PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers to See if it Protects Their Babies From Ear Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by University of Melbourne.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Menzies School of Health Research
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00310349
First received: March 31, 2006
Last updated: December 12, 2007
Last verified: March 2006
  Purpose

PneuMum is a randomised controlled trial that aims to find out if pneumococcal vaccination for Australian Indigenous mothers, in the last few months of pregnancy or at delivery, can prevent ear disease in infants. Mothers will receive the 23 valent pneumococcal polysaccharide vaccine (23vPPV) either: a) during the third trimester of pregnancy; b) soon after child birth; or c) seven months after child birth (control group). The adult diphtheria, tetanus and acellular pertussis vaccine (dTPa) will be used as the control vaccine for the birth dose.

The study aims to recruit 210 Indigenous women aged 18-39 years who have an uncomplicated pregnancy. Following recruitment, subjects will be randomly assigned to one of the three groups.

Each mother and infant will be followed from pregnancy until the baby is seven months of age. Children will receive all of their routinely recommended vaccinations in accordance with the standard vaccination schedule.

The primary outcome will be prevalence of ear infection at seven months of age, defined as middle ear effusion or tympanic membrane perforation or acute otitis media. Pneumatic otoscopy, video-otoscopy and tympanometry will be used in the ear examinations. The primary analyses will be a direct comparison of the proportion of infants in the control group who have nasopharyngeal carriage of vaccine type pneumococci at seven months of age compared to infants in each of the other two groups and a similar comparison of the proportion with middle ear disease.


Condition Intervention Phase
Middle Ear Effusion
Tympanic Membrane Perforation
Acute Otitis Media
Pneumococcal Infections
Biological: 23 valent pneumococcal polysaccharide vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: PneuMum: A Randomised Controlled Trial of Pneumococcal Polysaccharide Vaccination for Aboriginal and Torres Strait Islander Mothers to Protect Their Babies From Ear Disease

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Prevalence of ear infection at seven months of age, defined as middle ear effusion or tympanic membrane perforation or acute otitis media
  • Nasopharyngeal carriage of vaccine type pneumococci [ Time Frame: at seven months of age ]

Secondary Outcome Measures:
  • Prevalence of ear infection [ Time Frame: at one month of age ]
  • Nasopharyngeal carriage of vaccine type pneumococci [ Time Frame: at one month of age ]
  • Prevalence of ear infection [ Time Frame: at two months of age ]
  • Nasopharyngeal carriage of vaccine type pneumococci [ Time Frame: at two months of age ]
  • Relationship of maternal pneumococcal carriage, maternal anti-pneumococcal antibody levels, cord blood antibody levels and breast milk antibody levels to infant carriage and middle ear disease [ Time Frame: at one, two and seven months of age ]
  • Impact of each maternal vaccination strategy on breast milk antibody levels to serotypes contained in the vaccine
  • Impact of each maternal vaccination strategy on breast milk antibody avidity (to four selected serotypes)
  • Impact of each maternal vaccination strategy on maternal antibody response to antepartum or postpartum 23vPPV
  • Impact of each maternal vaccination strategy on infant anti-pneumococcal antibody levels [ Time Frame: at seven months of age (following the 3rd recommended dose of 7vPCV) ]

Estimated Enrollment: 210
Study Start Date: March 2006
Estimated Study Completion Date: January 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton uncomplicated pregnancy
  • Reside in Darwin, Maningrida, Wadeye or the Tiwi Islands
  • Intends to deliver child at the Royal Darwin Hospital
  • Has given informed consent to participate

Exclusion Criteria:

  • Had 23vPPV within the previous three years
  • Had a previous dose of dTpa
  • intends to leave the study area during the follow-up period
  • HIV positive
  • History of severe allergy, uncontrolled asthma or splenectomy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310349

Contacts
Contact: Ross M Andrews, PhD 613 9345 4647 ross.andrews@mcri.edu.au
Contact: Amanda J Leach, PhD 618 8922 8698 amanda.leach@menzies.edu.au

Locations
Australia, Northern Territory
Menzies School of Health Research Not yet recruiting
Darwin, Northern Territory, Australia, 0811
Contact: Amanda J Leach, PhD    618 8922 8698    amanda.leach@menzies.edu.au   
Contact: Peter S Morris, PhD    618 89228371    peterm@menzies.edu.au   
Principal Investigator: Amanda J Leach, PhD         
Principal Investigator: Peter S Morris, PhD         
Sub-Investigator: Simone Raye, MBBS         
Sponsors and Collaborators
University of Melbourne
National Health and Medical Research Council, Australia
Menzies School of Health Research
Investigators
Principal Investigator: Ross M Andrews, PhD The University of Melbourne and Murdoch Childrens Research Institute
Principal Investigator: Jonathan R Carapetis, PhD The University of Melbourne and Murdoch Childrens Research Institute
Principal Investigator: Amanda J Leach, PhD Menzies School of Health Research
Principal Investigator: Peter S Morris, PhD Menzies School of Health Research
Principal Investigator: Edward K Mulholland, DM The Univeristy of Melbourne and Murdoch Childrens Research Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00310349     History of Changes
Other Study ID Numbers: 2 November 2005
Study First Received: March 31, 2006
Last Updated: December 12, 2007
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by University of Melbourne:
pneumococcal vaccine
clinical trial
Indigenous
Maternal
Streptococcus pneumoniae

Additional relevant MeSH terms:
Ear Diseases
Otitis Media
Pneumococcal Infections
Otitis Media with Effusion
Tympanic Membrane Perforation
Otitis
Otorhinolaryngologic Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Wounds and Injuries

ClinicalTrials.gov processed this record on October 16, 2014