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

NCT00310349 | Unknown Phase 3

• 1 other identifier: 2 November 2005
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Middle Ear Effusion; Tympanic Membrane Perforation; Acute Otitis Media; Pneumococcal Infections

Keywords

pneumococcal vaccine; clinical trial; Indigenous; Maternal; Streptococcus pneumoniae

Outcome Measures

Primary Outcomes (2)

• 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

  at seven months of age

Secondary Outcomes (9)

• Prevalence of ear infection

  at one month of age

• Nasopharyngeal carriage of vaccine type pneumococci

  at one month of age

• Prevalence of ear infection

  at two months of age

• Nasopharyngeal carriage of vaccine type pneumococci

  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

  at one, two and seven months of age

Interventions

23 valent pneumococcal polysaccharide vaccine BIOLOGICAL

Eligibility Criteria

• Age: 16 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Melbourne: lead
• National Health and Medical Research Council, Australia: collaborator
• Menzies School of Health Research: collaborator

Study Sites (1)

Menzies School of Health Research

Darwin, Northern Territory, 0811, Australia

Location

Related Publications (1)

• Martinovich KM, Seppanen EJ, Bleakley AS, Clark SL, Andrews RM, Richmond PC, Binks MJ, Thornton RB, Kirkham LS. Evidence of maternal transfer of antigen-specific antibodies in serum and breast milk to infants at high-risk of S. pneumoniae and H. influenzae disease. Front Immunol. 2022 Sep 21;13:1005344. doi: 10.3389/fimmu.2022.1005344. eCollection 2022.

  PMID: 36211411 DERIVED

MeSH Terms

Conditions

Otitis Media with Effusion; Tympanic Membrane Perforation; Otitis Media; Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ross M Andrews, PhD

CONTACT

613 9345 4647; ross.andrews@mcri.edu.au

Amanda J Leach, PhD

CONTACT

618 8922 8698; amanda.leach@menzies.edu.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2006
• First Posted: April 3, 2006
• Study Start: March 1, 2006
• Study Completion: January 1, 2009
• Last Updated: December 13, 2007

Record last verified: 2006-03

Locations

AU (1)