Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

This study has been completed.
Sponsor:
Collaborator:
The University of Western Australia
Information provided by:
Papua New Guinea Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT00219401
First received: September 15, 2005
Last updated: July 10, 2011
Last verified: July 2011

September 15, 2005
July 10, 2011
May 2005
May 2009   (final data collection date for primary outcome measure)
Immunogenicity and Safety [ Time Frame: 5 yrs ] [ Designated as safety issue: Yes ]
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.
  • 2) Serum Pnc serotype-specific IgG and Diphtheria toxoid antibody at age 4 months will be compared between neonatal PCV and control groups
  • 1) Serum Pnc serotype-specific IgG antibody at age 2 months will be compared between neonatal PCV and control groups
  • 3) Serum Pnc serotype-specific IgG antibody at age 10 months following PPV booster immunisation at age 9 months of age will be compared between neonatal PCV and control groups
  • 4) Incidence of Systemic and local adverse events following neonatal immunisation will be compared between neonatal PCV and control groups
Complete list of historical versions of study NCT00219401 on ClinicalTrials.gov Archive Site
  • Immunogenicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Assessment of cellular immune responses to pneumococcal protein antigens at 9 and 18 months of age.
  • 1) Overall and serotype specific Pnc carriage at age 1, 2, 3, 4 weeks in neonatal PCV and control groups
  • 2) Hospital admissions for ALRI from 1 month of age will be compared between neonatal PCV and control groups
  • Diphtheria toxoid (DT) and tetanus toxoid (TT) antibody (% >0.1IU/mL & GMT) and hepatitis B antibody (%>10iu/Ml) at age 4 months will be compared between neonatal PCV and control groups
  • 3) T-cell cytokine responses (interferon gamma, IL-13, IL-5) to CRM197 , DT, hepatitis B surface antigen and TT at 3 months of age will be compared between neonatal PCV and control groups
  • 4) T-cell cytokine responses (interferon gamma, IL-13, IL-5) to PHA, and pneumococcal surface proteins at 3-9-18 months of age will be compared between neonatal PCV and control groups
  • 5) Salivary IgA and IgG responses to pneumococcal capsular polysaccharides and surface proteins over the first 18 months of life will be compared between neonatal PCV and control groups
Not Provided
Not Provided
 
Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea
Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pneumonia
  • Meningitis
  • Otitis Media
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.
  • Experimental: Neonatal 7vPCV
    Receive study vaccine (Prevnar) at birth, 1 and 2 months
    Intervention: Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
  • Experimental: Infant 7vPCV
    Receive the study vaccine (Prevnar) at 1, 2 and 3 months
    Intervention: Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
  • Placebo Comparator: Control
    Do not receive study vaccine (Prevnar)
    Intervention: Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
May 2010
May 2009   (final data collection date for primary outcome measure)

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;
Both
up to 3 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Papua New Guinea
 
NCT00219401
071613/Z/03/Z, 303123 NHMRC Australia
Yes
A/Prof. Deborah Lehmann, University of Western Australia
Papua New Guinea Institute of Medical Research
The University of Western Australia
Principal Investigator: Peter Siba, PhD Papua New Guinea Institute of Medical Research
Principal Investigator: Deborah Lehmann, MBBS, Msc Telethon Institute for Child Health Research
Papua New Guinea Institute of Medical Research
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP