PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Menzies School of Health Research.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
Menzies School of Health Research
ClinicalTrials.gov Identifier:
NCT00714064
First received: July 10, 2008
Last updated: October 22, 2009
Last verified: October 2009
  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 17-39 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. All routinely recommended vaccinations on the standard vaccination schedule will continue to be offered by the subject's vaccine provider in accordance with current clinical practice.

The primary outcome will be prevalence of middle ear disease 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 one or more vaccine type pneumococci at seven months of age compared to infants in each of the other two groups. A similar comparison of the proportion with middle ear disease will be undertaken between the control group and the respective intervention group.


Condition Intervention Phase
Middle Ear Effusion
Tympanic Membrane Perforation
Acute Otitis Media
Pneumococcal Infections
Biological: 23vPPV, dTpa (Pneumovax, Boostrix)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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 Menzies School of Health Research:

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

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

Estimated Enrollment: 210
Study Start Date: June 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Biological: 23vPPV, dTpa (Pneumovax, Boostrix)
Group A will receive 23vPPV during 3rd trimester and dTpa at delivery
Other Name: Pneumovax, Boostrix
Active Comparator: B Biological: 23vPPV, dTpa (Pneumovax, Boostrix)
Group B will receive 23vPPV at delivery and dTpa 7 months following delivery
Other Name: Pneumovax, Boostrix
C
Control
Biological: 23vPPV, dTpa (Pneumovax, Boostrix)
Group C will receive dTpa at delivery and 23vPPV 7 months following delivery
Other Name: Pneumovax, Boostrix

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton uncomplicated pregnancy
  • Reside in Darwin, the Tiwi Islands, or other remote community where consent has been obtained
  • Intends to deliver child at the Royal Darwin Hospital or other designated hospital where consent has been obtained
  • 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: NCT00714064

Contacts
Contact: Ross M Andrews, PhD 61 8 8922 7668 ross.andrews@menzies.edu.au
Contact: Amanda J Leach, PhD 61 8 8922 8698 amanda.leach@menzies.edu.au

Locations
Australia, Northern Territory
Menzies School of Health Research Recruiting
Darwin, Northern Territory, Australia, 0811
Principal Investigator: Ross M Andrews, PhD         
Sponsors and Collaborators
Menzies School of Health Research
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Ross M Andrews, PhD Menzies School of Health Research
Principal Investigator: Jonathan R Carapetis, PhD Menzies School of Health Research
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
Principal Investigator: Paul J Torzillo, MBBS Royal Prince Alfred Hospital, Sydney
Principal Investigator: Mimi LK Tang, PhD Royal Children's Hospital, Melbourne
  More Information

Additional Information:
No publications provided

Responsible Party: Assoc Prof Ross Andrews, Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT00714064     History of Changes
Other Study ID Numbers: NHMRC 490320, NHMRC 350499
Study First Received: July 10, 2008
Last Updated: October 22, 2009
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Ear Diseases
Otorhinolaryngologic Diseases
Otitis
Otitis Media
Otitis Media with Effusion
Pneumococcal Infections
Tympanic Membrane Perforation
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Wounds and Injuries
Pentetic Acid
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents

ClinicalTrials.gov processed this record on April 22, 2014