PneumoniaPhase 3PCV1103NCT01619462
Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children
A Phase 3 study testing Prevenar 13 and Synflorix in people with Pneumonia and Meningitis, run by Papua New Guinea Institute of Medical Research at 1 site in Papua New Guinea.
Trial summary
The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New Guinean children, who experience early dense upper respiratory tract colonisation with a broad range of pneumococcal serotypes, and to… Read more about this study
- Who is it for?
- Ages 28 to 35 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Meningitis, Bacteraemia
- What is being tested?
- Prevenar 13 and Synflorix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- Nov 2011to Nov 2016
- Phase
- Phase 3
- 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 28 to 35 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Health infants between 28 - 35 days old
Who cannot join
- Infants of women not intending to remain in the are for at least two years
- Birth weigh < 2000 g (2kg)
- Severe congenital abnormalities
- Mother or child known to be HIV positive
Trial locations and contacts
1 site in 1 country.
Papua New Guinea1 site, 1 recruiting
- Recruiting
Papua New Guinea Institute of Medical Research
Goroka, Eastern Highlands Province, 441
William Pomat, PhD, +6755322800 ext. 206, william.pomat@pngimr.org.pg
Vela Solomon, MBBS, +675322800 ext. 241, vela.solomon@pngimr.org.pg
About this study
Official title: A Study of Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines to Inform Policy Regarding Pneumococcal Vaccination of Papua New Guinean Children
The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New Guinean children, who experience early dense upper respiratory tract colonisation with a broad range of pneumococcal serotypes, and to compare antibody titres following a booster dose of polysaccharide vaccine at 9 months with those children who received no booster at the same age.
Read the detailed description
The primary aim of the study is to determine whether PCV10 and PCV13 are safe and immunogenic in PNG infants for the serotypes in the respective vaccines. This study is important for the following reasons:
- There is a lack of data worldwide on immunogenicity in populations with very high early onset of dense URT carriage.
- The EPI immunisation schedule is very accelerated in PNG (ages 1,2 and 3 months).
- There are not data on functional antibody to PCVs in PNG.
- 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.
- It is important to investigate impact of vaccine on carriage density in view of our finding of limited impact of 7vPCV on URT carriage.
- 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).
- 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.
- The broad range of serotypes causing IPD in PNG necessitates continuing consideration of 23vPPV as a potential booster at age 9 months.
- 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.
- 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
- Pneumonia, Meningitis, Bacteraemia, Sepsis, Otitis Media
- Being tested
- Prevenar 13 and Synflorix
- Keywords
- pneumococcal, vaccine, papua new guinea
- Medical subject headings
- Pneumonia, Meningitis, Toxemia, Sepsis, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar 13 and SynflorixBiological
Also called Synflorix(R), PCV10, Prevenar 13(R), PCV13
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.
| Study group | Role | What they receive |
|---|---|---|
| Synflorix or PCV10 | Other | 130 children will receive Synflorix at 1-2-3 months Receives: Biological: Prevenar 13 and Synflorix |
| Prevenar 13 | Other | 130 children will receive Prevenar 13 at 1-2-3 months Receives: Biological: Prevenar 13 and Synflorix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with serotype-specific IgG concentration >= 0.35ug/ml at 4 and 9 months of age for 90% of PCV vaccine serotypes and proportion of children with OPA >=1:8 titres at 4, 10 and 24 months
IgG concentration to vaccine serotypes are >= 0.35ug/ml post-dose 3 at 4 and 9 months. Serotype-specific IgG concentration >=0.35ug/ml is protective level against invasive pneumococcal diseases. Opsonophagocytic titre of >=1:8 examined at 4, 10 and 24 months will inform on functional antibodies induced by vaccination.
Measured: 3 years
Secondary outcomes (3)
Compare antibody concentrations to pneumococcal and Haemophilus influenzae protein antigens.
Measure antibody titres to surface proteins of pneumococci and Hi including Hi protein D, the carrier protein in PCV10 (Synflorix).
Measured: 2 years
Determine carriage rates and bacterial load of pneumococci and H.influenzae
Proportion of carriage before and after vaccination will be measured using conventional culture methods. Bacterial load will be measured using PCR to determine impact of vaccines
Measured: 3 years
Determine rates of hospital admission for acute respiratory tract infections at 9 and 23 months
Admissions and morbidity for acute respiratory tract infections will be documented at 9 and 23 months.
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionApr 2014 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papua New Guinea Institute of Medical Research
- Sponsor type
- Other government
- Collaborators
- The University of Western Australia
- Responsible party
- Sponsor
- Investigators
- William S Pomat, PhD, Principal investigator, Papua New Guinea Institute of Medical ResearchDeborah Lehmann, MSc, Principal investigator, Telethon Institute for Child Health ResearchPeter Richmond, MD, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619462
- Sponsor's protocol ID
- PCV1103
- Acronym
- PCV1103
- Status last verified
- Sep 2012
- First submitted
- 28 May 2012
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37479616Martinovich 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.
