Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pneumonia Meningitis Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Neonatal 7vPCV

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

Group Type EXPERIMENTAL

Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Intervention Type BIOLOGICAL

Accelerated PCV vaccinaton.

Infant 7vPCV

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

Group Type EXPERIMENTAL

Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Intervention Type BIOLOGICAL

Accelerated PCV vaccinaton.

Control

Do not receive study vaccine (Prevnar)

Group Type PLACEBO_COMPARATOR

Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Intervention Type BIOLOGICAL

Accelerated PCV vaccinaton.

Interventions

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Pneumococcal 7 valent conjugate vaccine (Prevenar®)

Accelerated PCV vaccinaton.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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;

Minimum Eligible Age

1 Minute

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes