women aged between 18-45 years old living in Goroka, Papua New Guinea.
Who may be able to join
- Healthy
- Non-pregnant
- 18-45 years old
Who cannot join
- Known hypersensitivity to any vaccine component
- Known/suspected to be immunocompromised
- Receipt of corticosteroids ≤30 days before
- Pregnant (pregnancy tests will be performed)
- Not being well at the time of vaccination
- Plan to travel out of the area in the month post-vaccination
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site
Papua New Guinea Institute of Medical Research
Goroka, Eastern Hghlands Province, 441
About this study
Official title: Reactogenicity and Immunogenicity of Pneumococcal Conjugate Vaccination in Non-pregnant Papua New Guinean Women
This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea.
- Conditions
- Pneumococcal Infections
- Being tested
- 13-valent pneumococcal conjugate vaccine
- Keywords
- Pneumococcal conjugate vaccine, PCV, Reactogenicity, Immunogenicity, Women childbearing age
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-valent pneumococcal conjugate vaccineBiological
Also called PCV13, 13-valent PCV, Prevnar13, Prevenar13
| Study group | Role | What they receive |
|---|---|---|
| Women of childbearing age | Healthy non-pregnant women between 18 and 45 years old living in Goroka, Papua New Guinea, will receive one dose of 13-valent pneumococcal conjugate vaccine (PCV). Receives: Biological: 13-valent pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
Mean Fold Increase (MFI; and 95% CI) in vaccine-serotype specific IgG concentrations at 28 days after compared to baseline (before vaccination)
Measured: 28 days
Secondary outcomes (2)
Reactogenicity
Proportion (% \& 95% CI) of participants with local and systemic side effects 24-48 hours after vaccination
Measured: 24-48 hours after vaccination
Adverse events
Proportion (% \& 95% CI) of participants reporting any unexpected adverse effect (AE) during 28 days after vaccination
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start10 May 2016
- Primary completion14 Sep 2016
- Study completion10 Apr 2018
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 InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telethon Kids Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183322
- Sponsor's protocol ID
- IRB 1515
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Javati S, Masiria G, Elizah A, Matlam JP, Ford R, Richmond PC, Lehmann D, Pomat WS, van den Biggelaar AHJ. An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of childbearing age in Papua New Guinea. Pneumonia (Nathan). 2020 Nov 25;12(1):13. doi: 10.1186/s41479-020-00076-1.
PubMed 33292822
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactogenicity and Immunogenicity of Pneumococcal Conjugate Vaccination in Non-pregnant Papua New Guinean Women
- ClinicalTrials.gov ID
- NCT04183322
- Acronym / sponsor ID
- IRB 1515
- Conditions
- Pneumococcal Infections
- Keywords
- Pneumococcal conjugate vaccine, PCV, Reactogenicity, Immunogenicity, Women childbearing age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Telethon Kids InstituteUniversity, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research
- Study start
- 10 May 2016 (actual)
- Primary completion
- 14 Sep 2016 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 3 Dec 2019 (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.
This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women of childbearing age | – | Biological: 13-valent pneumococcal conjugate vaccineHealthy non-pregnant women between 18 and 45 years old living in Goroka, Papua New Guinea, will receive one dose of 13-valent pneumococcal conjugate vaccine (PCV). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 50 healthy non-pregnant women aged between 18-45 years old living in Goroka, Papua New Guinea.
Key inclusion criteria (3 listed)
- Healthy
- Non-pregnant
- 18-45 years old
Key exclusion criteria (6 listed)
- Known hypersensitivity to any vaccine component
- Known/suspected to be immunocompromised
- Receipt of corticosteroids ≤30 days before
- Pregnant (pregnancy tests will be performed)
- Not being well at the time of 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 |
|---|---|---|
| 13-valent pneumococcal conjugate vaccineAlso: PCV13, 13-valent PCV, Prevnar13, Prevenar13 | Biological | Women of childbearing age |
Primary outcome
Immunogenicity
Time frame: 28 days
Mean Fold Increase (MFI; and 95% CI) in vaccine-serotype specific IgG concentrations at 28 days after compared to baseline (before vaccination)
2 secondary outcomes
Reactogenicity
Time frame: 24-48 hours after vaccination
Adverse events
Time frame: 28 days
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 17 Dec 2019.
- Derived from this study: PubMed 33292822Javati S, Masiria G, Elizah A, Matlam JP, Ford R, Richmond PC, Lehmann D, Pomat WS, van den Biggelaar AHJ. An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of childbearing age in Papua New Guinea. Pneumonia (Nathan). 2020 Nov 25;12(1):13. doi: 10.1186/s41479-020-00076-1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Infections, run by Telethon Kids Institute at 1 site in Papua New Guinea.
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 6 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 17 Dec 2019. 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 Papua New Guinea. 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.
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 (time frame: 28 days). 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 NCT04183322, 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 17 Dec 2019.