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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00714064

Registration number

NCT00714064

Ethics application status

Date submitted

10/07/2008

Date registered

14/07/2008

Date last updated

10/07/2014

Titles & IDs

Public title

PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers

Scientific title

PneuMum: A Randomised Controlled Trial of Pneumococcal Polysaccharide Vaccination for Aboriginal and Torres Strait Islander Mothers to Protect Their Babies From Ear Disease

Secondary ID [1]

NHMRC 350499

Secondary ID [2]

NHMRC 490320

Universal Trial Number (UTN)

Trial acronym

PneuMum

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Middle Ear Effusion

Tympanic Membrane Perforation

Acute Otitis Media

Pneumococcal Infections

Condition category

Condition code

Infection

Other infectious diseases

Ear

Other ear disorders

Infection

Studies of infection and infectious agents

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Other - 23vPPV, dTpa (Pneumovax, Boostrix)
Treatment: Other - 23vPPV, dTpa (Pneumovax, Boostrix)
Treatment: Other - 23vPPV, dTpa (Pneumovax, Boostrix)

Active comparator: 23vPPV in Pregnancy -

Active comparator: 23vPPV at Birth -

Other: Control - Control

Treatment: Other: 23vPPV, dTpa (Pneumovax, Boostrix)
Group A will receive 23vPPV during 3rd trimester and dTpa at delivery

Treatment: Other: 23vPPV, dTpa (Pneumovax, Boostrix)
Group B will receive 23vPPV at delivery and dTpa 7 months following delivery

Treatment: Other: 23vPPV, dTpa (Pneumovax, Boostrix)
Group C will receive dTpa at delivery and 23vPPV 7 months following delivery

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Prevalence of middle ear disease, defined as middle ear effusion or tympanic membrane perforation or acute otitis media

Timepoint [1]

at seven months of age

Primary outcome [2]

Nasopharyngeal carriage of vaccine type pneumococci

Timepoint [2]

at seven months of age

Secondary outcome [1]

Prevalence of middle ear disease

Timepoint [1]

at one month of age

Secondary outcome [2]

Nasopharyngeal carriage of vaccine type pneumococci

Timepoint [2]

at one month of age

Secondary outcome [3]

Prevalence of middle ear disease

Timepoint [3]

at two months of age

Secondary outcome [4]

Nasopharyngeal carriage of vaccine type pneumococci

Timepoint [4]

at two months of age

Secondary outcome [5]

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

Timepoint [5]

at one, two and seven months of age

Secondary outcome [6]

Impact of each maternal vaccination strategy on breast milk antibody levels to serotypes contained in the vaccine

Timepoint [6]

at seven months

Secondary outcome [7]

Impact of each maternal vaccination strategy on breast milk antibody avidity (to four selected serotypes)

Timepoint [7]

at seven months

Secondary outcome [8]

Impact of each maternal vaccination strategy on maternal antibody response to antepartum or postpartum 23vPPV

Timepoint [8]

at seven months

Secondary outcome [9]

Impact of each maternal vaccination strategy on infant anti-pneumococcal antibody levels (following the 3rd recommended dose of 7vPCV)

Timepoint [9]

at seven months of age

Eligibility

Key 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

Minimum age

17 Years

Maximum age

39 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key 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

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/06/2006

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/07/2011

Sample size

Target

Accrual to date

Final

227

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Menzies School of Health Research - Darwin

Recruitment postcode(s) [1]

0811 - Darwin

Funding & Sponsors

Primary sponsor type

Other

Name

Menzies School of Health Research

Address

Country

Other collaborator category [1]

Other

Name [1]

National Health and Medical Research Council, Australia

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

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 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.

Trial website

https://clinicaltrials.gov/study/NCT00714064

Trial related presentations / publications

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.
Binks MJ, Moberley SA, Balloch A, Leach AJ, Nelson S, Hare KM, Wilson C, Nelson J, Morris PS, Ware RS, Tang MLK, Torzillo PJ, Carapetis JR, Mulholland K, Andrews RM. Impact of the 23-valent pneumococcal polysaccharide vaccination in pregnancy against infant acute lower respiratory infections in the Northern Territory of Australia. Pneumonia (Nathan). 2018 Dec 25;10:13. doi: 10.1186/s41479-018-0057-2. eCollection 2018.
Binks MJ, Moberley SA, Balloch A, Leach AJ, Nelson S, Hare KM, Wilson C, Morris PS, Nelson J, Chatfield MD, Tang ML, Torzillo P, Carapetis JR, Mulholland EK, Andrews RM. PneuMum: Impact from a randomised controlled trial of maternal 23-valent pneumococcal polysaccharide vaccination on middle ear disease amongst Indigenous infants, Northern Territory, Australia. Vaccine. 2015 Nov 27;33(48):6579-87. doi: 10.1016/j.vaccine.2015.10.101. Epub 2015 Oct 31.

Public notes

Contacts

Principal investigator

Name

Ross M Andrews, PhD

Address

Menzies School of Health Research

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00714064

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00714064