Trial record 5 of 11 for:
Open Studies | "Pneumococcal Infections"
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
Recruitment status was Recruiting
Sponsor:
Menzies School of Health Research
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
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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:
Drug Information available for:
Boostrix
Heptavalent pneumococcal conjugate vaccine
Adacel
Pneumococcal Vaccines
U.S. FDA Resources
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:
|
Pneumococcal Infections Otitis Otitis Media Otitis Media with Effusion Tympanic Membrane Perforation Ear Diseases Otorhinolaryngologic Diseases 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 May 19, 2013