Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310349
Status:
UNKNOWN
Last Update Posted:
2007-12-13
First Post:
2006-03-31
Brief Title:
PneuMum Pneumococcal Vaccination of Australian Indigenous Mothers to See if it Protects Their Babies From Ear Disease
Sponsor:
University of Melbourne
Organization:
University of Melbourne
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2006-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 Two vaccines will be used in this trial
The 23 valent pneumococcal polysaccharide vaccine 23vPPV is currently recommended for all Indigenous people in the Northern Territory from 15 years of age but uptake among women of child-bearing age has been low
Adult diphtheria tetanus and acellular pertussis vaccine dTPa will be used as the control vaccine This vaccine is recommended for all new parents who have not previously been immunised but is not currently funded so would normally need to be purchased on prescription through a pharmacist
Rationale
Indigenous children experience the highest rates of acute and chronic ear infections in the world resulting in permanent ear damage hearing loss and educational disadvantage These infections are mainly bacterial Streptococcus pneumoniae pneumococcus is the predominant pathogen Pneumococcal colonisation and infection begins within days of birth months before any potential immunological protection from infant pneumococcal conjugate vaccine may be expected New strategies are needed to eliminate or at least delay this early-onset pneumococcal colonisation
Maternal vaccination with the 23 valent pneumococcal polysaccharide vaccine 23vPPV during pregnancy or at delivery is one strategy that may protect newborn infants through mechanisms such as transplacental antibody transfer increased secretory antibody in breast milk andor by reducing nasopharyngeal carriage and transmission to the infant of maternal pneumococci Previous small studies using this strategy have been encouraging but there have been no studies properly evaluating nasopharyngeal carriage or disease endpoints in infants
Methods
We hope to recruit 210 Indigenous women aged 18-39 years who have an uncomplicated pregnancy Following recruitment subjects will be randomly assigned to one of three groups
Group A will receive 23vPPV in the last few months of pregnancy
Group B will receive 23vPPV soon after childbirth
Group C will receive 23vPPV seven months after childbirth the control group
Women in Groups A and C will receive dTPa soon after childbirth to conceal the intervention groups whereas women in Group C will be offered dTpa seven months after childbirth end of the observation period
Study participants will be visited at least five times
1 During the last few months of pregnancy 30-36 weeks gestation
The group of mothers receiving 23vPPV at this visit will also have a sample taken of their blood
2 At Royal Darwin Hospital when the baby is born
Each mother will receive either 23vPPV or dTpa depending on their allocation
Each mother will have a sample taken of their blood the cord blood a nasopharyngeal swab and a sample of expressed breast milk
3 When the baby is one month old
Each baby will have their ears checked and a nasopharyngeal swab taken A swab will also be taken of any discharge from the babys ears Mothers will be asked for sample of expressed breast milk
4 When the baby is two months old
The same checks and samples as the previous month
5 When the baby is seven months old
Each mother and baby will have the same checks and samples as the previous months Babies will also have a sample taken of their blood Mothers who have not yet had 23vPPV will be offered that vaccine as will those who have not yet had dTpa
Primary Outcome
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 Group C 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
The 23 valent pneumococcal polysaccharide vaccine 23vPPV is currently recommended for all Indigenous people in the Northern Territory from 15 years of age but uptake among women of child-bearing age has been low
Adult diphtheria tetanus and acellular pertussis vaccine dTPa will be used as the control vaccine This vaccine is recommended for all new parents who have not previously been immunised but is not currently funded so would normally need to be purchased on prescription through a pharmacist
Rationale
Indigenous children experience the highest rates of acute and chronic ear infections in the world resulting in permanent ear damage hearing loss and educational disadvantage These infections are mainly bacterial Streptococcus pneumoniae pneumococcus is the predominant pathogen Pneumococcal colonisation and infection begins within days of birth months before any potential immunological protection from infant pneumococcal conjugate vaccine may be expected New strategies are needed to eliminate or at least delay this early-onset pneumococcal colonisation
Maternal vaccination with the 23 valent pneumococcal polysaccharide vaccine 23vPPV during pregnancy or at delivery is one strategy that may protect newborn infants through mechanisms such as transplacental antibody transfer increased secretory antibody in breast milk andor by reducing nasopharyngeal carriage and transmission to the infant of maternal pneumococci Previous small studies using this strategy have been encouraging but there have been no studies properly evaluating nasopharyngeal carriage or disease endpoints in infants
Methods
We hope to recruit 210 Indigenous women aged 18-39 years who have an uncomplicated pregnancy Following recruitment subjects will be randomly assigned to one of three groups
Group A will receive 23vPPV in the last few months of pregnancy
Group B will receive 23vPPV soon after childbirth
Group C will receive 23vPPV seven months after childbirth the control group
Women in Groups A and C will receive dTPa soon after childbirth to conceal the intervention groups whereas women in Group C will be offered dTpa seven months after childbirth end of the observation period
Study participants will be visited at least five times
1 During the last few months of pregnancy 30-36 weeks gestation
The group of mothers receiving 23vPPV at this visit will also have a sample taken of their blood
2 At Royal Darwin Hospital when the baby is born
Each mother will receive either 23vPPV or dTpa depending on their allocation
Each mother will have a sample taken of their blood the cord blood a nasopharyngeal swab and a sample of expressed breast milk
3 When the baby is one month old
Each baby will have their ears checked and a nasopharyngeal swab taken A swab will also be taken of any discharge from the babys ears Mothers will be asked for sample of expressed breast milk
4 When the baby is two months old
The same checks and samples as the previous month
5 When the baby is seven months old
Each mother and baby will have the same checks and samples as the previous months Babies will also have a sample taken of their blood Mothers who have not yet had 23vPPV will be offered that vaccine as will those who have not yet had dTpa
Primary Outcome
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 Group C 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None