NCT00219401

Brief Summary

The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the Telethon Institute for Child Health Research and the Department of Paediatrics, University of Western Australia will collaborate to examine very closely the safety of neonatal vaccination, particularly with regard to impact on the development of immunity and response to other vaccines given to infants. This study will also provide a unique opportunity for training of PNG and Australian scientists in both countries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
318

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 12, 2011

Status Verified

July 1, 2011

Enrollment Period

4 years

First QC Date

September 15, 2005

Last Update Submit

July 10, 2011

Conditions

PneumoniaMeningitisOtitis Media

Keywords

Pneumococcal vaccineAntibody responsesCellular immunologyTh1/Th2 immune responsesPaediatricNeonatalInfectious diseasesPapua New Guinea

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity and Safety

    Serum PCV serotype-specific IgG antibody at 2, 4 and 9 mths. Mucosal PCV serotype-specific IgG antibody at 1, 3, 4 and 9 mths. PCV-induced T-cell memory (against vaccine protein carrier) at 3 and 9 mths. Local and systemic reactogenicity 48-96 hrs after vaccination. Monitoring of serious adverse events during 18 mth follow-up. T-cell development to bystander antigens at 3 and 9 mths.

    5 yrs

Secondary Outcomes (2)

  • Immunogenicity

    5 years

  • Pneumococcal-specific acquired immunity

    5 years

Study Arms (3)

Neonatal 7vPCV

EXPERIMENTAL

Receive study vaccine (Prevnar) at birth, 1 and 2 months

Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Infant 7vPCV

EXPERIMENTAL

Receive the study vaccine (Prevnar) at 1, 2 and 3 months

Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Control

PLACEBO COMPARATOR

Do not receive study vaccine (Prevnar)

Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Interventions

Pneumococcal 7 valent conjugate vaccine (Prevenar®)BIOLOGICAL

Accelerated PCV vaccinaton.

ControlInfant 7vPCVNeonatal 7vPCV

Eligibility Criteria

Age1 Minute - 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • New born babies with birth weight \>2000 g (2 kgs) and parents giving consent

You may not qualify if:

  • Acute neonatal infection;
  • Severe congenital abnormality;
  • Children of mothers known to be HIV positive will be excluded;
  • Serious asphyxia at birth;
  • Intended migration in the next 2 years;
  • Parents withdraw consent;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papua New Guinea Institute of Medical Research

Goroka, EHP, 441, Papua New Guinea

Location

Related Publications (7)

  • van den Biggelaar AH, Richmond PC, Pomat WS, Phuanukoonnon S, Nadal-Sims MA, Devitt CJ, Siba PM, Lehmann D, Holt PG. Neonatal pneumococcal conjugate vaccine immunization primes T cells for preferential Th2 cytokine expression: a randomized controlled trial in Papua New Guinea. Vaccine. 2009 Feb 25;27(9):1340-7. doi: 10.1016/j.vaccine.2008.12.046. Epub 2009 Jan 14.

    PMID: 19150378RESULT

  • van den Biggelaar AH, Pomat W, Bosco A, Phuanukoonnon S, Devitt CJ, Nadal-Sims MA, Siba PM, Richmond PC, Lehmann D, Holt PG. Pneumococcal conjugate vaccination at birth in a high-risk setting: no evidence for neonatal T-cell tolerance. Vaccine. 2011 Jul 26;29(33):5414-20. doi: 10.1016/j.vaccine.2011.05.065. Epub 2011 Jun 7.

    PMID: 21645573RESULT

  • Francis JP, Richmond PC, Pomat WS, Michael A, Keno H, Phuanukoonnon S, Nelson JB, Whinnen M, Heinrich T, Smith WA, Prescott SL, Holt PG, Siba PM, Lehmann D, van den Biggelaar AH. Maternal antibodies to pneumolysin but not to pneumococcal surface protein A delay early pneumococcal carriage in high-risk Papua New Guinean infants. Clin Vaccine Immunol. 2009 Nov;16(11):1633-8. doi: 10.1128/CVI.00247-09. Epub 2009 Sep 23.

    PMID: 19776196RESULT

  • van den Biggelaar AHJ, Richmond PC, Fuery A, Anderson D, Opa C, Saleu G, Lai M, Francis JP, Alpers MP, Pomat WS, Lehmann D. Pneumococcal responses are similar in Papua New Guinean children aged 3-5 years vaccinated in infancy with pneumococcal polysaccharide vaccine with or without prior pneumococcal conjugate vaccine, or without pneumococcal vaccination. PLoS One. 2017 Oct 13;12(10):e0185877. doi: 10.1371/journal.pone.0185877. eCollection 2017.

    PMID: 29028802DERIVED

  • Francis JP, Richmond PC, Michael A, Siba PM, Jacoby P, Hales BJ, Thomas WR, Lehmann D, Pomat WS, van den Biggelaar AHJ. A longitudinal study of natural antibody development to pneumococcal surface protein A families 1 and 2 in Papua New Guinean Highland children: a cohort study. Pneumonia (Nathan). 2016 Aug 15;8:12. doi: 10.1186/s41479-016-0014-x. eCollection 2016.

    PMID: 28702291DERIVED

  • Aho C, Michael A, Yoannes M, Greenhill A, Jacoby P, Reeder J, Pomat W, Saleu G, Namuigi P, Phuanukoonnon S, Smith-Vaughan H, Leach AJ, Richmond P, Lehmann D; Neonatal Pneumococcal Conjugate Vaccine Trial Study Team. Limited impact of neonatal or early infant schedules of 7-valent pneumococcal conjugate vaccination on nasopharyngeal carriage of Streptococcus pneumoniae in Papua New Guinean children: A randomized controlled trial. Vaccine Rep. 2016 Dec;6:36-43. doi: 10.1016/j.vacrep.2016.08.002.

    PMID: 28580433DERIVED

  • Pomat WS, van den Biggelaar AH, Phuanukoonnon S, Francis J, Jacoby P, Siba PM, Alpers MP, Reeder JC, Holt PG, Richmond PC, Lehmann D; Neonatal Pneumococcal Conjugate Vaccine Trial Study Team. Safety and immunogenicity of neonatal pneumococcal conjugate vaccination in Papua New Guinean children: a randomised controlled trial. PLoS One. 2013;8(2):e56698. doi: 10.1371/journal.pone.0056698. Epub 2013 Feb 22.

    PMID: 23451070DERIVED

MeSH Terms

Conditions

PneumoniaMeningitisOtitis MediaCommunicable Diseases

Interventions

Pneumococcal VaccinesHeptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesNeuroinflammatory DiseasesNervous System DiseasesOtitisEar DiseasesOtorhinolaryngologic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Peter Siba, PhD

    Papua New Guinea Institute of Medical Research

    PRINCIPAL INVESTIGATOR

  • Deborah Lehmann, MBBS, Msc

    Telethon Institute for Child Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

May 1, 2005

Primary Completion

May 1, 2009

Study Completion

May 1, 2010

Last Updated

July 12, 2011

Record last verified: 2011-07

Locations

PA(1)