PubMed 34447389Rahman 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.
PubMed 34024658Pomat 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.
PubMed 30184183Lehmann 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.
PubMed 29299402
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines to Inform Policy Regarding Pneumococcal Vaccination of Papua New Guinean Children
- ClinicalTrials.gov ID
- NCT01619462
- Acronym / sponsor ID
- PCV1103 / PCV1103
- Conditions
- Pneumonia, Meningitis, Bacteraemia, Sepsis, Otitis Media
- Keywords
- pneumococcal, vaccine, papua new guinea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Papua New Guinea Institute of Medical ResearchOther government
- Collaborators
- The University of Western Australia
- Study start
- Nov 2011
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 14 Jun 2012 (estimated)
- 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.
The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New Guinean children, who experience early dense upper respiratory tract colonisation with a broad range of pneumococcal serotypes, and to compare antibody titres following a booster dose of polysaccharide vaccine at 9 months with those children who received no booster at the same age.
Detailed description
The primary aim of the study is to determine whether PCV10 and PCV13 are safe and immunogenic in PNG infants for the serotypes in the respective vaccines. This study is important for the following reasons:
- There is a lack of data worldwide on immunogenicity in populations with very high early onset of dense URT carriage.
- The EPI immunisation schedule is very accelerated in PNG (ages 1,2 and 3 months).
- There are not data on functional antibody to PCVs in PNG.
- 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.
- It is important to investigate impact of vaccine on carriage density in view of our finding of limited impact of 7vPCV on URT carriage.
- 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).
- 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.
- The broad range of serotypes causing IPD in PNG necessitates continuing consideration of 23vPPV as a potential booster at age 9 months.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synflorix or PCV10 | Other | Biological: Prevenar 13 and Synflorix130 children will receive Synflorix at 1-2-3 months |
| Prevenar 13 | Other | Biological: Prevenar 13 and Synflorix130 children will receive Prevenar 13 at 1-2-3 months |
Who may qualify
- Ages
- 28 to 35 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Health infants between 28 - 35 days old
Key exclusion criteria (4 listed)
- Infants of women not intending to remain in the are for at least two years
- Birth weigh < 2000 g (2kg)
- Severe congenital abnormalities
- Mother or child known to be HIV positive
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 |
|---|---|---|
| Prevenar 13 and SynflorixAlso: Synflorix(R), PCV10, Prevenar 13(R), PCV13260 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. | Biological | Prevenar 13, Synflorix or PCV10 |
Primary outcome
Proportion of children with serotype-specific IgG concentration >= 0.35ug/ml at 4 and 9 months of age for 90% of PCV vaccine serotypes and proportion of children with OPA >=1:8 titres at 4, 10 and 24 months
Time frame: 3 years
IgG concentration to vaccine serotypes are >= 0.35ug/ml post-dose 3 at 4 and 9 months. Serotype-specific IgG concentration >=0.35ug/ml is protective level against invasive pneumococcal diseases. Opsonophagocytic titre of >=1:8 examined at 4, 10 and 24 months will inform on functional antibodies induced by vaccination.
3 secondary outcomes
Compare antibody concentrations to pneumococcal and Haemophilus influenzae protein antigens.
Time frame: 2 years
Determine carriage rates and bacterial load of pneumococci and H.influenzae
Time frame: 3 years
Determine rates of hospital admission for acute respiratory tract infections at 9 and 23 months
Time frame: 2 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
- Derived from this study: PubMed 37479616Orami 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.
- Derived from this study: PubMed 34447389Martinovich 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.
- Derived from this study: PubMed 34024658Rahman 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.
- Derived from this study: PubMed 30184183Pomat 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.
- Derived from this study: PubMed 29299402Lehmann 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.
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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.
William S Pomat, PhD principal investigator
Papua New Guinea Institute of Medical Research
Deborah Lehmann, MSc principal investigator
Telethon Institute for Child Health Research
Peter Richmond, MD principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prevenar 13 and Synflorix in people with Pneumonia and Meningitis, run by Papua New Guinea Institute of Medical Research 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 1 inclusion and 4 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 21 Mar 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact William Pomat, PhD (+6755322800 ext. 206, william.pomat@pngimr.org.pg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children with serotype-specific IgG concentration >= 0.35ug/ml at 4 and 9 months of age for 90% of PCV vaccine serotypes and proportion of children with OPA >=1:8 titres at 4, 10 and 24 months (time frame: 3 years). 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 NCT01619462, which also lists 5 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 21 Mar 2014.