- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01619462
Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children (PCV1103)
March 20, 2014 updated by: Papua New Guinea Institute of Medical Research
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: William Pomat, PhD
- Phone Number: 206 +6755322800
- Email: william.pomat@pngimr.org.pg
Study Locations
-
-
Eastern Highlands Province
-
Goroka, Eastern Highlands Province, Papua New Guinea, 441
- Recruiting
- Papua New Guinea Institute of Medical Research
-
Contact:
- William Pomat, PhD
- Phone Number: 206 +6755322800
- Email: william.pomat@pngimr.org.pg
-
Contact:
- Vela Solomon, MBBS
- Phone Number: 241 +675322800
- Email: vela.solomon@pngimr.org.pg
-
Principal Investigator:
- William S Pomat, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Health infants between 28 - 35 days old
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Synflorix or PCV10
130 children will receive Synflorix at 1-2-3 months
|
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 Names:
|
Other: Prevenar 13
130 children will receive Prevenar 13 at 1-2-3 months
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare antibody concentrations to pneumococcal and Haemophilus influenzae protein antigens.
Time Frame: 2 years
|
Measure antibody titres to surface proteins of pneumococci and Hi including Hi protein D, the carrier protein in PCV10 (Synflorix).
|
2 years
|
Determine carriage rates and bacterial load of pneumococci and H.influenzae
Time Frame: 3 years
|
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
|
3 years
|
Determine rates of hospital admission for acute respiratory tract infections at 9 and 23 months
Time Frame: 2 yrs
|
Admissions and morbidity for acute respiratory tract infections will be documented at 9 and 23 months.
|
2 yrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Deborah Lehmann, MSc, Telethon Institute for Child Health Research
- Principal Investigator: William S Pomat, PhD, Papua New Guinea Institute of Medical Research
- Principal Investigator: Peter Richmond, MD, The University of Western Australia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Anticipated)
April 1, 2014
Study Completion (Anticipated)
November 1, 2016
Study Registration Dates
First Submitted
May 28, 2012
First Submitted That Met QC Criteria
June 12, 2012
First Posted (Estimate)
June 14, 2012
Study Record Updates
Last Update Posted (Estimate)
March 21, 2014
Last Update Submitted That Met QC Criteria
March 20, 2014
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Otorhinolaryngologic Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Sepsis
- Ear Diseases
- Otitis
- Bacteremia
- Meningitis
- Otitis Media
- Physiological Effects of Drugs
- Immunologic Factors
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- PCV1103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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