We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219401
First Posted: September 22, 2005
Last Update Posted: July 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The University of Western Australia
Information provided by:
Papua New Guinea Institute of Medical Research
  Purpose
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.

Condition Intervention Phase
Pneumonia Meningitis Otitis Media Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

Resource links provided by NLM:


Further study details as provided by Papua New Guinea Institute of Medical Research:

Primary Outcome Measures:
  • Immunogenicity and Safety [ Time Frame: 5 yrs ]
    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.


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 5 years ]
    Serum PCV and non-PCV serotype specific IgG antibody at 10 mths, after 23vPPV vaccination at 9 mths

  • Pneumococcal-specific acquired immunity [ Time Frame: 5 years ]
    Assessment of cellular immune responses to pneumococcal protein antigens at 9 and 18 months of age.


Enrollment: 318
Study Start Date: May 2005
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neonatal 7vPCV
Receive study vaccine (Prevnar) at birth, 1 and 2 months
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.
Experimental: Infant 7vPCV
Receive the study vaccine (Prevnar) at 1, 2 and 3 months
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.
Placebo Comparator: Control
Do not receive study vaccine (Prevnar)
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.

Detailed Description:
In order to obtain the earliest possible protection against invasive pneumococcal disease, achieve optimal coverage and reduce burden of early carriage, neonatal pneumococcal conjugate vaccine (PCV) immunization needs to be considered. This study in the PNG highlands will enrol 312 infants at birth, who will be randomised to receive PCV either at 1-2-3 months (infant schedule according to PNG national EPI schedule) or 0-1-2 months of age (neonatal schedule) or receive only routine immunizations (controls). Blood samples will be taken at birth-2-3-4 months of age, pre- and post-pneumococcal polysaccharide booster (23vPPV) at 9-10 months of age (to assess immune memory) and at 18 months at study completion. Carriage will be assessed weekly for the first month of life and at regular intervals thereafter. There will be ongoing surveillance for respiratory and other diseases throughout the study. In addition to serotype-specific IgG, we will examine IgG avidity, IgG subclasses, mucosal IgA and T-cell cytokine responses to PCV and pneumococcal protein antigens. To ensure immunological safety, particularly for neonatal PCV, immune responses to concomitant vaccines and viral and environmental antigens will also be examined as well as overall T-cell maturation.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Acute neonatal infection;
  2. Severe congenital abnormality;
  3. Children of mothers known to be HIV positive will be excluded;
  4. Serious asphyxia at birth;
  5. Intended migration in the next 2 years;
  6. Parents withdraw consent;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219401


Locations
Papua New Guinea
Papua New Guinea Institute of Medical Research
Goroka, EHP, Papua New Guinea, 441
Sponsors and Collaborators
Papua New Guinea Institute of Medical Research
The University of Western Australia
Investigators
Principal Investigator: Peter Siba, PhD Papua New Guinea Institute of Medical Research
Principal Investigator: Deborah Lehmann, MBBS, Msc Telethon Institute for Child Health Research
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A/Prof. Deborah Lehmann, University of Western Australia
ClinicalTrials.gov Identifier: NCT00219401     History of Changes
Other Study ID Numbers: 071613/Z/03/Z
303123 NHMRC Australia
First Submitted: September 15, 2005
First Posted: September 22, 2005
Last Update Posted: July 12, 2011
Last Verified: July 2011

Keywords provided by Papua New Guinea Institute of Medical Research:
Pneumococcal vaccine
Antibody responses
Cellular immunology
Th1/Th2 immune responses
Paediatric
Neonatal
Infectious diseases
Papua New Guinea

Additional relevant MeSH terms:
Pneumonia
Meningitis
Otitis Media
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Central Nervous System Diseases
Nervous System Diseases
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs


To Top