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

Sponsors and Collaborators:	University of Melbourne National Health and Medical Research Council, Australia Menzies School of Health Research
Information provided by:	University of Melbourne
ClinicalTrials.gov Identifier:	NCT00310349

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 III

MedlinePlus related topics: Ear Disorders Ear Infections

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
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

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

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
Darwin, Northern Territory, Australia, 0811

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

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

Keywords provided by University of Melbourne:

pneumococcal vaccine
clinical trial
Indigenous
Maternal
Streptococcus pneumoniae

Study placed in the following topic categories:

Bacterial Infections
Otorhinolaryngologic Diseases
Otitis Media with Effusion
Otitis Media
Wounds and Injuries
Disorders of Environmental Origin
Tympanic Membrane Perforation

Pneumococcal Infections
Ear Diseases
Gram-Positive Bacterial Infections
Streptococcal Infections
Otitis
Pneumonia

Additional relevant MeSH terms:

Bacterial Infections
Otorhinolaryngologic Diseases
Otitis Media with Effusion
Otitis Media
Wounds and Injuries
Disorders of Environmental Origin
Infection

Tympanic Membrane Perforation
Ear Diseases
Pneumococcal Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Otitis

ClinicalTrials.gov processed this record on May 07, 2009