NCT01619462

Brief 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 compare antibody titres following a booster dose of polysaccharide vaccine at 9 months with those children who received no booster at the same age.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 21, 2014

Status Verified

September 1, 2012

Enrollment Period

2.4 years

First QC Date

May 28, 2012

Last Update Submit

March 20, 2014

Conditions

PneumoniaMeningitisBacteraemiaSepsisOtitis Media

Keywords

pneumococcalvaccinepapua new guinea

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (3)

  • Compare antibody concentrations to pneumococcal and Haemophilus influenzae protein antigens.

    2 years

  • Determine carriage rates and bacterial load of pneumococci and H.influenzae

    3 years

  • Determine rates of hospital admission for acute respiratory tract infections at 9 and 23 months

    2 yrs

Study Arms (2)

Synflorix or PCV10

OTHER

130 children will receive Synflorix at 1-2-3 months

Biological: Prevenar 13 and Synflorix

Prevenar 13

OTHER

130 children will receive Prevenar 13 at 1-2-3 months

Biological: Prevenar 13 and Synflorix

Interventions

Prevenar 13 and SynflorixBIOLOGICAL

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.

Also known as: Synflorix(R), PCV10, Prevenar 13(R), PCV13
Prevenar 13Synflorix or PCV10

Eligibility Criteria

Age28 Days - 35 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Health infants between 28 - 35 days old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papua New Guinea Institute of Medical Research

Goroka, Eastern Highlands Province, 441, Papua New Guinea

RECRUITING

Related Publications (5)

  • 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.

    PMID: 37479616DERIVED

  • 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.

    PMID: 34447389DERIVED

  • 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.

    PMID: 34024658DERIVED

  • 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.

    PMID: 30184183DERIVED

  • 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.

    PMID: 29299402DERIVED

MeSH Terms

Conditions

PneumoniaMeningitisToxemiaSepsisOtitis Media

Interventions

13-valent pneumococcal vaccinePHiD-CV vaccine10-valent pneumococcal conjugate vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesNeuroinflammatory DiseasesNervous System DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsOtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • William S Pomat, PhD

    Papua New Guinea Institute of Medical Research

    PRINCIPAL INVESTIGATOR

  • Deborah Lehmann, MSc

    Telethon Institute for Child Health Research

    PRINCIPAL INVESTIGATOR

  • Peter Richmond, MD

    The University of Western Australia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William Pomat, PhD

CONTACT

+6755322800william.pomat@pngimr.org.pg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2012

First Posted

June 14, 2012

Study Start

November 1, 2011

Primary Completion

April 1, 2014

Study Completion

November 1, 2016

Last Updated

March 21, 2014

Record last verified: 2012-09

Locations

PA(1)